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protocolSection identificationModule nctId: NCT06282133, orgStudyIdInfo id: 2024-1862, briefTitle: Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study, acronym: EC-II-Ado-P, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universite du Quebec en Outaouais, class: OTHER, descriptionModule briefSummary: Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety.Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments., conditionsModule conditions: Generalized Anxiety Disorder, conditions: Adolescent - Emotional Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural Experiments for Intolerance of Uncertainty, outcomesModule primaryOutcomes measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5), secondaryOutcomes measure: Worry and Anxiety Questionnaire (WAQ), secondaryOutcomes measure: Penn State Worry Questionnaire (PSWQ), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Beck Depression Inventory-II (BDI-II), otherOutcomes measure: Intolerance of Uncertainty Scale (IUS), otherOutcomes measure: Safety Behaviors Questionnaire (SBQ), otherOutcomes measure: Treatment Acceptance and Adherence Scale (TAAS), otherOutcomes measure: Working Alliance Inventory (WAI), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universite du Quebec en Outaouais, status: RECRUITING, city: Gatineau, state: Quebec, zip: J8X 3X7, country: Canada, contacts name: Sylvain C Lemay, B.A., role: CONTACT, phone: +1 819-595-3900, phoneExt: 2501, email: [email protected], geoPoint lat: 45.47723, lon: -75.70164, hasResults: False |
protocolSection identificationModule nctId: NCT06282120, orgStudyIdInfo id: CSPC-DNY-BTC, briefTitle: Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-05, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, collaborators name: CSPC Ouyi Pharmaceutical Co., Ltd., descriptionModule briefSummary: The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer., conditionsModule conditions: Metastatic Biliary Tract Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy, outcomesModule primaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1, secondaryOutcomes measure: EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Cancer Hospital Airport Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Huikai Li, Doctor, role: CONTACT, phone: 18622228639, email: [email protected], contacts name: Xihao Zhang, Master, role: CONTACT, phone: 15510801035, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06282107, orgStudyIdInfo id: BiSAAE-RHT, briefTitle: Effectiveness and Safety of BiSAAE for Resistant Hypertension., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chengdu Medical College, class: OTHER, descriptionModule briefSummary: Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH., conditionsModule conditions: Resistant Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: BiSAAE, interventions name: traditional triple antihypertensive treatment, outcomesModule primaryOutcomes measure: Change of 24-h average systolic blood pressure, primaryOutcomes measure: Change of 24-h average systolic blood pressure, primaryOutcomes measure: Change of 24-h average systolic blood pressure, secondaryOutcomes measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure, secondaryOutcomes measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure, secondaryOutcomes measure: Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Change of home systolic and diastolic pressure, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of office systolic and diastolic pressure between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma aldosterone, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma cortisol, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of plasma renin measured, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of liver enzymes, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of kidney function, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of fasting blood glucose, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of lipids profiles, secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD), secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine microalbumin, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of 24-h urine creatinine, secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of echocardiography parameters (LVEF), secondaryOutcomes measure: Change of carotid intima-media thickness, secondaryOutcomes measure: Change of carotid intima-media thickness, secondaryOutcomes measure: Change of carotid intima-media thickness, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282094, orgStudyIdInfo id: LUX, briefTitle: ViSiGi LUX Bariatric Sizing and Calibration System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Boehringer Labs LLC, class: INDUSTRY, descriptionModule briefSummary: This study investigates the new ViSiGi LUX., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Physician Feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: WellSpan, status: RECRUITING, city: York, state: Pennsylvania, zip: 17405, country: United States, contacts name: Faiz Shariff, role: CONTACT, geoPoint lat: 39.9626, lon: -76.72774, hasResults: False |
protocolSection identificationModule nctId: NCT06282081, orgStudyIdInfo id: ML 45098, briefTitle: Serum Neurofilament Light in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dent Neuroscience Research Center, class: OTHER, collaborators name: Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG, collaborators name: Monogram Biosciences (LabCorp Specialty Testing Group), descriptionModule briefSummary: This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy., conditionsModule conditions: Multiple Sclerosis, conditions: Relapsing Remitting Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Serum Neurofilament Light, outcomesModule primaryOutcomes measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received, primaryOutcomes measure: Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice, primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale., primaryOutcomes measure: Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale., secondaryOutcomes measure: Describe patient demographics, secondaryOutcomes measure: Describe patient comorbidities, secondaryOutcomes measure: Describe patient concomitant medications, secondaryOutcomes measure: Describe patient MS medications, secondaryOutcomes measure: Describe patient reasons for MS medication changes, secondaryOutcomes measure: Describe patient MS relapses including date of relapse, secondaryOutcomes measure: Describe patient MS relapses including clinical findings, secondaryOutcomes measure: Describe patient MS relapses including radiologic findings, secondaryOutcomes measure: Describe patient MS relapses including severity, secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire., secondaryOutcomes measure: Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire., secondaryOutcomes measure: Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available., secondaryOutcomes measure: Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available., secondaryOutcomes measure: Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not., secondaryOutcomes measure: Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Describe changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., secondaryOutcomes measure: Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Compare changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available., secondaryOutcomes measure: Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available., secondaryOutcomes measure: Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available., secondaryOutcomes measure: Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06282068, orgStudyIdInfo id: CS2-23178, briefTitle: AI Determine Malignancy of GGO on Chest CT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Chung Shan Medical University, class: OTHER, descriptionModule briefSummary: Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment.Study Design Collect CT images of untreated lung nodules 4-30mm in size that are scheduled for surgery. No limits on age, gender, disease type, with image resolution \<2.5mm. AI and clinicians will judge nodule characteristics separately. Surgical resection followed by comparison with pathology reports will evaluate diagnostic accuracy.Study Procedures A double-blinded method will be used. AI and physicians will record nodules as likely benign or malignant separately. After surgical resection, the lesions will undergo pathological staging and the diagnostic accuracy of both groups will be compared.Expected Results Compare the diagnostic accuracy of AI and clinicians to improve AI training quality, achieve early diagnosis and treatment goals, and provide patients with better medical care quality.Monitoring Method AI and clinicians will read separately, adhering to shared decision making without affecting patient access to diagnosis and treatment.Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software, conditionsModule conditions: Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: AI computer-aided detection software, outcomesModule primaryOutcomes measure: The accuricy of the diagnostic power., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung Shan Medical University Hospital, city: Taichung, state: South, zip: 402, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False |
protocolSection identificationModule nctId: NCT06282055, orgStudyIdInfo id: TIMES, briefTitle: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes, acronym: TIMES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: DCB Research AG, class: OTHER, descriptionModule briefSummary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle, secondaryOutcomes measure: Total daily Insulin dose throughout the menstrual cycle, secondaryOutcomes measure: Coefficient of glucose variability throughout the menstrual cycle, secondaryOutcomes measure: Estimated insulin sensitivity throughout the menstrual cycle, secondaryOutcomes measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle, secondaryOutcomes measure: Correlations between insulin sensitivity trajectories and confounders, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282042, orgStudyIdInfo id: EMCAMI, briefTitle: Early Transcatheter Mitral Valve Repair After Myocardial Infarction, acronym: EMCAMI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-17, primaryCompletionDateStruct date: 2027-06-16, completionDateStruct date: 2028-06-16, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Fundación para la Investigación Biosanitaria del Principado de Asturias, class: OTHER, collaborators name: Meditrial Europe Ltd., descriptionModule briefSummary: To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up., conditionsModule conditions: Acute Mitral Regurgitation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, multicentre, randomised, open-label, comparative effectiveness clinical trial for the treatment of clinically significant functional mitral regurgitation within 60 days after acute myocardial infarction, who are treated per standard of care and who have been determined by the site's local heart team as inappropriate or too high risk for mitral valve surgery., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Early transcatheter edge-to-edge mitral valve repair (TEER)., interventions name: MitraClip, interventions name: Optimal medical treatment, outcomesModule primaryOutcomes measure: All-cause death or Cumulative Heart Failure hospitalizations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shaare Zedek Medical Center, city: Jerusalem, state: Jerusalen, zip: 9103102, country: Israel, contacts name: Mony Shuvy, role: CONTACT, contacts name: Dr. Mony Shuvy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center, city: Petah tikva, zip: 4941492, country: Israel, contacts name: Leor Perl, role: CONTACT, contacts name: Dr. Leor Perl, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.08707, lon: 34.88747, locations facility: Sheba Medical Center, city: Ramat Gan, country: Israel, geoPoint lat: 32.08227, lon: 34.81065, locations facility: Civil Hospital of Brescia, city: Brescia, zip: 25123, country: Italy, contacts name: Marianna Adamo, role: CONTACT, contacts name: Dra. Marianna Adamo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.53558, lon: 10.21472, locations facility: San Raffaele Hospital, city: Milano, zip: 20132, country: Italy, contacts name: Cosmo Godino, role: CONTACT, contacts name: Dr. Cosmo Godino, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Francesco Maisano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlínico San Donato, city: San Donato Milanese, zip: 20097, country: Italy, contacts name: Francesco Bedogni, role: CONTACT, contacts name: Dr. Francesco Bedogni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41047, lon: 9.26838, locations facility: Amsterdam University Medical Center, city: Amsterdam, zip: 1081 HV, country: Netherlands, contacts name: R. Delewi, role: CONTACT, contacts name: Dr. R. Delewi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Amphia Hospital, city: Breda, zip: 4818 CK, country: Netherlands, contacts name: B. van der Branden, role: CONTACT, contacts name: Dr. B. van der Branden, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.58656, lon: 4.77596, locations facility: Catharina Ziekenhuis Hospital, city: Eindhoven, zip: 5623 EJ, country: Netherlands, contacts name: P. Tonino, role: CONTACT, contacts name: Dr. P. Tonino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Leiden University Medical Center, city: Leiden, zip: 2333 ZA, country: Netherlands, contacts name: F. van der Kley, role: CONTACT, contacts name: Dr. F. van der Kley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Maastricht University Medical Center, city: Maastricht, zip: 6229 HX, country: Netherlands, contacts name: P.A. Vriesendorp, role: CONTACT, contacts name: Dr. P.A. Vriesendorp, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.84833, lon: 5.68889, locations facility: St. Antonius Hospital, city: Nieuwegein, zip: 3435 CM, country: Netherlands, contacts name: L. Timmers, role: CONTACT, contacts name: Dr. L. Timmers, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.02917, lon: 5.08056, locations facility: Erasmus University Medical Center, city: Rotterdam, zip: 3015 GD, country: Netherlands, contacts name: N. van Mieghem, role: CONTACT, contacts name: Dr. N. van Mieghem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Isala Hospital, city: Zwolle, zip: 8025 AB, country: Netherlands, contacts name: R. Hermanides, role: CONTACT, contacts name: Dr. R. Hermanides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.5125, lon: 6.09444, locations facility: Hospital Universitario Marqués de Valdecilla, city: Santander, state: Cantabria, zip: 39008, country: Spain, contacts name: Jose María de la Torre, MD, PhD, role: CONTACT, contacts name: Dr. Jose María de la Torre, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Universitario Doctor Negrin, city: Las Palmas de Gran Canaria, state: Las Palmas, zip: 35010, country: Spain, contacts name: Pedro Martín, MD, PhD, role: CONTACT, contacts name: Dr. Pedro Martín, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Hospital Álvaro Cunqueiro, city: Vigo, state: Pontevedra, zip: 36312, country: Spain, contacts name: Rodrigo Estévez-Loureiro, MD, PhD, role: CONTACT, contacts name: Dr. Rodrigo Estévez-Loureiro, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital General Universitario Dr. Balmis, city: Alicante, zip: 03010, country: Spain, contacts name: Juan M. Ruiz-Nodar, MD, PhD, role: CONTACT, contacts name: Juan M. Ruiz-Nodar, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Hospital de la Santa Creu i Sant Pau, city: Barcelona, zip: 08025, country: Spain, contacts name: Dabit Arzamendi, MD, PhD, role: CONTACT, contacts name: Dabit Arzamendi, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Vall d'Hebrón, city: Barcelona, zip: 08035, country: Spain, contacts name: Bruno García del Blanco, MD, PhD, role: CONTACT, contacts name: Dr. Bruno García del Blanco, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Clínic Barcelona, city: Barcelona, zip: 08036, country: Spain, contacts name: Xavier Freixa Rofastes, MD, PhD, role: CONTACT, contacts name: Dr. Xavier Freixa Rofastes, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Reina Sofía, city: Córdoba, zip: 14004, country: Spain, contacts name: Manuel Pan Álvarez, MD, PhD, role: CONTACT, contacts name: Dr. Manuel Pan Álvarez, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital Universitario Ramón y Cajal, city: Madrid, zip: 28034, country: Spain, contacts name: Ángel Sánchez-Recalde, MD, PhD, role: CONTACT, contacts name: Dr. Ángel Sánchez-Recalde, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario San Carlos, city: Madrid, zip: 28040, country: Spain, contacts name: Luis Nombela, MD, PhD, role: CONTACT, contacts name: Dr. Luis Nombela, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Puerta de Hierro, city: Madrid, zip: 28222, country: Spain, contacts name: María del Trigo, MD, PhD, role: CONTACT, contacts name: Dra. María del Trigo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Virgen de la Victoria, city: Málaga, zip: 29010, country: Spain, contacts name: Juan H. Alonso Briales, MD, PhD, role: CONTACT, contacts name: Dr. Juan H. Alonso Briales, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Clínico Universitario de Valladolid, city: Valladolid, zip: 47003, country: Spain, contacts name: Ignacio Amat-Santos, MD, PhD, role: CONTACT, contacts name: Dr. Ignacio Amat-Santos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False |
