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protocolSection identificationModule nctId: NCT06275633, orgStudyIdInfo id: H-18055648, briefTitle: Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-03-19, primaryCompletionDateStruct date: 2021-12-03, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Hospital Bispebjerg and Frederiksberg, class: OTHER, descriptionModule briefSummary: In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response., conditionsModule conditions: Parkinson Disease, conditions: Medication, conditions: UPDRS, conditions: Motor Function, conditions: Cognitive Impairment, conditions: Depression, conditions: Impulsive, conditions: Levodopa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective patient with Parkinson's Disease cohort. After acute levodopa challenge test patients with Parkinson's Disease are divided due to measured levodopa response and their self-rated medicine effect., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: There will be a blinded assessment of videos of participants with Parkinson's Disease ON and OFF medication, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Levodopa, outcomesModule primaryOutcomes measure: Motor improvement, secondaryOutcomes measure: Cognitive function, otherOutcomes measure: Cognitive function, otherOutcomes measure: Depressive symptoms, otherOutcomes measure: Impulsivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bispebjerg and Frederiksberg, city: Copenhagen, state: Region Hovedstaden, zip: 2400, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06275620, orgStudyIdInfo id: AGTC-RPGR-001 DAWN, briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN), statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Beacon Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein., conditionsModule conditions: X-Linked Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: AGTC-501 (high dose and standard corticosteroid regimen), interventions name: AGTC-501 (low dose and standard corticosteroid regimen), interventions name: AGTC-501 (high dose and modified corticosteroid regimen), outcomesModule primaryOutcomes measure: The primary safety outcome is the number and proportion of participants experiencing Grade 3 or higher local (ocular) or non-ocular treatment-emergent adverse events, including treatment-emergent serious adverse events (SAEs)., secondaryOutcomes measure: Change from baseline in mean sensitivity across the whole grid, as measured by MAIA microperimetry, secondaryOutcomes measure: Response, as measured by MAIA microperimetry, where response is defined as a greater than or equal to 7 dB visual sensitivity improvement from baseline in at least 7 loci., secondaryOutcomes measure: Change from baseline in BCVA using Early-Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, secondaryOutcomes measure: Change from baseline in LLVA using ETDRS visual acuity, secondaryOutcomes measure: Change from baseline in Ora-VNC mobility test score, eligibilityModule sex: MALE, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Jacksonville, state: Florida, zip: 32209, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Bascom Palmer Eye Institute, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Cincinnati Eye Institute, city: Cincinnati, state: Ohio, zip: 45242, 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: Casey Eye Institute, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Retina Foundation of the Southwest, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06275607, orgStudyIdInfo id: FY23-24-93, briefTitle: Maladaptive Anger Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: The University of Texas at San Antonio, class: OTHER, descriptionModule briefSummary: From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample., conditionsModule conditions: Anger, conditions: Intermittent Explosive Disorder, conditions: Emotional Distress, conditions: Aggression, conditions: Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Affective Therapy, interventions name: Emotional Discussion, outcomesModule primaryOutcomes measure: Anger Parameters Scale (APS), primaryOutcomes measure: Anger Parameters Scale (APS), primaryOutcomes measure: Anger Parameters Scale (APS), primaryOutcomes measure: Anger Expressions Scale (AES), primaryOutcomes measure: Anger Expressions Scale (AES), primaryOutcomes measure: Anger Expressions Scale (AES), primaryOutcomes measure: Self-Monitored Anger (Anger Log), primaryOutcomes measure: Self-Monitored Anger (Anger Log), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas at San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78249, country: United States, contacts name: Ephrem Fernandez, Ph.D., role: CONTACT, email: [email protected], contacts name: Brandon S Perez, M.S., role: CONTACT, email: [email protected], contacts name: Ephrem Fernandez, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Brandon S Perez, M.S., role: SUB_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06275594, orgStudyIdInfo id: YUMC2023-12-017, briefTitle: Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration, acronym: REST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Yeungnam University Hospital, class: OTHER, descriptionModule briefSummary: Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspirationPrimary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure., conditionsModule conditions: Midazolam, conditions: Remimazolam, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Byfavo, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Procedural success during EBUS-TBNA (composite outcome), secondaryOutcomes measure: Time to start of procedure after administration of the first dose of study medication, secondaryOutcomes measure: Time taken to achieve full alertness after the procedure, secondaryOutcomes measure: Requirement for flumazenil dosage during the procedure, secondaryOutcomes measure: Total fentanyl dose, secondaryOutcomes measure: Scale of coughing/discomfort/inconvenience, secondaryOutcomes measure: Changes in blood pressure, secondaryOutcomes measure: Changes of heart rate, secondaryOutcomes measure: Changes in respiration rate, secondaryOutcomes measure: Complications related to the procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yeungnam University Hospital, city: Daegu, state: Namgu, zip: 42415, country: Korea, Republic of, contacts name: June Hong Ahn, M.D. PhD, role: CONTACT, phone: 821028562008, email: [email protected], geoPoint lat: 35.87028, lon: 128.59111, hasResults: False |
protocolSection identificationModule nctId: NCT06275581, orgStudyIdInfo id: CR15_15 (EM-11-050055), briefTitle: Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population, statusModule overallStatus: TERMINATED, startDateStruct date: 2017-06-14, primaryCompletionDateStruct date: 2021-03-24, completionDateStruct date: 2021-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, collaborators name: 3M, descriptionModule briefSummary: STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment.STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTSPrimary Endpoint:1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.)Secondary Endpoints:1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)2. Evaluation of restoration wear based on comparison of digital impressionsSafety Endpoint:1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers* regarding overall survival* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.Treatment:After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.Evaluation periods:All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)* at baseline at day of restoration placement or up to 1 month after restoration placement* after 6 months (± 1 months)* after 1 year (± 1 months)* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline., conditionsModule conditions: Tooth Wear, conditions: Glass Ionomer Cements, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinded evaluation, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group), interventions name: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group), outcomesModule primaryOutcomes measure: Restoration survival over time based on the glass ionomer restoration criteria, secondaryOutcomes measure: Evaluation of restoration quality based on the glass ionomer restoration criteria, secondaryOutcomes measure: Evaluation of restoration wear based on comparison of digital impressions, secondaryOutcomes measure: Safety Endpoint: The safety endpoint is the incidence of Adverse Events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 66 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics, city: Madrid, zip: 28045, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06275568, orgStudyIdInfo id: HSC-SPH-23-0655, briefTitle: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant)., conditionsModule conditions: Nutrition in High-Risk Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 620, type: ESTIMATED, armsInterventionsModule interventions name: Usual Care Fresh Connect cardholder engagement, interventions name: Enhanced engagement communication, outcomesModule primaryOutcomes measure: Absolute gestational weight gain (GWG) in pounds, primaryOutcomes measure: Absolute gestational weight gain (GWG) in pounds, primaryOutcomes measure: Absolute gestational weight gain (GWG) in pounds, primaryOutcomes measure: Excess gestational weight gain (EGWG) in pounds, primaryOutcomes measure: Excess gestational weight gain (EGWG) in pounds, primaryOutcomes measure: Excess gestational weight gain (EGWG) in pounds, secondaryOutcomes measure: Number of participants diagnosed with pregnancy-induced hypertension, secondaryOutcomes measure: Number of participants diagnosed with gestational diabetes, secondaryOutcomes measure: Number of participants with pre-term birth (<37 weeks), secondaryOutcomes measure: Infant birth weight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Shreela Sharma, PhD, role: CONTACT, phone: 713-500-9344, email: [email protected], contacts name: Naomi Tice, MPH, role: CONTACT, phone: (713) 500-9000, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06275555, orgStudyIdInfo id: 2023-101, briefTitle: Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Xiaotong Hou, class: OTHER, descriptionModule briefSummary: The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin., conditionsModule conditions: Extracorporeal Membrane Oxygenation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: bivalirudin, interventions name: unfractionated heparin, outcomesModule primaryOutcomes measure: thrombotic complications, primaryOutcomes measure: bleeding complications, secondaryOutcomes measure: Hospitalization mortality, secondaryOutcomes measure: Loop replacement, secondaryOutcomes measure: Infusion volume of blood products, secondaryOutcomes measure: Acute renal failure, secondaryOutcomes measure: Heparin-induced thrombocytopenia, secondaryOutcomes measure: the time of reaching the target anticoagulant level for the first time, secondaryOutcomes measure: Percentage of time during ECMO within the target anticoagulant level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06275542, orgStudyIdInfo id: USurabaya, briefTitle: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Surabaya, class: OTHER, collaborators name: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada, collaborators name: Sardjito General Hospital, Yogyakarta, descriptionModule briefSummary: Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring., conditionsModule conditions: Anesthesia Intubation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was conducted through a randomized clinical trial with blinding of observers. Two parallel groups were selected to compare the incidence of paralysis in the recovery room. The research samples were collected using non-probability sampling method through consecutive enrollment over a specific period. This study consisted of 3 comparisons distinguished based on the type of volatile anesthetic gas maintenance and neuromuscular blockade agent, namely:* Comparison 1: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was rocuronium.* Comparison 2: The volatile anesthetic gas used was isoflurane and the muscular blockade agent used was rocuronium.* Comparison 3: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was atracurium., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Train of four monitoring device intraoperative, interventions name: Neostigmine, interventions name: Air chalenge prior to extubation, interventions name: Train of Four monitoring device in recovery room, outcomesModule primaryOutcomes measure: Residual paralysis in recovery room, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275529, orgStudyIdInfo id: 27.12.2023.685, briefTitle: Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification., conditionsModule conditions: Radiculopathy Lumbar, conditions: Low Back Pain, conditions: Disc Herniation, conditions: Injections, Epidural, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Transforaminal Epidural Steroid Injection, outcomesModule primaryOutcomes measure: Change of the pain severity score, primaryOutcomes measure: Change of the disability score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275516, orgStudyIdInfo id: 2024-208, briefTitle: Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: multi-sensory stimulation immersive VR+ treadmill training, interventions name: treadmill training, outcomesModule primaryOutcomes measure: Fugl-Meyer scale, primaryOutcomes measure: Berg balance scale, primaryOutcomes measure: three-dimensional gait detection, primaryOutcomes measure: Fall incidents, primaryOutcomes measure: Dizzy incidents, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275503, orgStudyIdInfo id: STROKESTOP III, briefTitle: STROKESTOP III - Optimized Method for Atrial Fibrillation Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Landstinget i Värmland, descriptionModule briefSummary: Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring., conditionsModule conditions: Atrial Fibrillation, conditions: Atrial Fibrillation New Onset, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomized trial, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2200, type: ESTIMATED, armsInterventionsModule interventions name: Screening invitation mode, outcomesModule primaryOutcomes measure: Participation in screening, secondaryOutcomes measure: AF detection in opportunistic compared to systematic screening, secondaryOutcomes measure: OAC treatment after AF detection, secondaryOutcomes measure: Compliance to OAC treatment 1 year after initiation, secondaryOutcomes measure: Health economy, secondaryOutcomes measure: Composite endpoint of stroke, death and severe bleeding, secondaryOutcomes measure: Reminder strategy effect on participation, secondaryOutcomes measure: Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group, secondaryOutcomes measure: Application of the FIND-AF algorithm, eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 76 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, Dept Med H, city: Stockholm, zip: 141 86, country: Sweden, contacts name: Emma Svennberg, MD PhD, role: CONTACT, phone: +46739584822, email: [email protected], contacts name: MD PhD, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Region Värmland, city: Värmland, country: Sweden, contacts name: Fredrik Carlstedt, role: CONTACT, geoPoint lat: 60.83333, lon: 16.5, hasResults: False |
protocolSection identificationModule nctId: NCT06275490, orgStudyIdInfo id: 181123PER6_3_1, briefTitle: Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: * The aim is to evaluate post extraction hard tissue changes following ridge preservation using partially demineralized dentin block versus L-PRF block in intact socket in the esthetic zone.* The main question: In patients with un restorable tooth, Will ridge preservation using partially demineralized dentin block be more effective than L-PRF block in managing the post extraction hard tissue alterations?* After enrolment, periodontal and radiographic examination and patients with badly un-restorative tooth in the esthetic zone will be identified. These patients will undergo to mesio-distal distance between adjacent teeth, corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and Relation to adjacent teeth measurements using trans gingival probing technique, and preapical radiograph or CBCT .* In both groups, the desired tooth will be extracted under local anesthesia using peritomies and surgical forceps.* In intervention group: the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size then partially demineralize dentin will obtained by using a tooth transformer machine. At the same time, blood samples are collected and processed to obtain fibrin membranes rich in platelets and leukocytes. This tissue is then mixed with partially demineralized dentin to create a solid mass called a "dentin block". During the process of preserving the alveolar bumps after extraction, this solid mass "dentin mass" is placed inside the dental pockets and covered with fibrin membranes rich in platelets and white blood cells, then 5/0 proline suture are used to fix the fibrin membranes and dentin mass in place. After the recovery period "4-6 months", a biopsy is taken for some cases from the site of the operation for histological evaluation during implant placement.* In control group: the same steps as the first group will be used, but by replacing the partially demineralized dental graft with a xenograft.* Outcomes: Radiographic vertical buccal bone changes, vertical Palatal bone changes, horizontal bone changes, Percentage of new vital bone formation, Percentage of residual bone graft, Implant Primary Stability. The results directly postoperative and 4-6 months postoperatively., conditionsModule conditions: Socket Preservation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Controlled Pilot Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Partially Demineralized Dentin Block, interventions name: L-PRF block, outcomesModule primaryOutcomes measure: Radiographic vertical bone changes, secondaryOutcomes measure: Radiographic horizontal bone changes, secondaryOutcomes measure: Percentage of new vital bone formation and residual graft, secondaryOutcomes measure: Implant Primary Stability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry Cairo University, status: RECRUITING, city: Cairo, state: Elmanil, zip: 4240101, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06275477, orgStudyIdInfo id: 29BRC23.0029, briefTitle: 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases, acronym: PARADISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-21, completionDateStruct date: 2026-04-21, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: This single-center pilot study is designed to explore the preliminary utility of the \[68Ga\] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of \[68Ga\] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases., conditionsModule conditions: Inflammatory Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single-center, descriptive and analytical pilot study, which will be implemented in 13 distinct and independent populations of patients with chronic inflammatory and/or fibrosing disease., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-FAPI46, outcomesModule primaryOutcomes measure: PET uptake intensity, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT parameters evolution, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT parameters evolution, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, secondaryOutcomes measure: [68Ga] Ga-FAPI PET/CT kinetic, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275464, orgStudyIdInfo id: BT-600-101, briefTitle: BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Biora Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: BT-600, interventions name: BT-600 Placebo, outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Pharmacokinetic (PK) Assessments, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, status: RECRUITING, city: Lincoln, state: Nebraska, zip: 68502, country: United States, geoPoint lat: 40.8, lon: -96.66696, hasResults: False |
