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protocolSection identificationModule nctId: NCT06325046, orgStudyIdInfo id: 23-003388, secondaryIdInfos id: NCI-2024-01669, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: GMROR2351, type: OTHER, domain: Mayo Clinic Radiation Oncology, secondaryIdInfos id: 23-003388, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Evaluating Changes in Quality of Life After Near Margin-less Adaptive Radiation Therapy Compared to Standard Stereotactic Ablative Body Radiotherapy in Localized Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR., conditionsModule conditions: Localized Prostate Adenocarcinoma, conditions: Stage I Prostate Cancer AJCC v8, conditions: Stage II Prostate Cancer AJCC v8, conditions: Stage III Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, interventions name: Cone-Beam Computed Tomography, interventions name: Image-Guided Adaptive Radiation Therapy, interventions name: Magnetic Resonance Imaging, interventions name: Stereotactic Ablative Radiotherapy, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Treatment-related, patient-reported early quality of life (QOL) changes, secondaryOutcomes measure: Treatment-related, patient-reported late QOL changes, secondaryOutcomes measure: Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events, secondaryOutcomes measure: Change in International Index of Erectile Function (IIEF), secondaryOutcomes measure: Change in International Prostate Symptom Score (IPSS), secondaryOutcomes measure: Change in financial adverse events - COST-FACIT, secondaryOutcomes measure: Fiducial-free treatment, secondaryOutcomes measure: Bladder filling, secondaryOutcomes measure: Biochemical recurrence, secondaryOutcomes measure: Prostate specific antigen (PSA) kinetics, secondaryOutcomes measure: Local recurrence, secondaryOutcomes measure: Overall survival, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Mark R. Waddle, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06325033, orgStudyIdInfo id: 18546, briefTitle: Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation.The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring.Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor., conditionsModule conditions: Deep Sedation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To identify effect-site target concentrations of propofol for the Eleveld model that are associated with moderate to deep sedation levels, MOAAS 3-1 and the associated BIS levels in adult patients., secondaryOutcomes measure: Induction time, secondaryOutcomes measure: Recovery time, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-23, uploadDate: 2024-02-29T03:59, filename: Prot_000.pdf, size: 454063, hasResults: False
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protocolSection identificationModule nctId: NCT06325020, orgStudyIdInfo id: 337367, briefTitle: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology, acronym: ORACLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Edinburgh, class: OTHER, descriptionModule briefSummary: The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events., conditionsModule conditions: Angina, Stable, conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: The assessment of patients with possible angina using the ORACLE pathway, outcomesModule primaryOutcomes measure: Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral., secondaryOutcomes measure: Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment., secondaryOutcomes measure: Proportion of valid and interpretable point-of-care troponin tests, secondaryOutcomes measure: Proportion of personal electrocardiograms that are interpretable, secondaryOutcomes measure: Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification., secondaryOutcomes measure: Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status., secondaryOutcomes measure: Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status., secondaryOutcomes measure: Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage., otherOutcomes measure: Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay., otherOutcomes measure: Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography, eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325007, orgStudyIdInfo id: 293-2024-HFH, briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Holy Family Hospital, Nazareth, Israel, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women.The main question it aims to answer are:Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil., conditionsModule conditions: Induction of Labor Affected Fetus / Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ESTIMATED, armsInterventionsModule interventions name: Induction of labor, outcomesModule primaryOutcomes measure: time to delivery, secondaryOutcomes measure: balloon expulsion time, secondaryOutcomes measure: Bishop score after catheter expulsion, secondaryOutcomes measure: Fetal presentation at the delivery, secondaryOutcomes measure: Duration of the active phase of labor, secondaryOutcomes measure: Duration of second stage, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Indications for cesarean or operative vaginal deliveries, secondaryOutcomes measure: Intrapartum fever, secondaryOutcomes measure: Number of patients that will require use of intrapartum use of antibiotic treatment., secondaryOutcomes measure: Number of Participants with that will develop clinical signs of chorioamnionitis., secondaryOutcomes measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations., secondaryOutcomes measure: Number of Participants with develop postpartrum hemorrhage., secondaryOutcomes measure: Number of Participants with need blood transfusion., secondaryOutcomes measure: Side effects related to castor oil use, secondaryOutcomes measure: Oxytocin maximal dosage, secondaryOutcomes measure: Number of participants with Umbilical Cord prolapse., secondaryOutcomes measure: Apgar score (0 to 10)., secondaryOutcomes measure: pH taken from umbilical artery, secondaryOutcomes measure: Neonatal birthweight, secondaryOutcomes measure: Number of neonates with Neonatal fever ≥ 38 °C, secondaryOutcomes measure: The number of neonates that will develop neonatal sepsis., secondaryOutcomes measure: The number of neonates that will require antibiotic treatment., secondaryOutcomes measure: Neonatal complications, secondaryOutcomes measure: The number of neonates that will Admit to neonatal intensive care unit (NICU), secondaryOutcomes measure: Length of stay in NICU., secondaryOutcomes measure: neonatal death, secondaryOutcomes measure: Maternal hemoglobin level after delivery., secondaryOutcomes measure: Number of participants that will require postpartum hysterectomy., secondaryOutcomes measure: Number of participants that will require postpartum laparotomy., secondaryOutcomes measure: postpartum maternal complications, secondaryOutcomes measure: The length of stay from birth to discharge home., secondaryOutcomes measure: Maternal satisfaction from delivery process., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Holy Family hospital, Nazareth, status: NOT_YET_RECRUITING, city: Nazareth, country: Israel, contacts name: Wiaamk Khatib, MD, role: CONTACT, phone: 0549192433, email: wiaam.khatib.95@gmail.com, contacts name: Wiaam Khatib, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.69925, lon: 35.30483, locations facility: Holy Family Hospital, status: RECRUITING, city: Nazareth, country: Israel, contacts name: Raed Salim, MD, role: CONTACT, email: r.salim@hfhosp.org, geoPoint lat: 32.69925, lon: 35.30483, hasResults: False
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protocolSection identificationModule nctId: NCT06324994, orgStudyIdInfo id: YY-20394-BV-MCL, briefTitle: Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Dalian Medical University, class: OTHER, descriptionModule briefSummary: This is a single arm, open label, national multicenter clinical study included patients with relapsed and refractory blastoid variant of mantle cell lymphoma (R/R BV-MCL), aiming to evaluate the efficacy of a chemotherapy free triple therapy of PI3K inhibitor (Linperlisib) combined with anti-CD20 monoclonal antibody (Obinutuzumab) and BCL-2 inhibitor (Venetoclax) in R/R BV-MCL patients., conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Linperlisib in combination with Obinutuzumab and Venetoclax, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) according to the RECIST 1.1, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of Overall Response (DOR), secondaryOutcomes measure: Adverse event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Hospital Dalian Medical University, city: Dalian, state: Liaoning, zip: 116000, country: China, contacts name: Xiuhua Sun, Doctor, role: CONTACT, phone: +86 17709873631, email: 3038668@vip.sina.com, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False
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protocolSection identificationModule nctId: NCT06324981, orgStudyIdInfo id: 22-2097, secondaryIdInfos id: 1UG3HL168504, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3HL168504, briefTitle: Using AI Text Messaging to Improve AHA's Life's Essential 8 Health Behaviors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking.This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes.The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes.The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center.The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease., conditionsModule conditions: Cardiovascular Diseases, conditions: Lifestyle Factors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 2100, type: ESTIMATED, armsInterventionsModule interventions name: Generic text messages, interventions name: Interactive AI chatbot text messaging, interventions name: Proactive pharmacist support, outcomesModule primaryOutcomes measure: Change in Life's Essential 8 risk score, secondaryOutcomes measure: Blood pressure (Individual Life's Essential 8 components), secondaryOutcomes measure: Total cholesterol (Individual Life's Essential 8 components), secondaryOutcomes measure: Blood sugar (Individual Life's Essential 8 components), secondaryOutcomes measure: Body Mass Index (Individual Life's Essential 8 components), secondaryOutcomes measure: Physical activity (Individual Life's Essential 8 components), secondaryOutcomes measure: Sleep (Individual Life's Essential 8 components), secondaryOutcomes measure: Smoking habits (Individual Life's Essential 8 components), secondaryOutcomes measure: Health diet pattern (Individual Life's Essential 8 components), secondaryOutcomes measure: Self-Efficacy for Managing Chronic Diseases, secondaryOutcomes measure: Number of medication refill gaps (Medication adherence), secondaryOutcomes measure: Length of refill gaps (Medication adherence), secondaryOutcomes measure: Clinic events, secondaryOutcomes measure: Risk Score for Recurrent Coronary Heart Disease, Framingham Risk Score, secondaryOutcomes measure: Risk Score for Coronary Heart Disease (2-year risk) - First Event, Framingham Risk Score, secondaryOutcomes measure: Rate of routine clinical visits and/or other procedures associated with the clinical condition, secondaryOutcomes measure: Cost, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denver Health, status: RECRUITING, city: Denver, state: Colorado, zip: 80204, country: United States, contacts name: Pamela Peterson, MD MPH, role: CONTACT, email: pamela.peterson@dhha.org, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Salud Family Health Centers, status: NOT_YET_RECRUITING, city: Fort Lupton, state: Colorado, zip: 80621, country: United States, contacts name: Emily Kosirog, PharmD, role: CONTACT, email: ekosirog@saludclinic.org, geoPoint lat: 40.08471, lon: -104.81303, locations facility: STRIDE Community Health Centers, status: NOT_YET_RECRUITING, city: Wheat Ridge, state: Colorado, zip: 80033, country: United States, contacts name: Danielle Montoya, PharmD, role: CONTACT, email: danielle.montoya@stridechc.org, geoPoint lat: 39.7661, lon: -105.07721, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-11, uploadDate: 2023-12-04T16:49, filename: Prot_000.pdf, size: 325640, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-02-26, uploadDate: 2024-03-04T15:41, filename: SAP_001.pdf, size: 235057, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-07, uploadDate: 2024-03-04T16:34, filename: ICF_002.pdf, size: 788437, hasResults: False
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protocolSection identificationModule nctId: NCT06324968, orgStudyIdInfo id: 22-AOIP-01, briefTitle: Ro60 Expression in Macrophages in Sjogren's Disease, acronym: RoMioSS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2025-02-09, completionDateStruct date: 2026-02-09, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD)., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Positive serology for anti-SSA, outcomesModule primaryOutcomes measure: SSA/Ro60 interactions, secondaryOutcomes measure: The molecular and functional impact : inflammatory cytokine and chemokine profiles, secondaryOutcomes measure: The molecular and functional impact : cell apoptosis/survival and cellular polarization, secondaryOutcomes measure: The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Nice, status: RECRUITING, city: Nice, state: Alpes-Mritimes, zip: 06000, country: France, contacts name: Nihal MARTIS, MD, MSc, role: CONTACT, phone: 4 92035444, phoneExt: +33, email: martis.n@chu-nice.fr, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
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protocolSection identificationModule nctId: NCT06324955, orgStudyIdInfo id: IRB-P00042507, briefTitle: Language During Inhalational Induction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-03-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group., conditionsModule conditions: Emergence Delirium, conditions: Anesthesia; Adverse Effect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Standard/common language during induction, interventions name: Positive language during induction, outcomesModule primaryOutcomes measure: Induction compliance, secondaryOutcomes measure: Length of induction, secondaryOutcomes measure: Verbal refusal of mask, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: John Fiadjoe, MD, role: CONTACT, email: john.fiadjoe@childrens.harvard.edu, contacts name: Rachel Bernier, MPH, role: CONTACT, phone: 857-218-5348, email: rachel.bernier@childrens.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06324942, orgStudyIdInfo id: REB24-0349, briefTitle: Analgesic Efficacy of Surgeon-administered Transversus Abdominis Plane Blocks for Caesarean Section., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to evaluate whether or not adding a Transversus Abdominis Plane Block (TAP block) improves pain control for patients having a cesarean section. A TAP block is a type of nerve block where at the end of the surgery an injection of a long acting local anesthetic is made into the abdominal wall. In studies in patient's having other abdominal surgeries this has reduced the amount of narcotics patients need for pain control. This may also led to patients being more active after surgery and maybe spending less time in hospital., conditionsModule conditions: Cesarean Section Complications, conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Surgeon-administered Transversus Abdominis Plane Block 0.25% bupivicaine 0.25 mL/kg, outcomesModule primaryOutcomes measure: Post operative Pain, secondaryOutcomes measure: Time to first request for rescue analgesia in hours, secondaryOutcomes measure: Post operative Opioid use, secondaryOutcomes measure: Time from surgery to discharge from hospital, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Calgary, city: Calgary, state: Alberta, zip: T2N 2T9, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
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protocolSection identificationModule nctId: NCT06324929, orgStudyIdInfo id: HSR220448, secondaryIdInfos id: R61AA030581-01, type: NIH, link: https://reporter.nih.gov/quickSearch/R61AA030581-01, briefTitle: Optimizing a Digital AEP Risk Intervention With Native Women and Communities Aim 1, acronym: CARRII Native, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, collaborators name: University of Minnesota, collaborators name: Missouri Breaks Industries Research, Inc., collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The purpose of this aim of the ovedrall study is to gather information to inform the development of a digital app that can be used on any platform (smartphone, tablet, computer) for Native American women to help them avoid a pregnancy affected by alcohol., conditionsModule conditions: Alcohol Exposed Pregnancy, conditions: Unplanned Pregnancies, conditions: Alcohol Use, Unspecified, conditions: Contraception Use, conditions: Sexual Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Mixed methods research during Aim 1 will include 4 different components. They are:1. Convene working group of Native American stakeholders.2. Collect data using a 35-minute survey of demographics, AEP risk, device use, recommendations for recruitment methods, and interest in subsequent trial with 300 Native women respondents, targeting approximately 100-150 per region (rural Great Northern Plains), urban Denver and mountain West, and rural Southwest .3. Conduct Iterative prototyping of existing and proposed CARRII components with 60 Native women across 10 focus group discussions. Content will be informed by Components 1 and 2, and will be added via modification request4. Conduct User Testing of existing CARRII and candidate components with Think-Aloud methods among 20 Native women., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Determine the characteristics of and rate of Native women eligible for, and interested in the CARRII intervention., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Virginia Fontaine Research Park, city: Charlottesville, state: Virginia, zip: 22908, country: United States, contacts name: Karen Ingersoll, PhD, role: CONTACT, phone: 804-651-6929, email: kes7a@uvahealth.org, geoPoint lat: 38.02931, lon: -78.47668, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-24, uploadDate: 2024-03-22T09:41, filename: Prot_SAP_000.pdf, size: 558452, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-02, uploadDate: 2024-03-22T09:41, filename: ICF_001.pdf, size: 242257, hasResults: False
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protocolSection identificationModule nctId: NCT06324916, orgStudyIdInfo id: vascularized fibular graft, briefTitle: Donor Site Morbidity After Free Vascularized Fibular Graft, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap., conditionsModule conditions: Osteosarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Xray, outcomesModule primaryOutcomes measure: Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut university, status: RECRUITING, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06324903, orgStudyIdInfo id: echo cath CHD, briefTitle: Role of Echocardiography in Optimization of Cardiac Catheterization in Children With Congenital Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Delineate and evaluate the role of echocardiography in children with congenital heart disease undergoing cardiac catheterization in the pediatric cardiology unit of Assiut university hospitals.1. To improve diagnostic accuracy by creating a systematic approach for image acquisition and interpretation across different procedural timepoints.2. To promote consistent hemodynamic evaluations to reliably assess cardiac function and blood flow.3. To enable optimized procedural planning and intraprocedural guidance via comprehensive delineation of anatomy and pathophysiology.4. To facilitate standardized longitudinal monitoring after interventions to evaluate outcomes and detect complications., conditionsModule conditions: Echocardiography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 67, type: ESTIMATED, armsInterventionsModule interventions name: echocardiography and percutaneous cardiac catheterization, outcomesModule primaryOutcomes measure: congenital heart defect dimensions in mm,, primaryOutcomes measure: pressure gradient in mmHg across valve, secondaryOutcomes measure: cardiac function by measuring fraction shortening (FS) % in percent, secondaryOutcomes measure: cardiac function TAPSV in cm/sec, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324890, orgStudyIdInfo id: 20240225, briefTitle: PET-CT Imaging Features of Meibomian Glands, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, descriptionModule briefSummary: Analysis the results of Dry eye analysis results and PET-CT imaging comprehensively, conditionsModule conditions: MGD-Meibomian Gland Dysfunction, conditions: Positron-Emission Tomography, conditions: Dry Eye, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Lacrimal river height, primaryOutcomes measure: Tear break-up time, primaryOutcomes measure: Tear-film lipid layer thickness, primaryOutcomes measure: Meibomian glands two-dimensional digital infrared images, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongnan Hospital of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430071, country: China, contacts name: Min Ke, Doctor, role: CONTACT, phone: +86-18672395959, email: keminyk@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06324877, orgStudyIdInfo id: HREC/24/QCHQ/106030, briefTitle: Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside, acronym: ATNAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The University of Queensland, class: OTHER, descriptionModule briefSummary: Study design: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain. Study population: 6-10 patients with Ataxia-Telangiectasia. Dose: Nicotinamide riboside 25 mg/kg/day in 3 equal divided doses.Primary endpoint: Scales for assessment and rating of ataxia (SARA), and International Cooperative Ataxia Rating Scale (ICARS). Improvement of at least ½ standard deviation in key clinical scales which includes either; a) significant improvement in total combined scores from the SARA and ICARS scales, and /or b) significant improvements any aspects of the SARA and ICARS scales individually, especially pertaining to; Postural and gait improvements, Improved syllable speed and articulation, Improved fine motor skills.Secondary endpoints: Serum analysis of neurofilament light chain (Nfl), Type 1 Interferon (INFs) epigenetic signature, conditionsModule conditions: Ataxia Telangiectasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 1. Primary objective: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain.2. Secondary objectives: * Determine to what extent the beneficial effects ongoing of NR on NFl translate to clinical efficacy in patients with A-T. * Type 1 Interferon (INFs) epigenetic signature specifically the cGAS-STING pathway., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Nicotinamide riboside, outcomesModule primaryOutcomes measure: Scales for assessment and rating of ataxia, primaryOutcomes measure: International Cooperative Ataxia Rating Scale, secondaryOutcomes measure: Serum analysis of neurofilament light chain, secondaryOutcomes measure: Type 1 Interferon epigenetic signature, otherOutcomes measure: Quality of Life Measures, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queensland Children's Hospital, city: Brisbane, state: Queensland, zip: 4101, country: Australia, contacts name: David Coman, MBBS FRACP, role: CONTACT, phone: +610730681111, email: david.coman@health.qld.gov.au, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False