protocolSection identificationModule nctId: NCT06282029, orgStudyIdInfo id: I-2720-0018-0003, briefTitle: ACT-group for Stroke Survivors (Pilot Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Bielefeld University, class: OTHER, collaborators name: Bielefeld Young Researchers' Fund, descriptionModule briefSummary: The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:* Is the group therapy feasible?* Is the group therapy accepted by stroke survivors and therapists?* Are there first indications on the efficacy of the group therapy to improve mental health?Participants will take part in 8 weekly group therapy sessions of 90 minutes each., conditionsModule conditions: Stroke, conditions: Intracerebral Hemorrhage, conditions: Depressive Symptoms, conditions: Anxiety, conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This pilot study includes a pre-/post test of a small intervention sample without control group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Group Therapy, outcomesModule primaryOutcomes measure: Drop-out rate, primaryOutcomes measure: Session adherence, primaryOutcomes measure: Homework completion, primaryOutcomes measure: Completion of outcome measures, primaryOutcomes measure: Treatment fidelity, primaryOutcomes measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German), primaryOutcomes measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German), primaryOutcomes measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German), primaryOutcomes measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German), secondaryOutcomes measure: Valuing Questionnaire (Smout, 2014; Plain German), secondaryOutcomes measure: Self-as-context scale (Zettle, 2018; Plain German), secondaryOutcomes measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German), secondaryOutcomes measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Neuropsychological Outpatient Clinic, status: RECRUITING, city: Bielefeld, zip: 33607, country: Germany, contacts name: Simon Ladwig, PhD, role: CONTACT, phone: 017664716035, email: [email protected], geoPoint lat: 52.03333, lon: 8.53333, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-12, uploadDate: 2024-02-12T06:57, filename: Prot_SAP_000.pdf, size: 260777, hasResults: False |
protocolSection identificationModule nctId: NCT06282016, orgStudyIdInfo id: BKR-2024-001, briefTitle: Risk Factors for Neuroendocrine Neoplasms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Bavarian Cancer Registry, class: OTHER_GOV, collaborators name: Bavarian Association of Statutory Health Insurance Accredited Physicians, descriptionModule briefSummary: Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors., conditionsModule conditions: Neuroendocrine Neoplasm of Lung, conditions: Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 7200, type: ESTIMATED, armsInterventionsModule interventions name: Case-control study (no intervention), outcomesModule primaryOutcomes measure: Depression/Persistent mood disorder, primaryOutcomes measure: Obesity, primaryOutcomes measure: Metabolic syndrome, primaryOutcomes measure: Previous malignant neoplasm, primaryOutcomes measure: Alcohol buse, primaryOutcomes measure: Diabetes, primaryOutcomes measure: Ulcerative colitis, primaryOutcomes measure: Crohn disease, primaryOutcomes measure: Allergic rhinitis, primaryOutcomes measure: Asthma, secondaryOutcomes measure: Area deprivation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282003, orgStudyIdInfo id: 380-59-10106-21-111/148, briefTitle: Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Masa Kontic, class: OTHER_GOV, collaborators name: Prof.Dinko Tonković, MD, PhD Head of Department of Anesthesiology, Reanimatology and Intensive Care Medicine and Pain Therapy, University Hospital Centre Zagreb, collaborators name: Assist. Prof. Slavica Sović, MD, PhD Department of Medical Statistics, Epidemiology and Medical Informatics, School of Public Health Andrija Štampar, collaborators name: Prof. Goran Šimić, MD, PhD Professor of Neuroscience and Anatomy, Chair, Department of Neuroscience, Croatian Institute for Brain Research, University of Zagreb, collaborators name: Prof. Anamarija Jazbec, Faculty of Forestry and Wood Technology, University of Zagreb, collaborators name: Marijan Jedvaj, MD Anesthesiologist and ICU physician (Consultant), Head of Department of Anesthesia and IC, General Hospital Zabok, descriptionModule briefSummary: Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia., conditionsModule conditions: Well-Being, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A crossover design should be utilized in addition to the randomization procedure to properly address outcome variability. This study was a prospective, single-center, randomized controlled, patient- and evaluator-blinded clinical investigation with a two-arm parallel design to assess the advantage of the protective (optimized) ventilation procedure (PV group of patients) compared to the conventional (standard) method of lung ventilation (CV) during general anesthesia., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: The procedure of protective lung ventilation, outcomesModule primaryOutcomes measure: Oxygentation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General hospital Zabok, status: RECRUITING, city: Zabok, zip: 49210, country: Croatia, contacts name: Maša Kontić, Medical Doctor, role: CONTACT, phone: 00385 98 97 95 648, email: [email protected], geoPoint lat: 46.02944, lon: 15.915, hasResults: False |
protocolSection identificationModule nctId: NCT06281990, orgStudyIdInfo id: BAUN-SBF-PO-01, briefTitle: Education and Information for Bariatric Surgery Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2024-01-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Balikesir University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs., conditionsModule conditions: Bariatric Surgeries, conditions: Education of Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups in the research: control and intervention groups., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded)., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Data collection form, primaryOutcomes measure: Visual Analog Scale (VAS), primaryOutcomes measure: State-Trait Anxiety Inventory (STAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pınar Ongün, city: Balıkesir, zip: 38000, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False |
protocolSection identificationModule nctId: NCT06281977, orgStudyIdInfo id: ES613, briefTitle: Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm, acronym: SEDATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-03-12, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ottawa Heart Institute Research Corporation, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit., conditionsModule conditions: Ventricular Tachycardia, conditions: Ventricular Arrhythmias, conditions: Ventricular Fibrillation, conditions: Recurrent Ventricular Tachycardia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Normal saline, outcomesModule primaryOutcomes measure: The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation., secondaryOutcomes measure: All-cause in-hospital death, secondaryOutcomes measure: Ventricular arrhythmia requiring treatment after study drug initiation, secondaryOutcomes measure: Resuscitated cardiac arrest after study drug initiation, secondaryOutcomes measure: Renal failure requiring new initiation of renal replacement therapy after study drug initiation, secondaryOutcomes measure: Intubation following study drug initiation, secondaryOutcomes measure: Length of stay in the intensive care unit, secondaryOutcomes measure: Length of stay in hospital, secondaryOutcomes measure: Need for mechanical circulatory support device after study drug initiation, secondaryOutcomes measure: Ventricular Arrhythmia requiring treatment only during active study drug treatment, secondaryOutcomes measure: Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281964, orgStudyIdInfo id: PLB1004-III-01, briefTitle: Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion., conditionsModule conditions: Non-Small-Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 327, type: ESTIMATED, armsInterventionsModule interventions name: PLB1004, interventions name: Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) by BICR, secondaryOutcomes measure: Progression-Free Survival (PFS) by the investigator, secondaryOutcomes measure: Intracranial Overall Response Rate（ORR）, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies, otherOutcomes measure: intracranial Progression-Free Survival（PFS）, otherOutcomes measure: second progression-free survival (PFS2), otherOutcomes measure: Assess the Quality of Healthy Living About Patients, otherOutcomes measure: EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs, otherOutcomes measure: Gene mutation status in plasma ctDNA before and after medication, and its correlation with clinical efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281951, orgStudyIdInfo id: 2022/0271/HP, briefTitle: Nebulized Fentanyl in Healthy Volunteers, acronym: AEROfen, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study, conditionsModule conditions: Analgesia, conditions: Emergencies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fentanyl - Inhalation by facial nebulization, interventions name: Fentanyl - Nebulisation, outcomesModule primaryOutcomes measure: Measurement of [F] bioavailability via facial nebulization and intranasal inhalation., secondaryOutcomes measure: Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation., secondaryOutcomes measure: Measurement of the difference between observed and predicted PUAL values by a PK/PD model., secondaryOutcomes measure: Time required to achieve >30% decrease in PUAL compared to baseline., secondaryOutcomes measure: Measurement of dose required to achieve >30% decrease in PUAL compared to baseline., secondaryOutcomes measure: Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, Rouen, city: Rouen, zip: 76031, country: France, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False |
protocolSection identificationModule nctId: NCT06281938, orgStudyIdInfo id: 1617209, briefTitle: Machine Learning and 3D Image-based Modeling for Body Weight Estimation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Florida Atlantic University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled clinical trial is to \[learn about, test, compare etc.\] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question\[s\] it aims to answer are:* Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?* Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group., conditionsModule conditions: No Specific Conditions, conditions: Weight, Body, conditions: Drug Dose, conditions: Weight-Estimation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention cohort and control cohort will be used, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Investigators and outcomes assessors will be blinded to the arm. Coded data will be used for masking., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Weight estimation using 3D camera, interventions name: Standard care weight estimation, outcomesModule primaryOutcomes measure: Weight estimation accuracy, primaryOutcomes measure: Time to obtain weight estimate, primaryOutcomes measure: Drug dosing accuracy, primaryOutcomes measure: Correct dosing scalar used, secondaryOutcomes measure: Accuracy of in-bed scales, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281925, orgStudyIdInfo id: 22-01363, briefTitle: Cryotherapy & Oxaliplatin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy., conditionsModule conditions: Colon Cancer, conditions: Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cryotherapy Gloves, outcomesModule primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 2, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 3, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 4, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 5, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: Mineola, state: New York, zip: 11501, country: United States, geoPoint lat: 40.74927, lon: -73.64068, locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06281912, orgStudyIdInfo id: 4504/23, briefTitle: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients, acronym: MELCAYA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Perugia, class: OTHER, descriptionModule briefSummary: This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease, conditionsModule conditions: Early Melanoma, conditions: Advanced Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: rate of objective response, secondaryOutcomes measure: adverse event incidence, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Aix-Marseille Universite, city: Marseille, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Curie, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Ospedale universitario della Charité, city: Berlino, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ), city: Heidelberg, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: University Children's Hospital Tuebingen, city: Tuebingen, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, locations facility: Universita Degli Studi Di Firenze, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Fondazione Irccs Istituto Nazionale Dei Tumori, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Universita Cattolica Del Sacro Cuore, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie), city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Institut Catala D'Oncologia, city: Barcellona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Instituto de Investigaciones Biomédicas August Pi i Sunyer, city: Barcellona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06281899, orgStudyIdInfo id: 01/2022, briefTitle: Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus, acronym: PRODAPA-CKD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Anemia Working Group Romania, class: OTHER, collaborators name: Sf Ioan Emergency Clinical Hospital, Nephrology and Dialysis Department, Bucharest, Romania, collaborators name: Dr Carol Davila Teaching Hospital of Nephrology, Nephrology Department, Bucharest, Romania, collaborators name: Carol Davila University of Medicine and Pharmacy, descriptionModule briefSummary: This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus, conditionsModule conditions: Chronic Kidney Diseases, conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin 10 mg Tab, interventions name: Low protein diet, outcomesModule primaryOutcomes measure: Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death, secondaryOutcomes measure: Rate of decline in the estimated Glomerular Filtration Rate, secondaryOutcomes measure: Variation of albuminuria, secondaryOutcomes measure: Variation of HbA1C, secondaryOutcomes measure: Variation of serum cholesterol levels, secondaryOutcomes measure: Variation of serum bicarbonate levels, secondaryOutcomes measure: Variation of serum potassium levels, secondaryOutcomes measure: Variation of serum sodium levels, secondaryOutcomes measure: Variation of hemoglobin levels, secondaryOutcomes measure: Variation of hematocrit levels, secondaryOutcomes measure: All cause hospitalizations, secondaryOutcomes measure: Variation in body weight, secondaryOutcomes measure: Variation in BMI, secondaryOutcomes measure: Variation in handgrip strength, secondaryOutcomes measure: Variation in serum albumin levels, secondaryOutcomes measure: Variation in CRP levels, secondaryOutcomes measure: Changes in the quality of life, otherOutcomes measure: Compliance to the protein intake, otherOutcomes measure: Compliance to the energy intake, otherOutcomes measure: Compliance to carbohydrate intake, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Carol Davila University of Medicine and Pharmacy Bucharest, status: RECRUITING, city: Bucharest, country: Romania, contacts name: Liliana Garneata, Assoc Prof, role: CONTACT, phone: +40722619358, email: [email protected], contacts name: Elena Cuiban, MD, role: CONTACT, phone: +40748975315, email: [email protected], geoPoint lat: 44.43225, lon: 26.10626, hasResults: False |
protocolSection identificationModule nctId: NCT06281886, orgStudyIdInfo id: GASTO-10107, briefTitle: Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma, conditionsModule conditions: Esophageal Squamous Cell Carcinoma, conditions: Efficacy, conditions: Toxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Induction Immunotherapy-Toripalimab, interventions name: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin, interventions name: Radiotherapy, interventions name: Apatinib, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Local-regional progression-free survival, secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, secondaryOutcomes measure: Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer), secondaryOutcomes measure: Distant metastasis-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Bo Qiu, Professor, role: CONTACT, phone: +86-020-87343031, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06281873, orgStudyIdInfo id: 0645, briefTitle: Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-27, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-02-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis., conditionsModule conditions: Oroantral Fistula, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ACTUAL, armsInterventionsModule interventions name: closure by PRF membrane, outcomesModule primaryOutcomes measure: Evaluation of the soft tissue wound's healing, secondaryOutcomes measure: Secondary radiographic outcomes, assessment of bone formation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Alexandria, zip: 562589, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False |