protocolSection identificationModule nctId: NCT06275451, orgStudyIdInfo id: EssaiClinique_QUALI-RES, briefTitle: Qualitative Study of Emotional Regulation in Schizophrenia, acronym: QUALI-RES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view.Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature., conditionsModule conditions: Schizophrenia, conditions: Schizophrenia Schizoaffective, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Semi-structured interview, outcomesModule primaryOutcomes measure: Emotional regulation in schizophrenia, secondaryOutcomes measure: Factors influencing emotional regulation in schizophrenia, secondaryOutcomes measure: Improved emotional regulation in schizophrenia, secondaryOutcomes measure: Stages of emotional regulation in schizophrenia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275438, orgStudyIdInfo id: 81829502.903/39, briefTitle: Comparison of Oxytocin Receptor Immunoreactivity in Placentas Obtained From Women Having Cesarean and Natural Birth, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-25, primaryCompletionDateStruct date: 2019-07-01, completionDateStruct date: 2019-12-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Kafkas University, class: OTHER, descriptionModule briefSummary: Our study examines the effects of oxytocin hormone receptors. mechanisms of placental tissue cells and therefore intrauterine development. It was conducted to investigate the effects on newborn babies apgar score, fontanel openings, birth weights, etc. By collecting data, normal and They were compared between cesarean births by statistical analysis. normal in this regard Based on the hypothesis that there is a difference between labor and cesarean delivery, this study has been made.OXTR primary antibody was used for immunohistochemical examination. There was no significant difference between the groups in terms of histological examination. In the study, it was found that OXTR immunoreactivity was strong in decidual cells and stromal cells in villi. A stronger OXTR immunoreactivity was detected in villous stroma of placenta of the natural birth group compared to the cesarean birth group. Reaction was not observed in syncytotrophoblast cells and syncytial nodes in both groups, but strong immunoreaction was observed fetal endothelial cells and fetal capillaries in both groups., conditionsModule conditions: Healthy Mothers Who Have Had Both Vaginal and Cesarean Deliveries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: "Our study was conducted on the placentas of 40 women admitted to the obstetrics clinics of Kars Harakani State Hospital and Kafkas University Training and Research Hospital, after obtaining necessary permissions. Out of 40 placentas, 5 were excluded due to blood incompatibility, 2 were excluded due to subsequent diagnosis of chronic conditions (thyroid disorder, Behçet's disease), and 1 was excluded due to the presence of an accessory placenta, resulting in a total of 32 placentas included in the study. Among these, 16 were from women who had undergone normal vaginal delivery (control group), and 16 were from women who had undergone cesarean section (case group). Tissue samples obtained from the placentas were subjected to histological and immunohistochemical methods to obtain various findings, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: The delivery being performed via cesarean section surgery rather than natural childbirth, outcomesModule primaryOutcomes measure: Oksitosin Receptor Immunoreactivity, secondaryOutcomes measure: Pearson correlation analysis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kafkas Universty, city: Kars, state: Merkez, zip: 36100, country: Turkey, geoPoint lat: 40.59825, lon: 43.08548, hasResults: False |
protocolSection identificationModule nctId: NCT06275425, orgStudyIdInfo id: 4-2023-0429, briefTitle: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-25, primaryCompletionDateStruct date: 2023-11-29, completionDateStruct date: 2023-11-29, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room., conditionsModule conditions: Thyroid Neoplasm, conditions: Cough, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a single-blinded randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ACTUAL, armsInterventionsModule interventions name: Total intravenous anesthesia with Byfavo, interventions name: Inhalation anesthesia with Sevoflurane, outcomesModule primaryOutcomes measure: Proportion of patients not coughing during postoperative extubation, secondaryOutcomes measure: Cough score, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University,, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06275412, orgStudyIdInfo id: IRB-23-04-5675, secondaryIdInfos id: 5R01MD018583-02, type: NIH, link: https://reporter.nih.gov/quickSearch/5R01MD018583-02, briefTitle: Family Intervention for Black Teens With Type 1 Diabetes, acronym: 3Ms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages)., conditionsModule conditions: Type 1 Diabetes, conditions: Family Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: CARE_PROVIDER, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: The 3Ms 2.0 Intervention, interventions name: Educational Attention Control (EAC), outcomesModule primaryOutcomes measure: Glycemic Control, secondaryOutcomes measure: Caregiver Diabetes Distress, secondaryOutcomes measure: Diabetes-Specific Family Conflict, secondaryOutcomes measure: Diabetes-Specific Parental Monitoring, secondaryOutcomes measure: Diabetes-Specific Family Support, otherOutcomes measure: Illness Management, otherOutcomes measure: Intervention Satisfaction, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's National Hospital, city: Washington, state: District of Columbia, zip: 20010, country: United States, contacts name: Angelica Eddington, Ph.D., ABPP, role: CONTACT, phone: 202-476-2342, email: [email protected], contacts name: Angelica Eddington, Ph.D., ABPP, role: SUB_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, locations facility: LeBonheur Children's Hospital, city: Memphis, state: Tennessee, zip: 38103, country: United States, contacts name: Kristoffer S Berlin, Ph.D., role: CONTACT, email: [email protected], contacts name: Kathryn Sumpter, MD, role: SUB_INVESTIGATOR, contacts name: Kristoffer S Berlin, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, locations facility: University of Tennessee Health Science Center-Memphis, city: Memphis, state: Tennessee, zip: 38163, country: United States, contacts name: Kristoffer S Berlin, Ph.D., role: CONTACT, email: [email protected], contacts name: Kathryn Sumpter, MD, role: SUB_INVESTIGATOR, contacts name: Kristoffer S Berlin, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False |
protocolSection identificationModule nctId: NCT06275399, orgStudyIdInfo id: INTERFORCE, briefTitle: Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery, acronym: INTERFORCE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-21, primaryCompletionDateStruct date: 2025-07-21, completionDateStruct date: 2026-07-21, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, collaborators name: National Science Centre, Poland, collaborators name: University College, London, collaborators name: Queen Mary University of London, descriptionModule briefSummary: The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery., conditionsModule conditions: Chronic Coronary Syndrome, conditions: Atherosclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: OCT examination, interventions name: Blood sampling, interventions name: Assessment of vFFR and shear stress parameters, outcomesModule primaryOutcomes measure: Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery., secondaryOutcomes measure: Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery, secondaryOutcomes measure: Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery, secondaryOutcomes measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs, secondaryOutcomes measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers, secondaryOutcomes measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity, secondaryOutcomes measure: Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel, secondaryOutcomes measure: Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel, secondaryOutcomes measure: Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel, secondaryOutcomes measure: Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes measure: Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes measure: Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery, secondaryOutcomes measure: Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient, secondaryOutcomes measure: Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient, secondaryOutcomes measure: Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Warsaw, status: RECRUITING, city: Warsaw, state: Mazowieckie, zip: 02-097, country: Poland, contacts name: Mariusz Tomaniak, MD, PhD, Assoc. Prof., role: CONTACT, email: [email protected], contacts name: Adrian Bednarek, role: CONTACT, email: [email protected], contacts name: Mariusz Tomaniak, MD, PhD, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06275386, orgStudyIdInfo id: 2.31/II/24, briefTitle: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention, acronym: IMAGINATION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Institute of Cardiology, Warsaw, Poland, class: OTHER, descriptionModule briefSummary: The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO., conditionsModule conditions: Coronary Artery Disease, conditions: Total Occlusion of Coronary Artery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Paclitaxel Drug-coated balloon, outcomesModule primaryOutcomes measure: In-segment late lumen loss, secondaryOutcomes measure: Angiographic outcomes assessed directly post-PCI, secondaryOutcomes measure: HQ-IVUS outcomes assessed directly post-PCI, secondaryOutcomes measure: Physiologic outcomes assessed directly post-PCI, secondaryOutcomes measure: Angiographic outcomes at 6-months follow-up, secondaryOutcomes measure: HQ-IVUS outcomes at 6-months follow-up, secondaryOutcomes measure: Physiologic outcomes at 6-months follow-up, secondaryOutcomes measure: Computed tomographic outcomes at 12-months follow-up (CCTA substudy), secondaryOutcomes measure: Clinical outcomes at 12-months follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Cardiology, city: Warsaw, state: Mazowieckie, zip: 04-628, country: Poland, contacts name: Agnieszka Zdziennicka, role: CONTACT, email: [email protected], geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06275373, orgStudyIdInfo id: 20-10974, briefTitle: The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction, acronym: Teprotumumab, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-12, primaryCompletionDateStruct date: 2026-05-12, completionDateStruct date: 2027-12-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Walter Reed National Military Medical Center, class: FED, descriptionModule briefSummary: This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang)., conditionsModule conditions: Thyroid Eye Disease, conditions: Graves Ophthalmopathy, conditions: Graves Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Teprotumumab Injection [Tepezza], outcomesModule primaryOutcomes measure: Ophthalmological Clinical Activity Score (CAS) scoring, primaryOutcomes measure: Thyroid stimulating immunoglobulin, secondaryOutcomes measure: HLA subtypes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Walter Reed National Military Medical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20889, country: United States, contacts name: Thanh D Hoang, DO, role: CONTACT, phone: 301-295-5165, phoneExt: 6220, email: [email protected], contacts name: Iris E Morris, PhD, role: CONTACT, phone: 3013194599, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, hasResults: False |
protocolSection identificationModule nctId: NCT06275360, orgStudyIdInfo id: SPLP-002-23F, briefTitle: Repositioning Immunotherapy in VetArans With Lung Cancer, acronym: RIVAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2030-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC., conditionsModule conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Progression-free survival, primaryOutcomes measure: Treatment Tolerance, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Best overall response rate (BOR), secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA, status: NOT_YET_RECRUITING, city: West Los Angeles, state: California, zip: 90073-1003, country: United States, contacts name: Daniel Shin, MD, role: CONTACT, phone: 310-478-3711, email: [email protected], contacts name: Michelle Treadwell, role: CONTACT, phone: 3104783711, phoneExt: 45003, email: [email protected], geoPoint lat: 34.0464, lon: -118.44813, locations facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT, status: RECRUITING, city: West Haven, state: Connecticut, zip: 06516-2770, country: United States, contacts name: Michal Rose, MD, role: CONTACT, phone: 203-932-5711, phoneExt: 2832, email: [email protected], contacts name: Alicia Roy, role: CONTACT, phone: 2039325711, phoneExt: 3006, email: [email protected], geoPoint lat: 41.27065, lon: -72.94705, locations facility: VA Ann Arbor Healthcare System, Ann Arbor, MI, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48105-2303, country: United States, contacts name: Brittany M Pannecouk, BS, role: CONTACT, phone: 734-845-3966, email: [email protected], contacts name: Laura A Randolph, BA, role: CONTACT, phone: (734) 845-5091, email: [email protected], contacts name: Michael D Green, role: PRINCIPAL_INVESTIGATOR, contacts name: Nithya Ramnath, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, status: NOT_YET_RECRUITING, city: Omaha, state: Nebraska, zip: 68105-1850, country: United States, contacts name: Apar Kishor P Ganti, MD, role: CONTACT, phone: 402-346-8800, phoneExt: 3846, email: [email protected], contacts name: Anna Kellogg, role: CONTACT, phone: 4029954143, email: [email protected], geoPoint lat: 41.25626, lon: -95.94043, locations facility: Durham VA Medical Center, Durham, NC, status: NOT_YET_RECRUITING, city: Durham, state: North Carolina, zip: 27705-3875, country: United States, contacts name: Michael Kelley, MD, role: CONTACT, phone: 919-286-0411, phoneExt: 172199, email: [email protected], contacts name: Maya Robinson, role: CONTACT, phone: 9192866926, email: [email protected], geoPoint lat: 35.99403, lon: -78.89862, locations facility: Louis Stokes VA Medical Center, Cleveland, OH, status: NOT_YET_RECRUITING, city: Cleveland, state: Ohio, zip: 44106-1702, country: United States, contacts name: Charles Nock, MD, role: CONTACT, phone: 216-791-3800, phoneExt: 64825, email: [email protected], contacts name: Margaret Titkin, role: CONTACT, phone: 2167913800, phoneExt: 36241, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, locations facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA, status: NOT_YET_RECRUITING, city: Richmond, state: Virginia, zip: 23249-0001, country: United States, contacts name: Bhaumik Patel, MD, role: CONTACT, phone: 804-675-5446, email: [email protected], geoPoint lat: 37.55376, lon: -77.46026, hasResults: False |