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protocolSection identificationModule nctId: NCT06324864, orgStudyIdInfo id: 2024-00212, briefTitle: START NOW Adapted: Culturally Adapted Version of START NOW, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Prof. Christina Stadler, class: NETWORK, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of the culturally adapted skills-training START NOW in youth migrant populations. The main question it aims to answer is: Is the culturally adapted skills training START NOW more effective than treatment as usual (TAU) in reducing mental health problems in migrants? Participants will be randomly assigned to the intervention group receiving the skills training START NOW Adapted or the control group receiving TAU. Researchers will compare both groups to see if START NOW Adapted is more effective than TAU in reducing mental health problems in migrants., conditionsModule conditions: Depression, conditions: Depression/Anxiety, conditions: Anxiety, conditions: Adolescent, conditions: Emotion Recognition, conditions: Mental Health, conditions: Resilience,Psychological, conditions: Refugee Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: START NOW Adapted, outcomesModule primaryOutcomes measure: Change from baseline in symptoms of depression and anxiety at the end of the intervention, primaryOutcomes measure: Change from baseline in symptoms of depression and anxiety at follow-up, secondaryOutcomes measure: Change from baseline in self-reported perceived stress at follow-up, secondaryOutcomes measure: Change from baseline in self-reported social-ecological resilience at the end of the intervention, secondaryOutcomes measure: Change from baseline in self-reported perceived stress at the end of the intervention, secondaryOutcomes measure: Change from baseline in self-reported social-ecological resilience at follow-up, secondaryOutcomes measure: Change from baseline in facial emotion recognition at the end of the intervention, secondaryOutcomes measure: Change from baseline in facial emotion recognition at follow-up, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University Psychiatric Clinics Basel, status: RECRUITING, city: Basel, state: Basel-Stadt, zip: 4002, country: Switzerland, contacts name: Donja Brunner, PhD, role: CONTACT, phone: +410613258031, email: donja.brunner@unibas.ch, contacts name: Janine Bacher, MSc, role: CONTACT, phone: +410613258048, email: janine.bacher@upk.ch, contacts name: Donja Brunner, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
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protocolSection identificationModule nctId: NCT06324851, orgStudyIdInfo id: DROVZOEFFIPREP, briefTitle: The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, collaborators name: University of Roma La Sapienza, descriptionModule briefSummary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy., conditionsModule conditions: Endometrial Polyp, conditions: Endometrial Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: Drospirenone / Estetrol, interventions name: Nomegestrol Acetate / Estradiol, interventions name: Ethinylestradiol / Dienogest, outcomesModule primaryOutcomes measure: Quality of endometrial preparation, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Andrea Etrusco, city: Palermo, zip: 90123, country: Italy, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Marco Monti, city: Rome, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06324838, orgStudyIdInfo id: 248-2021-NQ, briefTitle: Extended Mesenteric Resection in Ileocecal Crohn's Disease., acronym: EXCEED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, descriptionModule briefSummary: The EXCEED project aims to study the role of the mesentery in disease recurrence in Crohn's disease (CD), as evidence suggests that including the mesentery when doing ileocecal resections can significantly reduce recurrence rates. The EXCEED study is a blinded randomised clinical trial with 204 participants having ileocecal Crohn's disease requiring resection. Participants will undergo either "standard" mesocolic sparing resection or extended mesocolic resection to assess its impact on reducing recurrence at the anastomotic site. The primary endpoint is endoscopic recurrence 12 months postoperatively.Additionally, the study aims to evaluate the efficacy of different surveillance modalities in detecting anastomotic site recurrence. These examinations will be conducted pre- and postoperatively for a cohort of 20 participants.Through this study, we seek to understand the mesentery's role in Crohn's disease recurrence and identify effective non-invasive methods for postoperative monitoring., conditionsModule conditions: Crohn's Disease of Terminal Ileum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Blinded multicenter randomized controlled clinical trial (RCT)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: This randomized controlled trial will incorporate blinding procedures, with the understanding that due to the nature of this interventional surgical study, the operating surgeon cannot be blinded. However, rigorous measures will be implemented to ensure blinding of both patients and all other participants involved in patient treatment. The description of the surgery within the patient chart will follow a standardized format, with the exception of the resection details. Where the two treatment methods diverge, a predefined, standardized text referencing the study will be inserted., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: Standard laparoscopic ileocecal resection, interventions name: Extended laparoscopic ileocecal resection, outcomesModule primaryOutcomes measure: Endoscopic recurrence, secondaryOutcomes measure: Early endoscopic recurrence, secondaryOutcomes measure: Clinical signs of recurrence / morbidity., secondaryOutcomes measure: Difference in disease severity, secondaryOutcomes measure: Patient reported outcome 1, secondaryOutcomes measure: Patient reported outcome 2, secondaryOutcomes measure: Reoperations, secondaryOutcomes measure: Perioperative complications, secondaryOutcomes measure: Cost of treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324825, orgStudyIdInfo id: 2022CR64, briefTitle: Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-24, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule., conditionsModule conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Fuzhegn Nizeng Decoction, interventions name: Moluodan granules, outcomesModule primaryOutcomes measure: Recovery rate of Low-grade Intraepithelial Neoplasia, secondaryOutcomes measure: 7-point Global Overall Symptom Scale, secondaryOutcomes measure: Adverse event rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Xuezhi Zhang, Doctor, role: CONTACT, phone: +861083572634, email: zhang.xuezhi@263.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06324812, orgStudyIdInfo id: SSGJ-611-PED-AD-Ib/II-01, briefTitle: Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis., conditionsModule conditions: Dermatitis, Atopic, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant Anti-interleukin-4 Receptor Alpha Monoclonal Antibody Injection (611), outcomesModule primaryOutcomes measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit., primaryOutcomes measure: Minimum concentration (Cmin), secondaryOutcomes measure: Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline), secondaryOutcomes measure: Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points, secondaryOutcomes measure: Number of Participants with Eczema Area and Severity Index (EASI) - 50 Response (>= 50% Improvement in Score From Baseline), secondaryOutcomes measure: Number of Participants with Eczema Area and Severity Index (EASI) - 90 Response (>= 90% Improvement in Score From Baseline), secondaryOutcomes measure: Number of Participants Who Achieved >=4 Points/ >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline, secondaryOutcomes measure: Percentage Change From Baseline in EASI Score, secondaryOutcomes measure: Change From Baseline in Percent Body Surface Area (BSA) of AD Involvement, secondaryOutcomes measure: Change From Baseline in Weekly Average of Pruritus NRS, secondaryOutcomes measure: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI), secondaryOutcomes measure: Change From Baseline in Patient Oriented Eczema Measure (POEM), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324799, orgStudyIdInfo id: 2023/51, briefTitle: The Effect of Position Change Frequency on Hyperbilirubinemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-11-24, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study., conditionsModule conditions: Newborn; Vitality, conditions: Hyperbilirubinemia, Neonatal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled clinical trial, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: phototherapy treatment, outcomesModule primaryOutcomes measure: Bhutani Nomogram, secondaryOutcomes measure: bilirubin level, secondaryOutcomes measure: hematocrit levels, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 15 Days, stdAges: CHILD, contactsLocationsModule locations facility: Tarsus State Hospital, status: RECRUITING, city: Mersin, country: Turkey, contacts name: Atiye Karakul, Ass. Prof., role: CONTACT, phone: 90(324) 600 00 33, phoneExt: 2231, email: atiyekarakul@gmail.com, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
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protocolSection identificationModule nctId: NCT06324786, orgStudyIdInfo id: 2024 IBMT NF, briefTitle: Brain Mechanisms of Reducing Polysubstance Use, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, descriptionModule briefSummary: The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice., conditionsModule conditions: Multiple Drug Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: mindfulness or/and active/sham neurofeedback, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: IBMT, interventions name: NF, outcomesModule primaryOutcomes measure: Intervention effects on brain function using Functional Magnetic Resonance Imaging (fMRI), primaryOutcomes measure: Intervention effects on brain white matter using fMRI, primaryOutcomes measure: Intervention effects on brain grey matter using fMRI, secondaryOutcomes measure: Intervention effects on addiction behavior using substance use questionnaires in PhenX Toolkit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: YiYuan Tang, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: YiYuan Tang, role: CONTACT, phone: 480-790-3577, email: yiyuan@asu.edu, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
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protocolSection identificationModule nctId: NCT06324773, orgStudyIdInfo id: 9867, briefTitle: Prevalence of Postpartum Family Planning and Its Association With Spousal Joint Decision-Making in Family Planning, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Aga Khan University, class: OTHER, descriptionModule briefSummary: This community-based cross-sectional study investigates the prevalence of postpartum family planning (PPFP) uptake and its association with joint spousal family planning decision-making among married women in rural Sindh, Pakistan. The study, conducted in Thatta District with a population of approximately 0.98 million people, addresses sociodemographic challenges including high fertility rates, maternal and newborn mortality, and low contemporary contraception use. Targeting married women aged 18-49 who gave birth within the past year, the research utilizes data from the Global Network's Maternal and Newborn Health Registry. Data collection involves a pretested questionnaire administered by trained female data collectors. Statistical analysis includes descriptive statistics and logistic regression using STATA 17. The study aims to fill knowledge gaps regarding factors influencing PPFP uptake, particularly the role of joint decision-making in family planning. Findings could inform targeted interventions to enhance maternal and child health, contribute to existing knowledge, and guide policymakers and healthcare providers in addressing the unmet need for family planning in rural Pakistan., conditionsModule conditions: Postpartum Family Planning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 510, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of Postpartum Family Planning Uptake, primaryOutcomes measure: Frequency of spousal joint decision making for uptake of postpartum family planning, primaryOutcomes measure: Comparison between spousal joint decision making is using postpartum family planning method and non-users., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324760, orgStudyIdInfo id: LIPOICSPI2018, briefTitle: Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-04, primaryCompletionDateStruct date: 2021-06-02, completionDateStruct date: 2021-06-02, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Uriach Consumer Healthcare, class: INDUSTRY, descriptionModule briefSummary: Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues., conditionsModule conditions: Restless Legs Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Alpha-lipoic acid combined with B vitamins, outcomesModule primaryOutcomes measure: Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS), secondaryOutcomes measure: Anthropometric parameters of the patients., secondaryOutcomes measure: Patients' body measurements, secondaryOutcomes measure: Measurements of patient anatomy, secondaryOutcomes measure: Patients' body characteristics., secondaryOutcomes measure: Measurements of patient anatomy., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center Teknon, city: Barcelona, zip: 08017, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06324747, orgStudyIdInfo id: 23-046, briefTitle: Soft Tissue Stability in Immediate Implant Placement Using (VST) Versus Conventional Flap in Type II Extraction Sockets, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: British University In Egypt, class: OTHER, descriptionModule briefSummary: This study compare between the vestibular socket therapy (VST) and the traditional mucoperiosteal flap reflection in immediate implant placement in type II extraction socket in the esthetic zone.The technique of vestibular socket therapy (VST), introduced by Elaskry, enables the placement of implants immediately while simultaneously rehabilitating the entire socket, resulting in excellent esthetic and functional outcomes that meet the expectations of patients. VST involves socket augmentation through a minimally invasive vestibular access incision, eliminating the need for the traditional mucoperiosteal flap reflection, regardless of the extent of socket compromise., conditionsModule conditions: Badly Broken Tooth in a Socket Type II Eligible to be Replaced by Immediate Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two equal parallel groups with a 1:1 allocation ratio to receive either vestibular socket therapy (test group) or to be treated with conventional mucoperiosteal flap (control group)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Due to the differences in techniques, the operating surgeon can not be blinded to the procedure, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Vestibular socket therapy, interventions name: conventional full thickness flap, outcomesModule primaryOutcomes measure: Soft Tissue Stability, secondaryOutcomes measure: Bone Regeneration, otherOutcomes measure: Pink Esthetic Score (PES), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: The British university in Egypt, city: Cairo, state: New Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06324734, orgStudyIdInfo id: D0817R00082, briefTitle: Assessment of Safety of Olaparib in Chinese Patients With Ovarian Cancer in the Real-World Setting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Study D0817R00081 is a retrospective study using NCID database to assess the safety of Olaparib in Chinese patients with ovarian cancer by examining the incidence, seriousness, and severity of all AEs, including but not limiting to AESIs and SAEs, AEs related to Olaparib, and AEs leading to dose reduction, interruption or discontinuation of Olaparib. The first Olaparib prescription date will be set as the index date. The baseline period is from the patient's first ovarian cancer diagnosis recorded in the database to the patient's first treatment with Olaparib (as early as the database start date of January 1, 2013) to the index date for derivation of lines of therapy or one year pre-index date for other baseline variables. Patients will be followed until the patient's last medical record in the database, 30 days after the last dose of Olaparib, death, or June 30, 2023, whichever comes first. All patients who meet the inclusion/exclusion criteria will be enrolled., conditionsModule conditions: Using NCID Database to Assess the Safety of Olaparib in Chinese Patients With Ovarian Cancer by Examining the Incidence, Seriousness, and Severity of All AE, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The incidence, seriousness, and severity of all AEs, secondaryOutcomes measure: The number and proportion of patients according to different baseline demographics and characteristics, secondaryOutcomes measure: Overall number and proportion of patients with olaprib combination maintenance therapy in PSR patients, otherOutcomes measure: Overall number and proportion of patients with olap arib combination maintenance therapy in 1L patients 2), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324721, orgStudyIdInfo id: S68133, briefTitle: Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling, acronym: LymphSens, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Universiteit Antwerpen, descriptionModule briefSummary: Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment.The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. Subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without any objectively measurable swelling.At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL).The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6. and 12 month(s) post-surgery and the transitions between the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6. and 12 month(s) post-surgery)., conditionsModule conditions: Breast Cancer, conditions: Lymphedema, conditions: Sensory Processing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective cohort study, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Oedema measurements and sensory evaluations, outcomesModule primaryOutcomes measure: Presence of self-reported swelling at arm, primaryOutcomes measure: Presence of self-reported swelling at trunk, primaryOutcomes measure: Presence of self-reported swelling at breast, primaryOutcomes measure: Presence of subjective arm lymphedema, primaryOutcomes measure: Presence of subjective trunk lymphedema, primaryOutcomes measure: Presence of subjective breast lymphedema, primaryOutcomes measure: Relative hand volume difference, primaryOutcomes measure: Relative arm volume difference, primaryOutcomes measure: Extra-cellular water ratio by Bioimpedance Analysis, primaryOutcomes measure: Extra-cellular water ratio by Bioimpedance Spectroscopy, primaryOutcomes measure: Presence of objective arm lymphedema, primaryOutcomes measure: Relative percentage of water content (PWC) ratio, primaryOutcomes measure: Skin thickness, primaryOutcomes measure: Presence of objective trunk lymphedema, primaryOutcomes measure: Presence of objective breast lymphedema, secondaryOutcomes measure: Dermal rerouting score at arm, secondaryOutcomes measure: Dermal rerouting score at trunk, secondaryOutcomes measure: Severity of myofascial adhesions, secondaryOutcomes measure: Myofascial tissue stiffness, secondaryOutcomes measure: Pressure pain thresholds, secondaryOutcomes measure: Arm abduction range, secondaryOutcomes measure: Presence of neuropathic pain, secondaryOutcomes measure: Mechanical detection thresholds, secondaryOutcomes measure: Thermal detection and pain thresholds, secondaryOutcomes measure: Sensory acuity, secondaryOutcomes measure: Dysfunctional inhibitory pain mechanism, secondaryOutcomes measure: Enhanced facilitating mechanism, secondaryOutcomes measure: Body perception, secondaryOutcomes measure: Severity of subjective arm lymphedema, secondaryOutcomes measure: Severity of subjective trunk lymphedema, secondaryOutcomes measure: Severity of subjective breast lymphedema, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals of Leuven, center for lymphedema, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Nele Devoogdt, role: CONTACT, email: nele.devoogdt@uzleuven.be, contacts name: Ceren Gursen, role: CONTACT, email: ceren.guersen@kuleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06324708, orgStudyIdInfo id: THA_DXA, briefTitle: Analysis of Defined Elements on DXA in Patients Undergoing Hip Arthroplasty, acronym: THA_DXA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-07, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the role of two-dimensional FEM models obtained from DXA images in the longitudinal assessment of periprosthetic bone, in subjects undergoing hip arthroplasty. Specifically, the study will focus on the joint analysis of changes in the parameters of bone mineral density (BMD) and Bone Strain Index (BSI) at the level of periprosthetic bone of the proximal femur in patients undergoing hip replacement surgery using DXA, evaluating the densitometric variation of these two parameters over time, starting from an immediately postoperative data and checking the change at 6 months to follow the patient through the postoperative course, conditionsModule conditions: Bone Resorption, conditions: Arthroplasty Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: DXA, outcomesModule primaryOutcomes measure: Role of two-dimensional FEM models obtained from DXA images in longitudinal evaluation of periprosthetic bone, secondaryOutcomes measure: Role of two-dimensional FEM models of bone resistance to loading, secondaryOutcomes measure: Identification of mechanical stress, secondaryOutcomes measure: Assesment with PROMs: VAS, secondaryOutcomes measure: Assesment with PROMs; HHS, secondaryOutcomes measure: Assesment with PROMs: SF12, secondaryOutcomes measure: Assesment with PROMs: HOOS PS, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio, status: RECRUITING, city: Milan, zip: 20173, country: Italy, contacts name: Laura Mangiavini, role: CONTACT, phone: 0283506790, email: laura.mangiavini@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06324695, orgStudyIdInfo id: 01GY2105, briefTitle: Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases, acronym: DEVISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, collaborators name: German Federal Ministry of Education and Research, descriptionModule briefSummary: This project aims to develop and evaluate an online intervention to prevent and/or reduce self-stigma in German patients with visible chronic skin diseases. Evaluation of the intervention with regard to effectiveness and feasibility will follow an open-label randomized controlled design with 550 patients in total. The results of the program are expected to provide new insights and markedly extended knowledge on the mechanisms of self-stigma in chronic skin conditions. The new online intervention can be used in routine care, aiming for better patient care in practice and, ultimately decreased extent of self-stigma, increased quality of life of patients, and decreased rates of depression, anxiety, and suicide ideation., conditionsModule conditions: Psoriasis, conditions: Alopecia Areata, conditions: Hidradenitis Suppurativa, conditions: Vitiligo, conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: HautKompass, outcomesModule primaryOutcomes measure: Changes from baseline to post-intervention and follow-up in self-stigma, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in generic quality of life, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in skin-generic quality of life, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in depression, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in anxiety, secondaryOutcomes measure: Changes from baseline to post-intervention and follow-up in suicidal ideation, secondaryOutcomes measure: Feasibility of the HautKompass online program, secondaryOutcomes measure: Feasibility of the HautKompass online program - dropouts, secondaryOutcomes measure: User satisfaction with the HautKompass online program, secondaryOutcomes measure: Acceptability of the HautKompass online program, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in illness identity, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in avoidance and acceptance coping, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in generic body image/ appearance concerns, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in cutaneous body image, otherOutcomes measure: Changes from baseline to post-intervention and follow-up in self-compassion, otherOutcomes measure: Session Feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deutscher Vitiligo-Bund e.V., city: Adelsdorf, zip: 91325, country: Germany, contacts name: Georg Pliszewski, role: CONTACT, phone: 040 23532891, email: mail@vitiligo-bund.de, geoPoint lat: 49.47022, lon: 10.68522, locations facility: Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, city: Bad Bentheim, zip: 48455, country: Germany, contacts name: Athanasios Tsianakas, PD Dr.med., role: CONTACT, phone: 05922 74-0, email: info@fk-bentheim.de, geoPoint lat: 52.30077, lon: 7.15767, locations facility: Universitätsklinikum der Ruhr-Universität Bochum (UKRUB), Klinik für Dermatologie, Venerologie und Allergologie, city: Bochum, zip: 44791, country: Germany, contacts name: Falk Bechara, Prof.Dr.med., role: CONTACT, phone: 0234 509 6079, email: stephanie.pazia@kklbo.de, geoPoint lat: 51.48165, lon: 7.21648, locations facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP), city: Hamburg, zip: 20246, country: Germany, contacts name: Matthias Augustin, Prof.Dr.med., role: CONTACT, phone: +49 (0) 40 7410 55428, email: m.augustin@uke.