protocolSection identificationModule nctId: NCT06281860, orgStudyIdInfo id: PITHAC, secondaryIdInfos id: 2023-00099, type: REGISTRY, domain: BASEC, briefTitle: Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration, acronym: PITHAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-24, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dr Jean Yannis PERENTES, class: OTHER, descriptionModule briefSummary: Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD)., conditionsModule conditions: Mesothelioma, Malignant, conditions: Carcinoma, Non-Small-Cell Lung, conditions: Carcinoma Breast Stage IV, conditions: Ovarian Cancer, conditions: Esophageal Cancer, conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatine Teva®, outcomesModule primaryOutcomes measure: Dose Escalation and Maximum Tolerated Dose determination (Part A):, primaryOutcomes measure: Expansion phase (Part B):, secondaryOutcomes measure: Dose Escalation and MTD determination (Part A):, secondaryOutcomes measure: Expansion phase (Part B):, otherOutcomes measure: Dose Escalation and MTD determination (Part A):Exploratory outcomes, otherOutcomes measure: Expansion phase (Part B):Exploratory outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire Vaudois, status: RECRUITING, city: Lausanne, country: Switzerland, contacts name: Jean-Yannis PERENTES, role: CONTACT, contacts name: Jean Yannis PERENTES, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06281847, orgStudyIdInfo id: CCTx-001-AML-001, briefTitle: An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia, acronym: RESOLVE AML001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2041-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Advesya SAS, class: INDUSTRY, descriptionModule briefSummary: The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option., conditionsModule conditions: Acute Myeloid Leukemia, in Relapse, conditions: Acute Myeloid Leukemia Refractory, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study comprises 4 periods:* The pre-treatment period will consist of screening for eligibility, leukapheresis and a pre-treatment evaluation (prior to Lymphodepleting Chemotherapy (LDC)).* The treatment period will start with LDC, followed by CCTx-001 infusion 2 to 7 days after completion of LDC. A first response evaluation will be performed at approximately 28 days after CCTx-001 infusion.* The post-treatment period will consist of further clinical activity and safety follow-up visits at regular timepoints after CCTx-001 infusion, starting after the Month 3 visit up to the Month 24 visit.* The long-term follow-up period will start after the Month 24 visit up to 15 years post CCTx-001 infusion., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 143, type: ESTIMATED, armsInterventionsModule interventions name: CCTx-001, outcomesModule primaryOutcomes measure: Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001, primaryOutcomes measure: Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To assess the safety of CCTx-001, secondaryOutcomes measure: Phase 2: To assess HRQoL for patients treated with CCTx-001, secondaryOutcomes measure: Phase 2: To assess HRQoL for patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001, secondaryOutcomes measure: Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Besançon Regional and University Hospital, city: Besançon Cedex, country: France, contacts name: Eric Deconinck, role: CONTACT, contacts name: Eric Deconinck, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Hospital Saint Louis, city: Paris, country: France, contacts name: Nicolas Boissel, role: CONTACT, contacts name: Nicolas Boissel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Ludwig-Maximilians University of Munich, city: Munich, country: Germany, contacts name: Marion Subklewe, role: CONTACT, contacts name: Marion Subklewe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, locations facility: University Hospital Ulm, city: Ulm, country: Germany, contacts name: Elisa Sala, role: CONTACT, contacts name: Elisa Sala, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.39841, lon: 9.99155, locations facility: Vall d'Hebron University Hospital, city: Barcelona, country: Spain, contacts name: Pere Barba, role: CONTACT, contacts name: Pere Barba, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, contacts name: Stephan Mielke, role: CONTACT, contacts name: Stephan Mielke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06281834, orgStudyIdInfo id: 2024P000306, briefTitle: Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: APIN Public Health Initiatives, collaborators name: University of Cape Town, descriptionModule briefSummary: Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population., conditionsModule conditions: Pediatric HIV Infection, conditions: Latent Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective single-arm, open-label, pharmacokinetic and safety study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Rifapentine, interventions name: Dolutegravir, outcomesModule primaryOutcomes measure: Dolutegravir AUC during weekly rifapentine/isoniazid, secondaryOutcomes measure: Rifapentine AUC, secondaryOutcomes measure: Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events, eligibilityModule sex: ALL, minimumAge: 4 Weeks, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281821, orgStudyIdInfo id: 4947 [Study 2], briefTitle: Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Boston University Charles River Campus, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention., conditionsModule conditions: Alcohol Drinking, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Compare an intervention to an assessment only control condition, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: mhealth-pc, outcomesModule primaryOutcomes measure: Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale, primaryOutcomes measure: Time Line Follow-Back-30 Day Weekly Drinking, secondaryOutcomes measure: Time Line Follow-Back 30-Day Heavy Episodic Drinking, secondaryOutcomes measure: Perceptions of Treatment Questionnaire, secondaryOutcomes measure: Systems Usability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston University, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Maya Kratzer, BA, role: CONTACT, phone: 857-225-8843, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06281808, orgStudyIdInfo id: R490, briefTitle: Photon Counting Detector CT Image Quality, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Reto Sutter, MD, class: OTHER, descriptionModule briefSummary: This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard., conditionsModule conditions: Diagnostic Imaging, conditions: Tomography, X Ray Computed, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Photon Counting Detector CT, outcomesModule primaryOutcomes measure: Image Quality PCD CT, primaryOutcomes measure: Diagnostic Accuracy PCD CT, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281795, orgStudyIdInfo id: 1.24., briefTitle: Neuromodulation of the Autonomic Nervous System in Athletes, acronym: NANSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Bakulev Scientific Center of Cardiovascular Surgery, class: OTHER_GOV, collaborators name: Foundation for the Support of Physical Culture and Sports BECOME A CHAMPION, collaborators name: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION, descriptionModule briefSummary: There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels., conditionsModule conditions: Efficacy, Self, conditions: Fatigue; Muscle, Heart, conditions: Fatigue, Mental, conditions: Fatigue; Combat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 randomization of active stimulation vs. sham stimulation, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: tVNS, outcomesModule primaryOutcomes measure: Dynamics of maximum oxygen consumption (VO2max)., primaryOutcomes measure: The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism., secondaryOutcomes measure: Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism., secondaryOutcomes measure: The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism., secondaryOutcomes measure: The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism., secondaryOutcomes measure: The dynamics of RMSSD., secondaryOutcomes measure: HF dynamics, secondaryOutcomes measure: Dynamics of the LF/HF ratio., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION, city: Krasnodar, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, hasResults: False |
protocolSection identificationModule nctId: NCT06281782, orgStudyIdInfo id: PRP with topical retinoids, briefTitle: Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment., conditionsModule conditions: Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Topical retinoids versus topical retinoids wit PRP in acne vulgaris treatment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: topical retinoids and platalet rich plasma, outcomesModule primaryOutcomes measure: change of acne lasions, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, status: RECRUITING, city: Assiut, country: Egypt, contacts name: Howida Abdalla, role: CONTACT, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06281769, orgStudyIdInfo id: NL82101.000.22, briefTitle: Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: Angiogenesis Analytics, descriptionModule briefSummary: The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway)., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 438, type: ESTIMATED, armsInterventionsModule interventions name: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision, interventions name: MRI targeted biopsy pathway, outcomesModule primaryOutcomes measure: Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI., secondaryOutcomes measure: Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway., secondaryOutcomes measure: Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway)., secondaryOutcomes measure: Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway., secondaryOutcomes measure: Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC - location VUmc, status: RECRUITING, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Andros Clinics, status: RECRUITING, city: Baarn, country: Netherlands, geoPoint lat: 52.21167, lon: 5.2875, locations facility: Spaarne Gasthuis, status: RECRUITING, city: Hoofddorp, country: Netherlands, geoPoint lat: 52.3025, lon: 4.68889, locations facility: St. Antonius, status: RECRUITING, city: Nieuwegein, country: Netherlands, geoPoint lat: 52.02917, lon: 5.08056, locations facility: Fransiscus Gasthuis, status: RECRUITING, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-01-12T04:56, filename: Prot_SAP_000.pdf, size: 1638356, hasResults: False |
protocolSection identificationModule nctId: NCT06281756, orgStudyIdInfo id: STUDY00022285, secondaryIdInfos id: 1UG3HL161342-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3HL161342-01A1, briefTitle: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems., conditionsModule conditions: Insomnia, conditions: Insomnia Chronic, conditions: Insomnia, Primary, conditions: Blood Pressure, conditions: Blood Pressure, High, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Both prescribing physicians and participants will be blind to phenotype and treatment groups., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Treatment for Insomnia (CBT-I), interventions name: Trazodone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I), primaryOutcomes measure: Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT), primaryOutcomes measure: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score following CBT-I, secondaryOutcomes measure: Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I), secondaryOutcomes measure: Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I), secondaryOutcomes measure: Evening Cortisol levels following CBT-I, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score following RCT, secondaryOutcomes measure: PSG Total Sleep Time (TST) following RCT, secondaryOutcomes measure: Actigraphy Total Sleep Time (TST) following RCT, secondaryOutcomes measure: Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP), secondaryOutcomes measure: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP), secondaryOutcomes measure: Evening Cortisol levels following RCT, secondaryOutcomes measure: Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Jewish Health, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80206-2761, country: United States, contacts name: Roxane Horberg, role: CONTACT, phone: 303-270-2850, email: [email protected], contacts name: Rachel Johnson, role: CONTACT, phone: 303 398-1058, email: [email protected], geoPoint lat: 39.73915, lon: -104.9847, locations facility: Penn State University, status: RECRUITING, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts name: Carrie Criley, role: CONTACT, phone: 717-531-4123, email: [email protected], geoPoint lat: 40.28592, lon: -76.65025, locations facility: University of Pittsburgh, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213-3203, country: United States, contacts name: Laurie Brar, role: CONTACT, phone: 412-723-7998, email: [email protected], geoPoint lat: 40.44062, lon: -79.99589, locations facility: Université Laval, status: NOT_YET_RECRUITING, city: Quebec, zip: G1V 0A6, country: Canada, contacts name: Manon Lamy, role: CONTACT, phone: 418 656-2131, phoneExt: 412467, email: [email protected], geoPoint lat: 46.81228, lon: -71.21454, hasResults: False |
protocolSection identificationModule nctId: NCT06281743, orgStudyIdInfo id: LST-Ped Survey, briefTitle: Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children, acronym: LSTPedSurvey, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians., conditionsModule conditions: Pediatric Disorder, conditions: Critical Illness, conditions: Ethics, Narrative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Attitudes and experiences -questionnaire, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281730, orgStudyIdInfo id: 23-009197, briefTitle: Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2044-02, completionDateStruct date: 2044-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA., conditionsModule conditions: In Utero Procedure Affecting Fetus or Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Karl Storz New Generation Fetoscope - curved 11508AAK, interventions name: Karl Storz New Generation Fetoscope - straight 11506AAK, outcomesModule primaryOutcomes measure: Adverse events, primaryOutcomes measure: Serious Adverse Events, primaryOutcomes measure: Device malfunctions, secondaryOutcomes measure: Mean gestational age at delivery, secondaryOutcomes measure: Successful Completion, secondaryOutcomes measure: Satisfaction scores, secondaryOutcomes measure: Live births, secondaryOutcomes measure: Neonatal deaths, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Minnesota, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06281717, orgStudyIdInfo id: IRB-P00045047, briefTitle: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Alireza Shamshirsaz, class: OTHER, descriptionModule briefSummary: The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age., conditionsModule conditions: Congenital Diaphragmatic Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Fetal Endotracheal Occlusion (FETO), outcomesModule primaryOutcomes measure: Successful Ballon Placement, primaryOutcomes measure: Successful Balloon Removal, primaryOutcomes measure: Balloon placement operative time, primaryOutcomes measure: Balloon removal operative time, primaryOutcomes measure: Type of FETO release, primaryOutcomes measure: Maternal Complications, primaryOutcomes measure: Gestational age at delivery, secondaryOutcomes measure: Fetal lung volume, secondaryOutcomes measure: O/E LHR, secondaryOutcomes measure: Infant survival, secondaryOutcomes measure: Oxygen dependency, secondaryOutcomes measure: Number of infants requiring ECMO, secondaryOutcomes measure: NICU stay, secondaryOutcomes measure: Ventilator support, secondaryOutcomes measure: Presence of periventricular leukomalacia, secondaryOutcomes measure: Presence of neonatal sepsis, secondaryOutcomes measure: Presence of intraventricular hemorrhage, secondaryOutcomes measure: Retinopathy of prematurity, secondaryOutcomes measure: Presence of gastro-esophageal reflux, secondaryOutcomes measure: CDH repair type, secondaryOutcomes measure: Pulmonary function, secondaryOutcomes measure: Infant Neurodevelopment, secondaryOutcomes measure: Route of delivery, secondaryOutcomes measure: Maternal hospitalization, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Brittany Gudanowski, role: CONTACT, phone: 617-919-6658, email: [email protected], contacts name: Maternal Fetal Care Center, role: CONTACT, phone: 617-355-6512, email: [email protected], contacts name: Alireza Shamshirsaz, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eyal Krispin, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06281704, orgStudyIdInfo id: AK101-102, briefTitle: A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-26, primaryCompletionDateStruct date: 2022-05-17, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis., conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: AK101 IV, interventions name: AK101 SC, interventions name: Placebo, interventions name: AK101 IV/AK101 SC, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Elimination half-life (T1/2) of AK101, primaryOutcomes measure: Mean residence time (MRT) of AK101, primaryOutcomes measure: Area under curve (AUC) of AK101, primaryOutcomes measure: Apparent distribution volume (VD/F) of AK101, primaryOutcomes measure: Systemic clearance (CL/F) of AK101, primaryOutcomes measure: Maximum (peak) plasma concentration (Cmax) of AK101, primaryOutcomes measure: Time to maximum plasma concentration (Tmax) of AK101, secondaryOutcomes measure: Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment)., secondaryOutcomes measure: Proportion of subjects with clinical response at Week8(per the Mayo score)., secondaryOutcomes measure: Immunogenicity index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, city: Bengbu, state: Anhui, zip: 233099, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Affiliated Hospital of Fujian Medical University, city: Fuzhou, state: Fujian, zip: 350004, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Nanfang Hospital, city: Guangzhou, state: Guangdong, zip: 510515, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: The Sixth Affiliated Hospital of Sun Yat-Sen University, city: Guanzhou, state: Guangdong, zip: 510665, country: China, locations facility: The Second Hospital of Hebei Medical University, city: Shijiazhuang, state: Hebei, zip: 050004, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: People's Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Nanjing First Hospital, city: Nanjing, state: Jiangsu, zip: 210012, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221004, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Shengjing Hospital of China Medical University, city: Shengyang, state: Liaoning, zip: 110000, country: China, locations facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Tianjing People's Hospital, city: Tianjing, state: Tianjing, zip: 300122, country: China, hasResults: False |
protocolSection identificationModule nctId: NCT06281691, orgStudyIdInfo id: GreenBladder, briefTitle: GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-04-28, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Jørgen Bjerggaard Jensen, class: OTHER, collaborators name: Cepheid, collaborators name: Laborie Medical Technologies Inc., collaborators name: Vingmed Danmark A/S, collaborators name: OneMed A/S, descriptionModule briefSummary: The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland., conditionsModule conditions: Urinary Bladder Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Xpert® Bladder Cancer Detection Test, outcomesModule primaryOutcomes measure: Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Urology, Aarhus University Hopsital, city: Aarhus, zip: 8000, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Queen Ingrid's Hospital, city: Nuuk, zip: 3900, country: Greenland, geoPoint lat: 64.18347, lon: -51.72157, hasResults: False |