protocolSection identificationModule nctId: NCT06275347, orgStudyIdInfo id: 19CI 30 087 041, secondaryIdInfos id: 1/1142021, type: OTHER, domain: Comite del Centro de alta especialidad del Estado de Veracruz, briefTitle: Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD), acronym: Zelé2021, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-15, primaryCompletionDateStruct date: 2021-12-30, completionDateStruct date: 2023-05-25, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universidad Veracruzana, class: OTHER, descriptionModule briefSummary: This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Clinical Trial was conducted in patients with obesity type I patients, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Eligible patients were assigned to a one of the four VIME Weight Loss and Wellness Center for management and follow up according to their preference, a sequential number in inclusion order was given, with all the patients coded with a 4-digit number. This code was sent to the people in the food production plant where the patients were randomized in a double blinded study, with a 2:1 allocation for low-fat, normo-protein, controlled ketogenic diet (Zélé method) or low calories diet, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: Low-fat normoprotein Controlled Ketogenic Diet., interventions name: Hypocaloric Balanced Diet, outcomesModule primaryOutcomes measure: Evaluate the efficacy of this nutritional intervention, primaryOutcomes measure: Volume of total body tissue corresponding to muscle, primaryOutcomes measure: Percentage of body weight made up of adipose tissue, primaryOutcomes measure: Visceral Fat, primaryOutcomes measure: Bone mass, primaryOutcomes measure: Total body water, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Hip circumference, primaryOutcomes measure: Muscular strenght, primaryOutcomes measure: Weight, primaryOutcomes measure: Height, primaryOutcomes measure: BMI Body index mass, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Fasting Blood Glucose, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Urea, secondaryOutcomes measure: Uric acid, secondaryOutcomes measure: Sodium, secondaryOutcomes measure: Potassium, secondaryOutcomes measure: Calcium, secondaryOutcomes measure: Phosphorus, secondaryOutcomes measure: Magnesium, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: Direct bilirubin, secondaryOutcomes measure: Indirect bilirubin, secondaryOutcomes measure: Total bilirubin, secondaryOutcomes measure: Alanine aminotransferase, secondaryOutcomes measure: Aspartate Amino Transferase, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: High Density Lipoproteins, secondaryOutcomes measure: Low Density lipoproteins, secondaryOutcomes measure: Protein C Reactive, secondaryOutcomes measure: Thyroid stimulating hormone, secondaryOutcomes measure: Triiodothyronine, secondaryOutcomes measure: Thyroxine, secondaryOutcomes measure: Cholecalciferol, secondaryOutcomes measure: Gasometric variables, Partial pressure of oxygen (PaO2), secondaryOutcomes measure: HCO3 (Bicarbonate ion plasma concentration), secondaryOutcomes measure: Arterial pH, secondaryOutcomes measure: Lactic acid, otherOutcomes measure: Adherence to this nutritional intervention, otherOutcomes measure: Satisfaction survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 61 Years, stdAges: ADULT, contactsLocationsModule locations facility: Francisco J Nachón García, city: Ciudad de Mexico, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-04-23, uploadDate: 2024-02-16T19:37, filename: Prot_SAP_000.pdf, size: 549651, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-04-23, uploadDate: 2024-01-14T23:04, filename: ICF_001.pdf, size: 249137, hasResults: False |
protocolSection identificationModule nctId: NCT06275334, orgStudyIdInfo id: 9133, briefTitle: Dinutuximab Beta at the HUS and the Toulouse Oncopole, acronym: DNB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse., conditionsModule conditions: Neuroblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Service de Pharmacie - Stérilisation - CHU de Strasbourg - France, status: RECRUITING, city: Strasbourg, zip: 67091, country: France, contacts name: Anne EL AATMANI, Pharm, PhD, role: CONTACT, phone: 33 3 88 12 78 06, email: [email protected], contacts name: Emilie BERTHON, Pharm, PhD, role: CONTACT, phone: 33 3 88 12 78 06, email: [email protected], contacts name: Anne EL AATMANI, Pharm, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Emilie BERTHON, PhamD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Sophie PERRIAT, PhamD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False |
protocolSection identificationModule nctId: NCT06275321, orgStudyIdInfo id: Elena Garcia Roca, briefTitle: Physical Exercise Benefits for Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-05, primaryCompletionDateStruct date: 2024-07-27, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universitat Jaume I, class: OTHER, descriptionModule briefSummary: The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision., conditionsModule conditions: Cancer, Breast, conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A prospective ramonized clinical trial with two groups, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Synchronous-supervised online home-based group, interventions name: Exercise recommendation group, outcomesModule primaryOutcomes measure: Cardiorrespiratory fitness, primaryOutcomes measure: Strength - Chair Stand (repetitions), primaryOutcomes measure: Flexibility, primaryOutcomes measure: Incidence of treatments on quality of live assessed by EORTIC QLQ-C30, primaryOutcomes measure: Adherence, primaryOutcomes measure: Rating of perceived exertion, primaryOutcomes measure: Strength - Hand Grip (Kilograms), primaryOutcomes measure: Strength - Squat Jump (height in centimeters), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jaume I University, status: RECRUITING, city: Castellón De La Plana, state: Castellón, zip: 12071, country: Spain, contacts name: Elena Garcia Roca, MSc, role: CONTACT, phone: +34 629112367, email: [email protected], contacts name: Eladio J Collado-Boira, PhD, role: CONTACT, phone: +34 606133368, email: [email protected], geoPoint lat: 39.98567, lon: -0.04935, hasResults: False |
protocolSection identificationModule nctId: NCT06275308, orgStudyIdInfo id: STUDY21100163, briefTitle: Effect of Raised End-Tidal pCo2 on Choroidal Volume, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-27, primaryCompletionDateStruct date: 2025-02-27, completionDateStruct date: 2025-02-27, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, descriptionModule briefSummary: This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia., conditionsModule conditions: Intraocular Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a descriptive case series., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ventilation manipulation, outcomesModule primaryOutcomes measure: Intraocular Pressure (IOP) (mmHg), secondaryOutcomes measure: Choroidal thickness ( microns), eligibilityModule sex: ALL, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Pittsburgh Medical Center, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, contacts name: Amy Monroe, MPH, MBA, role: CONTACT, email: [email protected], contacts name: Kanwal Nischal, MD,FRCOphth, role: PRINCIPAL_INVESTIGATOR, contacts name: Lieu Tran, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06275295, orgStudyIdInfo id: ZRJY2021-BJ08-03-01-01, briefTitle: A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-24, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis., conditionsModule conditions: Pulmonary Fibrosis, conditions: Transbronchial Cryobiopsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: The diagnostic rate of MDD2 based on TBLC, secondaryOutcomes measure: The diagnostic rate of MDD1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275282, orgStudyIdInfo id: HUM00235849, briefTitle: Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.The main questions it aims to answer are:1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?Consenting participants with unilateral transfemoral amputation (TFA) will:1. Undergo RPNI surgery and electrode implantation in the residual limb.2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.3. Undergo explantation of electrodes following the conclusion of data collection., conditionsModule conditions: Amputation, conditions: Prostheses and Implants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Intramuscular electrodes, outcomesModule primaryOutcomes measure: Intensity of pain in residual and phantom limbs, primaryOutcomes measure: Neuropathic Pain in residual limb, primaryOutcomes measure: Health-Related Quality of Life, primaryOutcomes measure: Amplitude and signal-to-noise ratio for each RPNI, primaryOutcomes measure: Classification accuracy for movements of the phantom limb, primaryOutcomes measure: Threshold for sensation after electrical stimulation of RPNI, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Deanna Gates, PhD, role: CONTACT, phone: 723-647-2698, email: [email protected], contacts name: Deanna Gates, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False |
protocolSection identificationModule nctId: NCT06275269, orgStudyIdInfo id: ZRJY2021-BJ08-04-02, briefTitle: Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods., conditionsModule conditions: Subglottic Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-Guided, interventions name: Translaryngeal Endoscopic Mucosal Injection, outcomesModule primaryOutcomes measure: Incidence of Short-Term Postoperative Complications, secondaryOutcomes measure: Overall medical expenses incurred by patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275256, orgStudyIdInfo id: HS26226, briefTitle: Outcomes of MIST for BPH: A Single-Institution Prospective Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile., conditionsModule conditions: Benign Prostatic Hyperplasia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Rezum, interventions name: iTind, outcomesModule primaryOutcomes measure: Symptom Scores, primaryOutcomes measure: Uroflow, primaryOutcomes measure: Uroflow, primaryOutcomes measure: Symptom Scores, primaryOutcomes measure: Symptom Scores, primaryOutcomes measure: Symptom Scores, secondaryOutcomes measure: Pain Scale, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Men's Health Clinic, city: Winnipeg, state: Manitoba, zip: R3K 1M3, country: Canada, contacts name: Premal Patel, MD, role: CONTACT, phone: 204-221-4476, email: [email protected], contacts name: Harliv Dhillon, BSc, role: CONTACT, phone: 2049904153, email: [email protected], geoPoint lat: 49.8844, lon: -97.14704, hasResults: False |
protocolSection identificationModule nctId: NCT06275243, orgStudyIdInfo id: ETICA-ULE-021-2022, briefTitle: Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-07-06, primaryCompletionDateStruct date: 2023-03-13, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universidad de León, class: OTHER, collaborators name: Consejo General de Colegios Oficiales de Enfermería España, descriptionModule briefSummary: The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.The main questions it aims to answer are:* What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?* Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region?, conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is a longitudinal randomised clinical study, in which two study groups were used. A group of cases diagnosed with Alzheimer's disease and a control group of healthy individuals without Alzheimer's disease., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 511, type: ACTUAL, armsInterventionsModule interventions name: Kit Buccal swab collection & stabilization de Canvax®, interventions name: Cholesterol levels according to ApoE Genotype, interventions name: Assessing cardiovascular risk factors in all participants, outcomesModule primaryOutcomes measure: Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon., secondaryOutcomes measure: Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects., secondaryOutcomes measure: ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon., eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of León, city: León, zip: 240071, country: Spain, geoPoint lat: 42.60003, lon: -5.57032, hasResults: False |
protocolSection identificationModule nctId: NCT06275230, orgStudyIdInfo id: ZRJY2021-BJ08-02-07, briefTitle: Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:* Can human lung stem cell proliferate in vitro.* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of Patients completed bronchoscope., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275217, orgStudyIdInfo id: HMRF17182481, briefTitle: Mindful Yoga for Postpartum Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-08, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months., conditionsModule conditions: Mood Disorders, 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: 198, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness-based yoga program, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Edinburgh Postnatal Depression Scale, secondaryOutcomes measure: Depression Anxiety Stress Scale-Depression, secondaryOutcomes measure: Depression Anxiety Stress Scale-Anxiety, secondaryOutcomes measure: Depression Anxiety Stress Scale-Stress, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: 36 Item-Short Form Health Survey Questionnaire, secondaryOutcomes measure: Five Facet Mindfulness Questionnaire, secondaryOutcomes measure: Pregnancy Symptom Inventory, secondaryOutcomes measure: Cortisol concentration level, secondaryOutcomes measure: Physical fitness, secondaryOutcomes measure: Balance, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Jessie JX Lin, PhD, role: CONTACT, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06275204, orgStudyIdInfo id: 101101252, secondaryIdInfos id: 101101252, type: OTHER_GRANT, domain: EU4H-2022-PJ-01, briefTitle: H. Pylori Screen-and-treat Study in a Population of Young Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Latvia, class: OTHER, collaborators name: Clinical Hospital Center Rijeka, collaborators name: Clinical Hospital Centre Zagreb, collaborators name: Beacon Hospital, collaborators name: Wroclaw Medical University, collaborators name: Iuliu Hatieganu University of Medicine and Pharmacy, collaborators name: National Institute of Public Health, Slovenia, descriptionModule briefSummary: Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention., conditionsModule conditions: Gastric Cancer, conditions: H Pylori Infection, conditions: H Pylori Eradication, conditions: H-pylori, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6800, type: ESTIMATED, armsInterventionsModule interventions name: Bismuth-based quadruple therapy, interventions name: Levofloxacin-based quadruple therapy, interventions name: Standard triple therapy, interventions name: Levofloxacin-based triple, outcomesModule primaryOutcomes measure: Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program, secondaryOutcomes measure: Eradication rate of infection with H. pylori, secondaryOutcomes measure: Description of the adverse events profile, secondaryOutcomes measure: Participation rate of subjects selected for the program, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 34 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital Centre Zagreb, status: RECRUITING, city: Zagreb, state: Grad Zagreb, zip: 10000, country: Croatia, contacts name: Masa Cavlina Sevo, MD, role: CONTACT, phone: 00385995900847, email: [email protected], contacts name: Mirjana Kalauz, Asst. Prof., role: CONTACT, phone: 0038598519088, email: [email protected], contacts name: Mirjana Kalauz, Asst. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Pave Markos, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Tihomir Bradic, MD, role: SUB_INVESTIGATOR, contacts name: Masa Cavlina Sevo, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.81444, lon: 15.97798, locations facility: Clinical Hospital Center Rijeka, status: RECRUITING, city: Rijeka, zip: 51000, country: Croatia, contacts name: Sandra Milic, MD, role: CONTACT, phone: 0038551658122, email: [email protected], geoPoint lat: 45.32674, lon: 14.44239, locations facility: Beacon Hospital, status: RECRUITING, city: Dublin, zip: D18 AK68, country: Ireland, contacts name: Charlene Deane, MB Bch BAO, MSc, role: CONTACT, phone: 00353879114305, email: [email protected], contacts name: Ruth Pilkington, MB BcH BAO, role: CONTACT, phone: 0035312937521, email: [email protected], contacts name: Colm O Morain, MD, MB BcH BAO, FRCPI, role: PRINCIPAL_INVESTIGATOR, contacts name: Orlaith Kelly, PHD, MB BcH, role: SUB_INVESTIGATOR, contacts name: Charlene Deane, MB Bch BAO, MSc, MRCP, role: SUB_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Clinical and Preventive Medicine of the University of Latvia, status: NOT_YET_RECRUITING, city: Riga, zip: LV1079, country: Latvia, contacts name: Marcis Leja, MD, PhD, role: CONTACT, phone: 371+29497500, email: [email protected], contacts name: Marcis Leja, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Danute Razuka Ebela, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Linda Mezmale, MD, role: SUB_INVESTIGATOR, geoPoint lat: 56.946, lon: 24.10589, locations facility: Wroclaw Medical University, status: RECRUITING, city: Wroclaw, zip: 50-367, country: Poland, contacts name: Katarzyna Malinowska, role: CONTACT, phone: 00487178417 99, email: [email protected], contacts name: Elzbieta Olejnik, role: CONTACT, phone: 00717841666, email: [email protected], contacts name: Katarzyna Neubauer, MD, PhD, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Radoslaw Kempinski, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 51.1, lon: 17.03333, locations facility: Iuliu Hatieganu University of Medicine and Pharmacy, status: RECRUITING, city: Cluj-Napoca, state: Cluj County, zip: 400003, country: Romania, contacts name: Dan Lucian Dumitrascu, Prof, role: CONTACT, phone: 0040722756475, email: [email protected], contacts name: Radu Farcas, MD, PhD student, role: CONTACT, phone: 0040757554422, email: [email protected], contacts name: Radu Farcas, MD, PhD student, role: SUB_INVESTIGATOR, geoPoint lat: 46.76667, lon: 23.6, locations facility: National Institute of Public Health, Slovenia, status: RECRUITING, city: Ljubljana, zip: 1000, country: Slovenia, contacts name: Mitja Oblak, MSc, role: CONTACT, phone: 0038612441541, email: [email protected], contacts name: Tatjana Kofol, MD, role: CONTACT, phone: 0038612441484, email: [email protected], contacts name: Bojan Tepeš, prof., MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.05108, lon: 14.50513, hasResults: False |