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Deutscher Psoriasis Bund e.V. (DPB), city: Hamburg, zip: 20359, country: Germany, contacts name: Marius Grosser, role: CONTACT, phone: 040 2233990, email: info@psoriasis-bund.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Hautarztpraxis Dr. Daniela Kasche, city: Hamburg, zip: 22549, country: Germany, contacts name: Daniela Kasche, Dr. med., role: CONTACT, phone: 040 866 47 77 00, email: praxis@dr-kasche.de, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Psoriasis-Zentrum-Kiel, city: Kiel, zip: 24105, country: Germany, contacts name: Sascha Gerdes, Prof.Dr.med., role: CONTACT, phone: 0431 500 21102, email: ssievers@dermatology.uni-kiel.de, geoPoint lat: 54.32133, lon: 10.13489, locations facility: Alopecia Areata Deutschland e.V., city: Krefeld, zip: 47701, country: Germany, contacts name: Claudia Stenders, role: CONTACT, phone: 02151 786006, email: info@kreisrunderhaarausfall.de, geoPoint lat: 51.33645, lon: 6.55382, locations facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Hautklinik und Poliklinik, city: Mainz, zip: 55131, country: Germany, contacts name: Petra Staubach-Renz, Prof.Dr.med., role: CONTACT, phone: 06131 175244, phoneExt: 175732, email: petra.staubach@unimedizin-mainz.de, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Technische Universität München, Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein, city: München, zip: 80802, country: Germany, contacts name: Alexander Zink, PD Dr.med., role: CONTACT, phone: 089 4140 3038, email: alexander.zink@tum.de, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Universitätsklinikum Münster (UKM), Klinik für Hautkrankheiten - Allgemeine Dermatologie und Venerologie, city: Münster, zip: 48149, country: Germany, contacts name: Sonja Ständer, Prof.Dr.med., role: CONTACT, phone: 0251 8357458, email: sonja.staender@ukmuenster.de, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Dermatologische Spezial- und Schwerpunktpraxis Dr. med. Ralph von Kiedrowski, city: Selters, zip: 56242, country: Germany, contacts name: Ralph von Kiedrowski, Dr. med., role: CONTACT, phone: 02626 900775, email: dr.vonkiedrowski@cmss-selters.de, geoPoint lat: 50.51681, lon: 8.28953, locations facility: Privatpraxis Dr. med. Matthias Hoffmann, city: Witten, zip: 58453, country: Germany, contacts name: Matthias Hoffmann, Dr. med., role: CONTACT, phone: 02302 56060, email: service@hautarzt-dr-hoffmann.de, geoPoint lat: 51.44362, lon: 7.35258, hasResults: False
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protocolSection identificationModule nctId: NCT06324682, orgStudyIdInfo id: 825/2022/Oss/AOUFe, briefTitle: ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing, acronym: TREEBEARD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2033-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.Participants \[patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches., conditionsModule conditions: Arrhythmias, Cardiac, conditions: Atrioventricular Block, conditions: Reduced Systolic Function, conditions: Atrial Fibrillation, conditions: Bradyarrhythmia, conditions: Ventricular Tachycardia, conditions: Ventricular Dysfunction, conditions: Ventricular Fibrillation, conditions: Ventricular Arrythmia, conditions: Atrioventricular Nodal Disease, conditions: Atrioventricular Conduction Defects, conditions: Atrioventricular Block Complete, conditions: Atrioventricular Block Incomplete, conditions: Atrioventricular Junctional Rhythm, conditions: Bundle-Branch Block, conditions: Left Bundle-Branch Block, conditions: Heart Failure, Systolic, conditions: Block;Atrioventricular, conditions: Block; Arrhythmic, conditions: Block; Mobitz, conditions: Block, Heart, conditions: Block, Fascicular, conditions: Block Branch Bundle Left, conditions: Heart Failure，Congestive, conditions: Heart Arrhythmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 8400, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac pacing - Conventional RV pacing, interventions name: Cardiac pacing - Conduction System Pacing, interventions name: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD), interventions name: Cardiac pacing - Epicardial pacing, interventions name: Cardiac pacing - Leadless pacing, outcomesModule primaryOutcomes measure: 30 days efficacy, primaryOutcomes measure: Rate of hospitalizations for heart failure at 12 months, primaryOutcomes measure: All cause death at 12 months, secondaryOutcomes measure: All cause and cardiovascular death at 1, 3, 5, 10 years, secondaryOutcomes measure: Onset/worsening of heart failure, secondaryOutcomes measure: Onset/worsening of atrial tachyarrhythmias, secondaryOutcomes measure: Onset/worsening of ventricular tachyarrhythmias, secondaryOutcomes measure: Procedural time, secondaryOutcomes measure: Fluoroscopy time, secondaryOutcomes measure: Radiation exposure, secondaryOutcomes measure: Success rate of CRT in heart failure, secondaryOutcomes measure: Cardiac perforation rate, secondaryOutcomes measure: Hemothorax rate, secondaryOutcomes measure: Pneumothorax rate, secondaryOutcomes measure: Pocket hematoma rate, secondaryOutcomes measure: Pericardial effusion rate, secondaryOutcomes measure: Lead dislocation rate, secondaryOutcomes measure: Lead fracture rate, secondaryOutcomes measure: Cardiac Implantable Electronic Devices infections rate, secondaryOutcomes measure: Reintervention rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero-Universitaria di Ferrara, status: RECRUITING, city: Ferrara, state: FE, zip: 44124, country: Italy, contacts name: Matteo Bertini, MD, PhD, role: CONTACT, phone: +390532236269, email: brtmtt2@unife.it, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Ospedale San Donato, status: RECRUITING, city: Arezzo, country: Italy, contacts name: Pasquale Notarstefano, MD, role: CONTACT, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi Bologna, status: RECRUITING, city: Bologna, zip: 40138, country: Italy, contacts name: Mauro Biffi, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: spedale Maggiore di Bologna, status: RECRUITING, city: Bologna, country: Italy, contacts name: Valeria Carinci, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Bernardino Ramazzini, status: RECRUITING, city: Carpi, country: Italy, contacts name: Elia De Maria, MD, role: CONTACT, geoPoint lat: 44.78237, lon: 10.8777, locations facility: Ospedale SS Annunziata, status: RECRUITING, city: Cento, country: Italy, contacts name: Biagio Sassone, MD, role: CONTACT, geoPoint lat: 44.73099, lon: 11.28716, locations facility: Ospedale Bufalini, status: RECRUITING, city: Cesena, country: Italy, contacts name: Paolo Sabbatani, MD, role: CONTACT, geoPoint lat: 44.1391, lon: 12.24315, locations facility: Ospedale San Giuseppe, status: RECRUITING, city: Empoli, country: Italy, contacts name: Attilio Del Rosso, MD, role: CONTACT, geoPoint lat: 43.71795, lon: 10.94758, locations facility: Ospedale di Vaio, status: RECRUITING, city: Fidenza, country: Italy, contacts name: Paolo Pastori, role: CONTACT, geoPoint lat: 44.86694, lon: 10.06039, locations facility: Azienda Ospedaliero-Universitaria Careggi, status: RECRUITING, city: Firenze, country: Italy, contacts name: Giuseppe Ricciardi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale San Giovanni di Dio, status: RECRUITING, city: Firenze, country: Italy, contacts name: Iacopo Bertolozzi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Santa Maria Annunziata Bagno a Ripoli, status: RECRUITING, city: Firenze, country: Italy, contacts name: Maria Giaccardi, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti", status: RECRUITING, city: Foggia, country: Italy, contacts name: Pier Luigi Pellegrino, MD, role: CONTACT, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Ospedale Morgagni-Pierantoni, status: RECRUITING, city: Forlì, country: Italy, contacts name: Alberto Bandini, MD, role: CONTACT, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Ospedale Santa Maria della Misericordia Grosseto, status: RECRUITING, city: Grosseto, country: Italy, contacts name: Gennaro Miracapillo, MD, role: CONTACT, geoPoint lat: 42.76296, lon: 11.10941, locations facility: Ospedale della Versilia, status: RECRUITING, city: Lido Di Camaiore, country: Italy, contacts name: Gianluca Solarino, MD, role: CONTACT, geoPoint lat: 43.90012, lon: 10.2269, locations facility: Ospedali Riuniti di Livorno, status: RECRUITING, city: Livorno, country: Italy, contacts name: Federica Lapira, MD, role: CONTACT, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Ospedale San Luca, status: RECRUITING, city: Lucca, country: Italy, contacts name: Davide Giorgi, MD, role: CONTACT, geoPoint lat: 43.84369, lon: 10.50447, locations facility: Nuovo ospedale Apuano Massa, status: RECRUITING, city: Massa, country: Italy, contacts name: Giuseppe Arena, MD, role: CONTACT, geoPoint lat: 44.03541, lon: 10.13927, locations facility: Azienda Ospedaliero-Universitaria Policlinico di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Giuseppe Boriani, PhD, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Sant'Agostino Estense Modena Baggiovara, status: RECRUITING, city: Modena, country: Italy, contacts name: Mauro Zennaro, MD, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Civico, azienda Ospedaliera di Palermo, status: RECRUITING, city: Palermo, country: Italy, contacts name: Giuseppe Sgarito, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Policlinico Paolo Giaccone, status: RECRUITING, city: Palermo, country: Italy, contacts name: Giuseppe Coppola, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Azienda Ospedaliero-Universitaria Maggiore, status: RECRUITING, city: Parma, country: Italy, contacts name: Francesca Maria Notarangelo, MD, role: CONTACT, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Ospedale Guglielmo da Saliceto Piacenza, status: RECRUITING, city: Piacenza, zip: 29100, country: Italy, contacts name: Luca Rossi, MD, role: CONTACT, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Azienda Ospedaliero-Universitaria pisana Cisanello, status: RECRUITING, city: Pisa, country: Italy, contacts name: Giulio Zucchelli, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Fondazione Toscana Gabriele Monasterio, status: RECRUITING, city: Pisa, country: Italy, contacts name: Andrea Rossi, MD, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale Santa Maria delle Croci, status: RECRUITING, city: Ravenna, country: Italy, contacts name: Alessandro Dal Monte, role: CONTACT, geoPoint lat: 44.41344, lon: 12.20121, locations facility: ASMN Reggio Emilia, status: RECRUITING, city: Reggio Emilia, country: Italy, contacts name: Fabio Quartieri, MD, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale degli Infermi Rimini, status: RECRUITING, city: Rimini, country: Italy, contacts name: Davide Saporito, MD, role: CONTACT, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Azienda Ospedaliero-Universitaria Senese, status: RECRUITING, city: Siena, country: Italy, contacts name: Amato Santoro, MD, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, hasResults: False
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protocolSection identificationModule nctId: NCT06324669, orgStudyIdInfo id: 4765060, briefTitle: The Effect of a Ketone Drink on Blood Glucose Levels in People With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, collaborators name: University of British Columbia, collaborators name: Medical Research Council, descriptionModule briefSummary: Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important in the treatment of type 2 diabetes (T2D). The purpose of this research is to determine if a ketone drink can lower blood sugar in people with T2D following a meal. This research will provide new knowledge about the regulation of blood sugar. This may also inform if ketone drinks could be used as a treatment for T2D., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised cross over trial counterbalanced for trial order, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: Coded, known only to independent individual, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Ketone supplement, interventions name: Placebo supplement, outcomesModule primaryOutcomes measure: Rate of endogenous glucose production, secondaryOutcomes measure: Total rate of glucose appearance, secondaryOutcomes measure: Exogenous glucose rate of appearance, secondaryOutcomes measure: Total rate of glucose disappearance, secondaryOutcomes measure: Rate of gluconeogenesis, secondaryOutcomes measure: Rate of glycogenolysis, secondaryOutcomes measure: Beta-cell function, secondaryOutcomes measure: Insulin concentration, secondaryOutcomes measure: Glucagon concentration, secondaryOutcomes measure: GLP-1 concentration, secondaryOutcomes measure: GIP concentration, secondaryOutcomes measure: Glycerol concentration, secondaryOutcomes measure: Free fatty acid concentration, secondaryOutcomes measure: Ketone concentration, secondaryOutcomes measure: Energy expenditure, eligibilityModule sex: ALL, minimumAge: 41 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sport & Health Sciences University of Exeter, status: RECRUITING, city: Exeter, state: Devon, zip: EX1 2LU, country: United Kingdom, contacts name: Francis B Stephens, PhD, role: CONTACT, phone: +441392 722157, phoneExt: 2157, email: f.b.stephens@exeter.ac.uk, geoPoint lat: 50.7236, lon: -3.52751, hasResults: False
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protocolSection identificationModule nctId: NCT06324656, orgStudyIdInfo id: PRP-PNS, briefTitle: The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Necmi Kadıoğlu Hospital, class: OTHER, descriptionModule briefSummary: The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic qualities make it suitable for application in awake patients under local anesthesia. The treatment of pilonidal sinus diseas in children with crystallized phenol was first published by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require numerous sessions, potentially extending the duration of the treatment. IIn this study, the investigators, investigated whether the application of platelet-rich plasma following crystallized phenol treatment could accelerate the healing process and reach better outcomes. This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease in pediatric patients., conditionsModule conditions: Pilonidal Sinus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: crystallized phenol + platelet rich plasma application, interventions name: crystallized phenol, outcomesModule primaryOutcomes measure: Average time to full daily activities, primaryOutcomes measure: VAS scores, primaryOutcomes measure: Healing time, primaryOutcomes measure: Cosmetic score, primaryOutcomes measure: Success rate, primaryOutcomes measure: Recurrence rate, secondaryOutcomes measure: Bleeding rate, secondaryOutcomes measure: Infection rate, secondaryOutcomes measure: Skin burn rate, secondaryOutcomes measure: Total complication rate, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Mustafa Azizoğlu, status: RECRUITING, city: Istanbul, zip: 34430, country: Turkey, contacts name: Mustafa Azizoğlu, role: CONTACT, phone: +905447448244, email: mdmazizoglu@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06324643, orgStudyIdInfo id: Erb's Palsy, briefTitle: Sensory Motor Integration Training in Erb's Palsy Childern, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sara Elsayed Ali Abdelnaby Ali, class: OTHER, descriptionModule briefSummary: The aim of the study is to Study effect of sensory motor integration training on ADL activities in children with Erb's palsy., conditionsModule conditions: Sensory Motor Integration and Erb's, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: sensory motor integration training, outcomesModule primaryOutcomes measure: Effect of sensory motor integration training on ADL, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324630, orgStudyIdInfo id: 24FIM1266996, briefTitle: Implementation of Innovative Food Prescription Programs in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University at Buffalo, class: OTHER, descriptionModule briefSummary: In the USA, about 10% of grown-ups have a hard time finding healthy food, like fruits and vegetables. It's even harder for older grown-ups who might be sick and find it tricky to move around, which makes it tough to get healthy food. The investigators are trying to fix this by testing two new ways to help older people (aged 65 and up) get nutritious food. The investigators are getting lots of help and ideas from older adults to make these ways work the best they can.The study is happening at the Erie County Medical Center (ECMC) in the East Side of Buffalo, NY, where many African Americans live. This place hasn't been treated fairly, so there aren't many places to buy fresh fruits and vegetables in the local stores. On the ECMC campus, there are three clinics that can help people who can't easily get healthy food. Every participant in our study will be put into one of three programs, each lasting 12 weeks, and they will get food every week.In the "usual care" program, a doctor writes an order, and the participant gets a voucher to buy more fruits and vegetables at a market or store.In the "delivery of a produce prescription box" program, a box of fruits and vegetables is brought to the participant's home. The participant can pick what they like online or by calling a helper. If they don't pick, they get a regular box.In the "delivery of a meal kit box" program, the participant gets the ingredients for three meals in a box. The participant can pick three meals they like online or by calling. If the participant doesn't pick, three meals will be chosen for the participant.For the second and third programs, participants will get messages to remind the participant when to choose their food, when the time to choose is almost up, and when their food is on its way. If a participant can't use messages or the internet, they can call a helper for support. The investigators believe the study will show that these ways can help older adults who have a hard time getting food to eat more fruits and vegetables. The investigators will also find out which way works best compared to the usual way in the Buffalo, NY area., conditionsModule conditions: Food Preferences, conditions: Food Habits, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Produce Prescription Delivery, interventions name: Healthy Meal Kit Delivery, interventions name: Produce Prescription Mobile Market, outcomesModule primaryOutcomes measure: Program Redemption, secondaryOutcomes measure: Program Usage, secondaryOutcomes measure: Program Interest by Consenting to Being Contacted/Voiced Interest to Recruiter, secondaryOutcomes measure: Program Enrollment, otherOutcomes measure: Fruit and Vegetable Consumption, otherOutcomes measure: Nutrition Security, otherOutcomes measure: Self-Efficacy to Purchase, Prepare, and Eat Fresh Fruits and Vegetables, otherOutcomes measure: Barriers to Eating Fruits and Vegetables, otherOutcomes measure: Health Status and Disease Risk, otherOutcomes measure: Quality of Life in Older Age, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324617, orgStudyIdInfo id: soh-Med-24-02-06MS, briefTitle: Treatment of Failed Carpal Tunnel Syndrome by Dorsal Ulnar Artery Perforator Adipofascial Flap, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the general population. Surgical treatment by open or endoscopic carpal tunnel release (CTR) is the first choice of treatment and has clinical success rates of 75% to 90%.The rate of recurrence after primary median nerve release is 3-19% \[1,2\]. Between 0.3% and 12% of cases require surgical revision \[2,3\]. The risk factors for surgical revision for secondary release are male gender, staged or simultaneous bilateral carpal tunnel release, endoscopic release, smoking and rheumatoid arthritis.Treatment failures after primary CTR are classified as persistent CTS, recurrent CTS, or new symptoms. Recurrent symptoms are uncommon and are defined by a symptom-free interval after surgery. Persistent symptoms are relatively common, particularly in elderly patients and in patients with concurrent nerve compression or medical conditions that affect nerve function, such as diabetes. Persistent or recurrent CTS principally results from incomplete release of the transverse carpal ligament but may be accompanied by perineural scarring, leading to compression or tethering of the median nerve.New symptoms may be caused by iatrogenic nerve injury. Surgical treatment of recurrent or persistent CTS after primary CTR usually involves open revision CTR, extended proximally into unscarred tissue, and has also included internal or external neurolysis. Unsatisfactory results following revision CTR are common.A second compression site, or double-crush syndrome, may clinically present as RCTS or PCTS . Thorough preoperative clinical examination may uncover signs of a second compression site, which can then be confirmed on electroneuromyography (ENMG) of the entire arm.To improve outcomes of revision CTR, recent studies have emphasized the importance of median nerve coverage by well-vascularized soft tissue to enhance nerve healing, to prevent tethering in surrounding scar tissue, and to optimize nerve gliding in the carpal tunnel. Several local flaps (hypothenar fat pad flap, tenosynovial flap), regional flaps (posterior interosseous artery flap, reverse radial artery fascial flap, flexor digitorum superficialis flap), and free flap techniques have been described, but consensus for specific flap has not been reached. Following potential iatrogenic median nerve injury and reexploration for a painful neuroma incontinuity, flap coverage may also be beneficial.In 1988, Becker and Gilbert introduced a Fasciocutaneous pedicled flap based on a consistent dorsal perforator of the ulnar artery (absent in 1 % of population) named the dorsal ulnar artery (DUA) flap or simply the Becker flap. The authors described open revision CTR with nerve coverage by a DUA flap in 3 patients with recurrent CTS and reported good results as well as a quick and easy-to-perform dissection with low donor site morbidity and preservation of the radial andulnar artery. Since this introduction, additional studies describing fasciocutaneous DUA flaps have mostly focused on its use for reconstruction of hand or wrist wounds. Despite the original described benefits, additional studies of DUA flaps for the treatment of recurrent or persistent CTS have remained limited., conditionsModule conditions: Failed Carpal Tunnel Syndrome Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Treatment of failed carpal tunnel syndrome by dorsal ulnar artery perforator adipofascial flap, outcomesModule primaryOutcomes measure: Pain visual analogue scale (VAS), secondaryOutcomes measure: Two point discrimination test, secondaryOutcomes measure: Tinel sign, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag university Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06324604, orgStudyIdInfo id: MT-101-101, briefTitle: Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mozart Therapeutics Australia Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells., conditionsModule conditions: Healthy Volunteers, conditions: Celiac Disease, conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Part A will enroll Healthy Adult Volunteers will be randomized, double-blind, placebo-controlled, single ascending dose (SAD), randomized to MTX-101 or placebo in a 1:1 ratio for the first 2 participants (sentinel dosing) and a 3:1 ratio thereafter. Participants in the multiple ascending dose (MAD) will be randomized in a 3:1 ratio and be dosed on Days 1 and 22 for a total of 2 doses.Part B of this study plans to enroll at least 24 (up to 40) participants with Celiac Disease or Type 1 Diabetes, randomized in a 1:1 ratio, in a crossover design, dosed with MTX-101 or placebo on Days 1 and 22 for a total of 2 doses, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: MTX-101, outcomesModule primaryOutcomes measure: Safety of single, ascending dose levels of MTX-101, primaryOutcomes measure: Safety of multiple, ascending dose levels of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: pharmacokinetics (PK) of MTX-101, secondaryOutcomes measure: anti-drug antibody (ADA) formation, otherOutcomes measure: pharmacodynamics (PD) of MTX-101, otherOutcomes measure: Receptor occupancy of MTX-101, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nucleus Network Brisbane, city: Herston, state: Queensland, zip: 4006, country: Australia, contacts name: Gloria Wong, MD, role: CONTACT, phone: 1800243733, email: brisbane@nucleusnetwork.com, contacts name: Gloria Wong, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.44453, lon: 153.01852, hasResults: False