protocolSection identificationModule nctId: NCT06281678, orgStudyIdInfo id: CIBI363A202, briefTitle: A Study of IBI363 in Subjects With Advanced Solid Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Innovent Biologics (Suzhou) Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies., conditionsModule conditions: Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: IBI363, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Adverse Event （AE）, secondaryOutcomes measure: Dose-limiting Toxicity （DLT）, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medcial Center Research Institute, city: Fairway, state: Kansas, zip: 66205, country: United States, contacts name: Saqib Abbasi, role: CONTACT, phone: 913-945-7545, email: [email protected], geoPoint lat: 39.02223, lon: -94.6319, hasResults: False |
protocolSection identificationModule nctId: NCT06281665, orgStudyIdInfo id: STUDY23080099, secondaryIdInfos id: K23HL168356, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL168356, briefTitle: Treatment With Aspirin After Preeclampsia: TAP Trial, acronym: TAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Alisse Hauspurg, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital., conditionsModule conditions: Hypertensive Disorder of Pregnancy, conditions: Pre-Eclampsia, conditions: Hypertension, conditions: Eclampsia, conditions: Gestational Hypertension, conditions: Cardiovascular Diseases, conditions: Toxemia, conditions: Pregnancy Complications, conditions: Vascular Diseases, conditions: Hypertension, Pregnancy Induced, conditions: Hypertension;Pre-Eclamptic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring., primaryPurpose: OTHER, maskingInfo masking: TRIPLE, maskingDescription: Participants, Investigators and outcomes assessors will be blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Low-dose aspirin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent of participants eligible, enrolled and retained (feasibility), secondaryOutcomes measure: Study visit systolic BP, secondaryOutcomes measure: Study visit diastolic BP, secondaryOutcomes measure: Study visit systolic BP, secondaryOutcomes measure: Study visit diastolic BP, secondaryOutcomes measure: Study visit mean arterial pressure, secondaryOutcomes measure: Study visit mean arterial pressure, secondaryOutcomes measure: Anti-hypertensive medication use, secondaryOutcomes measure: Anti-hypertensive medication use, secondaryOutcomes measure: Therapeutic intensity score, secondaryOutcomes measure: Therapeutic intensity score, secondaryOutcomes measure: Mean home systolic blood pressure, secondaryOutcomes measure: Mean home diastolic blood pressure, secondaryOutcomes measure: Mean home mean arterial pressure, secondaryOutcomes measure: Mean daytime systolic blood pressure, secondaryOutcomes measure: Mean nocturnal systolic blood pressure, secondaryOutcomes measure: Mean daytime diastolic blood pressure, secondaryOutcomes measure: Mean nocturnal diastolic blood pressure, secondaryOutcomes measure: Mean nocturnal mean arterial pressure, secondaryOutcomes measure: Mean daytime mean arterial pressure, secondaryOutcomes measure: Mean overall mean arterial pressure, secondaryOutcomes measure: Mean overall systolic blood pressure, secondaryOutcomes measure: Mean overall diastolic blood pressure, secondaryOutcomes measure: Classification of hypertension, secondaryOutcomes measure: Classification of hypertension, secondaryOutcomes measure: Endothelial function EC50%, secondaryOutcomes measure: Endothelial function EC50%, secondaryOutcomes measure: Endothelial function Emax, secondaryOutcomes measure: Endothelial function Emax, secondaryOutcomes measure: Endothelial function change in Emax, secondaryOutcomes measure: Endothelial function change in EC50%, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in mean arterial pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Pittsburgh Magee-Womens Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sila Yavan, MS, role: CONTACT, phone: 412-417-4981, email: [email protected], contacts name: Alisse K Hauspurg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06281652, orgStudyIdInfo id: Cognichess, briefTitle: Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline, acronym: Cognichess, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-02-13, completionDateStruct date: 2025-02-13, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Milano Bicocca, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:* Do Go and Chess improve cognition?* Is a game better than the other? Is the effect of both games on cognition synergistic?* Do Go and Chess improve quality of life?* Do Go and Chess improve mood?* Do Go and Chess improve lifestyle?Participants will be randomized to one of four groups:* Group intervention with Go, once a week, for 12 weeks* Group intervention with Chess, once a week, for 12 weeks* Group intervention with Go and Chess, twice a week, for 12 weeks* Control group, conditionsModule conditions: Mild Cognitive Impairment, conditions: Subjective Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Go classes, interventions name: Chess classes, outcomesModule primaryOutcomes measure: General cognition, secondaryOutcomes measure: Digit Span Forward, secondaryOutcomes measure: Digit Span Backwards, secondaryOutcomes measure: Trail Making Test - part A, secondaryOutcomes measure: Trail Making Test - part B, secondaryOutcomes measure: Semantic fluency, secondaryOutcomes measure: Quality of life indicator, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Lifestyle, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS San Gerardo dei Tintori, status: RECRUITING, city: Monza, state: Lombardia, zip: 20900, country: Italy, contacts name: Lucio Tremolizzo, MD, PhD, role: CONTACT, phone: +390392339082, email: [email protected], contacts name: Federico Emanuele Pozzi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.58005, lon: 9.27246, hasResults: False |
protocolSection identificationModule nctId: NCT06281639, orgStudyIdInfo id: RAPID, briefTitle: RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box., conditionsModule conditions: Congenital Heart Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: RAPID, outcomesModule primaryOutcomes measure: RAPID imaging quality, eligibilityModule sex: ALL, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Gwenyth Fischer, MD, role: CONTACT, phone: 612-625-6678, email: [email protected], geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06281626, orgStudyIdInfo id: 2024_RIPH_01_Preservatif, briefTitle: Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25, acronym: Préservatif, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Université de Reims Champagne-Ardenne, class: OTHER, descriptionModule briefSummary: For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022)., conditionsModule conditions: Comdom, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: use of free male condoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ufr Medecine Urca, city: Reims, zip: 51100, country: France, geoPoint lat: 49.25, lon: 4.03333, locations facility: Université de Reims Champagne Ardenne, city: Reims, zip: 51100, country: France, geoPoint lat: 49.25, lon: 4.03333, hasResults: False |
protocolSection identificationModule nctId: NCT06281613, orgStudyIdInfo id: 2024-AMCOPTEO, briefTitle: Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1)., conditionsModule conditions: Skeletal Malocclusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: AMCOP group, interventions name: High-pull headgear, outcomesModule primaryOutcomes measure: Change in cephalometric angular measurements, primaryOutcomes measure: Linear regressions, primaryOutcomes measure: Change in cephalometric linear measurements, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False |
protocolSection identificationModule nctId: NCT06281600, orgStudyIdInfo id: REC: 23/SW/0042, secondaryIdInfos id: 326109, type: OTHER, domain: IRAS ID, briefTitle: An Intervention Study Using HMOs to Improve IBS Symptoms, acronym: GUT-HEAL-IBS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-08-20, completionDateStruct date: 2025-09-20, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Glenn Gibson, class: OTHER, collaborators name: Royal Berkshire NHS Foundation Trust, descriptionModule briefSummary: There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" \[8\]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens \[9\]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a 16-week, randomised, placebo-controlled, double-blinded crossover trial. We aim to recruit 44 participants with IBS. These participants will be screened and classified into a particular IBS subtype. After a 14-day baseline period, participants will be randomised to orally consume either 5g of HMO for 28 days, or a placebo for 28 days. This will be administered at the University of Reading. All participants will then stop taking the product for 28 days (wash out period) and then swap treatment type and have 28 days of either placebo or HMO. This is then followed by another 14 days without any product. During the study, participants will be asked to complete a 24-hour food recall weeks 0 and 16. Additionally, participants will complete validated questionnaires (IBS-Symptom Severity Score, anxiety and depression score and Pittsburgh Sleep Quality Index (PSQI) every time they provide urine and faecal samples at each visit., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Every individual involved in undertaking this trial will be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Human milk oligosaccharide, interventions name: Maltodextrin placebo, outcomesModule primaryOutcomes measure: IBS-SSS, secondaryOutcomes measure: Change in anxiety and depression scores (ADS), secondaryOutcomes measure: Improvement of the Pittsburgh Sleep Quality Index (PSQI)., secondaryOutcomes measure: Changes in faecal microbiota e.g. Bifidobacterium, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Reading, status: RECRUITING, city: Reading, state: Berkshire, zip: RG6 6LA, country: United Kingdom, contacts name: Patricia Sanz Morales, role: CONTACT, phone: +447843865554, email: [email protected], contacts name: Glenn Gibson, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 51.45625, lon: -0.97113, hasResults: False |
protocolSection identificationModule nctId: NCT06281587, orgStudyIdInfo id: SNFyodorov, briefTitle: Pathogenetic Risk Factors for Corneal Graft Rejection, statusModule overallStatus: COMPLETED, startDateStruct date: 2011-01, primaryCompletionDateStruct date: 2019-01, completionDateStruct date: 2019-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The S.N. Fyodorov Eye Microsurgery State Institution, class: OTHER_GOV, descriptionModule briefSummary: There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity., conditionsModule conditions: Graft Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 93, type: ACTUAL, armsInterventionsModule interventions name: penetrating keratoplasty, outcomesModule primaryOutcomes measure: Cohort group Kaplan-Meier survival analysis (clear graft engraftment), eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations city: Krasnodar, zip: 350012, country: Russian Federation, geoPoint lat: 45.04484, lon: 38.97603, hasResults: False |
protocolSection identificationModule nctId: NCT06281574, orgStudyIdInfo id: S67346, briefTitle: What Are the Determinants for RTW After SA, acronym: RTW after SA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW., conditionsModule conditions: Shoulder Arthroplasty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, outcomesModule primaryOutcomes measure: Return to work, secondaryOutcomes measure: Type of shoulder arthroplasty, secondaryOutcomes measure: WORQ-UP (work-related questionnaire for upper extremity disorders), secondaryOutcomes measure: SSV (Subjective Shoulder Value), secondaryOutcomes measure: SST (Dutch translation of the Simple Shoulder Test), secondaryOutcomes measure: OSS (Oxford Shoulder Score), secondaryOutcomes measure: Self-made questionnaire, secondaryOutcomes measure: Belgisch Kenniscentrum over welzijn op het werk (BeSWIC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 63 Years, stdAges: ADULT, contactsLocationsModule locations facility: UZ Leuven, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False |
protocolSection identificationModule nctId: NCT06281561, orgStudyIdInfo id: FirstAHXiamenU-YB, briefTitle: Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality., conditionsModule conditions: Postoperative Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Normal Saline, interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: Change from baseline sleep quality at after intervention, primaryOutcomes measure: Pittsburgh sleep quality index(PSQI), secondaryOutcomes measure: Early recovery evaluated by Aldrete rating scale, secondaryOutcomes measure: Later Recovery evaluated by QoR-40 questionnaire, eligibilityModule sex: FEMALE, minimumAge: 23 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281548, orgStudyIdInfo id: 23-2937, secondaryIdInfos id: 1F31DA058452, type: NIH, link: https://reporter.nih.gov/quickSearch/1F31DA058452, briefTitle: Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement., conditionsModule conditions: Stigma, Social, conditions: Substance Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: RESTART, outcomesModule primaryOutcomes measure: Change in Stigma Resistance Scale (SRS) Score, primaryOutcomes measure: Change in Substance Abuse Self-Stigma Scale (SASSS) Score, primaryOutcomes measure: Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment), primaryOutcomes measure: Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment), primaryOutcomes measure: Time to Sample Saturation (Feasibility - Recruitment), primaryOutcomes measure: Percentage of Participants Retained in Study (Feasibility - Retention), primaryOutcomes measure: Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User), primaryOutcomes measure: Percentage of Participants with High Text Message Frequency (Feasibility - User), primaryOutcomes measure: Percentage of Participants with High Text Messaging Comfort (Feasibility - User), primaryOutcomes measure: Percentage of Participants with Cell Phone Device Challenges (Feasibility - User), primaryOutcomes measure: Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User), primaryOutcomes measure: Percentage of Participants who Read Messages Daily (Feasibility - User), secondaryOutcomes measure: Change in Adult Dispositional Hope Scale Score, secondaryOutcomes measure: Change in Rosenberg Self-Esteem Scale Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SHRPS Syringe Service Program, status: RECRUITING, city: Portsmouth, state: Ohio, zip: 45662, country: United States, contacts name: Adams L Sibley, MPH, role: CONTACT, phone: 423-227-9198, email: [email protected], contacts name: Abby Spears, role: CONTACT, phone: 740-357-9773, email: [email protected], geoPoint lat: 38.73174, lon: -82.99767, hasResults: False |
protocolSection identificationModule nctId: NCT06281535, orgStudyIdInfo id: 21789, briefTitle: Early Versus Conventional Loading for Fully Guided Immediate Implant Placement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, collaborators name: Assiut University, descriptionModule briefSummary: Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate., conditionsModule conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Implant loading, outcomesModule primaryOutcomes measure: Implant stability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281522, orgStudyIdInfo id: University of Health Sciences, briefTitle: The Importance of Inflammatory Markers Calculated From Preoperative and Postoperative Peripheral Blood Results in the Diagnosis and Treatment of Patients Operated for Hydatid Cyst of the Lung (Lung Echinococcus Granulosus), acronym: Echinococcusis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Abdullah Adiyaman, class: OTHER, descriptionModule briefSummary: This study aims to investigate the role of these laboratory findings in the differential diagnosis and management of pulmonary hydatid cyst (PHC) by examining the number of euzonophils, neutrophils, lymphocytes, platelets and neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune inflammatory index values in the peripheral blood of patients diagnosed with pulmonary hydatid cyst (PHC) in the preoperative period and post-operative 3rd month. Although we have extensive data on hydatid liver cysts, there is limited information in the literature on the laboratory values of patients with PHC. This study aims to provide more scientific basis for the diagnosis and management of PHC and is considered as an inexpensive, reproducible and easily calculable method to improve the accurate diagnosis and management of AKH in clinical practice., conditionsModule conditions: Lung Hydatid Cyst, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Operated patients with hydatid cyst of the lung, outcomesModule primaryOutcomes measure: Calculation of laboratory markers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 83 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, Van Training and Research Hospital, status: RECRUITING, city: Van, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False |
protocolSection identificationModule nctId: NCT06281509, orgStudyIdInfo id: S68374, briefTitle: Palmaris Longus Muscle and Dupuytren, acronym: Palmaris, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition., conditionsModule conditions: Dupuytren's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups: Patients with Dupuytren Disease and healthy control group. They will be age matched (50 years of age or higher) with the objective to have a proportionate division (50/50) between the genders., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: No masking will be done in this study, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands., interventions name: Ultrasound, outcomesModule primaryOutcomes measure: PLM in the DD versus control, primaryOutcomes measure: PML in mild versus severe DD-group, secondaryOutcomes measure: PLM presence in DD affected group, secondaryOutcomes measure: PLM presence in control group, secondaryOutcomes measure: Dominant versus non-dominant hand, secondaryOutcomes measure: Male versus female population, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitaire Ziekenhuizen KU Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Ilse Degreef, Prof. Dr., role: CONTACT, phone: +32 16 33 88 43, email: [email protected], contacts name: Anna Tarasiuk, role: CONTACT, phone: +32 16 33 88 18, email: [email protected], geoPoint lat: 50.87959, lon: 4.70093, hasResults: False |