protocolSection identificationModule nctId: NCT06275191, orgStudyIdInfo id: 80758, secondaryIdInfos id: 1UG3DE032621-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG3DE032621-01, secondaryIdInfos id: 4UH3DE032621-02, type: NIH, link: https://reporter.nih.gov/quickSearch/4UH3DE032621-02, briefTitle: Alternatives to Dental Opioid Prescribing After Tooth Extraction, acronym: ADOPT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Douglas Oyler, class: OTHER, collaborators name: National Institute of Dental and Craniofacial Research (NIDCR), descriptionModule briefSummary: The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:* Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?* Do oral surgeons' beliefs about the intervention and opioid prescribing change?* Do patients that report using opioids after tooth removal have different experiences than patients that do not?Oral surgeon participants will:* Attend a 1-hour education session with a trained pharmacist* Receive patient instructions and blister packs of pain medicine to give to patients* Complete 2 surveys about feasibility and appropriatenessPatient participants will complete a survey about pain and medication use after having a tooth removed.Researchers will compare the intervention to usual care to see if it reduces opioid prescribing., conditionsModule conditions: Analgesics, Opioid, conditions: Acute Pain, conditions: Tooth Extraction, conditions: Adolescent, conditions: Acetaminophen, conditions: Ibuprofen, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Stepped wedge cluster randomized trial, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Blinding to the intervention is not possible in this study, as the intervention requires provider engagement. Provider participants and any clinic personnel will be blinded to the allocation sequence, and those not yet receiving the intervention will not be aware of the time at which they will have the intervention implemented. The study biostatistician will be aware of the allocation sequence.At the beginning of each period, the study biostatistician will inform the research coordinator, project manager, academic detailing pharmacist, and PIs which cluster will be transitioning to the intervention condition next. This information will be used to facilitate scheduling academic detailing visits and coordinate blister pack and patient instructions material assembly. The clinic will be informed of their allocation during Visit 4 to facilitate scheduling academic detailing visits., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 38159, type: ESTIMATED, armsInterventionsModule interventions name: Multicomponent intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction, secondaryOutcomes measure: (Change in) intervention feasibility, secondaryOutcomes measure: (Change in) intervention appropriateness, secondaryOutcomes measure: (Change in) opioid prescribing feasibility, secondaryOutcomes measure: (Change in) opioid prescribing appropriateness, secondaryOutcomes measure: Self-reported pain, secondaryOutcomes measure: Self-reported pain interference, secondaryOutcomes measure: Self-reported pain satisfaction, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40536, country: United States, contacts name: Jennifer Dolly Prothro, MPH, role: CONTACT, email: [email protected], contacts name: Enif Dominguez, DDS, role: SUB_INVESTIGATOR, contacts name: Patricia R Freeman, PhD, role: SUB_INVESTIGATOR, contacts name: Hannah K Knudsen, PhD, role: SUB_INVESTIGATOR, contacts name: Craig S Miller, DDS, role: SUB_INVESTIGATOR, contacts name: Sharon L Walsh, PhD, role: SUB_INVESTIGATOR, contacts name: Philip M Westgate, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False |
protocolSection identificationModule nctId: NCT06275178, orgStudyIdInfo id: ZRJY2021-BJ08-02-04, briefTitle: Medical Thoracoscopy for Diagnosing Unexplained Pleural Effusion: a National Multicenter Retrospective Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-12-24, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: China-Japan Friendship Hospital, class: OTHER, descriptionModule briefSummary: This study is a national multicenter retrospective study. Patients with unexplained pleural effusion who underwent thoracoscopic or video-assisted thoracoscopic biopsy for patients in recent 10 years were retrospectively collected from multiple centers to understand the proportion and final etiological composition of pleural effusion in China., conditionsModule conditions: Pleural Effusion, conditions: Pleural Effusion, Malignant, conditions: Fibrinous Pleuritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Medical thoracoscopy, outcomesModule primaryOutcomes measure: The proportion of fibrinous pleurisy in Chinese population, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06275165, orgStudyIdInfo id: 202301754B0, briefTitle: The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-07-18, completionDateStruct date: 2025-07-18, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: CHEN, CHIA-CHEN, class: OTHER, descriptionModule briefSummary: This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery., conditionsModule conditions: Esophageal Cancer, conditions: Gastrointestinal Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care.control group: received regular postoperative care., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: acupressure, outcomesModule primaryOutcomes measure: Change from Baseline in gastrointestinal symptom distress Scale at study day 5(end day), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung Memotial Hospital, status: RECRUITING, city: Taoyuan, country: Taiwan, contacts name: Chia-Chen Chen, role: CONTACT, phone: +886-3-3281200, phoneExt: 3005, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False |
protocolSection identificationModule nctId: NCT06275152, orgStudyIdInfo id: HDRIC-01, briefTitle: The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD), acronym: RIC-HD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2026-01-19, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Yuanjun Yang, class: OTHER, descriptionModule briefSummary: Hemodialysis (HD) is the main renal replacement therapy for patients with end-stage renal disease. However, factors such as hemodynamic instability can lead to gradual loss of residual renal function (RRF) in HD patients. The loss of RRF not only affects the adequacy of dialysis and complications control but also impacts the patients' quality of life and survival. Unfortunately, there are currently no effective methods to protect RRF. The purpose of this study is to validate the protective effect of remote ischemic conditioning (RIC) on RRF in HD patients. This will provide evidence for the application of RIC in protecting RRF in HD patients., conditionsModule conditions: End-stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled pilot study, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Only Research Assistant will be unblinded. Participant, clinical team, PI, etc. will all be blinded to the randomization group., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Remote ischemic conditioning, interventions name: Sham Remote Ischemic Conditioning, outcomesModule primaryOutcomes measure: time to anuria, primaryOutcomes measure: residual renal function (RRF), primaryOutcomes measure: Change in the renal cerebral oxygen saturation, secondaryOutcomes measure: serum creatinine, secondaryOutcomes measure: serum urea nitrogen, secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: Interleukin-6, secondaryOutcomes measure: TFF3, secondaryOutcomes measure: KIM-1, secondaryOutcomes measure: IP-10, otherOutcomes measure: hemoglobin, otherOutcomes measure: systolic pressure, otherOutcomes measure: diastolic pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06275139, orgStudyIdInfo id: 2023-GSP-GG-9, briefTitle: Integrated Assessment of Cervicocerebral Vessels to Improve the Brain Injury for CAGB Patients (IACV Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: The goal of this study is to establish a prospective study to focus on the high-risk stroke population who require coronary artery bypass graft surgery. It will divide the eligible patients into 1:1 group by simple randomization method. The control group adopt the traditional diagnosis and treatment mode, and only head CT plain scan and carotid artery ultrasound shall be performed. If necessary, relevant disciplines would be consulted but no integrated assessment of cervicocerebral vessels be arranged. The final treatment plan would be decided by the surgeon alone. The experimental group adopt the multidisciplinary collaboration and integrated evaluation mode. In addition to routine diagnosis and treatment as above-mentioned, integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment. Based on the above results, surgical plans will be formulated jointly by multiple disciplines including neurologists, vascular surgeons, ICU physicians and cardiac surgeons. Researchers will compare the two groups to investigate whether integrated assessment of cervicocerebral vessels can reduce the incidence of brain injury compared with conventional diagnosis and treatment mode., conditionsModule conditions: Coronary Disease, conditions: Coronary Artery Bypass, conditions: Strokes Thrombotic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Integrated assessment of cervicocerebral vessels shall be performed, including transcranial color-coded doppler, cerebral perfusion with multislice CT, and cognitive function assessment., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 348, type: ESTIMATED, armsInterventionsModule interventions name: Integrated Assessment of Cervicocerebral Vessels, outcomesModule primaryOutcomes measure: The incidence of neurological complications, secondaryOutcomes measure: The incidence of major adverse cardiac events, secondaryOutcomes measure: Neurological scale scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fuwai Hospital; National Cardiovascular Center; Peking Union Medical College & Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100037, country: China, contacts name: Huanmei Liu, MD, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06275126, orgStudyIdInfo id: 23-08026433, secondaryIdInfos id: R01CA256877-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA256877-01A1, briefTitle: Optimizing Surgical Decisions in Young Adults With Breast Cancer, acronym: CONSYDER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this study is to understand and improve the breast surgical decision-making process for young women newly diagnosed with breast cancer. As part of this study, the investigators will evaluate the impact and use a web-based tool called CONSYDER that is designed to provide useful information to young breast cancer patients. It is also meant to improve communication between young women and their surgeons with the purpose of helping patients make appropriate surgical decisions.Participants will complete surveys within 1 week of the surgical consult and 6 months after surgery. Patients who receive neoadjuvant chemotherapy will also be surveyed after the completion of neoadjuvant treatment but prior to surgery. Some patients will be invited for an interview after their surgery as part of the evaluation. A subset of patients/surgeons will also have their surgical consultation audio-recorded., conditionsModule conditions: Breast Cancer Stage 0, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is a pragmatic, Type II hybrid effectiveness-implementation, stepped-wedge design that will incorporate a mixed-methods approach to test the efficacy and evaluate the implementation of the CONSYDER intervention, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: CONSYDER decision aid, outcomesModule primaryOutcomes measure: Pre-surgical decisional conflict as measured by the Decisional Conflict Scale (DCS), primaryOutcomes measure: Use of CONSYDER pre-consult, secondaryOutcomes measure: Knowledge as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS -DQI), secondaryOutcomes measure: Treatment goals and preferences as measured by adapted Breast Cancer Surgery Decision Quality Instrument (BCS-DQI), secondaryOutcomes measure: Anxiety, as measured with the 8-item Patient Reported Outcomes Measurement Information System (PROMIS) - Anxiety - Short Form, secondaryOutcomes measure: Self-efficacy in communication as measured by the Perceived Efficacy in Patient-Physician Interactions scale (PEPPI)., secondaryOutcomes measure: Decisional regret as measured by the Decision Regret Scale (DRS), secondaryOutcomes measure: Receipt of contralateral prophylactic mastectomy, secondaryOutcomes measure: Fidelity of implementation of CONSYDER via patient portal email, secondaryOutcomes measure: Use of CONSYDER post-consult, secondaryOutcomes measure: Frequency of CONSYDER use pre-consult, secondaryOutcomes measure: Frequency of CONSYDER use post-consult, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yale Cancer Center, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, contacts name: Rachel Greenup, MD, MPH, role: CONTACT, phone: 203-737-2966, email: [email protected], contacts name: Rachel Greenup, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Dana-Farber Cancer Institute, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Ann Partridge, MD, MPH, role: CONTACT, phone: 617-632-3800, email: [email protected], contacts name: Ann Partridge, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Weill Cornell Medicine, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Shoshana Rosenberg, ScD, MPH, role: CONTACT, phone: 646-962-8041, email: [email protected], contacts name: Darima Dorzhieva, role: CONTACT, phone: 646-962-8666, email: [email protected], contacts name: Shoshana Rosenberg, ScD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke Cancer Institute, status: RECRUITING, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Jennifer Plichta, MD, MS, role: CONTACT, phone: 919-681-9156, email: [email protected], contacts name: Jennifer Plichta, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False |
protocolSection identificationModule nctId: NCT06275113, orgStudyIdInfo id: K25, briefTitle: BRING-UP Prevention, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Heart Care Foundation, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to assess in patients with a documented athero-thrombotic event: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD):* the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels.* the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence., conditionsModule conditions: Ischemic Heart Disease, conditions: Cerebrovascular Disorders, conditions: Peripheral Arterial Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Adherence to guideline for cholesterol level, secondaryOutcomes measure: Adherence to guideline for other risk factors, otherOutcomes measure: Patients' outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Barone Lombardo - Cardiologia E Utic, status: NOT_YET_RECRUITING, city: Canicatti', state: AG, zip: 92024, country: Italy, contacts name: LUCIANO SUTERA SARDO, MD, role: CONTACT, geoPoint lat: 37.35842, lon: 13.84786, locations facility: Ospedale San Giacomo D'Altopasso - Uoc Cardiologia, status: RECRUITING, city: Licata, state: AG, zip: 92027, country: Italy, contacts name: SALVATORE MONTALTO, MD, role: CONTACT, geoPoint lat: 37.10267, lon: 13.93972, locations facility: Ospedale Santo Spirito - Sc Cardiologia, status: RECRUITING, city: Casale Monferrato, state: AL, zip: 15033, country: Italy, contacts name: FEDERICO NARDI, MD, role: CONTACT, geoPoint lat: 45.13338, lon: 8.4525, locations facility: Ospedale San Giacomo - Sc Cardiologia, status: RECRUITING, city: Novi Ligure, state: AL, zip: 15067, country: Italy, contacts name: MARIA E ROVERE, MD, role: CONTACT, geoPoint lat: 44.76246, lon: 8.787, locations facility: Ospedali Riuniti - Clinica Di Cardiologia E Aritmologia, status: NOT_YET_RECRUITING, city: Ancona, state: AN, zip: 60122, country: Italy, contacts name: PAOLO COMPAGNUCCI, MD, role: CONTACT, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera E Utic, status: NOT_YET_RECRUITING, city: Ancona, state: AN, zip: 60122, country: Italy, contacts name: GIAN PIERO PERNA, MD, role: CONTACT, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Casa Di Cura Villa Serena - U.O. Cardiologia Riabilitativa, status: RECRUITING, city: Jesi, state: AN, zip: 60035, country: Italy, contacts name: NICOLA RUSSO, MD, role: CONTACT, geoPoint lat: 43.52142, lon: 13.24368, locations facility: Ospedale Madonna Del Soccorso - Uoc Cardiologia Indirizzo Riabilitativo, status: RECRUITING, city: San Benedetto Del Tronto, state: AP, zip: 63074, country: Italy, contacts name: MICHELA MOLISANA, MD, role: CONTACT, geoPoint lat: 42.9568, lon: 13.87676, locations facility: Ospedale San Donato - U.O.C Cardiologia, status: RECRUITING, city: Arezzo, state: AR, zip: 52100, country: Italy, contacts name: MATTEO ROCCO RECCIA, MD, role: CONTACT, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Ospedale Valdichiana Santa Margherita - Uosd Cardiologia S.O. Cortona, status: RECRUITING, city: Cortona, state: AR, zip: 52044, country: Italy, contacts name: SIMONA D'ORAZIO, MD, role: CONTACT, geoPoint lat: 43.27467, lon: 11.98533, locations facility: Aorn San Giuseppe Moscati - U.O. Cardiologia/Utic 'D. Rotiroti', status: RECRUITING, city: Avellino, state: AV, zip: 83100, country: Italy, contacts name: EMILIO DI LORENZO, MD, role: CONTACT, geoPoint lat: 40.91494, lon: 14.79103, locations facility: Ospedale Miulli - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Acquaviva Delle Fonti, state: BA, zip: 70021, country: Italy, contacts name: NICOLA VITULANO, MD, role: CONTACT, geoPoint lat: 40.89704, lon: 16.8433, locations facility: Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic, status: RECRUITING, city: Altamura, state: BA, zip: 70022, country: Italy, contacts name: PIETRO SCICCHITANO, MD, role: CONTACT, geoPoint lat: 40.82664, lon: 16.54952, locations facility: Ospedale San Paolo - Cardiologia-Utic, status: RECRUITING, city: Bari, state: BA, zip: 70123, country: Italy, contacts name: PASQUALE CALDAROLA, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ics Maugeri Spa Societa' Benefit Irccs Bari - Cardiologia Riabilitativa, status: RECRUITING, city: Bari, state: BA, zip: 70124, country: Italy, contacts name: ANDREA PASSANTINO, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Mater Dei Hospital - Riabilitazione Cardiologica, status: RECRUITING, city: Bari, state: BA, zip: 70124, country: Italy, contacts name: ROCCO LAGIOIA, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Umberto I - U.O.C. Cardiologia, status: RECRUITING, city: Corato, state: BA, zip: 70033, country: Italy, contacts name: ILARIA L NALIN, MD, role: CONTACT, geoPoint lat: 41.15171, lon: 16.41143, locations facility: Ospedale San Giacomo - Uoc Cardiologia, status: RECRUITING, city: Monopoli, state: BA, zip: 70043, country: Italy, contacts name: ONOFRIO ROSSI, MD, role: CONTACT, geoPoint lat: 40.94918, lon: 17.29717, locations facility: Ospedale Degli Infermi - Sc Di Cardiologia, status: RECRUITING, city: Ponderano, state: BI, zip: 13875, country: Italy, contacts name: ANDREA ROGNONI, MD, role: CONTACT, geoPoint lat: 45.53846, lon: 8.05592, locations facility: Presidio Ospedaliero "Santa Maria Del Prato" - U.O.C. Di Cardiologia-Utic, status: RECRUITING, city: Feltre, state: BL, zip: 32032, country: Italy, contacts name: CHRISTIAN PIERGENTILI, MD, role: CONTACT, geoPoint lat: 46.02085, lon: 11.90031, locations facility: Ospedale Di Bentivoglio - U.O. Cardiologia Pianura, status: RECRUITING, city: Bentivoglio, state: BO, zip: 40010, country: Italy, contacts name: GIANFRANCO TORTORICI, MD, role: CONTACT, geoPoint lat: 44.6369, lon: 11.41737, locations facility: Ospedale Maggiore - U.O.C. Di Cardiologia, status: RECRUITING, city: Bologna, state: BO, zip: 40133, country: Italy, contacts name: GIANMARCO IANNOPOLLO, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Bellaria - U.O. Di Cardiologia, status: RECRUITING, city: Bologna, state: BO, zip: 40139, country: Italy, contacts name: STEFANO URBINATI, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Ospedale Perrino - U.O.C. Di Cardiologia, status: RECRUITING, city: Brindisi, state: BR, zip: 72100, country: Italy, contacts name: GIAN PAOLO GIORDA, MD, role: CONTACT, geoPoint lat: 40.63215, lon: 17.93607, locations facility: Casa Di Cura San Camillo - U.O. Cardiologia, status: RECRUITING, city: Brescia, state: BS, zip: 25123, country: Italy, contacts name: MARCO CAPRETTI, MD, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Ospedale Di Desenzano Del Garda - Divisione Di Cardiologia - U.C.C., status: RECRUITING, city: Desenzano Del Garda, state: BS, zip: 25015, country: Italy, contacts name: GIOSUE' MASCIOLI, MD, role: CONTACT, geoPoint lat: 45.47127, lon: 10.53559, locations facility: Ospedale Civile 'La Memoria' - U.O. Di Cardiologia, status: RECRUITING, city: Gavardo, state: BS, zip: 25085, country: Italy, contacts name: MARCO TRIGGIANI, MD, role: CONTACT, geoPoint lat: 45.58939, lon: 10.44257, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Lumezzane - U.O. Di Cardiologia Riabilitativa, status: RECRUITING, city: Lumezzane, state: BS, zip: 25065, country: Italy, contacts name: FRANCESCA RIVADOSSI, MD, role: CONTACT, geoPoint lat: 45.64789, lon: 10.26487, locations facility: Ospedale Monsignor Angelo R. Di Miccoli - Uoc Cardiologia/Utic, status: NOT_YET_RECRUITING, city: Barletta, state: BT, zip: 76121, country: Italy, contacts name: FRANCESCO BARTOLOMUCCI, MD, role: CONTACT, geoPoint lat: 41.31429, lon: 16.28165, locations facility: Ospedale Centrale Bolzano - Cardiologia E Prove Funzionali, status: RECRUITING, city: Bolzano, state: BZ, zip: 39100, country: Italy, contacts name: PRISCILLA MILEWSKI, MD, role: CONTACT, geoPoint lat: 46.49067, lon: 11.33982, locations facility: Arnas G. Brotzu - Cardiologia Con Utic, status: NOT_YET_RECRUITING, city: Cagliari, state: CA, zip: 09134, country: Italy, contacts name: MARCO CORDA, MD, role: CONTACT, geoPoint lat: 39.23054, lon: 9.11917, locations facility: Arnas G. Brotzu - S.S.D. Cardioriabilitazione, status: RECRUITING, city: Cagliari, state: CA, zip: 09134, country: Italy, contacts name: ANDREA BIANCO, MD, role: CONTACT, geoPoint lat: 39.23054, lon: 9.11917, locations facility: A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica, status: NOT_YET_RECRUITING, city: Monserrato, state: CA, zip: 09124, country: Italy, contacts name: ROBERTA MONTISCI, MD, role: CONTACT, geoPoint lat: 39.25642, lon: 9.1444, locations facility: Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic, status: RECRUITING, city: Caserta, state: CE, zip: 81100, country: Italy, contacts name: PAOLO CALABRO', MD, role: CONTACT, geoPoint lat: 41.07262, lon: 14.33231, locations facility: Villa Delle Magnolie - Riabilitazione Cardiologica, status: RECRUITING, city: Castel Morrone, state: CE, zip: 81020, country: Italy, contacts name: FRANCESO PERONE, MD, role: CONTACT, geoPoint lat: 41.12102, lon: 14.35473, locations facility: Casa Di Cura San Michele - Uo Cardiologia, status: RECRUITING, city: Maddaloni, state: CE, zip: 81024, country: Italy, contacts name: MARCO PEPE, MD, role: CONTACT, geoPoint lat: 41.03578, lon: 14.3823, locations facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic, status: RECRUITING, city: Santa Maria Capua Vetere, state: CE, zip: 81055, country: Italy, contacts name: PIETRO IODICE, MD, role: CONTACT, geoPoint lat: 41.08156, lon: 14.25342, locations facility: Ospedale Policlinico Ss. Annunziata - Uoc Cardiologia-Utic, status: NOT_YET_RECRUITING, city: Chieti, state: CH, zip: 66013, country: Italy, contacts name: MARCO ZIMARINO, MD, role: CONTACT, geoPoint lat: 42.34827, lon: 14.16494, locations facility: Santa Barbara Hospital - Cardiologia, status: RECRUITING, city: Gela, state: CL, zip: 93012, country: Italy, contacts name: GIUSEPPE LA ROSA, MD, role: CONTACT, geoPoint lat: 37.07381, lon: 14.24038, locations facility: Azienda Ospedaliera Santa Croce E Carle - Sc Cardiologia, status: RECRUITING, city: Cuneo, state: CN, zip: 12100, country: Italy, contacts name: FRANCESCA GIORDANA, MD, role: CONTACT, geoPoint lat: 44.39071, lon: 7.54828, locations facility: Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic, status: RECRUITING, city: Mondovì, state: CN, zip: 12084, country: Italy, contacts name: MAURO FEOLA, MD, role: CONTACT, geoPoint lat: 44.39603, lon: 7.81764, locations facility: Ospedale Maggiore Ss. Annunziata - Sc Cardiologia, status: RECRUITING, city: Savigliano, state: CN, zip: 12038, country: Italy, contacts name: MICHELE DE BENEDICTIS, MD, role: CONTACT, geoPoint lat: 44.64808, lon: 7.65677, locations facility: Ospedale Oglio Po - U.O. Di Cardiologia-Utic, status: RECRUITING, city: Casalmaggiore, state: CR, zip: 26041, country: Italy, contacts name: CARLO PISCICELLI, MD, role: CONTACT, geoPoint lat: 44.98981, lon: 10.42055, locations facility: Ospedale Annunziata - Uoc Cardiologia Interventistica, status: RECRUITING, city: Cosenza, state: CS, zip: 87100, country: Italy, contacts name: FRANCESCO GRECO, MD, role: CONTACT, geoPoint lat: 39.2989, lon: 16.25307, locations facility: Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia, status: RECRUITING, city: Paola, state: CS, zip: 87027, country: Italy, contacts name: MARIA T MANES, MD, role: CONTACT, geoPoint lat: 39.36313, lon: 16.03691, locations facility: Policlinico Di Catania Presidio San Marco - Cardiologia Utic, status: NOT_YET_RECRUITING, city: Catania, state: CT, zip: 95100, country: Italy, contacts name: ALESSIO G LA MANNA, MD, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: P.O. Garibaldi-Nesima - Arnas Garibaldi - U.O.C. Di Cardiologia Con Utic, status: RECRUITING, city: Catania, state: CT, zip: 95122, country: Italy, contacts name: MICHELE M GULIZIA, MD, role: CONTACT, geoPoint lat: 37.49223, lon: 15.07041, locations facility: P.O. "Materdomini" - A.O.U. "Renato Dulbecco" - Ssd Cardiologia Riabilitativa, status: RECRUITING, city: Catanzaro, state: CZ, zip: 88100, country: Italy, contacts name: DOMENICO ZUCCO, MD, role: CONTACT, geoPoint lat: 38.88247, lon: 16.60086, locations facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia, status: RECRUITING, city: Forli', state: FC, zip: 47121, country: Italy, contacts name: DANIELA SPARTA', MD, role: CONTACT, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Arcispedale Sant'Anna - U.O. Cardiologia, status: RECRUITING, city: Ferrara, state: FE, zip: 44124, country: Italy, contacts name: GABRIELE GUARDIGLI, MD, role: CONTACT, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic, status: RECRUITING, city: Foggia, state: FG, zip: 71100, country: Italy, contacts name: NATALE D BRUNETTI, MD, role: CONTACT, geoPoint lat: 41.45845, lon: 15.55188, locations facility: San Francesco Hospital - U.O.C. Cardiologia, status: RECRUITING, city: Foggia, state: FG, zip: 71122, country: Italy, contacts name: ALDO RUSSO, MD, role: CONTACT, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica, status: RECRUITING, city: San Giovanni Rotondo, state: FG, zip: 71013, country: Italy, contacts name: GIUSEPPE DI STOLFO, MD, role: CONTACT, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Aou Careggi - Riabilitazione Cardiologica, status: RECRUITING, city: Firenze, state: FI, zip: 50134, country: Italy, contacts name: COSTANZA BURGISSER, MD, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, locations facility: E.O. Ospedali Galliera - S. C. Cardiologia E U.T.I.C., status: RECRUITING, city: Genova, state: GE, zip: 16128, country: Italy, contacts name: MARIA MOLFESE, MD, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Ospedale San Giovanni Di Dio - Sc Cardiologia (Gorizia-Monfalcone), status: RECRUITING, city: Gorizia, state: GO, zip: 34170, country: Italy, contacts name: GERARDINA LARDIERI, MD, role: CONTACT, geoPoint lat: 45.94088, lon: 13.62167, locations facility: Ospedale Civile San Polo - Sc Cardiologia (Gorizia-Monfalcone), status: NOT_YET_RECRUITING, city: Monfalcone, state: GO, zip: 34074, country: Italy, contacts name: GERARDINA LARDIERI, MD, role: CONTACT, geoPoint lat: 45.80463, lon: 13.53292, locations facility: Presidio Ospedaliero - U.O. Cardiologia, status: RECRUITING, city: Sanremo, state: IM, zip: 18038, country: Italy, contacts name: FABIO FERRARI, MD, role: CONTACT, geoPoint lat: 43.81725, lon: 7.7772, locations facility: Ospedale Alessandro Manzoni - S.C. Di Cardiologia, status: RECRUITING, city: Lecco, state: LC, zip: 23900, country: Italy, contacts name: ROBERTO SPOLADORE, MD, role: CONTACT, geoPoint lat: 45.85589, lon: 9.39704, locations facility: Presidio Ospedaliero F. Ferrari - Ssd Cardiologia - Utic, status: RECRUITING, city: Casarano, state: LE, zip: 73042, country: Italy, contacts name: DONATO MELISSANO, MD, role: CONTACT, geoPoint lat: 40.01131, lon: 18.16237, locations facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia, status: NOT_YET_RECRUITING, city: Copertino, state: LE, zip: 73043, country: Italy, contacts name: ALESSANDRO CALCAGNILE, MD, role: CONTACT, geoPoint lat: 40.26821, lon: 18.0543, locations facility: Ospedale Vito Fazzi - Uoc Cardiologia-Utic Ed Emodinamica, status: RECRUITING, city: Lecce, state: LE, zip: 73100, country: Italy, contacts name: STEFANIA MARAZIA, MD, role: CONTACT, geoPoint lat: 40.35481, lon: 18.17244, locations facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic "E. Vilei", status: RECRUITING, city: Scorrano, state: LE, zip: 73020, country: Italy, contacts name: COSIMO A GRECO, MD, role: CONTACT, geoPoint lat: 40.09018, lon: 18.29993, locations facility: Ospedali Riuniti - U.O.C. Cardiologia E Utic, status: RECRUITING, city: Livorno, state: LI, zip: 57124, country: Italy, contacts name: FRANCESCO BELLINI, MD, role: CONTACT, geoPoint lat: 43.54427, lon: 10.32615, locations facility: Istituto 'Marco Pasquali' Icot - Riabilitazione Cardiologica, status: RECRUITING, city: Latina, state: LT, zip: 04100, country: Italy, contacts name: ANTONIO GROSSI, MD, role: CONTACT, geoPoint lat: 41.46614, lon: 12.9043, locations facility: Nuovo Ospedale Versilia - Sc Cardiologia, status: RECRUITING, city: Camaiore, state: LU, zip: 55041, country: Italy, contacts name: GIANCARLO CASOLO, MD, role: CONTACT, geoPoint lat: 43.94265, lon: 10.29754, locations facility: Ospedale Giovanni Paolo Ii - Uosd Utic, status: NOT_YET_RECRUITING, city: Policoro, state: Matera, zip: 75025, country: Italy, contacts name: ANDREA ANDRIANI, MD, role: CONTACT, geoPoint lat: 40.2128, lon: 16.67795, locations facility: Ospedale Pio Xi - U.O.C. Di Cardiologia, status: RECRUITING, city: Desio, state: MB, zip: 20832, country: Italy, contacts name: FELICE ACHILLI, MD, role: CONTACT, geoPoint lat: 45.61831, lon: 9.20249, locations facility: Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia, status: RECRUITING, city: Monza, state: MB, zip: 20900, country: Italy, contacts name: LAURA F VALAGUSSA, MD, role: CONTACT, geoPoint lat: 45.58005, lon: 9.27246, locations facility: Ospedale Di Seregno - Riabilitazione Specialistica Cardiologica, status: RECRUITING, city: Seregno, state: MB, zip: 20831, country: Italy, contacts name: ELISABETTA SCANZIANI, MD, role: CONTACT, geoPoint lat: 45.65002, lon: 9.20548, locations facility: Nuovo Ospedale Di Vimercate - S.C. Cardiologia E Utic, status: RECRUITING, city: Vimercate, state: MB, zip: 20871, country: Italy, contacts name: DANIELA GRASSELLI, MD, role: CONTACT, geoPoint lat: 45.61545, lon: 9.36801, locations facility: Ospedale Generale Provinciale - U.O. Cardiologia, status: RECRUITING, city: Macerata, state: MC, zip: 62100, country: Italy, contacts name: MICAELA CAPPONI, MD, role: CONTACT, geoPoint lat: 43.29789, lon: 13.45293, locations facility: Iomi Istituto Ortopedico F. Scalabrino - Uo Cardiologia, status: RECRUITING, city: Messina, state: ME, zip: 98015, country: Italy, contacts name: ROBERTO CARUSO, MD, role: CONTACT, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Irccs Centro Neurolesi Bonino Pulejo - P.O Piemonte - Cardiologia E Utic, status: RECRUITING, city: Messina, state: ME, zip: 98124, country: Italy, contacts name: ANTONIO DUCA, MD, role: CONTACT, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Azienda Ospedaliera Papardo - U.O. Cardiologia Con Utic - Emodinamica, status: RECRUITING, city: Messina, state: ME, zip: 98158, country: Italy, contacts name: VITO PIPITONE, MD, role: CONTACT, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Ospedale Di Cernusco Sul Naviglio - U. O. Di Cardiologia E Ucc, status: NOT_YET_RECRUITING, city: Cernusco Sul Naviglio, state: MI, zip: 20063, country: Italy, contacts name: SERGIO SALA, MD, role: CONTACT, geoPoint lat: 45.52526, lon: 9.33297, locations facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico - Uoc Malattie Cardiovascolari, status: RECRUITING, city: Milano, state: MI, zip: 20122, country: Italy, contacts name: STEFANO CARUGO, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Centro Cardiologico Monzino Irccs - Terapia Intensiva Cardiologica (Utic), status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: FILIPPO TOMBARA, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Riabilitazione Cardiologica, status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: MAURIZIO BUSSOTTI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano - Uo Cure Subacute, status: RECRUITING, city: Milano, state: MI, zip: 20138, country: Italy, contacts name: MARCO FROLDI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Irccs Santa Maria Nascente Fond. Don Gnocchi - Cardiologia Riabilitativa, status: RECRUITING, city: Milano, state: MI, zip: 20148, country: Italy, contacts name: ANDREA A MORASCHI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: ASST SANTI PAOLO E CARLO - PO San Carlo - CARDIOLOGIA-UCC, status: RECRUITING, city: Milano, state: MI, zip: 20153, country: Italy, contacts name: MARTA RESCALDANI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Irccs Ospedale Galeazzi - Sant'Ambrogio - Cardiologia Universitaria Ed Imaging Cardiaco, status: RECRUITING, city: Milano, state: MI, zip: 20157, country: Italy, contacts name: EDOARDO CONTE, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Asst Ospedale Metropolitano Niguarda - Diagnosi E Cure Terr. Malattie Cardiache, status: RECRUITING, city: Milano, state: MI, zip: 20159, country: Italy, contacts name: GIULIANA G MOMBELLI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica, status: RECRUITING, city: Milano, state: MI, zip: 20162, country: Italy, contacts name: LAURA GARATTI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Asst Ospedale Metropolitano Niguarda - Cardiologia 4 - Diagnostica E Riabilitativa, status: RECRUITING, city: Milano, state: MI, zip: 20162, country: Italy, contacts name: ALESSANDRO MALOBERTI, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Presidio Ospedaliero Di Passirana - Cardiologia Riabilitativa, status: RECRUITING, city: RHO, state: MI, zip: 20017, country: Italy, contacts name: ANNA FRISINGHELLI, MD, role: CONTACT, geoPoint lat: 45.53245, lon: 9.0402, locations facility: Irccs Policlinico San Donato - Cardiologia Riabilitativa, status: RECRUITING, city: San Donato Milanese, state: MI, zip: 20097, country: Italy, contacts name: MASSIMO PIEPOLI, MD, role: CONTACT, geoPoint lat: 45.41047, lon: 9.26838, locations facility: Irccs Policlinico Multimedica - Uo Di Cardiologia, status: RECRUITING, city: Sesto San Giovanni, state: MI, zip: 20099, country: Italy, contacts name: LUCA P ALBERTI, MD, role: CONTACT, geoPoint lat: 45.53329, lon: 9.22585, locations facility: Ospedale Citta' Di Sesto San Giovanni - Sc Cardiologia-Ucc Asst Nord Milano (Bassini-Ssg), status: RECRUITING, city: Sesto San Giovanni, state: MI, zip: 20099, country: Italy, contacts name: CAMILLA FACCHINI, MD, role: CONTACT, geoPoint lat: 45.53329, lon: 9.22585, locations facility: Ospedale Santa Maria Bianca - U.O. Di Cardiologia, status: RECRUITING, city: Mirandola, state: MO, zip: 41037, country: Italy, contacts name: GIULIA NANNI, MD, role: CONTACT, geoPoint lat: 44.88515, lon: 11.06902, locations facility: Ospedale Civile Di Baggiovara - U.O. Di Cardiologia, status: RECRUITING, city: Modena, state: MO, zip: 41126, country: Italy, contacts name: STEFANIA SANSONI, MD, role: CONTACT, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Ospedale Di Sassuolo - Cardiologia, status: RECRUITING, city: Sassuolo, state: MO, zip: 41049, country: Italy, contacts name: WALTER SACCO, MD, role: CONTACT, geoPoint lat: 44.5432, lon: 10.7848, locations facility: Ospedale San Giovanni Di Dio - Uo Cardiologia - Utic, status: RECRUITING, city: Frattamaggiore, state: Napoli, zip: 80027, country: Italy, contacts name: FRANCESCO PIEMONTE, MD, role: CONTACT, geoPoint lat: 40.9414, lon: 14.27588, locations facility: Fondazione G. Giglio - U.O. Di Cardiologia, status: RECRUITING, city: Cefalu', state: PA, zip: 90015, country: Italy, contacts name: DONATELLA ARMATA, MD, role: CONTACT, geoPoint lat: 38.03856, lon: 14.02285, locations facility: Ospedale Buccheri La Ferla Fatebenefratelli - Ssd Riabilitazione Cardiovascolare, status: RECRUITING, city: Palermo, state: PA, zip: 90123, country: Italy, contacts name: FILIPPO M SARULLO, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aou Policlinico P. Giaccone - U.O.C. Cardiologia, status: RECRUITING, city: Palermo, state: PA, zip: 90127, country: Italy, contacts name: GIUSEPPINA NOVO, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Arnas P.O. Civico E Benfratelli - Uoc Utic, status: RECRUITING, city: Palermo, state: PA, zip: 90127, country: Italy, contacts name: IGNAZIO M SMECCA, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Maria Eleonora Hospital - Cardiologia, status: RECRUITING, city: Palermo, state: PA, zip: 90135, country: Italy, contacts name: VINCENZO PERNICE, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello P.O. Cervello - U.O. Cardiologia - Cervello, status: RECRUITING, city: Palermo, state: PA, zip: 90146, country: Italy, contacts name: VINCENZO POLIZZI, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia, status: RECRUITING, city: Palermo, state: PA, zip: 90146, country: Italy, contacts name: CARLO CICERONE, MD, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale Unico Della Val Tidone - Cardiologia E Riabilitazione, status: RECRUITING, city: Castel San Giovanni, state: PC, zip: 29015, country: Italy, contacts name: MARIATERESA DI DIO, MD, role: CONTACT, geoPoint lat: 45.06014, lon: 9.43784, locations facility: Ospedale Civile 'Guglielmo Da Saliceto' - Uoc Cardiologia E Utic, status: RECRUITING, city: Piacenza, state: PC, zip: 29100, country: Italy, contacts name: DANIELA ASCHIERI, MD, role: CONTACT, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Ospedale Di Cittadella - U.O. Cardiologia, status: RECRUITING, city: Cittadella, state: PD, zip: 35013, country: Italy, contacts name: GAETANO POVOLO, MD, role: CONTACT, geoPoint lat: 45.64523, lon: 11.78453, locations facility: Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic, status: RECRUITING, city: Pescara, state: PE, zip: 65124, country: Italy, contacts name: DOMENICO DI CLEMENTE, MD, role: CONTACT, geoPoint lat: 42.4584, lon: 14.20283, locations facility: Presidio Ospedaliero Citta' Di Castello - U.O. Cardiologia/Utic, status: RECRUITING, city: Citta' Di Castello, state: PG, zip: 06012, country: Italy, contacts name: ANDREA CHIOCCHINI, MD, role: CONTACT, geoPoint lat: 43.46556, lon: 12.2375, locations facility: Ospedale Gubbio-Gualdo Tadino - U.O. Di Utic E Cardiologia, status: RECRUITING, city: Gubbio, state: PG, zip: 06024, country: Italy, contacts name: DEBORAH COSMI, MD, role: CONTACT, geoPoint lat: 43.34996, lon: 12.57309, locations facility: Azienda Ospedaliera Di Perugia - S.C. Cardiologia, status: RECRUITING, city: Perugia, state: PG, zip: 06129, country: Italy, contacts name: FRANCESCO NOTARISTEFANO, MD, role: CONTACT, geoPoint lat: 43.1122, lon: 12.38878, locations facility: Ospedale Ss. Cosma E Damiano - Sos Cardiologia, status: RECRUITING, city: Pescia, state: Pistoia, zip: 51017, country: Italy, contacts name: GAIA C MAGNAGHI, MD, role: CONTACT, geoPoint lat: 43.8871, lon: 10.68849, locations facility: Ospedale Ss. Cosma E Damiano - Sos Riabilitazione Cardiologica, status: RECRUITING, city: Pescia, state: Pistoia, zip: 51017, country: Italy, contacts name: DUCCIO ROSSINI, MD, role: CONTACT, geoPoint lat: 43.8871, lon: 10.68849, locations facility: Ftgm - Stabilimento Di Pisa - Cardiologia E Medicina Cardiovascolare, status: RECRUITING, city: Pisa, state: PI, zip: 56124, country: Italy, contacts name: MICHELE EMDIN, MD, role: CONTACT, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Auxilium Vitae Volterra - Riabilitazione Cardiologica, status: RECRUITING, city: Volterra, state: PI, zip: 56048, country: Italy, contacts name: NICOLA SCELZA, MD, role: CONTACT, geoPoint lat: 43.40251, lon: 10.86152, locations facility: Presidio Ospedaliero Per La Salute Di Sacile - Cardiologia Preventiva E Riabilitativa, status: RECRUITING, city: Sacile, state: PN, zip: 33077, country: Italy, contacts name: ELISA LEIBALLI, MD, role: CONTACT, geoPoint lat: 45.95412, lon: 12.50274, locations facility: Ospedale Di S. Vito Al Tagliamento - Ssd Cardiologia San Vito - Spilimbergo, status: RECRUITING, city: San Vito Al Tagliamento, state: PN, zip: 33078, country: Italy, contacts name: DANIELA PAVAN, MD, role: CONTACT, geoPoint lat: 45.9168, lon: 12.85945, locations facility: Ospedale Civile - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Fidenza, state: PR, zip: 43036, country: Italy, contacts name: GIOVANNI TORTORELLA, MD, role: CONTACT, geoPoint lat: 44.86694, lon: 10.06039, locations facility: Istituto Don Gnocchi - U.O. Prevenzione E Riabilitazione Cardiovascolare, status: RECRUITING, city: Parma, state: PR, zip: 43100, country: Italy, contacts name: UMBERTO CAMAIORA, MD, role: CONTACT, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Presidio Ospedaliero San Salvatore - Cardiologia E Utic, status: RECRUITING, city: Pesaro, state: PU, zip: 61121, country: Italy, contacts name: SIMONE MAFFEI, MD, role: CONTACT, geoPoint lat: 43.90921, lon: 12.9164, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Pavia - U.O. Di Riabilitazione Cardiologica, status: RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: GIOVANNI FORNI, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Civile - U.O. Di Cardiologia, status: RECRUITING, city: Voghera, state: PV, zip: 27058, country: Italy, contacts name: TIZIANA SPEZZANO, MD, role: CONTACT, geoPoint lat: 44.99151, lon: 9.01175, locations facility: Ospedale Civile - Uo Servizio Cardiologia, status: RECRUITING, city: Lugo, state: RA, zip: 48022, country: Italy, contacts name: GIULIA RICCI LUCCHI, MD, role: CONTACT, geoPoint lat: 44.42137, lon: 11.91094, locations facility: Ospedale Civile Santa Maria Delle Croci - Uoc Cardiologia, status: RECRUITING, city: Ravenna, state: RA, zip: 48121, country: Italy, contacts name: ANDREA RUBBOLI, MD, role: CONTACT, geoPoint lat: 44.41344, lon: 12.20121, locations facility: Ospedale Civile Di Guastalla - Sos Cardiologia E Riabilitazione Card Area Nord, status: RECRUITING, city: Guastalla, state: RE, zip: 42016, country: Italy, contacts name: ALESSANDRO NAVAZIO, MD, role: CONTACT, geoPoint lat: 44.91172, lon: 10.66186, locations facility: Ospedale E. Franchini - S.O.S. Cardiologia, status: RECRUITING, city: Montecchio Emilia, state: RE, zip: 42027, country: Italy, contacts name: ELISABETTA CATELLANI, MD, role: CONTACT, geoPoint lat: 44.69937, lon: 10.45211, locations facility: Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera, status: RECRUITING, city: Reggio Emilia, state: RE, zip: 42100, country: Italy, contacts name: ALESSANDRO NAVAZIO, MD, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale Riccardo Guzzardi - U.O.C. Di Cardiologia-Utic, status: RECRUITING, city: Vittoria, state: RG, zip: 97019, country: Italy, contacts name: GIUSEPPE DI STABILE, MD, role: CONTACT, geoPoint lat: 36.95151, lon: 14.52788, locations facility: P.O. San Camillo de Lellis - U.O.C. Cardiologia, status: RECRUITING, city: Rieti, state: RI, zip: 02100, country: Italy, contacts name: AMIR KOL, MD, role: CONTACT, geoPoint lat: 42.40476, lon: 12.85735, locations facility: Ospedali Riuniti Anzio-Nettuno - U.O.C. Di Cardiologia - Utic, status: RECRUITING, city: Anzio, state: RM, zip: 00042, country: Italy, contacts name: NATALE DI BELARDINO, MD, role: CONTACT, geoPoint lat: 41.45263, lon: 12.62157, locations facility: Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic, status: RECRUITING, city: Ariccia, state: RM, zip: 00072, country: Italy, contacts name: FRANCESCO MONTI, MD, role: CONTACT, geoPoint lat: 41.72063, lon: 12.6723, locations facility: Ospedale Civile San Paolo - U.O.C. Cardiologia - Utic, status: RECRUITING, city: Civitavecchia, state: RM, zip: 00053, country: Italy, contacts name: SIMONE CALCAGNO, MD, role: CONTACT, geoPoint lat: 42.09325, lon: 11.79674, locations facility: Ospedale L. Parodi Delfino - U.O.C. Di Cardiologia - Utic, status: NOT_YET_RECRUITING, city: Colleferro, state: RM, zip: 00034, country: Italy, contacts name: ROBERTA IPPEDICO, MD, role: CONTACT, geoPoint lat: 41.72722, lon: 13.00481, locations facility: Icr Villa Delle Querce - Riabilitazione Cardiorespiratoria, status: NOT_YET_RECRUITING, city: Nemi, state: RM, zip: 00040, country: Italy, contacts name: MICHELE AZZARITO, MD, role: CONTACT, geoPoint lat: 41.72185, lon: 12.71809, locations facility: P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Clinica E Riabilitativa, status: RECRUITING, city: Roma, state: RM, zip: 00135, country: Italy, contacts name: FURIO COLIVICCHI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Inmi Lazzaro Spallanzani Irccs - Servizio Di Cardiologia Del Dipartimento Clinico, status: RECRUITING, city: Roma, state: RM, zip: 00149, country: Italy, contacts name: MARIA C GATTO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Camillo - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00152, country: Italy, contacts name: LEONARDO DE LUCA, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00157, country: Italy, contacts name: ANTONINO GRANATELLI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sandro Pertini - Uosd Cardiologia D'Urgenza, status: RECRUITING, city: Roma, state: RM, zip: 00157, country: Italy, contacts name: STEFANIA CHERUBINI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Fondazione Policlinico Universitario A. Gemelli Irccs - Uosd Cardiologia D'Urgenza, status: NOT_YET_RECRUITING, city: Roma, state: RM, zip: 00168, country: Italy, contacts name: GIOVANNA LIUZZO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Casilino - U.O.C. Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00169, country: Italy, contacts name: LEONARDO CALO', MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Osp. Fatebenefratelli Isola Tiberina - Uoc Cardiologia Diagnostica Interventistica-Utic, status: NOT_YET_RECRUITING, city: Roma, state: RM, zip: 00188, country: Italy, contacts name: MATTEO RUZZOLINI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Sant'Andrea Di Roma - U.O.C. Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00189, country: Italy, contacts name: EMANUELE BARBATO, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Santo Spirito - Uoc Cardiologia, status: RECRUITING, city: Roma, state: RM, zip: 00193, country: Italy, contacts name: MARINA DELFINI, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Giovanni Evangelista - U.O.C. Di Cardiologia - Utic, status: RECRUITING, city: Tivoli, state: RM, zip: 00019, country: Italy, contacts name: ALFREDO POSTERARO, MD, role: CONTACT, geoPoint lat: 41.95952, lon: 12.8016, locations facility: Ospedale Infermi - U.O. Cardiologia, status: NOT_YET_RECRUITING, city: Rimini, state: RN, zip: 47900, country: Italy, contacts name: ANDREA GARDI, MD, role: CONTACT, geoPoint lat: 44.05755, lon: 12.56528, locations facility: Ospedale Maria Ss. Addolorata - U.O. Di Cardiologia Utic, status: RECRUITING, city: Eboli, state: SA, zip: 84025, country: Italy, contacts name: EDUARDO CAPUANO, MD, role: CONTACT, geoPoint lat: 40.61747, lon: 15.05693, locations facility: Presidio Ospedaliero Umberto I - Uoc Cardiologia - Utic, status: RECRUITING, city: Nocera Inferiore, state: SA, zip: 84014, country: Italy, contacts name: MARIO PACILEO, MD, role: CONTACT, geoPoint lat: 40.7454, lon: 14.64542, locations facility: Presidio Ospedaliero Luigi Curto - Uo Cardiologia-Utic, status: RECRUITING, city: Polla, state: SA, zip: 84035, country: Italy, contacts name: SILVIO SAPONARA, MD, role: CONTACT, geoPoint lat: 40.51433, lon: 15.49715, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva Ospedaliera, status: RECRUITING, city: Salerno, state: SA, zip: 84131, country: Italy, contacts name: MICHELE R DI MURO, MD, role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Ssd Utic, status: RECRUITING, city: Salerno, state: SA, zip: 84131, country: Italy, contacts name: AMELIA RAVERA, MD, role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Aou S. Giovanni Di Dio-Ruggi D'Aragona - Uoc Clinica Cardiologica, status: RECRUITING, city: Salerno, state: SA, zip: 84131, country: Italy, contacts name: MICHELE CICCARELLI, MD, role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: Ospedale Villa Malta - Cardiologia E Utic, status: RECRUITING, city: Sarno, state: SA, zip: 84087, country: Italy, contacts name: MARIA C RUSSO, MD, role: CONTACT, geoPoint lat: 40.80748, lon: 14.62151, locations facility: Ospedale San Luca - U.O. Utic - Cardiologia, status: RECRUITING, city: Vallo Della Lucania, state: SA, zip: 84078, country: Italy, contacts name: ANTONIO ALOIA, MD, role: CONTACT, geoPoint lat: 40.22786, lon: 15.26635, locations facility: Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia, status: RECRUITING, city: Siena, state: SI, zip: 53100, country: Italy, contacts name: SERAFINA VALENTE, MD, role: CONTACT, geoPoint lat: 43.31822, lon: 11.33064, locations facility: Ospedale San Bartolomeo - Sc Riabilitazione Cardiologica, status: RECRUITING, city: Sarzana, state: SP, zip: 19038, country: Italy, contacts name: DANIELE BERTOLI, MD, role: CONTACT, geoPoint lat: 44.11178, lon: 9.9622, locations facility: P.O. Lentini - Uosd Di Cardiologia Con Utic, status: RECRUITING, city: Lentini, state: SR, zip: 96016, country: Italy, contacts name: VINCENZO CRISCI, MD, role: CONTACT, geoPoint lat: 37.28556, lon: 14.99737, locations facility: Ospedale Ss. Annunziata - Cardiologia Clinica Ed Interventistica, status: RECRUITING, city: Sassari, state: SS, zip: 07100, country: Italy, contacts name: GAVINO CASU, MD, role: CONTACT, geoPoint lat: 40.72586, lon: 8.55552, locations facility: Po Ponente - Ospedale Santa Corona - Sc Cardiologia Ponente, status: RECRUITING, city: Pietra Ligure, state: SV, zip: 17027, country: Italy, contacts name: CHIARA BERNELLI, MD, role: CONTACT, geoPoint lat: 44.1492, lon: 8.28206, locations facility: Casa Di Cura Villa Verde - Cardiologia, status: RECRUITING, city: Taranto, state: TA, zip: 74100, country: Italy, contacts name: ANNA N JOHN, MD, role: CONTACT, geoPoint lat: 40.46435, lon: 17.24707, locations facility: Osp. San Pancrazio-Santo Stefano - Riabilitazione Cardiologica, status: RECRUITING, city: Arco, state: TN, zip: 38062, country: Italy, contacts name: GIOVANNI CIOFFI, MD, role: CONTACT, geoPoint lat: 45.91772, lon: 10.88672, locations facility: Ospedale Santa Chiara - Divisione Di Cardiologia, status: RECRUITING, city: Trento, state: TN, zip: 38122, country: Italy, contacts name: FILIPPO ZILIO, MD, role: CONTACT, geoPoint lat: 46.06787, lon: 11.12108, locations facility: Por Cirie' Lanzo Presidio Cirie' - S.C. Cardiologia, status: RECRUITING, city: Ciriè, state: TO, zip: 10073, country: Italy, contacts name: Michele Capriolo, MD, role: CONTACT, geoPoint lat: 45.23486, lon: 7.60125, locations facility: Aou San Luigi Gonzaga - S.C.D.O. Cardiologia, status: RECRUITING, city: Orbassano, state: TO, zip: 10043, country: Italy, contacts name: Carloalberto Biolù, MD, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, locations facility: Casa Di Cura Villa Serena - Riabilitazione Cardiorespiratoria, status: RECRUITING, city: Piossasco, state: TO, zip: 10045, country: Italy, contacts name: ALEX MICANTI, MD, role: CONTACT, geoPoint lat: 44.98802, lon: 7.4601, locations facility: Ospedale Degli Infermi - Sc Cardiologia, status: RECRUITING, city: Rivoli, state: TO, zip: 10098, country: Italy, contacts name: EMANUELE TIZZANI, MD, role: CONTACT, geoPoint lat: 45.07073, lon: 7.51465, locations facility: Ospedale San Giovanni Bosco - Sc Cardiologia, status: RECRUITING, city: Torino, state: TO, zip: 10154, country: Italy, contacts name: MAURIZIO BERTAINA, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Casa Di Cura Pineta Del Carso - U.O. Riabilitazione Cardiologica, status: RECRUITING, city: Aurisina, state: TS, zip: 34011, country: Italy, contacts name: LARA GOMBAC, MD, role: CONTACT, geoPoint lat: 45.74968, lon: 13.67345, locations facility: Asugi Trieste - Sc Patologie Cardiovascolari, status: RECRUITING, city: Trieste, state: TS, zip: 34125, country: Italy, contacts name: LUISA MATTEI, MD, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Pou "Santa Maria Della Misericordia" - S.O.C. Cardiologia, status: RECRUITING, city: Udine, state: UD, zip: 33100, country: Italy, contacts name: MARIZA DE BIASIO, MD, role: CONTACT, geoPoint lat: 46.0693, lon: 13.23715, locations facility: Ospedale Multimedica Castellanza - Cardiologia, status: RECRUITING, city: Castellanza, state: VA, zip: 21053, country: Italy, contacts name: ANNA PICOZZI, MD, role: CONTACT, geoPoint lat: 45.61079, lon: 8.89616, locations facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia, status: RECRUITING, city: Saronno, state: VA, zip: 21047, country: Italy, contacts name: DANIELE NASSIACOS, MD, role: CONTACT, geoPoint lat: 45.62513, lon: 9.03517, locations facility: Ospedale Di Circolo Galmarini - Cardiologia, status: NOT_YET_RECRUITING, city: Tradate, state: VA, zip: 21049, country: Italy, contacts name: MASSIMO BIGNOTTI, MD, role: CONTACT, geoPoint lat: 45.70843, lon: 8.90763, locations facility: Ospedale Sant'Andrea - Sc Cardiologia, status: RECRUITING, city: Vercelli, state: VC, zip: 13100, country: Italy, contacts name: MARIA BERTOLAZZI, MD, role: CONTACT, geoPoint lat: 45.32163, lon: 8.41989, locations facility: Ospedale Dell'Angelo - U.O.C. Cardiologia, status: RECRUITING, city: Mestre, state: VE, zip: 30171, country: Italy, contacts name: SAKIS THEMISTOCLAKIS, MD, role: CONTACT, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Policlinico San Marco - Riabilitazione Cardiologica, status: RECRUITING, city: Mestre, state: VE, zip: 30173, country: Italy, contacts name: FRANCO DEL PICCOLO, MD, role: CONTACT, geoPoint lat: 45.49167, lon: 12.24538, locations facility: Ospedale P.F. Calvi - Uos Di Cardiologia Riabilitativa, status: RECRUITING, city: Noale, state: VE, zip: 30033, country: Italy, contacts name: VALENTINA PESCATORE, MD, role: CONTACT, geoPoint lat: 45.54596, lon: 12.06445, locations facility: Ospedale Civile - U.O.C. Di Cardiologia, status: NOT_YET_RECRUITING, city: San Dona' Di Piave, state: VE, zip: 30027, country: Italy, contacts name: LEONARDO DI ASCENZO, MD, role: CONTACT, geoPoint lat: 45.63019, lon: 12.5681, locations facility: Ospedale Civile - U.O.C. Di Cardiologia, status: RECRUITING, city: Arzignano, state: VI, zip: 36071, country: Italy, contacts name: CLAUDIO BILATO, MD, role: CONTACT, geoPoint lat: 45.52027, lon: 11.33446, locations facility: Ospedale Alto Vicentino - U.O.C. Cardiologia - Ucic, status: RECRUITING, city: Santorso, state: VI, zip: 36014, country: Italy, contacts name: GIOVANNI MORANI, MD, role: CONTACT, geoPoint lat: 45.73383, lon: 11.38785, locations facility: Ospedale Civile San Bortolo - U.O.C. Cardiologia, status: RECRUITING, city: Vicenza, state: VI, zip: 36100, country: Italy, contacts name: VALENTINA SIVIERO, MD, role: CONTACT, geoPoint lat: 45.54672, lon: 11.5475, locations facility: Irccs Ospedale Sacro Cuore Don Calabria - U.O. Di Cardiologia, status: RECRUITING, city: Negrar, state: VR, zip: 37024, country: Italy, contacts name: GIULIO MOLON, MD, role: CONTACT, geoPoint lat: 45.52918, lon: 10.93899, locations facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia, status: RECRUITING, city: San Bonifacio, state: VR, zip: 37047, country: Italy, contacts name: MAURIZIO ANSELMI, MD, role: CONTACT, geoPoint lat: 45.39595, lon: 11.27352, locations facility: Aoui Di Verona - U.O. Cardiologia, status: RECRUITING, city: Verona, state: VR, zip: 37126, country: Italy, contacts name: MARIA G GASPARI, MD, role: CONTACT, geoPoint lat: 45.4299, lon: 10.98444, locations facility: Ospedale Belcolle - Uoc Cardiologia Ed Emodinamica, status: RECRUITING, city: Viterbo, state: VT, zip: 01100, country: Italy, contacts name: LUIGI SOMMARIVA, MD, role: CONTACT, geoPoint lat: 42.41937, lon: 12.1056, locations facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia, status: RECRUITING, city: Borgomanero, zip: 28021, country: Italy, contacts name: PIERFRANCO S DELLAVESA, MD, role: CONTACT, geoPoint lat: 45.69873, lon: 8.4623, locations facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Veruno - Uo Cardiologia Riabilitativa, status: RECRUITING, city: Gattico, zip: 28013, country: Italy, contacts name: MASSIMO PISTONO, MD, role: CONTACT, geoPoint lat: 45.70717, lon: 8.52003, locations facility: Presidio Ospedaliero San Giugliano - U.O. Cardiologia - Utic, status: RECRUITING, city: Giugliano in Campania, zip: 80014, country: Italy, contacts name: GIOVANNI NAPOLITANO, MD, role: CONTACT, geoPoint lat: 40.92849, lon: 14.20197, locations facility: Ospedale Madonna Delle Grazie - Ssd Utic, status: NOT_YET_RECRUITING, city: Matera, zip: 75100, country: Italy, contacts name: MICHELE A CLEMENTE, MD, role: CONTACT, geoPoint lat: 40.66599, lon: 16.60463, locations facility: Ospedale Buon Consiglio Fatebenefratelli - U.O.Complessa Di Cardiologia E Utic, status: RECRUITING, city: Napoli, zip: 80123, country: Italy, contacts name: GAETANO M RUOCCO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Cardarelli - U.O. Cardiologia Con Utic, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: CIRO MAURO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aorn Ospedale Dei Colli - P.O. Monaldi - Uosd Malattie Cardiologiche Congenite Adulti-Guch, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: BERARDO SARUBBI, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale Dei Pellegrini - Uoc Cardiologia-Utic, status: NOT_YET_RECRUITING, city: Napoli, zip: 80134, country: Italy, contacts name: GIUSEPPE BRUZZESE, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale S. Giovanni Bosco - Sc Cardiologia - Utic, status: RECRUITING, city: Napoli, zip: 80134, country: Italy, contacts name: PAOLO TAMMARO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale Del Mare - U.O. Cardiologia Con Utic-Emodinamica, status: RECRUITING, city: Napoli, zip: 80147, country: Italy, contacts name: BERNARDINO TUCCILLO, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Aou Maggiore Della Carita' - Scdo Cardiologia Ii, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: LIDIA ROSSI, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Clinica San Gaudenzio - Uoa Cardiologia, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: NADIA PODIMANI, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic Con Emodinamica, status: NOT_YET_RECRUITING, city: Pozzuoli, zip: 80078, country: Italy, contacts name: GIANLUIGI TAGLIAMONTE, MD, role: CONTACT, geoPoint lat: 40.84394, lon: 14.0952, locations facility: Ospedale Mauriziano Umberto I - Sc Cardiologia, status: RECRUITING, city: Torino, zip: 10128, country: Italy, contacts name: Giuseppe Musumeci, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False |
protocolSection identificationModule nctId: NCT06275100, orgStudyIdInfo id: HUTH, briefTitle: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry, acronym: (PREP-ACE), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Hull, class: OTHER, descriptionModule briefSummary: This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further., conditionsModule conditions: Cardiac Disease, conditions: Aortic Valve Disease, conditions: Coronary Artery Disease, conditions: Endocarditis, conditions: Valve Heart Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation, outcomesModule primaryOutcomes measure: Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery, secondaryOutcomes measure: Efficacy of prehabilitation, secondaryOutcomes measure: Efficacy of prehabilitation, secondaryOutcomes measure: Efficacy of prehabilitation, secondaryOutcomes measure: Efficacy of prehabilitation, secondaryOutcomes measure: Efficacy of prehabilitation, secondaryOutcomes measure: Complication rate, secondaryOutcomes measure: Safety of Prehabilitation in acute inpatients waiting for surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hull University Teaching Hospital, status: RECRUITING, city: Hull, zip: HU1 3DR, country: United Kingdom, geoPoint lat: 53.7446, lon: -0.33525, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-06, uploadDate: 2024-02-15T17:59, filename: Prot_000.pdf, size: 146015, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-06, uploadDate: 2024-02-15T18:01, filename: ICF_001.pdf, size: 107547, hasResults: False |
protocolSection identificationModule nctId: NCT06275087, orgStudyIdInfo id: situm1phd, briefTitle: Differences in Speed of Recovery From Anesthesia for Intraoral Surgery, acronym: PSIOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Clinical Hospital Centre Zagreb, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare two groups of patients going in general anesthesia for intraoral surgery, the first group TIVA with propofol and the second group inhalational with sevoflurane. The main questions it aims to answer are to asses speed and quality of recovery from general anesthesia.Participants will fill out a questionnaire to evaluate the quality of recovery from anesthesia using the QoR-40 1h, 24h, and 30 days after waking up from anesthesia in comparison to the results of the same questionnaire before surgery. Also, the investigators will perform a hand grip and bite strength test on the patients after waking up from anesthesia in the operating room, after 1 hour in the recovery room, and after 24 hours compared to preoperative values.The investigators will compare TIVA and Volatile groups to see if there are any differences in recovery seed, muscle strength recovery, postoperative nausea and vomiting, and shivering between groups., conditionsModule conditions: Intraoral Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, interventions name: Sevoflurane, outcomesModule primaryOutcomes measure: "Quality of recovery from anesthesia" QoR-40 questionnaire, secondaryOutcomes measure: bite strength and hand grip strength, secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Postoperative shivering, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Centre Zagreb, status: RECRUITING, city: Zagreb, zip: 10000, country: Croatia, contacts name: Ivan Šitum, role: CONTACT, phone: 0915143620, email: [email protected], contacts name: Ivan Šitum, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.81444, lon: 15.97798, hasResults: False |
protocolSection identificationModule nctId: NCT06275074, orgStudyIdInfo id: 23-007716, briefTitle: Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance., conditionsModule conditions: Neck Pain, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors will be blinded to group assignment of participants., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Dry Needling, interventions name: Therapeutic Exercise, outcomesModule primaryOutcomes measure: Participant retention rate, primaryOutcomes measure: Participant intervention adherence, primaryOutcomes measure: Number of adverse responses to treatment, secondaryOutcomes measure: Sleep Duration, secondaryOutcomes measure: Sleep Quality, otherOutcomes measure: Disability Level, otherOutcomes measure: Pain Level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic - Motion Analysis Lab, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Ray Lunasin, role: CONTACT, phone: 507-538-0839, email: [email protected], geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06275061, orgStudyIdInfo id: KY-2020-021, briefTitle: Chinese Obesity and MEtabolic Surgery Database (COMES Database), acronym: COMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2040-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Jinan University Guangzhou, class: OTHER, collaborators name: Chinese Obesity and Metabolic Surgery Collaborative, descriptionModule briefSummary: The purpose of the Chinese Obesity and MEtabolic Surgery Database (COMES Database) is to collect data and examine the long-term effects of metabolic and bariatric surgery on obesity and metabolic disorders in the Chinese population., conditionsModule conditions: Obesity, conditions: Metabolic Surgery, conditions: Bariatric Surgery, conditions: Weight Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000000, type: ESTIMATED, armsInterventionsModule interventions name: Metabolic and Bariatric Surgery, outcomesModule primaryOutcomes measure: Excess weight loss effect of metabolic and bariatric surgery after 1 year, secondaryOutcomes measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Excess weight loss effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery after 1 year, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery after 1 year, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery after 1 year, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery after 1 year, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, secondaryOutcomes measure: Glycemic control effect of metabolic and bariatric surgery in long-term follow-ups, otherOutcomes measure: Adverse events rate of metabolic and bariatric surgery, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510630, country: China, contacts name: Wah Yang, MD, role: CONTACT, phone: +8615920373823, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06275048, orgStudyIdInfo id: STUDY00006302, briefTitle: The Influence of Oral Contraceptives During Disuse, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Central Florida, class: OTHER, descriptionModule briefSummary: Studies across various sports and physical activities have consistently shown that females incur more injuries compared to their male counterparts, but the underlying reasons for this disparity remain poorly understood. While differences in hormone levels between males and females have been speculated to play a role, very little rigorous research has been conducted to directly examine potential connections between sex hormones and injury risk. Specifically, females have been shown to be at greater risk for hand and wrist injuries. The higher injury incidence begins at puberty and persists across the lifespan, suggesting a link to hormonal factors. However, significant gaps remain in understanding the relationships between the menstrual cycle, exogenous hormones from birth control, and risk factors for sports-related injury in females. The purpose of this study is to examine changes in muscle strength and neuromuscular activation among females using monophasic oral contraceptives, females not using oral contraceptives, and males during one week of wrist/hand immobilization., conditionsModule conditions: Oral Contraceptives, conditions: Rehabilitation, conditions: Menstrual Cycle, conditions: Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Wrist/hand immobilization, outcomesModule primaryOutcomes measure: Grip Strength, secondaryOutcomes measure: Muscle activation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Central Florida, status: RECRUITING, city: Orlando, state: Florida, zip: 32816, country: United States, contacts name: Matt S Stock, Ph.D., role: CONTACT, phone: 407-823-0364, email: [email protected], contacts name: Matt S Stock, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False |
protocolSection identificationModule nctId: NCT06275035, orgStudyIdInfo id: 4235, briefTitle: Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI, acronym: MEMENTO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2031-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tata Memorial Centre, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy., conditionsModule conditions: Neurocognitive Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 101, type: ESTIMATED, armsInterventionsModule interventions name: Memantine Oral Tablet, outcomesModule primaryOutcomes measure: Cognitive-deterioration-free survival at 2 years, secondaryOutcomes measure: Full-Scale Intelligence Quotient (FSIQ) in children, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Academic performance by scholastic performance and grades, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Memantine, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Full-Scale Intelligence Quotient (FSIQ) in adults, otherOutcomes measure: Full Scale Intelligence Quotient change in subgroups, otherOutcomes measure: Radiological features of cognitive decline on Magnetic Resonance Imaging, otherOutcomes measure: Neuroinflammatory markers correlation with neurocognitive decline and survival, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Tata Memorial Hospital, status: RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, contacts name: Dr Tejpal Gupta, MD, role: CONTACT, phone: 022-24177000, phoneExt: 6015, email: [email protected], geoPoint lat: 19.07283, lon: 72.88261, hasResults: False |
protocolSection identificationModule nctId: NCT06275022, orgStudyIdInfo id: NanjingCH011665, briefTitle: A Prospective Study on the Treatment of cLM Based on ICG Imaging, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Nanjing Children's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.Participants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.Researchers will compare difference in curative effect between two groups., conditionsModule conditions: Lymphatic Malformation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Inflow occlusion with perforation of septation and sclerotherapy, interventions name: Perforation of septation and sclerotherapy, interventions name: Indocyanine green-guided partial resection and sclerotherapy, interventions name: Partial resection and sclerotherapy, outcomesModule primaryOutcomes measure: Cure rate, primaryOutcomes measure: Effective rate, primaryOutcomes measure: Treatment frequency, secondaryOutcomes measure: Likert score, secondaryOutcomes measure: Wound infection, secondaryOutcomes measure: Delayed healing, secondaryOutcomes measure: Pigmentation, eligibilityModule sex: ALL, minimumAge: 30 Days, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's hospital of Nanjing medical university, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Tao Han, Dr., role: CONTACT, phone: +86 186 5190 3495, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06275009, orgStudyIdInfo id: 2023-1990, briefTitle: Chinese Occupational Population Cohort of Lifestyle and Physical Fitness (LiFitChina), acronym: LiFitChina, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2026-12-11, completionDateStruct date: 2026-12-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: China National Center for Cardiovascular Diseases, class: OTHER_GOV, descriptionModule briefSummary: The incidence and prevalence of metabolic risk factors such as obesity, hypertension, diabetes, and dyslipidemia, as well as cardiovascular diseases (CVD), are continuously rising among the occupational population in China, primarily comprising the middle-aged and young adults. Unhealthy lifestyles and declining physical fitness are independent risk factors affecting cardiovascular health. Additionally, the level of physical fitness is influenced by postnatal lifestyles. Lifestyle factors related to cardiovascular health in the occupational population encompass various aspects, including smoking, physical activity, diet, sleep, psychological stress, etc. These factors may interact or have a synergistic effect, necessitating a comprehensive assessment.This project proposes a prospective cohort study design to establish a monitoring cohort for lifestyle and physical fitness among the occupational population. The study will track and follow individuals with or without any CVD metabolic risk factors, collecting information on general status, lifestyle, physical fitness, and health examination data. Exposure factors such as lifestyle and physical fitness will be measured annually, and the occurrence of CVD-related health outcomes will be observed. The aim is to develop a comprehensive evaluation index for cardiovascular health lifestyle, analyze the direct and indirect impacts of lifestyle and physical fitness on the occurrence and development of CVD, and explore potential mediating and moderating effects of physical fitness in the association between lifestyle and cardiovascular health., conditionsModule conditions: Lifestyle, conditions: Physical Fitness, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 18512, type: ESTIMATED, outcomesModule primaryOutcomes measure: the composite end point of new major adverse cardiovascular events, secondaryOutcomes measure: new incidence of each major adverse cardiovascular events, secondaryOutcomes measure: new incidence of cancer, secondaryOutcomes measure: new incidence of all-cause death, secondaryOutcomes measure: level of systolic pressure, secondaryOutcomes measure: level of diastolic pressure, secondaryOutcomes measure: level of blood lipid, secondaryOutcomes measure: level of BMI, secondaryOutcomes measure: level of maximal oxygen uptake (VO2max), secondaryOutcomes measure: level of metabolic equivalents (METs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Xue Feng, MD PhD, role: CONTACT, phone: +86-15601378512, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06274996, orgStudyIdInfo id: 2024ZSLYEC-063, briefTitle: Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study focuses on evaluating Upadacitinib, a new oral medication that inhibits specific enzymes involved in inflammation, for treating inflammatory bowel disease (IBD), which includes conditions such as Crohn\'s Disease and Ulcerative Colitis. The goal is to determine how effective and safe this drug is for patients in China, where data is currently lacking.IBD significantly affects individuals\' quality of life and imposes a high burden on society and healthcare systems. Current treatments don\'t work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating IBD and