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protocolSection identificationModule nctId: NCT06324591, orgStudyIdInfo id: RISKCROHNBIOM, briefTitle: Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-03, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Collection biological sample and analysis, outcomesModule primaryOutcomes measure: Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy), secondaryOutcomes measure: Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk, secondaryOutcomes measure: Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine, city: Graz, country: Austria, geoPoint lat: 47.06667, lon: 15.45, locations facility: Ospedale Maggiore-Azienda Usl Di Bologna, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Meyer Children's Hospital IRCCS, city: Florence, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
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protocolSection identificationModule nctId: NCT06324578, orgStudyIdInfo id: RC 25/2023, briefTitle: Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: The main study hypothesis is that Sjögren Disease (SD), usually considered a disorder typical of adult females, may occur not exceptionally in adolescence or even in childhood as a subclinical process. There are several pieces of evidence in favor of this hypothesis, from the incidental detection of asymptomatic SD in pediatric age to biobank-based studies showing that biological signs of SD may precede the disease clinical onset by years or decades. The best scenario to verify this hypothesis could be that of autoimmune thyroiditis, for the following three reasons: 1) subjects with Autoimmune thyroiditis (AT) have a high risk of developing SD (7%); 2) in cases with comorbidity of SD and AT the diagnosis of AT had usually been made before; 3) subjects with AT routinely undergo periodic blood examination and neck ultrasonography (US), which may include Salivary Gland Ultrasound (SGUS) providing contributive data to detect an asymptomatic pre-SD. The knowledge of the real association between AT and pre-SD may impact on several aspects of medicine., conditionsModule conditions: Sjögren, conditions: Autoimmune Thyroid Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: AT Testing, outcomesModule primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, primaryOutcomes measure: Prevalence of pre-SD in pediatric subjects with AT, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Alberto Tommasini, MD PhD Prof, role: CONTACT, phone: +39.040.785.422, email: alberto.tommasini@burlo.trieste.it, contacts name: Barbara Bonifacio, role: CONTACT, phone: +39.040.3785.422, email: barbara.bonifacio@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06324565, orgStudyIdInfo id: RC 24/2021, briefTitle: Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-13, primaryCompletionDateStruct date: 2024-12-13, completionDateStruct date: 2024-12-13, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy., conditionsModule conditions: Adnexal Torsion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: D-Dimer test, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the D-Dimer, eligibilityModule sex: FEMALE, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Alessandro Boscarelli, MD, role: CONTACT, phone: +393931757607, email: alessandro.boscarelli@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06324552, orgStudyIdInfo id: RC 16/18, briefTitle: Defects of Keratinocytes Function in Dermatologic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-12, primaryCompletionDateStruct date: 2023-06-03, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT), secondaryOutcomes measure: Evaluation of the impact of photobiomodulation (PBM) therapy in hair follicles epithelial cells derived from patients and in HaCaT KO cells,, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Paola Maura Tricarico, BSc, role: CONTACT, phone: +39 0403785111, email: paolamaura.tricarico@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06324539, orgStudyIdInfo id: PNRR-POC-2022-12376280, briefTitle: Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Celiac disease (CD) is a common auto-immune disorder induced by gluten ingestion in genetically susceptible individuals (HLA-DQ2/DQ8). Gluten induces small-bowel villous atrophy and a specific immune response characterized by the production of CD-autoantibodies against transglutaminase 2 (anti-TG2) and endomysium (EMA). In symptomatic patients with positive-serum antibodies and villous atrophy, the diagnosis of CD is clearcut.However, 10-30% of patients evaluated for suspected CD show only mild histopathologic changes and fluctuating serologic markers, a condition identified as potential CD. In such cases the diagnosis may remain uncertain.CD-autoantibodies are produced by intestinal B-cells in the early phases of the disease, before their appearance in the serum and when the duodenal mucosa is still normal. Intestinal CD-antibodies (I-CD-abs) are a marker of CD, have a high sensitivity and specificity for CD and identify those patients with potential CD who are at risk of progression to villous atrophy. I-CD-abs can be detected by double immunofluorescence staining on frozen duodenal sections or by using an endomysial antibody assay in the culture medium of duodenal biopsies (EMAbiopsy).The diagnostic accuracy of these techniques is comparable as they both have high sensitivity and specificity. However, their implementation in clinical practice is limited because they require both experienced operators and well-equipped laboratories. There is an unmet need: the development of a new simple and effective diagnostic tool that any gastroenterology unit can use in routine diagnostics to ensure a prompt diagnosis in suspected CD patients, who may benefit from a therapy based on gluten-free diet, and to reduce both unnecessary medical investigations and diagnostic delays.In order to simplify and shorten times for the detection of these intestinal antibodies, the study aims to substitute the EMAbiopsy assay with a supernatant obtained quickly after mechanical lysis of fresh intestinal biopsy specimen. The obtained samples will be tested with rapid (about 15 minutes) immune-chromatographic anti-TG2 assay (Rapid Intestinal anti-TG2 Assay)., conditionsModule conditions: Celiac Disease in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 332, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic Test: Rapid Intestinal anti-TG2 Assay, interventions name: Diagnostic Test: Rapid Intestinal anti-TG2 Assay, outcomesModule primaryOutcomes measure: Sensitivity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis, primaryOutcomes measure: Specificity of the EMA-biopsy in comparison to the reference standard (serology + histology) for CD diagnosis, primaryOutcomes measure: Sensitivity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis, primaryOutcomes measure: Specificity of the Rapid Intestinal anti-TG2 Assay in comparison to the reference standard (serology + histology) for CD diagnosis, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Luigina De Leo, role: CONTACT, phone: +39.040.3785.472, email: luigina.deleo@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06324526, orgStudyIdInfo id: 070324QL, briefTitle: Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-06-01, primaryCompletionDateStruct date: 2022-11-23, completionDateStruct date: 2022-11-23, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: University of Oxford, descriptionModule briefSummary: United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time., conditionsModule conditions: Quality of Life, conditions: Obesity, Morbid, conditions: Bariatric Surgery Candidate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2160, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: EQ-5D (EuroQol Five Dimension), primaryOutcomes measure: BMI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery and Cancer, Imperial College London, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06324513, orgStudyIdInfo id: Med-CDED, briefTitle: Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-27, primaryCompletionDateStruct date: 2025-07-27, completionDateStruct date: 2025-10-27, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean Crohn's Disease Exclusion Diet (Med-CDED), interventions name: Crohn's disease exclusion diet (CDED), outcomesModule primaryOutcomes measure: Clinical response to the first phase of diet, primaryOutcomes measure: Clinical remission rate, primaryOutcomes measure: Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort, primaryOutcomes measure: Clinical remission rate in adult patients at the end of phase I of diet, secondaryOutcomes measure: Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Endoscopic response rate obtained at 6 months both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort, secondaryOutcomes measure: Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Paolo Lionetti, role: CONTACT, email: paolo.lionetti@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedali Riuniti Villa Sofia-Cervello, status: RECRUITING, city: Palermo, country: Italy, contacts name: Ambrogio Orlando, role: CONTACT, email: ambrogiorlando@gmail.com, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Università La Sapienza di Roma, status: RECRUITING, city: Roma, country: Italy, contacts name: Salvatore Oliva, role: CONTACT, email: salvatore.oliva@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06324500, orgStudyIdInfo id: ASC-US, briefTitle: Prognostic Role of Bowel Ultrasound Scan in Children Affected by Acute Severe Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-03-02, primaryCompletionDateStruct date: 2025-03-02, completionDateStruct date: 2025-05-02, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: ASC is a life-threatening medical emergency. The lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. Therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. At the state of the art, PUCAI represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in ASC.BUS has proven to be a reliable tool in assessing disease activity in children with UC and it has also shown statistically significant correlation with endoscopic features of disease activity. Given the literature suggesting a role for BUS in severe UC and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of BUS in ASC., conditionsModule conditions: Acute Severe Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: Colonic wall thickness of BUS (bowel ultrasound) parameter to predict the failure of first line treatment, primaryOutcomes measure: Color and power Doppler vascularization of BUS (bowel ultrasound) parameter to predict the failure of first line treatment, primaryOutcomes measure: Mesenteric lymph nodes BUS (bowel ultrasound) parameter, secondaryOutcomes measure: evaluation of the prognostic value of the ultrasound parameters, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, zip: 50139, country: Italy, contacts name: Paolo Lionetti, role: CONTACT, email: paolo.lionetti@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Maggiore, status: RECRUITING, city: Bologna, country: Italy, contacts name: Patrizia Alvisi, role: CONTACT, email: Patrizia.alvisi@ausl.bologna.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: IRCCS Materno Infantile Burlo Garofolo, status: RECRUITING, city: Trieste, country: Italy, contacts name: Matteo Bramuzzo, role: CONTACT, email: matteo.bramuzzo@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, locations facility: CMED Centro Médico-Quirúrgico de Enfermedades Digestivas, status: RECRUITING, city: Madrid, country: Spain, contacts name: Marta Velasco Rodriguez- Belvis, role: CONTACT, email: martavrb@gmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06324487, orgStudyIdInfo id: E-10840098-772.02-7487, briefTitle: A New Application in Subacromial Impingement Syndrome, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment. Pain, shoulder ROM, shoulder functional level, quality of life, shoulder muscle strength, grip strength, and sleep quality evaluation will be performed. The treatment program will be 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist., conditionsModule conditions: Subacromial Impingement Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Progressive Exercises, interventions name: Blood Flow Restriction Therapy, outcomesModule primaryOutcomes measure: Pain İntensity, primaryOutcomes measure: Shoulder ROM, secondaryOutcomes measure: Quality of Life Assessment, secondaryOutcomes measure: Sleep Quality Assessment, secondaryOutcomes measure: Shoulder Functional Level Assessment, secondaryOutcomes measure: Shoulder Muscle Strength Assessment, secondaryOutcomes measure: Grip Strength Assessment, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06324474, orgStudyIdInfo id: HA treatment of periodontitis, briefTitle: Clinical and Immunological Evaluation of HA in Treatment of Periodontitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12-12, completionDateStruct date: 2024-12-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sana'a University, class: OTHER, descriptionModule briefSummary: To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone.Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Hyaluronic acid, interventions name: scaling and root planning, outcomesModule primaryOutcomes measure: Changes in Plaque Index, primaryOutcomes measure: Changes in Gingival Index, primaryOutcomes measure: Changes in Papillary Bleeding Index., primaryOutcomes measure: Periodontal Probing Depth, primaryOutcomes measure: Clinical attachment loss, primaryOutcomes measure: Changes in IGF-1, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sana'a university, city: Sana'a, country: Yemen, geoPoint lat: 15.35472, lon: 44.20667, hasResults: False
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protocolSection identificationModule nctId: NCT06324461, orgStudyIdInfo id: GLUMINS, briefTitle: GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery, acronym: GLUMINS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 4 days prior to surgery or receive routine care.Semaglutide (Ozempic; Novo Nordisk, Denmark) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery., conditionsModule conditions: Myocardial Injury, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-labelled, superiority randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 372, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide 0.25mg subcutaneous injection, outcomesModule primaryOutcomes measure: Proportion of patients with MINS, secondaryOutcomes measure: Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality, secondaryOutcomes measure: Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction, secondaryOutcomes measure: Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction, secondaryOutcomes measure: Proportion of patients with ischemic stroke, secondaryOutcomes measure: Proportion of patients with cardiovascular death, secondaryOutcomes measure: Proportion of patients with all-cause mortality, secondaryOutcomes measure: Mean days alive and out of hospital, secondaryOutcomes measure: Clinically important atrial fibrillation, secondaryOutcomes measure: Clinically significant hypoglycaemia, secondaryOutcomes measure: Mean peak troponin T concentration, secondaryOutcomes measure: Mean area under curve of troponin T concentration, otherOutcomes measure: Proportion of patients with coronary revascularization, otherOutcomes measure: Proportion of patients who require readmission for cardiovascular conditions, otherOutcomes measure: Proportion of patients with non-fatal cardiac arrest, otherOutcomes measure: Proportion of patients who require hospitalization for heart failure, otherOutcomes measure: Proportion of patients who develop pulmonary embolism and/or deep vein thrombosis, otherOutcomes measure: Proportion of patients with International Society on Thrombosis and Haemostasis (ISTH) major bleeding, otherOutcomes measure: Proportion of patients with bleeding independently associated with mortality following noncardiac surgery (BIMS), otherOutcomes measure: Proportion of patients with infection or sepsis, otherOutcomes measure: Proportion of patients with acute renal failure fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria, otherOutcomes measure: Proportion of patients with acute renal failure requiring dialysis, otherOutcomes measure: Proportion of patients requiring amputation, otherOutcomes measure: Mean length of stay, otherOutcomes measure: Mean length of intensive care unit stay, otherOutcomes measure: Mean days alive without need for intensive care support, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Mary Hospital, city: Hong Kong, state: Hong Kong SAR, country: China, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False