protocolSection identificationModule nctId: NCT06281496, orgStudyIdInfo id: Rigshospitalet, Hematology, briefTitle: AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation, acronym: AlloCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: Danish Cancer Society, descriptionModule briefSummary: A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase., conditionsModule conditions: Hematological Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One site, two arm randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: AlloCare, outcomesModule primaryOutcomes measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100), secondaryOutcomes measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Mette Schaufuss Engedal, MSc, role: CONTACT, phone: +45 51896699, email: [email protected], contacts name: Mary Jarden, Professor, role: CONTACT, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06281483, orgStudyIdInfo id: APCs in chronic skin ulcers, briefTitle: PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, collaborators name: Helwan University, descriptionModule briefSummary: To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment., conditionsModule conditions: Chronic Non-healing Skin Ulcers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: platelet-rich plasma, interventions name: platelet-rich fibrin, interventions name: Surgical debridement, normal saline washing and dressing coverage, outcomesModule primaryOutcomes measure: Objective assessment of ulcer size for effectiveness, using Image J software., primaryOutcomes measure: Pain assessment, primaryOutcomes measure: Any adverse effects related to treatment modality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Badr Hospital - Helwan University and Kafrelseikh University Hospital, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Mohamed Aboshabana Hussein, Assistant Lecturer, role: CONTACT, phone: 01007981008, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06281470, orgStudyIdInfo id: WS016-Ⅰ-01, briefTitle: The Safety and Tolerability of WS016 in Healthy Chinese Volunteers, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-13, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Waterstone Pharmaceutical (Wuhan) Co., LTD., class: INDUSTRY, descriptionModule briefSummary: This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo., conditionsModule conditions: Hyperkalemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: WS016 Single Dose(6g), interventions name: WS016 Single Dose(12g), interventions name: WS016 Single Dose(24g), interventions name: WS016 Single Dose(36g), interventions name: WS016 Single Dose(48g), interventions name: SAD matching placebo, interventions name: WS016 Multiple Dose(12g), interventions name: WS016 Multiple Dose(24g), interventions name: WS016 Multiple Dose(48g), interventions name: MAD matching placebo, outcomesModule primaryOutcomes measure: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhejiang Xiaoshan Hospital, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06281457, orgStudyIdInfo id: 5-24-0030: 2.1, secondaryIdInfos id: R01EY035300, type: NIH, link: https://reporter.nih.gov/quickSearch/R01EY035300, briefTitle: Probing the Role of Feature Dimension Maps in Visual Cognition: Impact of Task Demands (Expt 2.1), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of California, Santa Barbara, class: OTHER, collaborators name: National Eye Institute (NEI), descriptionModule briefSummary: How does one know what to look at in a scene? Imagine a "Where's Waldo" game - it's challenging to find Waldo because there are many 'salient' locations in the picture, each vying for one's attention. One can only attend to a small location on the picture at a given moment, so to find Waldo, one needs to direct their attention to different locations. One prominent theory about how one accomplishes this claims that important locations are identified based on distinct feature types (for example, motion or color), with locations most unique compared to the background most likely to be attended. An important component of this theory is that individual feature dimensions (again, color or motion) are computed within their own 'feature maps', which are thought to be implemented in specific brain regions. However, whether and how specific brain regions contribute to these feature maps remains unknown.The goal of this study is to determine how brain regions that respond strongly to different feature types (color and motion) and which encode spatial locations of visual stimuli transform 'feature dimension maps' based on stimulus properties as a function of task instructions. The investigators hypothesize that feature-selective brain regions act as neural feature dimension maps, and thus encode representations of relevant location(s) based on their preferred feature dimension, such that the stimulus representation in the most relevant feature map is up-regulated to support adaptive behavior. The investigators will scan healthy human participants using functional MRI (fMRI) in a repeated-measures design while they view visual stimuli made relevant based on a cued feature dimension (e.g., color or motion). The investigators will employ state-of-the-art multivariate analysis techniques that allow them to reconstruct an 'image' of the stimulus representation encoded by each brain region to dissect how neural tissue identifies salient locations. Each participant will perform a challenging discrimination task based on the cued feature (report motion direction or color of stimulus dots) of a stimulus presented in the periphery, which are identical across trial types. Across trials the investigators will manipulate the attended feature value (color, motion, or fixation point). This manipulation will help the investigators fully understand these critical relevance computations in the healthy human visual system., conditionsModule conditions: Basic Science: Visual Attention in Healthy Participants, conditions: Basic Science: Neural Representations of Location, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a basic science study in which all participants will participate in all task conditions within each experiment (repeated-measures design)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants will typically be unaware of the conditions presented, though because these involve manipulations of stimuli or task demands, they may be aware of the manipulation. This is not expected to impact the primary outcome measures (e.g., BOLD signal activation patterns)., enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Stimulus properties: task-defining feature, outcomesModule primaryOutcomes measure: Blood Oxygenation Level Dependent (BOLD) fMRI signal, primaryOutcomes measure: Gaze position, primaryOutcomes measure: Behavioral response (button press), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, Santa Barbara, status: RECRUITING, city: Santa Barbara, state: California, zip: 93117, country: United States, contacts name: Melodie Blakemore, role: CONTACT, phone: 805-893-4286, email: [email protected], contacts name: Tommy C Sprague, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.42083, lon: -119.69819, hasResults: False |
protocolSection identificationModule nctId: NCT06281444, orgStudyIdInfo id: i07-453-23, briefTitle: Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ankara University, class: OTHER, descriptionModule briefSummary: Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients who accepted to participate in the study by meeting the criteria will be randomly divided into two groups as the first group treatment ESWT + exercise, the second group sham ESWT + exercise., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Patients who meet the study conditions and agree to participate in this study will not know whether they are in the first group or the second group., enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: ESWT, interventions name: Sham-ESWT, outcomesModule primaryOutcomes measure: Change in pain [by using the Visual Analogue Scale(VAS)], secondaryOutcomes measure: Change from baseline in functionality and walking distance, secondaryOutcomes measure: Change from baseline in walking distance, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara University, status: RECRUITING, city: Ankara, state: Altındağ, zip: 06230, country: Turkey, contacts name: Birkan Sonel Tur, Prof. Dr., role: CONTACT, phone: +903125956331, email: [email protected], contacts name: Taha Can Başar, Dr., role: CONTACT, phone: +90312595 6331/2822, email: [email protected], contacts name: Birkan Sonel Tur, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Taha Can Başar, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06281431, orgStudyIdInfo id: CPSP, briefTitle: A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-12, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \>20% of patients suffer from chronic postoperative pain. China has \>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management., conditionsModule conditions: Chronic Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Echogenic nerve block needle, interventions name: Non-echogenic nerve block needle, outcomesModule primaryOutcomes measure: Chronic postoperative pain, primaryOutcomes measure: Moderate to severe pain, secondaryOutcomes measure: Acute postoperative pain, secondaryOutcomes measure: Acute postoperative pain, secondaryOutcomes measure: Acute postoperative pain, secondaryOutcomes measure: Puncture operation time, secondaryOutcomes measure: Number of needle passes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: He Huang, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 4000000, country: China, contacts name: He Huang, ph.D, role: CONTACT, phone: 13708385559, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06281418, orgStudyIdInfo id: 5-24, briefTitle: Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Future University in Egypt, class: OTHER, descriptionModule briefSummary: Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC., conditionsModule conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Granisetron 1 Mg/mL Intravenous Solution, interventions name: Normal saline, outcomesModule primaryOutcomes measure: VAS score, secondaryOutcomes measure: Time to analgesic request, secondaryOutcomes measure: Quality of life (QoL) after laparoscopic cholecystectomy (LC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Hepatology and Tropical Research Institute, status: RECRUITING, city: Cairo, zip: 11617, country: Egypt, contacts name: Hoda Mohamed Bayoumi, Bachelor's, role: CONTACT, phone: 01126143971, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06281405, orgStudyIdInfo id: FDRT-2023-290-3409, briefTitle: CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer, acronym: TORCH-iTNT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc., conditionsModule conditions: Locally Advanced Rectal Cancer, conditions: Neoadjuvant Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 198, type: ESTIMATED, armsInterventionsModule interventions name: PD-1 antibody, interventions name: Capecitabine, interventions name: Short-course radiotherapy, outcomesModule primaryOutcomes measure: Complete response (CR) rate, secondaryOutcomes measure: Grade 3-4 adverse effects rate, secondaryOutcomes measure: 3 year anal preservation rate, secondaryOutcomes measure: 3 year disease free survival rate, secondaryOutcomes measure: 3 year local recurrence free survival rate, secondaryOutcomes measure: 3 year overall survival rate, secondaryOutcomes measure: Rate of surgical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06281392, orgStudyIdInfo id: CEIm: 106/23, briefTitle: Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2026-11-15, completionDateStruct date: 2026-11-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, class: OTHER, collaborators name: University of Valencia, descriptionModule briefSummary: Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD)., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Dysplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: CADe system, interventions name: NBI, outcomesModule primaryOutcomes measure: "Per lesion" dysplasia detection rate (DDR), primaryOutcomes measure: "Per patient" dysplasia detection rate (DDR), secondaryOutcomes measure: Duration of endoscopic examination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antonio López-Serrano, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Antonio López-Serrano, Ph.D., role: CONTACT, phone: 0034656495490, email: [email protected], geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06281379, orgStudyIdInfo id: Basaksehir City Hospital, briefTitle: Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.Study design:Randomised-controlled studyPlace and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization., conditionsModule conditions: Gastric Cancer, conditions: Gastric Neoplasm, conditions: Gastric Cancer Stage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Total mesogastrectomy, outcomesModule primaryOutcomes measure: Postoperative outcome, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yigit Duzkoylu, city: Istanbul, zip: 34480, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06281366, orgStudyIdInfo id: PR(AMI)470-2023, briefTitle: Diamine Oxidase and Adverse Pregnancy Outcomes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, collaborators name: DR Healthcare, descriptionModule briefSummary: In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity., conditionsModule conditions: Pregnancy Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diamine oxidase activity first trimester, primaryOutcomes measure: Diamine oxidase gene polymorphisms, secondaryOutcomes measure: Blood Diamine oxidase activity at delivery, secondaryOutcomes measure: Placental Diamine oxidase activity at delivery, secondaryOutcomes measure: Blood histamine levels at delivery, secondaryOutcomes measure: Placental histamine levels at delivery, secondaryOutcomes measure: Urine histamine levels at delivery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manel Mendoza, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Manel Mendoza, PhD, role: CONTACT, phone: +34934893085, email: [email protected], contacts name: Erika Bonacina, PhD, role: CONTACT, phone: +34934893264, email: [email protected], contacts name: Erika Bonacina, PhD, role: SUB_INVESTIGATOR, contacts name: Manel Mendoza, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mireia Armengol, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06281353, orgStudyIdInfo id: 22-07-0754, briefTitle: The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-16, primaryCompletionDateStruct date: 2023-09-06, completionDateStruct date: 2023-09-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include:* To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and* To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin.The main questions it aims to answer are:* Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)?* Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls?* Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW?Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW., conditionsModule conditions: Anogenital Wart, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Curcumin Oral Capsule, interventions name: Trichloroacetic acid, interventions name: Blood sample collection, interventions name: Cotton swab, outcomesModule primaryOutcomes measure: Clinical improvement in patients with AGW, secondaryOutcomes measure: Level of IFN-γ in lesions of AGW patients, secondaryOutcomes measure: Level of FOXP3+Treg in lesions of AGW patients, secondaryOutcomes measure: Level of NFĸB in lesions of AGW patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, city: Jakarta Pusat, state: DKI Jakarta, zip: 10430, country: Indonesia, geoPoint lat: -6.1818, lon: 106.8223, hasResults: False |
protocolSection identificationModule nctId: NCT06281340, orgStudyIdInfo id: He-ankle US, briefTitle: Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-21, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Investigación en Hemofilia y Fisioterapia, class: NETWORK, descriptionModule briefSummary: Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, maskingDescription: Randomization will be performed using a computerized randomization procedure by permuted blocks of 4 subjects in each recruitment center. The 6 possible sequence alternatives will be modified in each block. This task will be carried out by a person who is not involved in the study and who will not know the identity of the subjects., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Manual therapy, interventions name: Placebo therapy, outcomesModule primaryOutcomes measure: Change from baseline sonographic changes after 4 hours, secondaryOutcomes measure: Change from baseline joint pain after 4 hours, secondaryOutcomes measure: Change from baseline joint damage after 4 hours, secondaryOutcomes measure: Change from baseline degree of joint inflammation after 4 hours, eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Oviedo, city: Oviedo, state: Asturias, zip: 33006, country: Spain, geoPoint lat: 43.36029, lon: -5.84476, hasResults: False |