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protocolSection identificationModule nctId: NCT06324448, orgStudyIdInfo id: PD-tDCS-RCT, briefTitle: Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Timed-up and go test (sec), primaryOutcomes measure: Timed-up and go test under dual-task condition (sec), secondaryOutcomes measure: Dual-task effect (%) in Timed-up and go test, secondaryOutcomes measure: modified Attention Allocation Index (mAAI) in Timed-up and go test, secondaryOutcomes measure: Gait parameters, secondaryOutcomes measure: Single-leg stance test, secondaryOutcomes measure: Stroop test, secondaryOutcomes measure: Trail making test, secondaryOutcomes measure: New freezing of gait questionnaire (NFoGQ), secondaryOutcomes measure: Geriatric depression scale (GDS)-short form, secondaryOutcomes measure: Timed-up and go test (sec), secondaryOutcomes measure: Timed-up and go test under dual-task condition (sec), secondaryOutcomes measure: Dual-task effect (%) in Timed-up and go test, secondaryOutcomes measure: modified Attention Allocation Index (mAAI) in Timed-up and go test, secondaryOutcomes measure: Gait parameters, secondaryOutcomes measure: Single-leg stance test, secondaryOutcomes measure: Stroop test, secondaryOutcomes measure: Trail making test, secondaryOutcomes measure: New freezing of gait questionnaire (NFoGQ), secondaryOutcomes measure: Geriatric depression scale (GDS)-short form, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: Han Gil Seo, MD, role: CONTACT, phone: 82-2-2072-1659, email: hgseo80@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06324435, orgStudyIdInfo id: 2000037439, secondaryIdInfos id: U54AA027989, type: NIH, link: https://reporter.nih.gov/quickSearch/U54AA027989, briefTitle: Apremilast for Alcohol Use Disorder Treatment in Women and Men, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), collaborators name: Office of Research on Women's Health (ORWH), descriptionModule briefSummary: For this protocol, the investigators plan to collect pilot data to evaluate apremilast (60mg/day) in adults with Alcohol Use Disorders (AUD)., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Apremilast, outcomesModule primaryOutcomes measure: Alcohol Consumption, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324422, orgStudyIdInfo id: Fatigue & Parkinson's disease, briefTitle: Exercise as Treatment of Fatigue in Parkinson´s Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: The primary goal of this study is to test whether 12 weeks of high-intensity aerobic exercise can treat fatigue in Parkinsons disease (PD).The study will be a randomized multi-site controlled trial with follow up. Clinically fatigued persons with PD will be allocated to either 12 weeks of high-intensity aerobic exercise or to a waitlist control group receiving high-intensity resistance exercise after 24 weeks of habitual lifestyle (control period).It is hypothesized that persons with PD receiving 12 weeks of high-intensity aerobic exercise will show superior effects on perceived fatigue (i.e., clinical relevant reductions) when compared to the PD control group (primary hypothesis), and that these effects are sustained after 12-weeks of follow up (secondary hypothesis)., conditionsModule conditions: Parkinson's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled multi-site trial with follow-up, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise intervention, interventions name: Resistance exercise intervention, outcomesModule primaryOutcomes measure: Change in Modified Fatigue Impact Scale, secondaryOutcomes measure: Change in Fatigue Severity Scale, secondaryOutcomes measure: Change in Parkinson's Fatigue Scale, secondaryOutcomes measure: Change in Parkinson's Disease Questionnaire 39, secondaryOutcomes measure: Change in Baecke Habitual Physical Activity Questionnaire, secondaryOutcomes measure: Change in Pitchburg Sleep Quality Index, secondaryOutcomes measure: Change in Major Depression Inventory, secondaryOutcomes measure: Change in European Quality of life - 5 Dimensions, secondaryOutcomes measure: Change in Non-motor Symptoms Questionnaire, secondaryOutcomes measure: Change in Brief Pain Inventory (Short Form), secondaryOutcomes measure: Change in The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale, secondaryOutcomes measure: Change in Six Minute Walk Test, secondaryOutcomes measure: Change in Timed Up and Go, secondaryOutcomes measure: Change in Six Spot Step Test, secondaryOutcomes measure: Change in Symbol Digit Modalities Test, secondaryOutcomes measure: Change in Montreal Cognitive Assessment, secondaryOutcomes measure: Change in Muscle strength, secondaryOutcomes measure: Change in aerobic capacity, secondaryOutcomes measure: Change in Physical activity, secondaryOutcomes measure: Change in Rochester Fatigue Diary, secondaryOutcomes measure: Change in Visual Analog Scale for fatigue, tremor, bradykinesia, rigidity and postural instability, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Exercise Biology, Dep. of Public Health, Aarhus University, city: Aarhus, state: Midtjylland, zip: 8000, country: Denmark, contacts name: Cecilie Thrue, PhD student, role: CONTACT, phone: 004520768102, email: ceth@ph.au.dk, contacts name: Cecilie Thrue, PhD student, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06324409, orgStudyIdInfo id: H-350, briefTitle: ImmigrantScreen Telephone Reminder Trial in Colorectal Cancer Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Norwegian Institute of Public Health, class: OTHER_GOV, descriptionModule briefSummary: The goal of this randomized trial is to test the effect of a reminder telephone call in the official native language in the country where the invitee is born, in addition to the reminder letter in Norwegian on participation in the National Colorectal Cancer Screening Program in Pakistani and Somalian immigrants, compared to the reminder letter in Norwegian only.The main question it aims to answer is:•Does a reminder telephone call in the language of origin increase participation in colorectal cancer screening in Pakistani and Somalian immigrants in Norway?Participants in this trial are individuals with Pakistan or Somalia as their country of birth invited to the National Colorectal Cancer Screening Program, who have not participated by mailing a faecal sample to the screening laboratory.In the intervention group, the participants will be called in the official language in their country of origin, to inform about colorectal cancer screening, in addition to the reminder letter in Norwegian language sent to all non-participants.Participants in the comparison group will only be sent the reminder letter in Norwegian language.The researchers will compare differences in the participation rate in the National Colorectal Cancer Screening Program between the intervention and comparison groups., conditionsModule conditions: Cancer Colorectal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There is an intervention group and a comparison group in the study., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Reminder telephone call, outcomesModule primaryOutcomes measure: First round screening participation, secondaryOutcomes measure: Overall screening participation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324396, orgStudyIdInfo id: STUDY00002974, briefTitle: IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease, acronym: IMPROVE-FALD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Children's Mercy Hospital Kansas City, class: OTHER, collaborators name: Indiana Clinical and Translational Sciences Institute, descriptionModule briefSummary: This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation., conditionsModule conditions: Fontan Circulation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), interventions name: Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years), outcomesModule primaryOutcomes measure: Sildenafil concentration as measured by area under the curve (AUC), primaryOutcomes measure: Pravastatin concentration as measured by area under the curve (AUC), eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Mercy Hospital, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64108, country: United States, contacts name: Jonathan Wagner, DO, role: CONTACT, contacts name: Jonathan Wagner, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False
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protocolSection identificationModule nctId: NCT06324383, orgStudyIdInfo id: 1782599, briefTitle: Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-03-28, completionDateStruct date: 2025-03-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing., conditionsModule conditions: Depression, Anxiety, PTSD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intervention (videoconferencing), outcomesModule primaryOutcomes measure: France and Finney "Mattering", primaryOutcomes measure: (Patient Health Questionnaire) PHQ-8, primaryOutcomes measure: (Generalized Anxiety Disorder) GAD-7, primaryOutcomes measure: (Posttraumatic Stress Disorder Checklist) PCL-5, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Clinical Management Research (CCMR), North Campus Research Complex, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-28, uploadDate: 2024-03-12T11:49, filename: ICF_000.pdf, size: 166776, hasResults: False
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protocolSection identificationModule nctId: NCT06324370, orgStudyIdInfo id: FIERC-2022-023, briefTitle: Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-13, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Food and Nutrition Research Institute, Philippines, class: OTHER_GOV, collaborators name: Ateneo de Manila University, collaborators name: De La Salle Medical and Health Sciences Institute, descriptionModule briefSummary: This is a balanced, open-label, single- and multiple-dose pharmacokinetic (PK) study of virgin coconut oil (VCO) among healthy Filipino male adults 18-45 years of age in Dasmariñas, Cavite. This study aims to determine the rate and extent of absorption of virgin coconut oil (VCO) administered in healthy male human study participants under fed conditions in single and multiple doses and to monitor the safety and tolerability of virgin coconut oil (VCO) following the standard protocol developed by the De La Salle Medical and Health Sciences Institute (DLSMHSI)., conditionsModule conditions: Pharmacological Action, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: This will be a two-sequence (single- and multiple-dose) pharmacokinetic study in healthy Filipino male human participants under fed conditions., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: This will be an open-label pharmacokinetic study in healthy Filipino male human participants under fed conditions., enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Virgin Coconut Oil, outcomesModule primaryOutcomes measure: Pharmacokinetics (AUC0-t), primaryOutcomes measure: Pharmacokinetics (Cmax), secondaryOutcomes measure: Pharmacokinetics (AUC0-inf), secondaryOutcomes measure: Pharmacokinetics (tmax), secondaryOutcomes measure: Pharmacokinetics (Kel), secondaryOutcomes measure: Pharmacokinetics (t1/2), secondaryOutcomes measure: Vital Signs (Systolic and Diastolic Blood Pressure), secondaryOutcomes measure: Vital Signs (Pulse rate), secondaryOutcomes measure: Vital Signs (Body temperature), secondaryOutcomes measure: Vital Signs (Respiratory rate), secondaryOutcomes measure: Safety and Tolerability (Adverse events), secondaryOutcomes measure: Post Study Evaluation (Fasting Blood Sugar Test), secondaryOutcomes measure: Post Study Evaluation (Blood Urea Nitrogen Test), secondaryOutcomes measure: Post Study Evaluation (Creatinine), secondaryOutcomes measure: Post Study Evaluation (Uric Acid), secondaryOutcomes measure: Post Study Evaluation (Serum Glutamic Pyruvic Transaminase Test), secondaryOutcomes measure: Post Study Evaluation (Serum Glutamic-oxaloacetic Transaminase Test), secondaryOutcomes measure: Post Study Evaluation (Alkaline Phosphatase Test), secondaryOutcomes measure: Post Study Evaluation (TPAG- Total Protein, Albumin, Globulin Ratio Test), secondaryOutcomes measure: Post Study Evaluation (Indirect, Direct and Total Bilirubin), secondaryOutcomes measure: Post Study Evaluation (Lipid Profile - High-density lipoprotein, Low-density lipoprotein, Cholesterol and Triglycerides), secondaryOutcomes measure: Post Study Evaluation (Lipase Test), secondaryOutcomes measure: Post Study Evaluation (Amylase Test), secondaryOutcomes measure: Post Study Evaluation (Complete Blood Count with Platelet Count Test), secondaryOutcomes measure: Post Study Evaluation (Complete Urinalysis), secondaryOutcomes measure: Post Study Evaluation (Fecalysis), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI), city: Taguig, state: Metro Manila, zip: 1630, country: Philippines, geoPoint lat: 14.52429, lon: 121.07921, hasResults: False
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protocolSection identificationModule nctId: NCT06324357, orgStudyIdInfo id: 1479-0012, briefTitle: Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2027-02-22, completionDateStruct date: 2028-08-21, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd) or with trastuzumab emtansine (T-DM1). Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.The study is split into treatment cycles. All study participants are treated with zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1, participants receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Metastatic Breast Cancer, conditions: Metastatic Gastric Adenocarcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, conditions: Esophageal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Zongertinib, interventions name: Trastuzumab deruxtecan, interventions name: Trastuzumab emtansine, outcomesModule primaryOutcomes measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period, primaryOutcomes measure: Dose optimization (Phase II): Objective response (OR), secondaryOutcomes measure: Dose escalation (Phase Ib): Objective response (OR), secondaryOutcomes measure: Dose escalation (Phase Ib): Occurrence of dose-limiting toxicities (DLTs) during the entire treatment period, secondaryOutcomes measure: Dose escalation (Phase Ib): Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Dose escalation (Phase Ib): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2), secondaryOutcomes measure: Dose optimization (Phase II): Progression-free survival (PFS), secondaryOutcomes measure: Dose optimization (Phase II): Disease control (DC), secondaryOutcomes measure: Dose optimization (Phase II): Occurrence of treatment-emergent AEs leading to zongertinib (BI 1810631) dose reduction during the on-treatment period, secondaryOutcomes measure: Dose optimization (Phase II): Maximum measured concentration of the analyte in plasma (Cmax), secondaryOutcomes measure: Dose escalation (Phase II): Area under the concentration-time curve of the analyte in plasma from 0 to t2 (AUC0-t2), secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - PRO-CTCAE, secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL46, secondaryOutcomes measure: Dose optimization (Phase II): Patient-reported outcome (PRO) - EORTC IL19, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324344, orgStudyIdInfo id: H-50753-B, briefTitle: Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2025-10-02, completionDateStruct date: 2025-10-02, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: NeuroMetrix, Inc., descriptionModule briefSummary: The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance., conditionsModule conditions: Chemotherapy-induced Peripheral Neuropathy, conditions: Pain, conditions: Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Double, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High-Dose TENS, interventions name: Low-Dose TENS, outcomesModule primaryOutcomes measure: Change in pain level at 8 weeks from baseline, secondaryOutcomes measure: Change in vibration perception threshold at 8 weeks from baseline, secondaryOutcomes measure: Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline, secondaryOutcomes measure: Changes in Quality of Life at 8 weeks from baseline, otherOutcomes measure: Changes in stride time at 8 weeks from baseline, otherOutcomes measure: Changes in cadence at 8 weeks from baseline, otherOutcomes measure: Changes in double-support phase at 8 weeks from baseline, otherOutcomes measure: Changes in Range of Motion (RoM) at 8 weeks from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor College of Medicine, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Bijan Najafi, PhD, role: CONTACT, phone: 713-798-7536, email: bijan.najafi@bcm.edu, contacts name: Maria Noun, BS, role: CONTACT, phone: 713-798-7538, email: maria.noun@bcm.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06324331, orgStudyIdInfo id: Decidual sparing & CS niche, briefTitle: Effect of Decidual Sparing in cs Niche Formation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment, conditionsModule conditions: Cesarean Section Complications, conditions: Cesarean Section Niche, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SCREENING, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule interventions name: Decidual sparing, interventions name: Non decidual sparing, outcomesModule primaryOutcomes measure: Impact of decidual sparing on niche formation, secondaryOutcomes measure: Impact of uterine closure technique on post CS niche criteria, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06324318, orgStudyIdInfo id: R01DA056417, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA056417, secondaryIdInfos id: R01DA056417, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA056417, briefTitle: Parenting in 2 Worlds Multisite Trial, acronym: (P2W), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-14, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, collaborators name: Phoenix Indian Center, collaborators name: Ain Dah Yung Center, collaborators name: Denver Indian Center Inc, collaborators name: Native American Community Services of Erie and Niagara Counties, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors., conditionsModule conditions: Parenting, conditions: Mental Health Wellness 1, conditions: Substance Use, conditions: Risky Health Behavior, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: Parenting in 2 Worlds (P2W), interventions name: Healthy Families in 2 Worlds (HF2W), outcomesModule primaryOutcomes measure: Change from baseline in family functioning and cohesion, primaryOutcomes measure: Change from baseline in parental involvement, primaryOutcomes measure: Change from baseline in parental supervision, primaryOutcomes measure: Change from baseline in parental monitoring, primaryOutcomes measure: Change from baseline in positive parenting practices, primaryOutcomes measure: Change from baseline in relational warmth, primaryOutcomes measure: Change from baseline in relational hostility, primaryOutcomes measure: Change from baseline in family conflict, primaryOutcomes measure: Change from baseline in parental self-agency, primaryOutcomes measure: Change from baseline in effective discipline, primaryOutcomes measure: Change from baseline in parental communication about sex, primaryOutcomes measure: Change from baseline in child problem behaviors., primaryOutcomes measure: Change from baseline in decision making about risk behaviors, primaryOutcomes measure: Change from baseline in substance use, primaryOutcomes measure: Change from baseline in risky sexual behaviors, secondaryOutcomes measure: Change from baseline in depressive symptoms, secondaryOutcomes measure: Change from baseline in suicidality, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Phoenix Indian Center, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85012, country: United States, contacts name: Jolyana Begay-Kroupa, role: CONTACT, phone: 602-264-6768, email: jbegay-kroupa@phxindcenter.org, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Denver Indian Center, status: RECRUITING, city: Denver, state: Colorado, zip: 80219, country: United States, contacts name: Rick Waters, role: CONTACT, phone: 303-936-2688, email: rick@denverindiancenter.org, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Ain Dah Yung Center, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55104, country: United States, contacts name: Amy Arndt, role: CONTACT, phone: 651-227-4184, email: amy.arndt@adycenter.org, geoPoint lat: 44.94441, lon: -93.09327, locations facility: Native American Community Services Erie and Niagara Counties, status: RECRUITING, city: Buffalo, state: New York, zip: 14207, country: United States, contacts name: Michael Martin, role: CONTACT, phone: 716-299-0914, email: mmartin@nacswny.org, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
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protocolSection identificationModule nctId: NCT06324305, orgStudyIdInfo id: SRF drainage techniques in RRD, briefTitle: Comparative Study Between Three Different Techniques in Drainage of SRF During PPV in RRD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The study will investigate and compare the three techniques in drainage of subretinal fluid in patients with macula off RRD: namely using the original break, performing a posterior drainage retinotomy and using PFC with drainage through the original break or peripheral retinotomy regarding the presence of persistent sub-retnal fluid and related intra or postoperative complications, conditionsModule conditions: Rhegmatogenous Retinal Detachment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Pars plana vitrectomy (PPV) and drainage of subretinal fluid, outcomesModule primaryOutcomes measure: The presence versus absence of sub-macular fluid using each of the three different techniques in pars plana vitrectomy (PPV), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324292, orgStudyIdInfo id: FDASU-RecID112324, briefTitle: Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture., conditionsModule conditions: Complete Edentulism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: complete denture, CG, interventions name: complete denture, DG, outcomesModule primaryOutcomes measure: quality of life assessment, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Ain Shams University, city: Cairo, zip: 11361, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Faculty of Dentistry, Ain Shams University, city: Cairo, zip: 11361, country: Egypt, contacts name: ahmed MA mohamed, Bsc, Msc,MD, role: CONTACT, phone: 01111191337, phoneExt: 020, email: ahmedmostafa@dent.asu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06324279, orgStudyIdInfo id: 000017585, briefTitle: Cervical Sliding Sign to Predict Outcome of Induction of Labor, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ain Shams Maternity Hospital, class: OTHER, descriptionModule briefSummary: Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor.The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe.Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction., conditionsModule conditions: Induction of Labor, conditions: Transvaginal Ultrasound: Cervical Sliding Sign, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Transvaginal ultrasound, interventions name: Misoprostol 200mcg Tab, outcomesModule primaryOutcomes measure: Mode of delivery, primaryOutcomes measure: Induction to active labor time, primaryOutcomes measure: Active labor to delivery time, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Maternity hospital, ainshams university hospitals, city: Cairo, zip: 11799, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06324266, orgStudyIdInfo id: 2023NZKY-044-02, briefTitle: Study on the Efficacy and Safety of Low-dose CTX as Maintenance Therapy for MM Unsuitable for Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-16, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Jinling Hospital, China, class: OTHER, descriptionModule briefSummary: The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group., conditionsModule conditions: Newly Diagnosed Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Lenalidomide, outcomesModule primaryOutcomes measure: PFS1, secondaryOutcomes measure: Incidence of Efficacy as assessed by IMWG, secondaryOutcomes measure: Incidence of Safety as assessed by CTCAE 4.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: Zhao Qian, role: CONTACT, phone: 18251835035, email: 540598707@qq.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06324253, orgStudyIdInfo id: 1/24 UROL2, briefTitle: Thoracic Epidural Analgesia With Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery, acronym: TEAvsESB, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-10, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, collaborators name: Amal Ismael Abdelrahman Hassan, collaborators name: Ibrahim Mowafy Gomaa Atawia, descriptionModule briefSummary: The aim of this study is to compare between Thoracic Epidural Analgesia (TEA) with ultrasound-guided bilateral erector spinae plane (ESP) block in radical cystectomy surgery for analgesic efficacy and hemodynamic effects, conditionsModule conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group A: will receive bilateral Erector Spinae Block after induction of anesthesia.Group B: will receive Thoracic Epidural Block before induction of anesthesia., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected., interventions name: Thoracic epidural analgesia, outcomesModule primaryOutcomes measure: Time for first rescue analgesia, secondaryOutcomes measure: Visual analogue scale score at 1st,2nd,4th,6th,8th,12th and 24 h (where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain), secondaryOutcomes measure: the number of rescue analgesics within 24hrs after surgery, otherOutcomes measure: The heart rate, mean arterial blood pressure, otherOutcomes measure: Complications like bradycardia or hypotension, intraoperative and postoperative dysrhythmia, nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Menoufia university, city: Cairo, state: Shibin Elkom, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06324240, orgStudyIdInfo id: STUDY00004185, secondaryIdInfos id: NCI-2022-01950, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STUDY00004185, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: WINSHIP5522-22, type: OTHER, domain: Emory University Hospital/Winship Cancer Institute, secondaryIdInfos id: P30CA138292, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA138292, secondaryIdInfos id: R44CA257278, type: NIH, link: https://reporter.nih.gov/quickSearch/R44CA257278, briefTitle: Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing., conditionsModule conditions: Anatomic Stage I Breast Cancer AJCC v8, conditions: Anatomic Stage IA Breast Cancer AJCC v8, conditions: Anatomic Stage IB Breast Cancer AJCC v8, conditions: Anatomic Stage II Breast Cancer AJCC v8, conditions: Anatomic Stage IIA Breast Cancer AJCC v8, conditions: Anatomic Stage IIB Breast Cancer AJCC v8, conditions: Anatomic Stage III Breast Cancer AJCC v8, conditions: Anatomic Stage IIIA Breast Cancer AJCC v8, conditions: Anatomic Stage IIIB Breast Cancer AJCC v8, conditions: Anatomic Stage IIIC Breast Cancer AJCC v8, conditions: Anatomic Stage IV Breast Cancer AJCC v8, conditions: Early Stage Triple-Negative Breast Carcinoma, conditions: Locally Advanced Triple-Negative Breast Carcinoma, conditions: Metastatic Triple-Negative Breast Carcinoma, conditions: Prognostic Stage I Breast Cancer AJCC v8, conditions: Prognostic Stage IA Breast Cancer AJCC v8, conditions: Prognostic Stage IB Breast Cancer AJCC v8, conditions: Prognostic Stage II Breast Cancer AJCC v8, conditions: Prognostic Stage IIA Breast Cancer AJCC v8, conditions: Prognostic Stage IIB Breast Cancer AJCC v8, conditions: Prognostic Stage III Breast Cancer AJCC v8, conditions: Prognostic Stage IIIA Breast Cancer AJCC v8, conditions: Prognostic Stage IIIB Breast Cancer AJCC v8, conditions: Prognostic Stage IIIC Breast Cancer AJCC v8, conditions: Prognostic Stage IV Breast Cancer AJCC v8, conditions: Recurrent Breast Carcinoma, conditions: Unresectable Triple-Negative Breast Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Ipilimumab, interventions name: Pembrolizumab, interventions name: Vaccine Therapy, outcomesModule primaryOutcomes measure: Incidence of adverse events (Phase Ia), primaryOutcomes measure: Dose limiting toxicity (Phase Ia), secondaryOutcomes measure: Immune stimulating activity- T cell activity, secondaryOutcomes measure: Immune stimulating activity- Plasma cytokine/chemokines, secondaryOutcomes measure: Optimal biologic dose, secondaryOutcomes measure: Recommended phase 2 dose (Phase Ib), secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, otherOutcomes measure: PD-L1 expression, otherOutcomes measure: TIL density, otherOutcomes measure: BRCA 1/2 mutation status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Grady Health System, city: Atlanta, state: Georgia, zip: 30303, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory University Hospital Midtown, city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory University Hospital/Winship Cancer Institute, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory Saint Joseph's Hospital, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Deborah Omoyege, role: CONTACT, email: deborah.omoyege@emory.edu, contacts name: Keerthi Gogineni, MD, MSHP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06324227, orgStudyIdInfo id: 311203003, briefTitle: Effects of Multimodal Music Intervention on Mild Cognitive Impairment Elderly, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-17, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2024-05-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about whether music therapy can ameliorate cognitive function, physical fitness and psychology in mild cognitive impairment and mild dementia population. The main questions it aims to answer are:1. To build a model of multimodal music therapy.2. To discuss the effect of twelve-week multimodal music therapy in ameliorating community-based elders with MCI and mild dementia. Main outcome variables: cognitive function (Montreal Cognitive Assessment Scale, trail making test, Saint Louis University Mental Status Examination). Secondary outcome variables: physical fitness (muscle strength, muscular endurance, flexibility, balance ability), depression., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: multimodal music therapy, interventions name: no intervention, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, primaryOutcomes measure: Saint Louis University Mental Status, primaryOutcomes measure: Trail Making Test, secondaryOutcomes measure: 30s chair stand, secondaryOutcomes measure: back scratch test, secondaryOutcomes measure: sit and reach test, secondaryOutcomes measure: 8-foot up-and-go test, secondaryOutcomes measure: handgrip, secondaryOutcomes measure: Geriatric Depression Scale 15 items, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NationalYangMingU, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Wei Zu Lo, role: CONTACT, phone: 02-2823-9753, phoneExt: 66378, email: weitzu@nycu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06324214, orgStudyIdInfo id: 2023-9352, briefTitle: Oral Supplementation During PR Participation in COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03-04, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: Amazentis SA, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement.In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function.The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted., conditionsModule conditions: Copd, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Urolithin A (Mitopure), interventions name: Placebo, outcomesModule primaryOutcomes measure: Constant Work Rate Exercise Test (CRWET), secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Quadriceps strength, secondaryOutcomes measure: Mitochondrial function, secondaryOutcomes measure: Muscle histology, secondaryOutcomes measure: Tissue microscopy, secondaryOutcomes measure: Tissue microscopy, secondaryOutcomes measure: Specific protein detection, secondaryOutcomes measure: RNA analyses, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Body impedance, secondaryOutcomes measure: Disease-specific impact on quality of life, secondaryOutcomes measure: Burden of disease, secondaryOutcomes measure: Cognition, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Differences in dosed missed, secondaryOutcomes measure: Blood levels of the intervention, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: McGill University Health Centre, status: RECRUITING, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Bryan A Ross, MD, FRCPC, MSc (Epi, Physiol), role: CONTACT, phone: (514) 843-1465, email: bryan.ross@mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06324201, orgStudyIdInfo id: QDOT PAS, briefTitle: The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation., acronym: QDOT PAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Heart Rhythm Clinical and Research Solutions, LLC, class: OTHER, collaborators name: Biosense Webster, Inc., descriptionModule briefSummary: Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria., conditionsModule conditions: Paroxysmal Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Ablation Procedure, outcomesModule primaryOutcomes measure: Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module, primaryOutcomes measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months., primaryOutcomes measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months., primaryOutcomes measure: Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centra Health, Inc.dba Stroobants Cardiovascular Center, status: RECRUITING, city: Lynchburg, state: Virginia, zip: 24501, country: United States, contacts name: Cindy Baumann, role: CONTACT, contacts name: Mathhew Sackett, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.41375, lon: -79.14225, locations facility: Mercy Health, status: RECRUITING, city: Janesville, state: Wisconsin, zip: 53548, country: United States, contacts name: Kaitlyn Phetteplace, role: CONTACT, contacts name: Imdad Ahmed, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.68279, lon: -89.01872, hasResults: False
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protocolSection identificationModule nctId: NCT06324188, orgStudyIdInfo id: EASThigh-AFNET 11, briefTitle: Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2030-02, completionDateStruct date: 2030-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Atrial Fibrillation Network, class: OTHER, descriptionModule briefSummary: EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: blinded endpoint assessment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2312, type: ESTIMATED, armsInterventionsModule interventions name: Early atrial fibrillation ablation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Composite of cardiovascular complications related to AF, primaryOutcomes measure: The primary safety outcome is a composite of all-cause death and serious complications of AF therapy., secondaryOutcomes measure: Number of nights spent in hospital, secondaryOutcomes measure: Time from randomisation to first occurrence of each of the individual components of the primary outcome, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Serious adverse events related to AF therapy, secondaryOutcomes measure: Time from randomisation to first cardiovascular hospitalisation, secondaryOutcomes measure: Number of cardiovascular hospitalisations (over-night stay), secondaryOutcomes measure: Changes in left ventricular ejection fraction, secondaryOutcomes measure: Changes in quality of life, secondaryOutcomes measure: Changes in quality of life, secondaryOutcomes measure: Changes in cognitive function, secondaryOutcomes measure: Cardiac rhythm status, secondaryOutcomes measure: AF pattern, secondaryOutcomes measure: Time from randomisation to first clinical recurrence of AF, secondaryOutcomes measure: Time from randomisation to first progression of AF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Several sites, city: Multiple Locations, country: Australia, locations facility: Several sites, city: Multiple Locations, country: Canada, locations facility: Several sites, city: Multiple Locations, country: Germany, locations facility: Several sites, city: Multiple Locations, country: Netherlands, locations facility: Several sites, city: Multiple Locations, country: United Kingdom, hasResults: False
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protocolSection identificationModule nctId: NCT06324175, orgStudyIdInfo id: 6353, briefTitle: Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours, acronym: CO-MOULD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes.Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity.Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context.On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers., conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC, secondaryOutcomes measure: Biological validation of spatial radiomics in HGSOC, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Radiology Center, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Camilla Panico, MD, role: CONTACT, phone: +390630158637, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06324162, orgStudyIdInfo id: JagiellonianU Gibas-Stanek, briefTitle: Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?, acronym: Debonding, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Piotr Fudalej, class: OTHER, descriptionModule briefSummary: The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal., conditionsModule conditions: Debonding, conditions: Orthodontic Brackets, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: bracket removal pliers, LODI, outcomesModule primaryOutcomes measure: Pain during active treatment, primaryOutcomes measure: Pain during brackets removal, primaryOutcomes measure: Pain on adhesive removal, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University Collegium Medicum, city: Kraków, zip: 31-008, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
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protocolSection identificationModule nctId: NCT06324149, orgStudyIdInfo id: AGE-IT-FRAILTY, briefTitle: Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa, acronym: AGE-IT-FRAILTY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital., conditionsModule conditions: Frailty, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: completion of scales and questionnaires; venous blood sampling; muscle ultrasound; cardiac ultrasound; electrocardiogram; bioelectrical impedance analysis, outcomesModule primaryOutcomes measure: identify new molecular markers of frailty and sarcopenia, secondaryOutcomes measure: evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Raffaele Hospital, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06324136, orgStudyIdInfo id: KIDNEY-PNRR, briefTitle: Validation, Implementation, and Cost-analysis of a Strategy for Personalized Diagnosis of Rare Kidney Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-06, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Chronic kidney disease (CKD) affects about 10% of the world population, with high morbidity and mortality. Genetic kidney diseases are increasingly recognized across all age groups and represent over 20% of all the causes of CKD. Accurate diagnosis allows necessary and unnecessary diagnostic procedures to be defined, avoids unnecessary treatments, improves prognosis prediction, identifies other family members for genetic counseling, and defines risks for living donor kidney transplantation. The research group coordinated by the Principal Investigator has recently developed an algorithm for the genetic diagnosis in pediatric and adult patients with CKD. The application of this personalized diagnostic algorithm on a local study led to a global diagnostic yield of 70%, suggesting that this strategy has the potential to substantially improve the diagnostic approach to patients with rare kidney disorders. The aim of this study is to validate and implement these results by extending its application in a multicentric study involving nephrology units that are referral centers for rare kidney diseases at national level., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Implementation of the diagnostic algorithm, outcomesModule primaryOutcomes measure: Implementation of a diagnostic algorithm for personalized diagnosis of rare kidney diseases, secondaryOutcomes measure: Analysis of the functional role of variant of unknown clinical significance (VUS), secondaryOutcomes measure: Identification of immunological and/or structural factors in genetic and nongenetic forms., secondaryOutcomes measure: Cost-effectiveness of the diagnostic algorithm., eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Paola Romagnani, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliero Universitaria Vanvitelli, status: RECRUITING, city: Napoli, country: Italy, contacts name: Miriam Zacchia, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, status: RECRUITING, city: Palermo, country: Italy, contacts name: Santina Cottone, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06324123, orgStudyIdInfo id: 23C304, briefTitle: Observational Study Aimed at Evaluating the Trend of Neuropathic Pain, acronym: NEURATIL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score., conditionsModule conditions: Neuropathic Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Peacetil, outcomesModule primaryOutcomes measure: Change in neuropathic pain after two months of treatment with Peacetil, secondaryOutcomes measure: Change in neuropathic pain after one month of treatment with Peacetil, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 82 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, state: Lombardy, zip: 20149, country: Italy, contacts name: Luca Maderna, MD, role: CONTACT, phone: 0261911, email: l.maderna@auxologico.it, contacts name: Alberto Doretti, MD, role: CONTACT, phone: 0261911, phoneExt: 2937, email: neurotrial@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST Fatebenefratelli Sacco, status: NOT_YET_RECRUITING, city: Milano, zip: 20157, country: Italy, contacts name: Fabrizio Gervasoni, MD, role: CONTACT, email: fabrizio.gervasoni@asst-fbf-sacco.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione Don Carlo Gnocchi ONLUS, status: NOT_YET_RECRUITING, city: Milano, country: Italy, contacts name: Angela Comanducci, MD, role: CONTACT, email: acomanducci@dongnocchi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06324110, orgStudyIdInfo id: RG1124119, secondaryIdInfos id: NCI-2024-01763, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 20250, type: OTHER, domain: Fred Hutch/University of Washington Cancer Consortium, secondaryIdInfos id: R01CA284032, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA284032, briefTitle: Evaluating the Impact of Centralized Interventions on Lung Cancer Screening Adherence in Community Settings, ACCELL Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fred Hutchinson Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings., conditionsModule conditions: Lung Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 8658, type: ESTIMATED, armsInterventionsModule interventions name: Electronic Health Record Review, interventions name: Interview, interventions name: Patient Navigation, outcomesModule primaryOutcomes measure: Adherence to appropriate follow-up, secondaryOutcomes measure: Characteristics associated with adherence to follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fred Hutch/University of Washington Cancer Consortium, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Tinnie Louie, role: CONTACT, phone: 206-667-3323, email: tlouie@fredhutch.org, contacts name: Matthew Triplette, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06324097, orgStudyIdInfo id: 2024-357, briefTitle: Diagnostic Value of Endocytoscopy for Colorectal Lesions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hong Xu, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated., conditionsModule conditions: Colorectal Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: endocytoscopy, outcomesModule primaryOutcomes measure: sensitivity, primaryOutcomes measure: specificity, primaryOutcomes measure: accuracy, primaryOutcomes measure: positive predictive value, primaryOutcomes measure: negative predictive value, secondaryOutcomes measure: inter-observer agreement, secondaryOutcomes measure: intra-observer agreement, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University, status: RECRUITING, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Mingqing Liu, Doctor, role: CONTACT, phone: +8613204300453, email: liumq23@mails.jlu.edu.cn, contacts name: Hong Xu, Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Mingqing Liu, Doctor, role: SUB_INVESTIGATOR, contacts name: Nan Zhang, Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06324084, orgStudyIdInfo id: 05M201, briefTitle: PATHophysiology of OSteoporosis: Role of Hidden Cortisol Excess and Its Predictors in Bone Fragility, acronym: PATHOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-24, primaryCompletionDateStruct date: 2024-10-24, completionDateStruct date: 2025-04-24, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Osteoporosis is a chronic skeletal disease which leads to a decrease in bone strength which increases the risk of fractures.Clinically overt hypercortisolism leads to hypertension, central obesity, diabetes and osteoporosis. More recently, even the condition of mild and asymptomatic hypercortisolism has been associated with increased prevalence of chronic complications of cortisol excess and mortality. In patients with osteoporosis this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo).Although asymptomatic, however, this subtle cortisol excess is associated with an increased risk of osteoporosis and fragility fractures.Moreover, HidHyCo prevalence seems to be increased in osteoporotic patients. The HidHyCo case finding is of utmost importance. However, given the high prevalence of bone fragility and the relatively low diagnostic accuracy of the currently available tests for the HidHyCo detection, a mass screening for HidHyCo is considered unthinkable. As now, no guidelines are available for addressing the HidHyCo screening in osteoporosis.Therefore, the aims of the present study are the following: i) to assess the HidHyCo prevalence in a sample of osteoporotic patients; ii) to compare the clinical characteristics between osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo in order to determine the clinical characteristics more frequently associated with the HidHyCo presence and to identify those osteoporotic patients worthy of HidHyCo screening; iii) to further investigate bone quality and turnover in HidHyCo patients, to characterize HidHyco patients from a molecular and genetic point of view and to evaluate the pathogenetic mechanisms explaining the negative effects of endogenous cortisol excess on bone health in these patients and the potential role of the genetic background and of the gut microbiome.The HidHyCo could be present in a not negligible percentage of osteopenic/osteoporotic patients. In these patients, osteoporosis and, if present, other comorbidities can improve by the surgical resection of the adrenal or pituitary adenoma if feasible, or by the use of drugs able to modulate cortisol secretion or glucocorticoid sensitivity. Moreover, the case-finding could be reserved in those patients at higher risk of having HidHyCo, therefore, reducing the costs of a scarcely specific mass screening., conditionsModule conditions: Osteoporosis, conditions: Bone Fracture, conditions: Cortisol Excess, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of hidden hypercortisolism in osteoporosis, primaryOutcomes measure: Statistical comparison of the clinical and biochemical characteristics of osteoporotic/osteopenic patients with HidHyCo and those without HidHyCo to identify the characteristics predictive of the presence of HidHyCo in osteoporosis, secondaryOutcomes measure: Further investigation of bone turnover in HidHyCo patients, as assessed by serum osteocalcin, CrossLaps, bone alkaline phosphatase and amino-terminal propeptide of type 1 procollagen (P1NP) and additional new potential serum markers of bone status., secondaryOutcomes measure: Further investigation of bone quality as assessed by Radiofrequency Echographic Multi Spectrometry (REMS), secondaryOutcomes measure: Characterization of HidHyco patients from a molecular and genetic point of view by the determination of circulating microRNAs, peripheral glucocorticoid activity and the polymorphic variants of the 11ßHSD1, GR and B2AR gene., secondaryOutcomes measure: Assessment of gut microbiome composition by the analysis of fecal samples, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-San Marco", status: NOT_YET_RECRUITING, city: Catania, country: Italy, contacts name: Agostino Gaudio, Professor, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, country: Italy, contacts name: Cristina Eller-Vainicher, MD, role: CONTACT, contacts name: Giorgia Grassi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milan, country: Italy, contacts name: Elisa Cairoli, MD, role: CONTACT, contacts name: Carmen Aresta, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale "Casa Sollievo della Sofferenza" IRCCS, status: RECRUITING, city: San Giovanni Rotondo, country: Italy, contacts name: Alfredo Scillitani, MD, role: CONTACT, contacts name: Flavia Pugliese, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Azienda Ospedaliera Universitaria Senese, status: NOT_YET_RECRUITING, city: Siena, country: Italy, contacts name: Luigi Gennari, Professor, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, hasResults: False