protocolSection identificationModule nctId: NCT06281327, orgStudyIdInfo id: TX-ITP-001, briefTitle: Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, collaborators name: Henan Cancer Hospital, collaborators name: Tianjin Medical University Second Hospital, collaborators name: Tianjin Children's Hospital, collaborators name: The Second Affiliated Hospital of Kunming Medical University, descriptionModule briefSummary: To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons., conditionsModule conditions: Immune Thrombocytopenia, conditions: Treatment, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Avatrombopag, outcomesModule primaryOutcomes measure: Overall efficacy response after AVA treatment within 12 weeks, secondaryOutcomes measure: Treatment response-1, secondaryOutcomes measure: Treatment response-2, secondaryOutcomes measure: Time to Response, secondaryOutcomes measure: Persistent response, secondaryOutcomes measure: Emergency treatment, secondaryOutcomes measure: Reduction of concomitant drug, secondaryOutcomes measure: Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale., secondaryOutcomes measure: Number of participants with clinically significant bleeding as assessed using the bleeding scale for pediatric patients with ITP., secondaryOutcomes measure: Health-related quality of life survey of subjects(HRQoL)-1, secondaryOutcomes measure: Health-related quality of life survey of subjects(HRQoL)-2, secondaryOutcomes measure: Health-related quality of life survey of subjects(HRQoL)-3, secondaryOutcomes measure: Health-related quality of life survey of subjects(HRQoL)-4, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Tianjin, country: China, contacts name: Lei Zhang, MD, role: CONTACT, phone: +8602223909009, email: [email protected], contacts name: Ting Sun, MD, role: CONTACT, phone: +8602223909009, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06281314, orgStudyIdInfo id: VESPA 2.0, briefTitle: The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2022-12-27, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders., conditionsModule conditions: Neurodegenerative Diseases, conditions: Cognitive Decline, conditions: Parkinson Disease Dementia, conditions: Alzheimer Disease, conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Vespa software, outcomesModule primaryOutcomes measure: Montreal cognitive assessment (MoCA), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi Bonino Pulejo, city: Messina, state: Sicily, zip: 98124, country: Italy, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False |
protocolSection identificationModule nctId: NCT06281301, orgStudyIdInfo id: HSC-MS-23-1023, briefTitle: Improving Patient Understanding of Macrosomia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool., conditionsModule conditions: Macrosomia, Fetal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: education tool, interventions name: no additional information, outcomesModule primaryOutcomes measure: Number of participants that showed Macrosomia knowledge greater than 50 percent as assessed by the score on a survey, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Kristen Cagino, MD, role: CONTACT, phone: 713-500-6412, email: [email protected], contacts name: Suneet Chauhan, role: CONTACT, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06281288, orgStudyIdInfo id: P.T.REC/012/004754, briefTitle: Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-25, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Doaa Tammam Atia, class: OTHER, descriptionModule briefSummary: PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptomsBACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive-Behavioral Therapy, interventions name: Exercise Training, outcomesModule primaryOutcomes measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC),, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: doaa Tammam Atia, city: Suez, country: Egypt, geoPoint lat: 29.97371, lon: 32.52627, hasResults: False |
protocolSection identificationModule nctId: NCT06281275, orgStudyIdInfo id: TJ-IRB202402008, briefTitle: A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: To gain a clearer understanding of the association between frailty and postoperative acute pain in elderly thoracoscopic surgery patients and its underlying mechanisms, to provide new solution ideas to reduce the level of postoperative acute pain and improve the debilitating state of elderly thoracoscopic surgery patients, and consequently improve their quality of life and mental status., conditionsModule conditions: Frailty, conditions: Acute Postoperative Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 78, type: ESTIMATED, outcomesModule primaryOutcomes measure: All patients' Numerical Rating Scale （NRS） scores for most significant pain at rest in the 48h postoperative period, primaryOutcomes measure: Numerical Rating Scale （NRS） scores for the most pronounced pain in the patient's coughing state in the 48h postoperative period, secondaryOutcomes measure: PCA pump consumption, secondaryOutcomes measure: Number of PCA pump presses, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06281262, orgStudyIdInfo id: GIP-23-L-04-223, briefTitle: Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia, acronym: PRIME, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: General University Hospital, Prague, class: OTHER, collaborators name: Charles University, Czech Republic, collaborators name: Institute of Hematology and Blood Transfusion, Czech Republic, descriptionModule briefSummary: The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota., conditionsModule conditions: Preterm Birth, conditions: Preeclampsia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Peripheral blood collection, interventions name: Swab sample collection, outcomesModule primaryOutcomes measure: Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth, primaryOutcomes measure: Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia, secondaryOutcomes measure: Association of maternal microbiota and maternal T regulatory cell populations., eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague, status: RECRUITING, city: Prague, zip: 128 08, country: Czechia, contacts name: Zdeněk Laštůvka, MUDr., Ph.D., role: CONTACT, phone: +420777724640, email: [email protected], contacts name: Michal Koucký, Doc., MUDr., Ph.D., role: CONTACT, phone: +420603219916, email: [email protected], geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06281249, orgStudyIdInfo id: 73172, briefTitle: Neuraxial Ultrasound Device Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: Rivanna Medical, Inc., descriptionModule briefSummary: The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method., conditionsModule conditions: Labor Pain, conditions: Cesarean Delivery Regional Anesthesia Induction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound placement device, outcomesModule primaryOutcomes measure: Incidence of difficult block placement, secondaryOutcomes measure: Incidence of failed block, secondaryOutcomes measure: Incidence of post-dural puncture headache, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False |
protocolSection identificationModule nctId: NCT06281236, orgStudyIdInfo id: SPI-62-CL-1002, briefTitle: A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sparrow Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited., conditionsModule conditions: Polymyalgia Rheumatica, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Prednisolone, interventions name: SPI-62, outcomesModule primaryOutcomes measure: Erythrocyte sedimentation rate, primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Plasma fibrinogen, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emovis Gmbh, city: Berlin, country: Germany, contacts name: Anna Wieczorek, role: CONTACT, phone: +49 30 439741221, email: [email protected], contacts name: Frank Zollmann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Klinische Forschung Hannover Mitte GmbH/Pratia, city: Hannover, zip: 30159, country: Germany, contacts name: Matilde Planer, role: CONTACT, phone: +49 511 169 7650, email: [email protected], contacts name: Jan Wagner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37052, lon: 9.73322, locations facility: Klinische Forschung Schwerin GmbH/Pratia, city: Schwerin, zip: 19055, country: Germany, contacts name: Julia Grindel, role: CONTACT, phone: +49 385 557 740, email: [email protected], contacts name: Charlotte von Engelhardt, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.62937, lon: 11.41316, hasResults: False |
protocolSection identificationModule nctId: NCT06281223, orgStudyIdInfo id: JBR_2023_9, briefTitle: Study of Brain-spinal Cord Neural Connectivity in Spasticity, acronym: MOVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondation Ophtalmologique Adolphe de Rothschild, class: NETWORK, descriptionModule briefSummary: Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic., conditionsModule conditions: Spasticity, Muscle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: intraoperative neuroelectrophysiological monitoring, outcomesModule primaryOutcomes measure: variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06281210, orgStudyIdInfo id: IEO 2034, briefTitle: Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery, acronym: BETTY-CRASY, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT., conditionsModule conditions: Breast Cancer, conditions: Triple Negative Breast Cancer, conditions: HER2-positive Breast Cancer, conditions: Neoadjuvant Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: Omission of surgical treatment, outcomesModule primaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Positive predictive value of MRI, secondaryOutcomes measure: Contrast-Enhanced Mammography (CEM) positive predictive value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto di Candiolo IRCCS, status: NOT_YET_RECRUITING, city: Candiolo, state: Turin, zip: 10060, country: Italy, contacts name: Antonio Toesca, MD, role: CONTACT, geoPoint lat: 44.95858, lon: 7.59812, locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Elisabetta Rossi, MD, role: CONTACT, phone: +390294372191, email: [email protected], contacts name: Mara Negri, role: CONTACT, email: [email protected], contacts name: Elisabetta Rossi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06281197, orgStudyIdInfo id: 2021/48, briefTitle: Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2021-08-15, completionDateStruct date: 2022-05-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation., conditionsModule conditions: Maxillofacial Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double blind, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double blind, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Conventional, interventions name: Subspinal, outcomesModule primaryOutcomes measure: Evaluation of Septum Deviation, primaryOutcomes measure: Evaluation of Nasal Airway, secondaryOutcomes measure: nasal obstruction scale evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selin Çelebi, city: Kayseri, state: Meligazi, zip: 38320, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06281184, orgStudyIdInfo id: DIA2024.1, secondaryIdInfos id: 715758, type: REGISTRY, domain: Regional committee for medical and health research ethics, briefTitle: A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA., acronym: MERINO:2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Diakonhjemmet Hospital, class: OTHER, descriptionModule briefSummary: In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression., conditionsModule conditions: Hand Osteoarthritis, conditions: Erosive Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, interventions name: No treatment, outcomesModule primaryOutcomes measure: Effect of MTX on radiographic progression of erosive hand OA., secondaryOutcomes measure: Effect of MTX on pain, function and life quality, secondaryOutcomes measure: Effect of MTX on radiographic progression of hand OA., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diakonhjemmet Hospital, city: Oslo, zip: 0319, country: Norway, contacts name: Ida Løchting, role: CONTACT, phone: +4722451500, email: [email protected], contacts name: Alexander Mathiessen, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False |
protocolSection identificationModule nctId: NCT06281171, orgStudyIdInfo id: 90BISB0022, briefTitle: Evaluation of SkillTalk for Autistic Young Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: dfusion Inc, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.The main questions it aims to answer are:* Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?* Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?* Does using SkillTalk increase interpersonal competence?* Does using SkillTalk increase ability to cope with rejection?* Does using SkillTalk improve mental health and wellbeing?Participants will be asked to:* Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up* Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up* Watch a minimum of 85% of the 60 minutes of video assigned, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: SkillTalk for Autistic Young Adults, interventions name: Flyer Library, outcomesModule primaryOutcomes measure: Demonstrated Skill Score in communication skills., secondaryOutcomes measure: Participant Confidence & Satisfaction in their communication skills, secondaryOutcomes measure: Interpersonal Competence Score, secondaryOutcomes measure: Coping with Rejection, Jealousy and Relationship Anxiety, secondaryOutcomes measure: Mental Health and Wellbeing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 28 Years, stdAges: ADULT, contactsLocationsModule locations facility: Virtual Study, city: Santa Cruz, state: California, zip: 95060, country: United States, geoPoint lat: 36.97412, lon: -122.0308, hasResults: False |
protocolSection identificationModule nctId: NCT06281158, orgStudyIdInfo id: DNLI-F-0009, briefTitle: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Denali Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-DNL343, outcomesModule primaryOutcomes measure: PK Parameter: AUC0-∞, primaryOutcomes measure: PK Parameter: AUC0-tlast, primaryOutcomes measure: PK Parameter: Cmax, primaryOutcomes measure: PK Parameter: Tmax, primaryOutcomes measure: PK Parameter: t1/2, primaryOutcomes measure: Total radioactivity in plasma and whole blood, primaryOutcomes measure: Total radioactivity in blood-to-plasma ratio, primaryOutcomes measure: Extent and rate of recovery of total radioactivity in urine and feces, secondaryOutcomes measure: PK Parameter: AUC0-∞, secondaryOutcomes measure: PK Parameter: AUC0-tlast, secondaryOutcomes measure: PK Parameter: Cmax, secondaryOutcomes measure: PK Parameter: Tmax, secondaryOutcomes measure: PK Parameter: t1/2, secondaryOutcomes measure: DNL343 and a DNL343 metabolite recoveries in urine, secondaryOutcomes measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Site, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06281145, orgStudyIdInfo id: RSV-SK001/UC-SK004/OUSA, briefTitle: Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer, acronym: SRI-BrCa_CRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2029-03-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Comenius University, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC)., conditionsModule conditions: Breast Cancer, conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study consists of two cohorts (breasts cancer and colorectal cancer) with two arms SOC + intervention vs SOC alone., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Heart-rate variability biofeedback intervention, outcomesModule primaryOutcomes measure: Primary endpoint - inflammation, primaryOutcomes measure: Primary endpoint - QoL, primaryOutcomes measure: Primary endpoint - executive functions, primaryOutcomes measure: Primary endpoint- salivary cortisol slopes, primaryOutcomes measure: Primary endpoint- sleep quality, primaryOutcomes measure: Primary endpoint - heart rate variability (HRV), primaryOutcomes measure: Primary endpoint - Working memory, secondaryOutcomes measure: Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A, secondaryOutcomes measure: Secondary endpoint - Relapse-free Survival (RFS), secondaryOutcomes measure: Secondary endpoint - Overall survival (OS), secondaryOutcomes measure: Secondary endpoint - Serious Adverse Events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Elizabeth Cancer Institute, status: RECRUITING, city: Bratislava, zip: 81250, country: Slovakia, contacts name: Bela Mrinakova, MD, role: CONTACT, phone: 00421232249111, email: [email protected], contacts name: Miriam Hancinova, MD, role: CONTACT, phone: 00421232249111, email: [email protected], contacts name: Bela Mrinakova, role: PRINCIPAL_INVESTIGATOR, contacts name: Miriam Hancinova, role: SUB_INVESTIGATOR, geoPoint lat: 48.14816, lon: 17.10674, hasResults: False |
protocolSection identificationModule nctId: NCT06281132, orgStudyIdInfo id: A126_03BE2316, briefTitle: Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-14, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Chong Kun Dang Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: CKD-341, D956, outcomesModule primaryOutcomes measure: area under curve(AUC) of CKD-341, D956, primaryOutcomes measure: Cmax of CKD-341, D956, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jeonbuk National University Hospital, city: Jeonju, country: Korea, Republic of, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False |
protocolSection identificationModule nctId: NCT06281119, orgStudyIdInfo id: SII-qHPV/MC-03, briefTitle: Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Serum Institute of India Pvt. Ltd., class: INDUSTRY, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years., conditionsModule conditions: Human Papillomavirus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Cervavac as three dose regimen, interventions name: Cervavac as two dose regimen, interventions name: Gardasil as three dose regimen, outcomesModule primaryOutcomes measure: Geometric mean titers of anti HPV 16 and 18 IgG antibodies, secondaryOutcomes measure: Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies, secondaryOutcomes measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion, secondaryOutcomes measure: Adverse Events, otherOutcomes measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion, otherOutcomes measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage, otherOutcomes measure: CD4+ cell count, HIV viral load, and HIV clinical staging, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Centre For Clinical Research, Kemri, city: Nairobi, zip: 54840-00200, country: Kenya, contacts name: Nelly Mugo, role: CONTACT, phone: +254733629665, email: [email protected], geoPoint lat: -1.28333, lon: 36.81667, locations facility: Partners in Health and Research Development (Phrd), city: Thika, zip: 19865-00202, country: Kenya, contacts name: Nelly Mugo, role: CONTACT, phone: +254733629665, email: [email protected], geoPoint lat: -1.03326, lon: 37.06933, locations facility: Manhiça Health Research Center - Manhiça Foundation (CISM-FM), city: Manhiça, zip: 1929, country: Mozambique, contacts name: Tacilta Nhampossa, role: CONTACT, phone: +258 21 810 181, email: [email protected], locations facility: Clinical HIV Research Unit (CHRU), Helen Joseph Hospital, city: Johannesburg, zip: 2092, country: South Africa, contacts name: Carla Chibwesha, role: CONTACT, phone: +27 072 744 7899, email: [email protected], geoPoint lat: -26.20227, lon: 28.04363, hasResults: False |