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protocolSection identificationModule nctId: NCT06324071, orgStudyIdInfo id: 2022_TSOD_125, briefTitle: Study to Verify the Efficacy of a Product Containing 125 mg of TetraSOD® for the Treatment of Male Infertility, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Fitoplancton Marino, S.L., class: INDUSTRY, collaborators name: Fundacio Clinic Barcelona, collaborators name: Fertypharm, descriptionModule briefSummary: TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain). In a previous pilot trial, the ability of TetraSOD® (dose: 250 mg/day) to improve semen characteristics in idiopathic infertile men after three months of treatment was assessed, revealing significant improvements in almost all of the analyzed parameters. In a further clinical trial close to finish (ClinicalTrials.gov Identifier: NCT04864314) using the same dose, such positive results have been tested again in a higher number of patients, and additional parameters have been included in order to gain insights into the sperm physiological changes that underpin the improvement in semen quality. In this new clinical trial, an intermediate dose (125 mg/day) is going to be tested in an attempt to determine a range of TetraSOD® dosage being clinically active for the treatment of male infertility., conditionsModule conditions: Male Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Sham, interventions name: Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity, outcomesModule primaryOutcomes measure: Sperm motility, primaryOutcomes measure: Sperm concentration, primaryOutcomes measure: Sperm oxidative stress, secondaryOutcomes measure: DNA integrity, secondaryOutcomes measure: sORP by MiOXSYS, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Clinic, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Juan M Corral, role: CONTACT, phone: +34 932275545, email: jmcorral@clinic.cat, contacts name: Meritxell Jodar, role: CONTACT, phone: +34 932275510, email: mjodar@clinic.cat, contacts name: Marta Guimerà, role: SUB_INVESTIGATOR, contacts name: Juan M Mayorga-Torres, role: SUB_INVESTIGATOR, contacts name: Antonio Alcaraz, role: SUB_INVESTIGATOR, contacts name: Dolors Manau, role: SUB_INVESTIGATOR, contacts name: Rafael Oliva, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06324058, orgStudyIdInfo id: Huashan_H, briefTitle: Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2026-03-18, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Transurethral cryoablation, interventions name: Transurethral resection of bladder tumor, interventions name: Bcg Intravesical, outcomesModule primaryOutcomes measure: Tumor residual rate, secondaryOutcomes measure: Recurrence, secondaryOutcomes measure: Progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06324045, orgStudyIdInfo id: MRC-01-22-314, briefTitle: Deprescribing Intervention for Patients With Chronic Kidney Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, collaborators name: Qatar University, collaborators name: Winchester District Memorial Hospital, descriptionModule briefSummary: Chronic Kidney Disease (CKD) is recognized as a leading health problem globally. It is associated with multiple consequences such as cardiovascular diseases, infections, reduced cognitive function, and higher mortality rates. In Qatar, it is estimated that 13% of the population suffers from CKD. Management of CKD is associated with polypharmacy (the use of multiple medications), which burdens the patients and leads to adverse health and economic outcomes. As documented by previous studies, CKD setting is associated with a high medication burden, which leads to non-adherence, reduced quality of life, and other negative sequelae. These consequences can be minimized or averted by implementing a deprescribing program. Deprescribing is defined as the supervised process of intentionally stopping a medication, altering the dose or introducing a safer alternative to improve a person's clinical and quality of life outcomes. Previous deprescribing initiatives in inpatient and outpatient hospital settings were successfully implemented.In general, there are limited deprescribing initiatives in CKD settings. There is a need to provide evidence of the impact of deprescribing programs on improving clinical and economic outcomes in this setting. In Qatar, there is no evidence of the effectiveness of implementing deprescribing programs in clinical settings. Therefore, we have built a team of researchers, clinicians, and stakeholders, and initiated a collaboration with deprescribing experts to fit into the Qatar healthcare system. This project aims to initiate a deprescribing multidisciplinary team and to evaluate the impact of providing such services on the clinical and economic outcomes among CKD patients in Qatar using a randomized controlled trial approach. The findings could have a potential positive impact on the professional practice and patient safety represented by health and economic outcomes., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: CKD patients will be screened using medical records. Eligible patients will be approached during their routine visits to FBJ Kidney Center and other ambulatory kidney centers. Due to feasibility and practicality issues, selecting the patients will be consecutive case series as per their availability during the time of the recruitment (nonprobabilistic).After obtaining informed consent, patients will be randomized into one of the two study arms. Randomization will be stratified by dialysis dependency (dialysis vs. pre-dialysis); randomly permuted balanced block sizes of 4 for dialysis patients and 1 for pre-dialysis will be used. Neither the practitioners nor the patients will be blinded to the patients' allocated groups due to the nature of the intervention. Due to feasibility and practicalities, selecting the patients will be consecutive as per their availability during the time of the recruitment (non-probabilistic)., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 424, type: ESTIMATED, armsInterventionsModule interventions name: Deprescribing, outcomesModule primaryOutcomes measure: Percentage of participants with at least one Potentially inappropriate medications (PIMs), primaryOutcomes measure: Number of Potentially inappropriate medications (PIMs), secondaryOutcomes measure: Pill burden, secondaryOutcomes measure: Health-related quality of life (HRQoL), secondaryOutcomes measure: Treatment burden, secondaryOutcomes measure: Self-reported adherence, secondaryOutcomes measure: Medication Refills adherence, secondaryOutcomes measure: Emergency department visits and hospitalizations, secondaryOutcomes measure: Unanticipated adverse effects, secondaryOutcomes measure: Cost avoidance, secondaryOutcomes measure: Cost savings, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hamad Medical Corporation, status: RECRUITING, city: Doha, state: Unlisted (UL), zip: 00000, country: Qatar, contacts name: Abdulla Hamad, MD, role: CONTACT, phone: +97444394804, email: ahamad9@hamad.qa, contacts name: Rania Ibrahim, MSc., role: CONTACT, phone: +9744394808, email: ribrahim4@hamad.qa, contacts name: Abdulla Hamad, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed Awaisu, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Daoud Al-Badriyeh, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Muhammad Abdul Hadi, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Ali Elbeddini, Pharm D, role: SUB_INVESTIGATOR, contacts name: Rania Ibrahim, MSc., role: SUB_INVESTIGATOR, contacts name: Amani Zidan, MSc., role: SUB_INVESTIGATOR, contacts name: Kheloud Khaled, Pharm D, role: SUB_INVESTIGATOR, geoPoint lat: 25.28545, lon: 51.53096, hasResults: False
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protocolSection identificationModule nctId: NCT06324032, orgStudyIdInfo id: 021-FPO20, briefTitle: SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS, acronym: SunnyDay021, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-17, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione del Piemonte per l'Oncologia, class: OTHER, descriptionModule briefSummary: This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients, conditionsModule conditions: Subepithelial Gastrointestinal Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: EUS Elastography (EUS-E), outcomesModule primaryOutcomes measure: Evaluation of EUS-E accuracy qualitative, primaryOutcomes measure: Evaluation of EUS-E accuracy quantitative, secondaryOutcomes measure: Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB), secondaryOutcomes measure: Evaluation of gene mutations in EUS-guided specimen, secondaryOutcomes measure: Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification., secondaryOutcomes measure: Complication rate (perforations, bleeding) of the procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Santa Maria della Scaletta, status: RECRUITING, city: Imola, state: Bologna, country: Italy, contacts name: Pietro Fusaroli, MD, role: CONTACT, geoPoint lat: 44.35916, lon: 11.7132, locations facility: Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, state: Milano, country: Italy, contacts name: Silvia Carrara, MD, role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, status: RECRUITING, city: Candiolo, state: Turin,, zip: 10060, country: Italy, contacts name: Teresa Staiano, MD, role: CONTACT, phone: +390119933413, email: teresa.staiano@ircc.it, geoPoint lat: 44.95858, lon: 7.59812, locations facility: Ospedale Humanitas Mater Domini, status: RECRUITING, city: Castellanza, state: Varese, country: Italy, contacts name: Benedetto Mangiavillano, MD, role: CONTACT, geoPoint lat: 45.61079, lon: 8.89616, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Pietro Occhipinti, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Istituto Oncologico Veneto, status: RECRUITING, city: Padova, country: Italy, contacts name: Alberto Fantin, MD, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: AOU Città della Salute e della Scienza di Torino, Ospedale Molinette, status: RECRUITING, city: Turin, zip: 10126, country: Italy, contacts name: Claudio G. De Angelis, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False
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protocolSection identificationModule nctId: NCT06324019, orgStudyIdInfo id: Ethics number E.405221, briefTitle: Gynaecological Examination Gown and Patient Satisfaction, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2022-04-30, completionDateStruct date: 2022-06-22, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: ayşegül muslu, class: OTHER, descriptionModule briefSummary: The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have a significant impact on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. The use of different clothes in the patient during the examination will ensure that the patient\'s physical privacy is ensured from the moment of application, during diagnosis and treatment, and that the examination experience will be positively affected by preventing the use of additional covers to protect the privacy of all patients during examination and intervention. This will contribute to the maintenance of health by eliminating the intense stress and embarrassment experienced by patients during the examination and ensuring that they regularly attend health checks. In addition, meeting the privacy expectations of the patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided.The attitude of the health personnel before, during and after the examination and the positive examination experience of the person have an important effect on ensuring the continuity of the subsequent examination and increasing the quality of the service provided. With the examination suit, it will be ensured that the patient\'s bodily privacy is ensured from the moment of application, during diagnosis, treatment and care, the use of the same cover to protect the privacy of all patients during examination and intervention will be prevented to prevent infection transmission and the examination experience will be positively affected. Thus, the intense stress and embarrassment experienced by patients during the examination will be eliminated and will contribute to the maintenance of health through regular visits to health checks. In addition, meeting the privacy expectations of patients will ensure that they are satisfied with the health service they receive, thus increasing the quality of the health service provided. In order to ensure patient privacy, to protect and improve women\'s health and to provide convenience in gynecological examination, the gynecological examination garment to be used in the examination can be designed as disposable, perineum and thigh open for the examination to be performed. In order to protect privacy, extra parts can be used to ensure that the open parts remain closed outside the examination process. Properties of the fabric used in the examination garment;* Grama: 32,07 g/m\^2* Explosion.: 135,77 kpç* Detachment: Ȼ: 115NȺ: 120 N* Air permeability: 1750* Type of material: PolypropyleneThe study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted., conditionsModule conditions: Gynecology, conditions: Gynecology/Obstetrics Conditions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study was carried out as a post-test control group design from randomised controlled studies. The intervention group of the study was dressed in gynaecological examination clothes, while the control group used the drape given to the patient during the examination, which is a routine practice in the health institution where the study was conducted.Hypotheses of the Study1. Ho: There is no difference between the perception of privacy in the experimental and control group women. H1: There is a difference between the perception of privacy in the experimental group and control group women.2. Ho: There is no difference between the perception of satisfaction in the experimental group and control group women.H1: There is a difference between the satisfaction perception of women in the experimental group and the control group., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: putting on an examination gown, outcomesModule primaryOutcomes measure: Gynaecological examination gown, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: EGE, city: İzmir, state: Konak, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06324006, orgStudyIdInfo id: DCT3934, briefTitle: A Phase 1 Trial of LIB-01 in Healthy Participants., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-25, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Dicot AB, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are:* How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels.* What are the pharmacokinetic characteristics of LIB-01Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by:* Adverse events* ECG* Blood sampling for laboratory parameters and pharmacokinetic analysis, conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a Phase I, double-blind, parallel-group, placebo-controlled, randomized first-in-human trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: LIB-01, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01., primaryOutcomes measure: To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01., primaryOutcomes measure: To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01., primaryOutcomes measure: To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01., primaryOutcomes measure: To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01., primaryOutcomes measure: To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01., secondaryOutcomes measure: To characterise the maximum plasma concentration of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the plasma concentration area under curve of LIB-01, following a single oral dose., secondaryOutcomes measure: To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing., secondaryOutcomes measure: To characterise the plasma concentration half life of LIB-01 following multiple oral dosing., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trial Consultants, city: Uppsala, zip: 75237, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
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protocolSection identificationModule nctId: NCT06323993, orgStudyIdInfo id: 2021-115, briefTitle: The Effect of Different Window-preparation Approaches on the Clinical Outcomes of Lateral Sinus Floor Elevation, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-05-01, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The Dental Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: This study retrospectively evaluated the effect of two different lateral window preparation techniques on peri-implant bone augmentation for patients who underwent lateral sinus floor elevation with simultaneous implant placement using two-dimensional and three-dimensional radiographic results, with special emphasis placed on the stability of the graft material after surgery., conditionsModule conditions: Dental Implantation, conditions: Cone-Beam Computed Tomography, conditions: Surgical Procedure, Unspecified, conditions: Maxillary Sinus Floor Augmentation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Piezoelectric osteotomy, outcomesModule primaryOutcomes measure: Apical bone height, primaryOutcomes measure: Endo-sinus bone gain, primaryOutcomes measure: Palatal bone height, primaryOutcomes measure: Buccal bone height, primaryOutcomes measure: Augmentation volume, secondaryOutcomes measure: Perforation incidence, secondaryOutcomes measure: Early implant loss, secondaryOutcomes measure: Lateral window length, secondaryOutcomes measure: Lateral bone length, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06323980, orgStudyIdInfo id: DSM202108, briefTitle: INHANCE Stemless Reverse Shoulder IDE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-15, primaryCompletionDateStruct date: 2027-11-10, completionDateStruct date: 2028-04-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: DePuy Orthopaedics, class: INDUSTRY, descriptionModule briefSummary: 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder., conditionsModule conditions: Arthroplasty, conditions: Replacement, conditions: Shoulder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 Randomized (Stemless to Stemmed), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Reverse Total Shoulder, outcomesModule primaryOutcomes measure: Constant Murley Score (CMS), primaryOutcomes measure: Removal of any system component, primaryOutcomes measure: Revision of any system component, primaryOutcomes measure: Reoperation of any system component, primaryOutcomes measure: Supplemental Fixation of any system component, primaryOutcomes measure: Radiolucent Lines (Humeral & Glenoid), primaryOutcomes measure: Migration and Tilt (Humeral & Glenoid), secondaryOutcomes measure: Constant Murley Score (CMS), secondaryOutcomes measure: EQ-5D-5L and EQ-VAS, secondaryOutcomes measure: Simple Shoulder Test, secondaryOutcomes measure: Single Assessment Numeric Evaluation (SANE) Score, secondaryOutcomes measure: Survivorship, secondaryOutcomes measure: Complications, otherOutcomes measure: Constant Murley Score (CMS), otherOutcomes measure: EQ-5D-5L and EQ-VAS, otherOutcomes measure: Simple Shoulder Test, otherOutcomes measure: Single Assessment Numeric Evaluation (SANE) Score, otherOutcomes measure: Range of Motion, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hoag Orthopedic Institute, city: Irvine, state: California, zip: 92618, country: United States, geoPoint lat: 33.66946, lon: -117.82311, locations facility: Atlantis Orthopaedics, city: Lake Worth, state: Florida, zip: 33463, country: United States, geoPoint lat: 26.61708, lon: -80.07231, locations facility: Boston Sports & Shoulder Center, city: Waltham, state: Massachusetts, zip: 02451, country: United States, geoPoint lat: 42.37649, lon: -71.23561, locations facility: Trinity Health Grand Rapids, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: Missouri Orthopaedic Institute (MOI), city: Columbia, state: Missouri, zip: 65201, country: United States, geoPoint lat: 38.95171, lon: -92.33407, locations facility: Lindner Research Center, city: Cincinnati, state: Ohio, zip: 45219, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Slocum Center for Orthpaedics and Sports Medicine, city: Eugene, state: Oregon, zip: 97401, country: United States, geoPoint lat: 44.05207, lon: -123.08675, locations facility: Rothman Orthopaedics Institute, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: TOSH- The Orthopedic Specialty Hospital, city: Murray, state: Utah, zip: 84107, country: United States, geoPoint lat: 40.66689, lon: -111.88799, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84108, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06323967, orgStudyIdInfo id: 231981, briefTitle: Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University, class: OTHER, collaborators name: Women in Need (Win), collaborators name: The Samuels Group, collaborators name: New York City Center for Innovation through Data Intelligence (CIDI), descriptionModule briefSummary: The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care., conditionsModule conditions: Time to Shelter Exit, conditions: Family Well-being, conditions: Child Well-being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel assignment to 1) active treatment and 2) active comparison. A third, passive comparison group will be constructed and followed anonymously via administrative records., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants will be blind to condition at the baseline assessment but will be unmasked immediately afterwards (they will receive debit cards and learn whether they are eligible for peer support). At baseline, interviewers will likely be aware of study conditions because they will interview respondents at shelters and shelter is associated with condition. At subsequent assessments interviewers will remain blind to study condition to the extent possible, but may well learn the condition from respondents, especially those who complete qualitative interviews. Win staff who provide usual care to both groups will be blind to the study condition. Participants in the passive comparison group will be unaware of the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Large unconditional cash transfers plus voluntary peer support., interventions name: Nominal cash transfers, interventions name: Passive comparison group, outcomesModule primaryOutcomes measure: Time to shelter exit, secondaryOutcomes measure: Housing: Total time in shelter*, secondaryOutcomes measure: Housing: Housing Stability, secondaryOutcomes measure: Target Child Development: Child Behavior Problems*, secondaryOutcomes measure: Target Child Development: Child Prosocial Behavior*, secondaryOutcomes measure: Target Child Development: Child Verbal Development, secondaryOutcomes measure: Parenting: Chaos in the Home*, secondaryOutcomes measure: Parenting: Early Learning Activities with Target Child*, secondaryOutcomes measure: Parenting: Target-Child-Focused Expenditure Index, secondaryOutcomes measure: Parenting: Household Routines, secondaryOutcomes measure: Parenting: Parenting Stress, secondaryOutcomes measure: Family Separation: Separation of Parent and Target Child (Cumulative at any time point)*, secondaryOutcomes measure: Family Separation: Indicated Investigations, Preventive services, or Child Placement of Target Child by Child Protective Services (No/Yes), secondaryOutcomes measure: Adult Well-Being: Adult Psychological Distress*, secondaryOutcomes measure: Adult Well-Being: Adult Alcohol or Drug Abuse, secondaryOutcomes measure: Adult Well-Being: Hope, secondaryOutcomes measure: Domestic Violence: Adult Domestic Violence*, secondaryOutcomes measure: Financial Well-Being: Food Insecurity*, secondaryOutcomes measure: Financial Well-Being: Adult Economic Stress, secondaryOutcomes measure: Financial Well-Being: Financial Well-Being as Measured by the Consumer Financial Protection Bureau Financial Well-Being Scale, secondaryOutcomes measure: Financial Well-Being: Financial Hardship as Measured by the Urban Institute Well-Being and Basic Needs Survey, secondaryOutcomes measure: Employment: Income from Employment in Most Recent Period*, secondaryOutcomes measure: Employment: Adult Work for Pay, secondaryOutcomes measure: Health