protocolSection identificationModule nctId: NCT06281106, orgStudyIdInfo id: IM011-1118, secondaryIdInfos id: KOFAM 2023-01731, type: OTHER, domain: CER-VD, briefTitle: TYK2 Inhibition in Paradoxical Psoriasis, acronym: TYPP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Prof Curdin Conrad, class: OTHER, collaborators name: Centre Hospitalier Universitaire Vaudois, descriptionModule briefSummary: Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During 4 weeks the patients of the 2 arms receive either Deucravacitinib 6mg 1x/day or an identically looking placebo.At Week 4, Patients with underlying disease of Crohn's disease, colitis ulcerosa, uveitis will stop the study, to avoid that they are too long without efficient treatment for their underlying disease.Patients with underlying disease of psoriasis or psoriatic arthritis will have the possiblity to continue in Part 2, where they all will receive Deucravacitinib 6mg 1x/day, open label for 3 months, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Lab personnel, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Deucravacitinib, outcomesModule primaryOutcomes measure: Paradoxical Psoriasis Investigator Global Assessment, secondaryOutcomes measure: Paradoxical Psoriasis Body Surface Area, secondaryOutcomes measure: Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index, secondaryOutcomes measure: Paradoxical Psoriasis Scalp Investigator General Assessment, secondaryOutcomes measure: Psoriasis Area and Severity Index (PASI), secondaryOutcomes measure: American College of Rheumatology (ACR) Score, otherOutcomes measure: Nanostring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier universitaire vaudois (CHUV), city: Lausanne, state: VD, zip: 1011, country: Switzerland, contacts name: Franziska Stuber, RN, role: CONTACT, phone: +41 21 3143427, email: [email protected], contacts name: Curdin Conrad, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False |
protocolSection identificationModule nctId: NCT06281093, orgStudyIdInfo id: PI2022_843_0089, briefTitle: Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System, acronym: CHARLINE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, collaborators name: University Hospital, Brest, collaborators name: CHU LYON, collaborators name: University Hospital, Strasbourg, France, collaborators name: University Hospital, Toulouse, descriptionModule briefSummary: Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase., conditionsModule conditions: Preterm Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: questionary, interventions name: Daily continuous recording of radiofrequency exposure levels, interventions name: Follow-up of daily infants clinical parameters, interventions name: recording of cerebral (EEG), interventions name: autonomic nervous (ECG) activity, outcomesModule primaryOutcomes measure: Variation of the spectral power in the α band (8-12 Hz) of the EEG, secondaryOutcomes measure: variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule locations facility: Amiens University Hospital, status: RECRUITING, city: Amiens, state: Picardie, zip: 80054, country: France, contacts name: Pierre Tourneux, MD, role: CONTACT, phone: +33 3 22 66 82 86, email: [email protected], contacts name: Erwan STÉPHAN-BLANCHARD, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Stéphane DELANAUD, PhD, role: SUB_INVESTIGATOR, contacts name: Frédéric TELLIEZ, Pr, role: SUB_INVESTIGATOR, contacts name: Karen CHARDON, Pr, role: SUB_INVESTIGATOR, contacts name: Brahim SELMAOUI, Dr, role: SUB_INVESTIGATOR, contacts name: Débora TUKA, role: SUB_INVESTIGATOR, contacts name: Jean-Michel ROUÉ, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Marine BUTIN, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierre KUHN, Pr, role: PRINCIPAL_INVESTIGATOR, contacts name: Géraldine GASCOIN, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False |
protocolSection identificationModule nctId: NCT06281080, orgStudyIdInfo id: CRE2023.589-T, briefTitle: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Agilis Robotics Limited, descriptionModule briefSummary: This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: En-Bloc Resection of Bladder Tumours, outcomesModule primaryOutcomes measure: Successful en-bloc tumour resection by the robotic system, secondaryOutcomes measure: Dissection time and speed, secondaryOutcomes measure: Total procedure time, secondaryOutcomes measure: Surgeon Console time, secondaryOutcomes measure: Presence of detrusor muscle in specimen, secondaryOutcomes measure: Resection Margin, secondaryOutcomes measure: Intra-operative bladder perforation event, secondaryOutcomes measure: Post-operative complications, secondaryOutcomes measure: Need of bladder irrigation, secondaryOutcomes measure: Residual tumour or upstaging of tumour after second look TURBT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06281067, orgStudyIdInfo id: 271.673, briefTitle: Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine, acronym: RIALTO PRO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, collaborators name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro", descriptionModule briefSummary: The "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment., conditionsModule conditions: Myocardial Bridge, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: "full-physiology approach" arm, interventions name: "standard approach" arm, outcomesModule primaryOutcomes measure: The composite of significant angina and MACE, secondaryOutcomes measure: Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70), secondaryOutcomes measure: Incidence of MACE, secondaryOutcomes measure: Rate of cardiac death, secondaryOutcomes measure: Rate of MI, secondaryOutcomes measure: Rate of cardiac hospitalization, secondaryOutcomes measure: Rate of TLR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Generale Regionale F. Miulli, status: NOT_YET_RECRUITING, city: Acquaviva Delle Fonti, country: Italy, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo, status: NOT_YET_RECRUITING, city: Alessandria, country: Italy, geoPoint lat: 44.90924, lon: 8.61007, locations facility: Ospedale San Donato, status: NOT_YET_RECRUITING, city: Arezzo, country: Italy, geoPoint lat: 43.46276, lon: 11.88068, locations facility: ASST Papa Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bergamo, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Ospedale degli Infermi di Biella, status: NOT_YET_RECRUITING, city: Biella, country: Italy, geoPoint lat: 45.56304, lon: 8.05796, locations facility: Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria, status: NOT_YET_RECRUITING, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano, status: NOT_YET_RECRUITING, city: Caserta, country: Italy, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Villa Maria Cecilia Hospital, status: NOT_YET_RECRUITING, city: Cotignola, country: Italy, geoPoint lat: 44.38572, lon: 11.93852, locations facility: Azienda Ospedaliero Universitaria di Ferrara, status: NOT_YET_RECRUITING, city: Ferrara, country: Italy, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Azienda Ospedaliero Universitaria Careggi, status: NOT_YET_RECRUITING, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliera Universitaria Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale Della Misericordia, status: NOT_YET_RECRUITING, city: Grosseto, country: Italy, geoPoint lat: 42.76296, lon: 11.10941, locations facility: Centro Cardiologico Monzino IRCCS, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale Galeazzi, status: NOT_YET_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS San Gerardo dei Tintori, status: NOT_YET_RECRUITING, city: Monza, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Domenico D'Amario, Prof, role: CONTACT, phone: 0039 0321 3733141, email: [email protected], contacts name: Domenico D'Amario, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Giuseppe Patti, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Azienda Ospedaliero Universitaria di Parma, status: NOT_YET_RECRUITING, city: Parma, country: Italy, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Azienda Ospedaliera di Perugia, status: NOT_YET_RECRUITING, city: Perugia, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Azienda Ospedaliero Universitaria Pisana, status: NOT_YET_RECRUITING, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale San Jacopo, status: NOT_YET_RECRUITING, city: Pistoia, country: Italy, geoPoint lat: 43.93064, lon: 10.92365, locations facility: Ospedali Riuniti di Rivoli, status: NOT_YET_RECRUITING, city: Rivoli, country: Italy, geoPoint lat: 45.07073, lon: 7.51465, locations facility: Aurelia Hospital, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliera San Camillo-Forlanini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero Universitaria Sant'Andrea, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Santo Spirito, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Universitario Tor Vergata Fondazione PTV, status: NOT_YET_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Civile Santissima Annunziata, status: NOT_YET_RECRUITING, city: Sassari, country: Italy, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Azienda Sanitaria Provinciale di Siracusa, status: NOT_YET_RECRUITING, city: Siracusa, country: Italy, geoPoint lat: 37.08415, lon: 15.27628, locations facility: Azienda Ospedaliera Ordine Mauriziano, status: NOT_YET_RECRUITING, city: Torino, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Azienda Ospedaliero Universitaria Città Della Salute E Scienza, status: NOT_YET_RECRUITING, city: Torino, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Presidio Ospedaliero Sant'Andrea, status: NOT_YET_RECRUITING, city: Vercelli, country: Italy, geoPoint lat: 45.32163, lon: 8.41989, locations facility: Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento, status: NOT_YET_RECRUITING, city: Verona, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06281054, orgStudyIdInfo id: SMC2023-12-027, briefTitle: Acute Myocardial Infarction in Cancer Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2002-01-01, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: Chonnam National University, descriptionModule briefSummary: Using national health insurance service database, current study aim to evaluate the risk and prognosis of acute myocardial infarction in cancer patients and to find the optimal treatment strategy for acute myocardial infarction that can improve long-term prognosis., conditionsModule conditions: Acute Myocardial Infarction, conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4500000, type: ESTIMATED, armsInterventionsModule interventions name: Revascularization, outcomesModule primaryOutcomes measure: All-cause death, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Revascularization, secondaryOutcomes measure: Hospitalization for heart failure, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Clinically relevant bleeding, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chonnam National University Hospital, Chonnam National University Medical School, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, hasResults: False |
protocolSection identificationModule nctId: NCT06281041, orgStudyIdInfo id: NHIS20240220, briefTitle: Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention, acronym: NHIS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2013-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: Chonnam National University, descriptionModule briefSummary: There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR\>0.80)., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Artery Stenosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4657, type: ACTUAL, armsInterventionsModule interventions name: Antiplatelet Agents, outcomesModule primaryOutcomes measure: Major adverse cardiac and cerebrovascular events, primaryOutcomes measure: Gastrointestinal bleeding, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Unplanned revascularization, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: Gastrointestinal bleeding necessitated hospitalization without documented transfusion, secondaryOutcomes measure: Intracranial hemorrhage, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chonnam National University Medical School, city: Gwangju, country: Korea, Republic of, geoPoint lat: 35.15472, lon: 126.91556, hasResults: False |
protocolSection identificationModule nctId: NCT06281028, orgStudyIdInfo id: 2023-A02280-45, briefTitle: SOLACEA-H in Heparin-sparing Haemodialysis, acronym: SOLHEPA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU), conditionsModule conditions: Dialysis Membrane Reaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective, multicenter, randomized, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: SOLACEA-H/HYDROLINK-NVU, interventions name: HYDROLINK-NVU/SOLACEA-H, outcomesModule primaryOutcomes measure: SOLACEA-H vs HYDROLINK-NVU efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Privé La Louvière, city: Lille, zip: 59800, country: France, contacts name: Maxime HOFFMANN, MD, role: CONTACT, phone: 6 86 70 91 23, phoneExt: +33, email: [email protected], geoPoint lat: 50.63297, lon: 3.05858, hasResults: False |
protocolSection identificationModule nctId: NCT06281015, orgStudyIdInfo id: 2023PI095-407, briefTitle: Artificial Intelligence and Bone Tomoscintigraphies Achieved With CZT Camera, acronym: IATOS, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2023-09-10, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: This study aimed to determine whether the whole-body bone Single Photon Emission Computed Tomography (SPECT) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (CZT) camera, can be further reduced by a deep learning noise reduction (DLNR) algorithm., conditionsModule conditions: Bone Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 19, type: ACTUAL, armsInterventionsModule interventions name: Whole-body bone single photon emission tomography (SPECT) for detection or follow-up of bone metastasis, outcomesModule primaryOutcomes measure: Assess a dedicated deep learning noise reduction algorithm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU Nancy, city: Vandoeuvre les Nancy cedex, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False |
protocolSection identificationModule nctId: NCT06281002, orgStudyIdInfo id: FDASU-RecIM112323, briefTitle: Trueness of Full Arch Scans and Generated Digital Implant Models, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible., conditionsModule conditions: Denture, conditions: Complete Edentulism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: conventional impression stone casts digitization, interventions name: digital scanning with coupled scanning aiding device, interventions name: Digital Implant Model assessment of accuracy, outcomesModule primaryOutcomes measure: Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies., secondaryOutcomes measure: Trueness of the generated 3D-printed digital implant models., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06280989, orgStudyIdInfo id: P.T.REC/012/004768, briefTitle: Effect of Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females, conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: kinesio taping and myofascial release technique, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: kinesio taping, interventions name: myofascial release technique, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: pain pressure threshold, secondaryOutcomes measure: severity of dysmenorrhea, secondaryOutcomes measure: Assess the function disability level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hala mohamed ahmed morsy, city: Giza, zip: 12511, country: Egypt, contacts name: hala ma morsy, Bachelor, role: CONTACT, phone: 00201028616865, email: [email protected], geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06280976, orgStudyIdInfo id: 23.0001, briefTitle: Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP), acronym: ARTCAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-01-31, completionDateStruct date: 2029-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat., conditionsModule conditions: Coronary Artery Disease, conditions: Atherosclerosis, conditions: Heart Attack, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PROBE design: Prospective Randomized Open Label Blinded End-point, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Statin, interventions name: Aspirin tablet, interventions name: Nexlizet, interventions name: LEQVIO, interventions name: Vascepa, interventions name: Jardiance, interventions name: Colchicine, outcomesModule primaryOutcomes measure: Plaque quantification, primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - positive remodeling, primaryOutcomes measure: Quantification of stenosis, primaryOutcomes measure: Quantification of pericoronary fat attenuation., primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - low CT attenuation, primaryOutcomes measure: Characterization of plaque to evaluate for high-risk features - napkin-ring sign, primaryOutcomes measure: Quantification of epicardial fat attenuation., secondaryOutcomes measure: Major adverse cardiac and cardiovascular events (MACCE), secondaryOutcomes measure: Polygenic risk score (PRS), secondaryOutcomes measure: Next generation sequencing (NGS), secondaryOutcomes measure: Change in Lipoprotein (a), secondaryOutcomes measure: Change in myeloperoxidase (MPO) activity, secondaryOutcomes measure: Change in trimethylamine-N-oxide (TMAO) levels, secondaryOutcomes measure: Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels, secondaryOutcomes measure: Change in interleukin-6 (IL-6) levels, secondaryOutcomes measure: Change in high sensitivity C-creative protein (HS-CRP) levels, secondaryOutcomes measure: Buffy coat for chromatin immunoprecipitation (ChIP), secondaryOutcomes measure: Change in high sensitivity Troponin (HS-Tn), secondaryOutcomes measure: Change in natriuretic peptide (BNP, NT-pro BNP, secondaryOutcomes measure: Change in levels of open reading frame 1 protein (ORF1p), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Dinesh Kalra, MD, role: CONTACT, phone: 502-588-7010, email: [email protected], contacts name: Muhammad Umer, MD, role: CONTACT, phone: 502-588-7010, email: [email protected], geoPoint lat: 38.25424, lon: -85.75941, hasResults: False |
protocolSection identificationModule nctId: NCT06280963, orgStudyIdInfo id: 012/005532, briefTitle: Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction, acronym: MET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Mahmoud Yousry Rashwan Hefny, class: OTHER, descriptionModule briefSummary: the goal of this clinical trial study is to compare between posterior innominate mobilization and muscle energy techniqueon lumbopelvic angles in sacroiliac joint dysfunction patients.the main questions they aim to answer are1. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?2. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on pain intensity level in sacroiliac joint dysfunction patients ? * purpose of the study is to measure the effect of muscle energy technique versus posterior innominate mobilization on lumbopelvic angles in sacroiliac joint dysfunction, conditionsModule conditions: Sacroiliac Joint Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: group one will receive muscle energy technique group two will receive posterior innominate mobilization group three will receive conventional treatment ( TENS, US, stertching exercises and strenghening exercises ), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: muscle energy technique, interventions name: posterior innominate mobilization, interventions name: conventional treatment, outcomesModule primaryOutcomes measure: lumbopelvic angles, secondaryOutcomes measure: pain intensity, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Dokki, state: Giza, zip: 12612, country: Egypt, contacts name: Haytham M Elhafez, PhD, role: CONTACT, phone: +201001909630, email: [email protected], geoPoint lat: 30.03823, lon: 31.2113, hasResults: False |
protocolSection identificationModule nctId: NCT06280950, orgStudyIdInfo id: DAIT CTOT-43, briefTitle: Expanding Liver Transplant Immunosuppression Minimization Via Everolimus, acronym: ELIMINATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2029-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months., conditionsModule conditions: Liver Transplant, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: Everolimus, interventions name: Tacrolimus (continued reduction), interventions name: Tacrolimus (maintain 50% reduction), interventions name: Everolimus, outcomesModule primaryOutcomes measure: Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2, primaryOutcomes measure: Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2, secondaryOutcomes measure: Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function, secondaryOutcomes measure: Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function, secondaryOutcomes measure: Changes in liver graft function: Total bilirubin, secondaryOutcomes measure: Changes in liver graft function: Direct bilirubin, secondaryOutcomes measure: Changes in liver graft function: Alanine Aminotransaminase (ALT), secondaryOutcomes measure: Changes in liver graft function: Aspartate Aminotransferase (AST), secondaryOutcomes measure: Changes in liver graft function: Alkaline Phosphatase, secondaryOutcomes measure: Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft, secondaryOutcomes measure: Time to all-cause mortality, secondaryOutcomes measure: Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE), secondaryOutcomes measure: Proportion of subjects experiencing infection requiring hospitalization, secondaryOutcomes measure: Proportion of subjects experiencing any malignancy, secondaryOutcomes measure: Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation, secondaryOutcomes measure: Proportion of subjects developing any major immunosuppressive therapy complications, secondaryOutcomes measure: Proportion of subjects developing new onset peripheral edema, secondaryOutcomes measure: Proportion of subjects developing new onset cytopenia deemed WBC <3.0x10^9 /L, Hb <8.0 g/dL, or platelets <50 x 10^9/L., secondaryOutcomes measure: Proportion of subjects developing new onset oral/gastrointestinal ulcerations, secondaryOutcomes measure: Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy., secondaryOutcomes measure: Proportion of subjects developing new onset pneumonitis, secondaryOutcomes measure: Proportion of subjects developing new onset hepatic artery thrombosis, secondaryOutcomes measure: Proportion of subjects developing other adverse events deemed, secondaryOutcomes measure: Proportion of subjects developing any adverse events related to everolimus therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Hospital Arizona (Site #: 71144), city: Phoenix, state: Arizona, zip: 85054, country: United States, contacts name: Hugo Vargas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: University of California, San Francisco (Site #: 71108), city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Joanna Kwan, role: CONTACT, phone: 415-476-2574, email: [email protected], contacts name: Sandy Feng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Northwestern University (Site #: 71110), city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Dania Jahangir, role: CONTACT, email: [email protected], contacts name: Justin Boike, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Icahn School of Medicine at Mount Sinai (Site #: 71115), city: New York, state: New York, zip: 10029, country: United States, contacts name: Bharathi Ramesh, role: CONTACT, email: [email protected], contacts name: Thomas Schiano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke University Medical Center (Site #: 71139), city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Linda Perry, role: CONTACT, email: [email protected], contacts name: Carl Berg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: University of Pennsylvania (Site #: 71111), city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Lexi Tumblety, role: CONTACT, phone: 267-441-1800, email: [email protected], contacts name: Abraham Shaked, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh Medical Center (Site #: 71162), city: Pittsburgh, state: Pennsylvania, zip: 15260, country: United States, contacts name: Lois Kipling, role: CONTACT, email: [email protected], contacts name: Scott Biggins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Baylor Medical Center (Site #: 71153), city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: Angela Roy, role: CONTACT, email: [email protected], contacts name: Sumeet Asrani, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06280937, orgStudyIdInfo id: BEUFTR-2, briefTitle: Short Term Effect of Wearing a Tie, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Bitlis Eren University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled study is to assess the short term effect of wearing a ties on musculoskeletal system. In this scope viscoelastic properties and the mechanosensitivity of the muscles, and cervical range of motion will be measured. In addition to these measurements activity limitation due to wearing a tie and trunk mobility will be assessed., conditionsModule conditions: Musculoskeletal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control group will go on their routine daily activities. Study group will wear a tie during one office working day., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Interventions and assessment will be performed by separate researchers., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Wearing a tie, outcomesModule primaryOutcomes measure: The Change in the Viscoelastic Properties of the Muscles, primaryOutcomes measure: The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius, primaryOutcomes measure: Cervical Range of Motion, secondaryOutcomes measure: Activity Limitation, secondaryOutcomes measure: Global Rating of Change, secondaryOutcomes measure: Trunk Forward Bending Mobility, secondaryOutcomes measure: Trunk Lateral Bending Mobility, secondaryOutcomes measure: Neck Circumference, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bitlis Eren University, city: Bitlis, state: Merkez, zip: 13000, country: Turkey, geoPoint lat: 38.40115, lon: 42.10784, hasResults: False |
protocolSection identificationModule nctId: NCT06280924, orgStudyIdInfo id: HREBA.CC-23-0220, briefTitle: Prehab Prior to Stem Cell Transplantation in Multiple Myeloma, acronym: MOTIVATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy., conditionsModule conditions: Multiple Myeloma, conditions: Exercise, conditions: Prehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Supported Exercise, interventions name: Standard Care, outcomesModule primaryOutcomes measure: Study completion rate, secondaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Attendance rate, secondaryOutcomes measure: Edmonton Symptom Assessment System, secondaryOutcomes measure: Functional Assessment of Cancer Therapy Multiple Myeloma, secondaryOutcomes measure: Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item), secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body height, secondaryOutcomes measure: Grip Strength, secondaryOutcomes measure: Calf muscle size, secondaryOutcomes measure: Thigh muscle thickness, secondaryOutcomes measure: Short Physical Performance Battery, secondaryOutcomes measure: Six-minute walk test, secondaryOutcomes measure: One leg stance balance, secondaryOutcomes measure: Shoulder flexion range of motion, secondaryOutcomes measure: Sit and reach test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alberta/ Cross Cancer Institute, city: Edmonton, state: Alberta, zip: T6G 2G4, country: Canada, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False |
protocolSection identificationModule nctId: NCT06280911, orgStudyIdInfo id: 098, briefTitle: The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-10-10, primaryCompletionDateStruct date: 2014-06-30, completionDateStruct date: 2017-12-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014., conditionsModule conditions: Augmentation, conditions: Induction, conditions: Labor, conditions: Stimulation, Self, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was designed to be randomly controlled., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 198, type: ACTUAL, armsInterventionsModule interventions name: Date Fruit group, interventions name: Nipple group, outcomesModule primaryOutcomes measure: The spontaneous onset of labor, primaryOutcomes measure: Induction and augmentation of labor, secondaryOutcomes measure: Mode of delivery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06280898, orgStudyIdInfo id: KC22RISI0395, briefTitle: Perioperative Factors and Early Postoperative Kidney Graft Function Recovery, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-01, primaryCompletionDateStruct date: 2022-03-14, completionDateStruct date: 2022-03-14, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Seoul St. Mary's Hospital, class: OTHER, descriptionModule briefSummary: Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using, and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis., conditionsModule conditions: Heart Injuries, conditions: Kidney Transplant; Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 539, type: ACTUAL, armsInterventionsModule interventions name: Remote ischemic conditioning, outcomesModule primaryOutcomes measure: Troponin I, secondaryOutcomes measure: Troponin T, secondaryOutcomes measure: QTc interval, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul St. Mary's hospital, city: Seoul, zip: 06591, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06280885, orgStudyIdInfo id: FIERCE, briefTitle: A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy, acronym: FIERCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, collaborators name: St. James's Hospital, Ireland, descriptionModule briefSummary: The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility randomised controlled trial using a 2:1 randomisation, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Not indicated for this feasibility study., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Health Behaviour Change (Pedometer), outcomesModule primaryOutcomes measure: Feasibility: Recruitment rates, primaryOutcomes measure: Feasibility: Adherence rates, primaryOutcomes measure: Feasibility: Attendance rates, primaryOutcomes measure: Feasibility: Retention Rates, primaryOutcomes measure: Feasibility: Reason for drop0out, secondaryOutcomes measure: Cardiorespiratory Fitness, secondaryOutcomes measure: Muscular Strength, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Mid-arm circumference, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Bioimpedance Analysis, secondaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St James's Hospital, city: Dublin, zip: 8, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False |
protocolSection identificationModule nctId: NCT06280872, orgStudyIdInfo id: P2023/Neonat/PhyCordPrem, briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns, acronym: PhyCordPrem, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, collaborators name: The Belgian Kids Fund, collaborators name: Fonds IRIS-Recherche, collaborators name: Ars Statistica, descriptionModule briefSummary: Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother., conditionsModule conditions: Premature Birth, conditions: Respiratory Distress Syndrome in Premature Infant, conditions: Sepsis, conditions: Intraventricular Hemorrhage of Prematurity, conditions: Bronchodysplasia, conditions: Jaundice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Physiological Based Cord Clamping, interventions name: Differed Cord Clamping, outcomesModule primaryOutcomes measure: Duration of non-invasive or invasive respiratory support., secondaryOutcomes measure: Rate of neonatal mortality, secondaryOutcomes measure: Rate of neonatal resuscitation, secondaryOutcomes measure: Rate of neonatal respiratory morbidity, secondaryOutcomes measure: Number of admission to the NICU or special care baby unit, secondaryOutcomes measure: Length of hospitalization, secondaryOutcomes measure: Gestational age corrected at discharge, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Bilirubin level, secondaryOutcomes measure: Occurrence of Neonatal adverse events, secondaryOutcomes measure: Biological markers of oxidative stress, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal postoperative hemoglobin level, secondaryOutcomes measure: Number of maternal adverse events, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Rate of Maternal-infant bonding, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Parental satisfaction survey, secondaryOutcomes measure: Child development assessment, secondaryOutcomes measure: Success of PBCC, eligibilityModule sex: ALL, minimumAge: 32 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: CHU Brugmann, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Andrew CARLIN, role: CONTACT, phone: +3224773295, email: [email protected], contacts name: Andrew CARLIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Hôpital Universitaire Des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Anna AMORUSO, MD, role: CONTACT, phone: +3224773250, email: [email protected], contacts name: Anna AMORUSO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06280859, orgStudyIdInfo id: 18784, briefTitle: Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: United States Department of Agriculture (USDA), descriptionModule briefSummary: The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities., conditionsModule conditions: Cardiovascular Diseases, conditions: Sedentary Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Students enrolled in physical education (PE) class will be eligible to enroll in the study, and serve as the intervention group. Those not enrolled in PE that semester will be recruited as the control group., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Hoosier Sport, outcomesModule primaryOutcomes measure: Feasibility of Intervention Measure (FIM), primaryOutcomes measure: Acceptability of Intervention Measure (IAM), primaryOutcomes measure: Intervention Appropriateness Measure (AIM), secondaryOutcomes measure: Daily Steps of Participants, secondaryOutcomes measure: Daily Moderate to Vigorous Physical Activity of Participants, secondaryOutcomes measure: Heart Rate of Participants, secondaryOutcomes measure: Blood Pressure of Participants, secondaryOutcomes measure: Basic Psychological Needs of Participants in Intervention Environment, secondaryOutcomes measure: Physical Literacy of Participants, secondaryOutcomes measure: Cardiovascular Fitness Levels of Participants, secondaryOutcomes measure: Muscular Endurance Levels of Participants, secondaryOutcomes measure: Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants, secondaryOutcomes measure: Nutrition Knowledge of Participants, secondaryOutcomes measure: Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior., eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Indiana University, city: Bloomington, state: Indiana, zip: 47405, country: United States, geoPoint lat: 39.16533, lon: -86.52639, hasResults: False |
protocolSection identificationModule nctId: NCT06280846, orgStudyIdInfo id: P.T.REC/012/004878, briefTitle: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, collaborators name: King Khalid University, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP)., conditionsModule conditions: Chronic Nonspecific Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: random generator, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: high-intensity laser acupuncture and Exercise therapy program, interventions name: low-intensity laser acupuncture and Exercise therapy program, interventions name: Sham laser acupuncture, outcomesModule primaryOutcomes measure: peak torque, primaryOutcomes measure: peak torque, primaryOutcomes measure: Fatigue, primaryOutcomes measure: Fatigue, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: lumbar flexion ROM assessment, secondaryOutcomes measure: lumbar flexion ROM assessment, secondaryOutcomes measure: Disability, secondaryOutcomes measure: Disability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Doaa Ayoub Elimy, status: RECRUITING, city: Giza, zip: 11251, country: Egypt, contacts name: Doaa A Elimy, lecturer, role: CONTACT, phone: 00201066474654, email: [email protected], geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
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