Care: Family Use of Emergency Medical Care or Hospitalization (Cumulative at any point)*, secondaryOutcomes measure: Health Care: Proportion of Target Child Immunizations Recommended by Age by the American Academy of Pediatrics, secondaryOutcomes measure: Health Care: Proportion of Well-Child Visits by Target Child Recommended by Age by the American Academy of Pediatrics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Win NYC Shelter System, city: New York, state: New York, zip: 10004, country: United States, contacts name: Kirsten Cafarella, B.A., role: CONTACT, phone: 646-899-6943, email: kcafarella@winnyc.org, contacts name: Marybeth Shinn, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06323954, orgStudyIdInfo id: H24110, briefTitle: tVNS During Motor Training in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Georgia Institute of Technology, class: OTHER, collaborators name: University of Florida, descriptionModule briefSummary: The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation., conditionsModule conditions: Older Adults, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: tVNS stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Rate of error reduction, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 84 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Human Neuromuscular Physiology Lab, city: Atlanta, state: Georgia, zip: 30332, country: United States, contacts name: Minoru Shinohara, Ph.D., role: CONTACT, phone: 404-894-1030, email: shinohara@gatech.edu, contacts name: Minoru Shinohara, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06323941, orgStudyIdInfo id: UV0003, briefTitle: Motor Imagery and Isometric Exercises on Pelvic Floor Sensorimotor Condition, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-14, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: Mental practice (both in isolation and also in combination with real practice) has been shown to improve somatosensory and motor variables but so far no study has taken it into the study of women's health. Through the present study the investigators want to offer some interesting data regarding the effectiveness of mental practice combined with physical practice., conditionsModule conditions: Isometric Exercise, conditions: Motor Imagery, conditions: Women's Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Motor Imagery plus therapeutic exercise, interventions name: Therapeutic exercises, outcomesModule primaryOutcomes measure: Skin conductance (for asessing electrodermal activity), secondaryOutcomes measure: Algometry for assessing pressure pain thresholds (Pain sensitivity), secondaryOutcomes measure: maximal pelvic floor muscle strength (measured in grams and with the phenix device), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ferran Cuenca Martínez, city: Valencia, zip: 46017, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06323928, orgStudyIdInfo id: 20297A, secondaryIdInfos id: 2023-508821-28-00, type: OTHER, domain: EU Trial, briefTitle: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments, acronym: PROCEED, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: H. Lundbeck A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them., conditionsModule conditions: Migraine, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 498, type: ESTIMATED, armsInterventionsModule interventions name: Lu AG09222, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs), secondaryOutcomes measure: Change From Baseline in MMDs, secondaryOutcomes measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs, secondaryOutcomes measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs, secondaryOutcomes measure: Change from Baseline in the Number of Monthly Headache Days, secondaryOutcomes measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of Participants with Anti-drug Antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Accellacare of Charleston, status: RECRUITING, city: Mount Pleasant, state: South Carolina, zip: 29464, country: United States, geoPoint lat: 32.79407, lon: -79.86259, hasResults: False
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protocolSection identificationModule nctId: NCT06323915, orgStudyIdInfo id: 2020_03_C3M, briefTitle: Comparative Study of 3 Multifocal Intraocular Lenses in Murcia, acronym: C3M, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2025-06-20, completionDateStruct date: 2025-09-20, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Cristalens Industrie, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve.This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve.The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: intraocular lens implantation in cataract surgery, outcomesModule primaryOutcomes measure: defocus curve comparison, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vista Clinic Ircovision Murcia, status: RECRUITING, city: Murcia, zip: 30008, country: Spain, contacts name: Juan Zapata, role: CONTACT, phone: +34 968 27 17 35, email: juanf.zapata.diaz@gmail.com, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
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protocolSection identificationModule nctId: NCT06323902, orgStudyIdInfo id: PT-CO39, briefTitle: Autologous Platelet-rich Plasma as a Treatment for Macular Holes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-25, primaryCompletionDateStruct date: 2023-06-08, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Clinica Oftalmologica Paredes, class: OTHER, descriptionModule briefSummary: For a series of patients with full-thickness macular hole, an autologous plasma rich in growth factors was developed in the form of a clot and applied to the retinal defect. These patients were followed up for a period of one year, obtaining substantial improvement both anatomically and functionally., conditionsModule conditions: Macular Holes, conditions: Macular Hole of Left Eye (Disorder), conditions: Macular Hole of Right Eye (Disorder), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: Pars plana vitrectomy, with or without epiretinal membrane peeling, plus PRGF membrane implantation, outcomesModule primaryOutcomes measure: Macular hole closure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Ofalmologica Paredes, city: Pasto, state: Nariño, zip: 520002, country: Colombia, geoPoint lat: 1.21361, lon: -77.28111, hasResults: False
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protocolSection identificationModule nctId: NCT06323889, orgStudyIdInfo id: LIMITFOOD2, briefTitle: Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults, acronym: LIMITFOOD2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling., conditionsModule conditions: Intermittent Fasting, conditions: Obesity, conditions: Time Restricted Eating, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Modified Alternate Day Fasting, interventions name: Time-Restricted Eating, interventions name: Weight-loss counseling, outcomesModule primaryOutcomes measure: Fat Volume, secondaryOutcomes measure: Distribution of fat volume, secondaryOutcomes measure: Concentration of Leptin, secondaryOutcomes measure: Changes in Insulin Sensitivity, secondaryOutcomes measure: Changes in Fasting Lipids, secondaryOutcomes measure: Changes in Inflammatory Markers, secondaryOutcomes measure: Free triiodothyronine (fT3), otherOutcomes measure: Correlation of longitudinally measured parameters, otherOutcomes measure: Serum Metabolomics, otherOutcomes measure: Genetic Analysis, otherOutcomes measure: LDL Particle Size, otherOutcomes measure: Fecal Microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Diabetology and Clinical Nutrition, city: Zürich, zip: 8091, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06323876, orgStudyIdInfo id: HSR301252, secondaryIdInfos id: R01HL171918, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL171918, briefTitle: The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: HRCT, interventions name: Blood Draw, outcomesModule primaryOutcomes measure: Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes., primaryOutcomes measure: Determine whether known IPF-risk genetic variants are associated with DTA score., primaryOutcomes measure: Identify novel genetic variants that associate with DTA score progression., primaryOutcomes measure: Determine if DTA or any constituent radiomic features correlate with select plasma proteins., primaryOutcomes measure: Determine if DTA or any of constituent radiomic features correlate with transcriptomic, primaryOutcomes measure: Determine the best combination of markers (DTA, proteins and transcriptome) for machine learning algorithms for AUC evaluation of ROCs on all 3 cohorts., secondaryOutcomes measure: Determine associations of changes in DTA scores with 12-month changes in FVC and DLCO., secondaryOutcomes measure: Determine associations of changes in DTA scores with drug treatment (i.e., antifibrotics), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 101 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06323863, orgStudyIdInfo id: N°4-RCB/EUDRACT, briefTitle: Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting., conditionsModule conditions: Otosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: stapedectomy, interventions name: ultra high resolution CT, outcomesModule primaryOutcomes measure: length, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Nancy, city: Nancy, zip: 54000, country: France, contacts name: romain gillet, md, role: CONTACT, phone: 00383851811, email: r.gillet@chru-nancy.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
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protocolSection identificationModule nctId: NCT06323850, orgStudyIdInfo id: HM20028878, briefTitle: Improving Access to Community-Based Occupations Via a Rideshare Training Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, collaborators name: Organization for Autism Research, descriptionModule briefSummary: Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population., conditionsModule conditions: Autism, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A hybrid type-2 effectiveness-implementation randomized wait-list control design . The experimental group will receive the intervention first, while the waitlist group receives no intervention (Phase 1). After the 2-month intervention period, the waitlist group will receive the intervention, while the experimental group participates in a 2-month follow-up (Phase 2). During phase three, the waitlist group will participate in the 2-month follow up., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Intervention Phase, interventions name: Virtual Training Sessions, interventions name: Ride-Along Training Sessions, outcomesModule primaryOutcomes measure: Evaluate the intervention by conducting an effectiveness-implementation waitlist-controlled trial using our Safe Rideshare Program (SRP), evaluate autistic adults participating in the SRP intervention find the intervention acceptable?, primaryOutcomes measure: Evaluate if the trainers conducting the SRP intervention find the intervention to be appropriate, primaryOutcomes measure: Autistic adults who have participated in the SRP program display greater independence in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group), primaryOutcomes measure: Autistic adults who have participated in the SRP program display greater safety in using Rideshare compared to autistic adults who did not participate in the SRP program (wait-list group)?, secondaryOutcomes measure: In the wait-list group, is there a change in community engagement, social participation, and employment from the waitlist phase (no intervention) to the 2-month follow-up period (after the intervention), secondaryOutcomes measure: How do SRP participants use of Rideshare for community, social, and/or employment activities after the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Commonwealth University, status: RECRUITING, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Stacey Reynolds, role: CONTACT, phone: 410-241-2140, email: reynoldsse3@vcu.edu, contacts name: Alissa Brooke, role: CONTACT, phone: 804-827-0746, email: admolinelli@vcu.edu, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
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protocolSection identificationModule nctId: NCT06323837, orgStudyIdInfo id: 20383, briefTitle: Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment, acronym: MIRROM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Washington State University, class: OTHER, descriptionModule briefSummary: This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods., conditionsModule conditions: Stimulant Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mirtazapine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Urinanalysis Verified Increased Days of MA Abstinence, secondaryOutcomes measure: Actigraphy Verified Improved Sleep Patterns, otherOutcomes measure: Self Reported Quantity of Adverse Events, otherOutcomes measure: Urinanalysis Verified Increased Days of Abstinence from Other Substances, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06323824, orgStudyIdInfo id: 2000033271, secondaryIdInfos id: CTN-0131, type: OTHER, domain: Clinical Trials Network, secondaryIdInfos id: 5UG1DA015831-21, type: NIH, link: https://reporter.nih.gov/quickSearch/5UG1DA015831-21, briefTitle: Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), collaborators name: The Emmes Company, LLC, collaborators name: University of California, San Francisco, collaborators name: Boston Medical Center (BMC), collaborators name: Hennepin Healthcare Research Institute, collaborators name: Alameda Health System, collaborators name: Marshall Health, collaborators name: Kaiser Permanente, descriptionModule briefSummary: The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The comparative effectiveness of two strategies to address retention in medication for opioid use disorder (MOUD) treatment will be tested over a 168-day period. Behavioral treatments offered to patients are designed to be similar across the two medication conditions.Office-based methadone where the clinician prescribes methadone and oral methadone is administered and/or dispensed at a pharmacy. Providers and Randomized Control Trial (RCT) participants will have flexibility to use behavioral and pharmacological services as clinically indicated.Office-based buprenorphine (BUP) where the clinician prescribes BUP formulations that are dispensed at a pharmacy or administered in the office (e.g., extended-release formulations). Providers and RCT participants will have flexibility to use behavioral and pharmacological services as clinically indicated., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Methadone, interventions name: Buprenorphine (BUP), outcomesModule primaryOutcomes measure: Number of days of continuous treatment with study site clinician-prescribed methadone or buprenorphine, as randomized, during the 168 days post-randomization among RCT participants., secondaryOutcomes measure: Number of self-reported days in any FDA-approved formulation of MOUD treatment (e.g., buprenorphine, methadone or naltrexone) during the 168 days post-randomization., secondaryOutcomes measure: Number of self-reported days in formal OUD treatment, according to American Society of Addiction Medicine (ASAM) levels of care 1-4, during the 168 days post-randomization., secondaryOutcomes measure: Number of days prescribed any FDA-approved MOUD formulation during the 168 days post-randomization., secondaryOutcomes measure: Number of days of self-reported non-prescribed opioid use per month., secondaryOutcomes measure: Number of days of self-reported non-prescribed stimulant use per month., secondaryOutcomes measure: Number of days of self-reported non-prescribed benzodiazepine use per month., secondaryOutcomes measure: Urine toxicology, secondaryOutcomes measure: Participant satisfaction with MOUD, secondaryOutcomes measure: Total number of self-reported overdose events per total number of participant days at risk., secondaryOutcomes measure: Total number of self-reported injection drug use related events per total number of participant days at risk., secondaryOutcomes measure: Pain measured using PEG-3: "Pain average," "interference with Enjoyment of life," and "interference with General activity.", secondaryOutcomes measure: Number of self-reported days with acute care utilization (ED or hospitalization) events during the 168 days post-randomization per month., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06323811, orgStudyIdInfo id: COPE CMR, briefTitle: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics, acronym: COPE-CMR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, collaborators name: ETH Zurich, descriptionModule briefSummary: This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.The present study aims to:* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence* refine the role and diagnostic potential of advanced quantitative CMR imaging* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomesParticipants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months)., conditionsModule conditions: Myocardial Infarction With Non-Obstructive Coronary Artery, conditions: Myocarditis Acute, conditions: Takotsubo Cardiomyopathy, conditions: Spontaneous Coronary Artery Dissection, conditions: Non ST Elevation Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months), primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: CMR, outcomesModule primaryOutcomes measure: Myocardial perfusion reserve index, secondaryOutcomes measure: epicardial adipose tissue (EAT), secondaryOutcomes measure: cardiovascular events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, status: RECRUITING, city: Zürich, zip: 8091, country: Switzerland, contacts name: Robert Manka, role: CONTACT, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06323798, orgStudyIdInfo id: 2024PI035, briefTitle: Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-07-28, completionDateStruct date: 2024-12-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined, conditionsModule conditions: Pyocele; Sinus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: apparent diffusion coefficient, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06323785, orgStudyIdInfo id: 2022-D0067, briefTitle: Whole-body Hyperthermia for Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is:• Does whole-body hyperthermia alleviate symptoms of depression?Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Active whole-body hyperthermia, interventions name: Sham whole-body hyperthermia, outcomesModule primaryOutcomes measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression), secondaryOutcomes measure: Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression), secondaryOutcomes measure: Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status), secondaryOutcomes measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zurich, Institute of Psychology, status: RECRUITING, city: Zurich, zip: 8050, country: Switzerland, contacts name: Susanne Fischer, PhD, role: CONTACT, phone: +41446357460, email: s.fischer@psychologie.uzh.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06323772, orgStudyIdInfo id: RDC-RP-01, briefTitle: Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Optical coherence tomography (OCT), primaryOutcomes measure: Fundus autofluorescence imaging, primaryOutcomes measure: Wide-field fundus photography, primaryOutcomes measure: Adaptive optics imaging, primaryOutcomes measure: V1 morphology (MRI), primaryOutcomes measure: Diffusion Tensor Imaging (DTI), primaryOutcomes measure: flavoprotein fluorescence (FPF), primaryOutcomes measure: Retinal oxymetry, primaryOutcomes measure: Local dark adapted adaptation curves, primaryOutcomes measure: best corrected visual acuity (BCVA), primaryOutcomes measure: Static cone perimetry and dark adapted perimetry, primaryOutcomes measure: chromatic pupil campimetry (CPC), primaryOutcomes measure: electroretinogram (ERG), primaryOutcomes measure: Virtual reality (VR) functional test, eligibilityModule sex: ALL, minimumAge: 5 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Ophthalmic Research, University Tübingen, status: RECRUITING, city: Tübingen, state: Baden-Württemberg, zip: 72076, country: Germany, contacts name: Katarina Stingl, Prof, role: CONTACT, phone: 070712988088, email: katarina.stingl@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
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protocolSection identificationModule nctId: NCT06323759, orgStudyIdInfo id: 2022-14, briefTitle: Perinatal EDucation: Pedagogical Strategy and Facilitators for the PROMotion of BreastFeeding, acronym: PED-PROM-BF, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Lépine Alexandra, class: OTHER, descriptionModule briefSummary: Breastfeeding up to 6 months of a child's life, for its benefits to mother and child, has become a global public health goal. However, there is a disparity in the prevalence of breastfeeding (BF) in different regions of the world. According to French perinatal surveys, the rate of BF at birth decreased significantly between 2010 and 2016. Even if that figure remains stable according to the last perinatal survey in 2021, it decreases sharply, to 34.4%, at 2 months.While many plans at the national level advocate for BF, it is rare to see an action plan or an education intervention for women and couples aimed at promoting BF. However, women's needs to educate about BF and the need for professionals to reflect on their practices are highlighted by numerous perinatal surveys. It should be noted that despite the importance given to the promotion of BF found in all National Nutrition and Health Programs, none of them provide pedagogical means or an education program to achieve the objectives set. At present, in France, there is no breastfeeding education program and professionals accompany women by implementing experimental actions without considering the complexity of the promotional dimension (producing a behavioral change) and the educational dimension (understanding the pedagogy of the proposed actions), conditionsModule conditions: Breast Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This intervention is based on a pedagogical engineering that proposes a favorable learning environment more adapted than the courses already offered in preparing for parenthood and promoting breastfeeding, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ACTUAL, armsInterventionsModule interventions name: educational intervention, outcomesModule primaryOutcomes measure: To find out the contribution of educational engineering to the choice and continuation of breastfeeding from the point of view of women until 4 months after the birth of the child., secondaryOutcomes measure: To explain contexts and generative mechanisms of pedagogical design that influence breastfeeding management up to 4 months afther birth., secondaryOutcomes measure: To explain interactions between existing contexts, generative mechanisms and effects on women's breastfeeding management skills., secondaryOutcomes measure: To determine contexts and generative mechanisms of pedagogical design that influence women's knowledge of breastfeeding up to 4 months afther birth., otherOutcomes measure: To evaluate the level of satisfaction about the educational intervention among nursing mothers., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Université Sorbonne Paris Nord - Laboratoire d'Educations et Promotion de la Santé - UR 3412, city: Bobigny, zip: 93017, country: France, geoPoint lat: 48.9, lon: 2.45, hasResults: False
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