related conditions and has been approved by the US FDA for such use.Our study is retrospective and multicenter, meaning it will look back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib. Investigators aim to enroll patients treated between January 2020 and December 2023, focusing on adults who have taken Upadacitinib for at least 8 weeks.For patients, families, and healthcare providers, this research could mean a potential new treatment option for IBD. Understanding Upadacitinib\'s efficacy and safety could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life for those affected by IBD. The ultimate goal is to provide more personalized and effective treatment strategies for IBD patients in China., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 81, type: ACTUAL, armsInterventionsModule interventions name: Upadacitinib, outcomesModule primaryOutcomes measure: Steroid-Free Clinical Remission, secondaryOutcomes measure: Clinical Response, secondaryOutcomes measure: Endoscopic Remission, secondaryOutcomes measure: Mucosal Healing, secondaryOutcomes measure: Radiological remission, secondaryOutcomes measure: Radiological response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Sixth Affiliated Hospital of Sun Yat-Sen University, city: Guangzhou, state: Guangdong, zip: 510655, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06274983, orgStudyIdInfo id: SCH-2629, briefTitle: DMD- Interactive Virtual Reality Study, acronym: DMD-IVR, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-20, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sheffield Children's NHS Foundation Trust, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: Sheffield Hallam University, collaborators name: UCL Great Ormond Street Institute of Child Health, collaborators name: Leeds General Infirmary, descriptionModule briefSummary: This study will help determine if an Interactive Virtual Reality system can improve the physiotherapy of young patients with Duchenne muscular dystrophy (DMD)., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: IVR platform trial, outcomesModule primaryOutcomes measure: Compliance: Ratings of frequency of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises., primaryOutcomes measure: Compliance: Ratings of duration of the DMD-IVR device use for the participant's to complete recommended physiotherapy exercises., primaryOutcomes measure: Post-trial qualitative interviews on perceptions, acceptability, usability and effectiveness of DMD-IVR device in the context of the family's overall burden of care, primaryOutcomes measure: DMD-IVR Effectiveness standard functional assessments: North Star Ambulatory Assessment (NSAA), primaryOutcomes measure: DMD-IVR effectiveness measures with a Timed test 4 stair climb, primaryOutcomes measure: DMD-IVR effectiveness measured joint range of movement using Goniometer (Standard BASELINE® 12-inch), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sheffield Childrens NHS FT, city: Sheffield, state: South Yorkshire, zip: S10 2TH, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False |
protocolSection identificationModule nctId: NCT06274970, orgStudyIdInfo id: 2022-143-Mch-EXP-50, briefTitle: PaThERAS: ERAS Protocols in Thyroid & Parathyroid Surgery, acronym: PaThERAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-25, primaryCompletionDateStruct date: 2024-09-25, completionDateStruct date: 2024-09-25, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Sanjay Gandhi Postgraduate Institute of Medical Sciences, class: OTHER_GOV, descriptionModule briefSummary: Enhanced recovery after surgery protocols are evidence-based multidisciplinary programs implemented in the perioperative setting to improve postoperative recovery and attenuate the surgical stress response. They have been used with success after many different types of surgery to improve perioperative patient outcomes. However, evidence on their effectiveness in thyroid and parathyroid surgery remains sparse. Goal of PaThERAS study is to investigate the clinical benefits and cost-effectiveness of enhanced recovery protocols for the perioperative management in patients undergoing total thyroidectomy for large goiters/ cancers and parathyroidectomy for symptomatic hyperparathyroidism in non-day-care setting., conditionsModule conditions: Thyroid Diseases, conditions: Parathyroid Diseases, conditions: ERAS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Enhanced recovery protocols, interventions name: Conventional Protocols, outcomesModule primaryOutcomes measure: To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols, secondaryOutcomes measure: To compare length of hospital stay in patients undergoing thyroid and parathyroid surgery in days, secondaryOutcomes measure: To compare hospital costs in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols, secondaryOutcomes measure: To compare postoperative complication rates in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols, secondaryOutcomes measure: To compare readmission rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences, status: RECRUITING, city: Lucknow, state: Uttar Pradesh, zip: 226014, country: India, contacts name: Gaurav Agarwal, role: CONTACT, phone: 8004904646, email: [email protected], contacts name: Rinelle Mascarenhas, role: CONTACT, phone: 8004904653, email: [email protected], contacts name: Gaurav Agarwal, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Rinelle Mascarenhas, DNB General Surgery, role: SUB_INVESTIGATOR, geoPoint lat: 26.83928, lon: 80.92313, hasResults: False |
protocolSection identificationModule nctId: NCT06274957, orgStudyIdInfo id: SaglikBilimleriUN, briefTitle: The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, collaborators name: Gulhane Training and Research Hospital, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work ., conditionsModule conditions: COPD Exacerbation Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: CONTROL, interventions name: PEP DEVICE, interventions name: HFCWO DEVICE, outcomesModule primaryOutcomes measure: COPD assessment test, primaryOutcomes measure: Clinical COPD Questionnaire, primaryOutcomes measure: mMRC dyspnea scale, primaryOutcomes measure: Richard-Campbell Sleep Questionnaire, primaryOutcomes measure: 30 second sit and stand, primaryOutcomes measure: BODE index, primaryOutcomes measure: chest circumference measurements, primaryOutcomes measure: Modified Borg Scale, primaryOutcomes measure: muscle strenght test, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, city: Istanbul, zip: 34353, country: Turkey, contacts name: ZUHAL KUNDURACILAR PROF DR, role: CONTACT, phone: +90 530 219 5286, email: [email protected], contacts name: GAMZE KOYUTÜRK PT, PhD(c), role: CONTACT, phone: +90 5065798671, email: [email protected], contacts name: GAMZE KOYUTÜRK PT, PhD (C), role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06274944, orgStudyIdInfo id: PEDS-2023-31694, briefTitle: Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants., conditionsModule conditions: Premature Birth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: nasogastric tube placement pH confirmation device, outcomesModule primaryOutcomes measure: PH reading comparison, eligibilityModule sex: ALL, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Brittany Faanes, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False |
protocolSection identificationModule nctId: NCT06274931, orgStudyIdInfo id: 373, briefTitle: Analysis of the Pulmonary Microbiome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Magna Graecia, class: OTHER, descriptionModule briefSummary: The purpose of the protocol is to study the pulmonary microbiome in patients who develop pneumonia., conditionsModule conditions: Pneumonia, conditions: Microbial Colonization, conditions: Microbial Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Bronchoscopy, outcomesModule primaryOutcomes measure: Assessment of Lung Microbiome in Acute Respiratory Failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hosp[ital, status: RECRUITING, city: Catanzaro, zip: 88100, country: Italy, contacts name: Andrea Bruni, role: CONTACT, phone: 3401414553, email: [email protected], geoPoint lat: 38.88247, lon: 16.60086, hasResults: False |
protocolSection identificationModule nctId: NCT06274918, orgStudyIdInfo id: 202111418, briefTitle: Reducing ESKAPE Transmission in the Operating Room, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Iowa, class: OTHER, collaborators name: RDB Bioinformatics, LLC, collaborators name: Georgia-Pacific, descriptionModule briefSummary: This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia., conditionsModule conditions: Surgical Procedure, Unspecified, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Body-Worn Alcohol Dispenser, outcomesModule primaryOutcomes measure: ESKAPE transmission events with and without the body worn device, secondaryOutcomes measure: The epidemiology of ESKAPE transmission events, secondaryOutcomes measure: The epidemiology of ESKAPE transmission events, secondaryOutcomes measure: The epidemiology of ESKAPE transmission events, secondaryOutcomes measure: The epidemiology of ESKAPE transmission events, secondaryOutcomes measure: The epidemiology of ESKAPE transmission events, secondaryOutcomes measure: 90-Day Healthcare-Associated Infections, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Iowa, status: RECRUITING, city: Iowa City, state: Iowa, zip: 52242, country: United States, contacts name: Randy W Loftus, MD, role: CONTACT, geoPoint lat: 41.66113, lon: -91.53017, hasResults: False |
protocolSection identificationModule nctId: NCT06274905, orgStudyIdInfo id: 160123, briefTitle: Topical Anaesthesia in Cutaneous Head and Neck Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2023-07-07, completionDateStruct date: 2023-07-07, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Hospital Waterford, class: OTHER, descriptionModule briefSummary: This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design., conditionsModule conditions: Pain, Acute, conditions: Head and Neck Cancer, conditions: Cutaneous Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Single blinding (for participants) only for patients receiving EMLA or EMLA placebo., whoMasked: PARTICIPANT, enrollmentInfo count: 124, type: ACTUAL, armsInterventionsModule interventions name: EMLA, interventions name: Ethyl chloride, interventions name: Aqueous cream BP, outcomesModule primaryOutcomes measure: Pain score, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Waterford, city: Waterford, zip: X91 ER8E, country: Ireland, geoPoint lat: 52.25833, lon: -7.11194, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-12-20, uploadDate: 2024-02-06T12:37, filename: Prot_SAP_000.pdf, size: 417714, hasResults: False |
protocolSection identificationModule nctId: NCT06274892, orgStudyIdInfo id: 23-5818, briefTitle: Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process, acronym: PROMOTE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making.Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life.Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT.Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life., conditionsModule conditions: Prostate Cancer, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: Remote monitoring PROs, outcomesModule primaryOutcomes measure: Remote monitoring efficiency, secondaryOutcomes measure: Remote monitoring efficacy, secondaryOutcomes measure: Remote monitoring value, secondaryOutcomes measure: Remote monitoring comprehensiveness, secondaryOutcomes measure: Influencing factors (patient), secondaryOutcomes measure: Influencing factors (disease), secondaryOutcomes measure: Influencing factors (treatment), secondaryOutcomes measure: Influencing factors (toxicity), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Margaret Cancer Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2J9, country: Canada, contacts name: Tara Rosewall, role: CONTACT, phone: 4162098269, email: [email protected], contacts name: Winnie Li, role: CONTACT, phone: 4169462000, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06274879, orgStudyIdInfo id: 1938 Ablatio-bilica, secondaryIdInfos id: SNCPT, type: OTHER, domain: Portal for clinical trials in Switzerland, briefTitle: Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer, acronym: Ablatio, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: Swiss Cancer League, descriptionModule briefSummary: The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate., conditionsModule conditions: Bile Duct Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Gemcitabin, Cisplatin and Durvalumab, interventions name: Biliary Radiofrequency Ablation, interventions name: Endoscopic Retrograde Cholangio-Pancreatography with stenting, outcomesModule primaryOutcomes measure: Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after enrolment., secondaryOutcomes measure: Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions, secondaryOutcomes measure: Progression-free survival, which is defined as the time till the progression of disease or death, whatever comes first, from the time of enrolment to the end of follow-up., secondaryOutcomes measure: Death from any cause from the time of enrolment to the end of follow-up (overall survival)., secondaryOutcomes measure: Development of disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle plus at 3 and 6 months from the start of the CICI treatment, secondaryOutcomes measure: Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30, secondaryOutcomes measure: Stent patency at month 3 visit and end of study visit, secondaryOutcomes measure: Number of courses of CICI applied, secondaryOutcomes measure: Total dose of CICI applied, otherOutcomes measure: Details of adverse events, otherOutcomes measure: Prognostic significance of response to intraductal biliary RFA by genetic tumor characterization using next-generation sequencing, otherOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inselspital Bern University Hospital, city: Bern, state: Be, zip: 3010, country: Switzerland, contacts name: Reiner Prof. Dr. med. Wiest, role: CONTACT, phone: +41 31 632 59 41, email: [email protected], contacts name: Martin Prof. Dr. med. Berger, role: CONTACT, phone: +41 31 632 41 14, email: [email protected], contacts name: Reiner Prof. Dr. med. Wiest, role: PRINCIPAL_INVESTIGATOR, contacts name: Martin Prof. Dr. med. Berger, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False |
protocolSection identificationModule nctId: NCT06274866, orgStudyIdInfo id: dsahinoglu, briefTitle: Effects Of A Home Based Exercise Program Following Total Hip Arthroplasty, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-10, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. Forty-four individuals with hip osteoarthritis were included in current study. Individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. Individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. Individuals in the control group were followed up with an exercise training brochure. The exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. All individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. Range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the Q angle was measured with a goniometer. In addition to these,Tampa kinesiophobia scale, Oxford hip score and international physical activity scale were used. Timed up-and-go test was used to evaluate functional performance. Foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control., conditionsModule conditions: PHYSİOTHERAPY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomize controlled two groups, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no blinding, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: exercise program, interventions name: control group, outcomesModule primaryOutcomes measure: OXFORD HİP SCORE, primaryOutcomes measure: TAMPA SCALE FOR KINESİOPHOBİA, primaryOutcomes measure: İNTERNATİONAL PHYSİCAL ACTİVİTY QUESTİONAİRE (SHORT FORM), primaryOutcomes measure: JOİNT POSİTİON SENSE ERROR TEST, primaryOutcomes measure: FOUR SQUARE STEP TEST, primaryOutcomes measure: THE TİMED UP and GO TEST, primaryOutcomes measure: Assessment of Hip Muscle Strength, primaryOutcomes measure: Assessment of Hip Joint Range of Motion, primaryOutcomes measure: Assessment of Postural Control, secondaryOutcomes measure: MEASURİNG LEG LENGTH DİSCREPANCY, secondaryOutcomes measure: Q ANGLE, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yeditepe Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06274853, orgStudyIdInfo id: 170327-0001, secondaryIdInfos id: 6830/0003, type: OTHER, domain: ICON plc, briefTitle: GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: National Center for Advancing Translational Sciences (NCATS), class: NIH, collaborators name: Leidos Biomedical Research, Inc., collaborators name: ICON Government and Public Health Solutions, Inc, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: GS-441524, interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Blood Pressure in mm/Hg, primaryOutcomes measure: Pulse in beats/min, primaryOutcomes measure: Respiratory Rate in breaths per minute, primaryOutcomes measure: Body Temperature in degrees, primaryOutcomes measure: Electrocardiogram (ECG) as measured by PR interval, primaryOutcomes measure: Electrocardiogram (ECG) as measured by QT interval, primaryOutcomes measure: Electrocardiogram (ECG) as measured by QT corrected (Fridericia's), secondaryOutcomes measure: Plasma PK Parameter C-Max, secondaryOutcomes measure: Plasma PK Parameter t-max, secondaryOutcomes measure: Plasma PK Parameter t-lag, secondaryOutcomes measure: Plasma PK Parameter AUC 0-last, secondaryOutcomes measure: Plasma PK Parameter AUC 0-inf, secondaryOutcomes measure: Plasma PK Parameter t 1/2, secondaryOutcomes measure: Plasma PK Parameter CL/F, secondaryOutcomes measure: Plasma PK Parameter Vz/F, secondaryOutcomes measure: Urine PK Parameter Ae urine, secondaryOutcomes measure: Urine PK Parameter Fe urine, secondaryOutcomes measure: Urine PK Parameter CL R, secondaryOutcomes measure: Plasma PK Parameter C trough, secondaryOutcomes measure: Plasma PK Parameter AUC 0-tau, secondaryOutcomes measure: Plasma PK Parameter CL/F ss, secondaryOutcomes measure: Plasma PK Parameter Vz/F ss, secondaryOutcomes measure: Plasma PK Parameter R ac, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274840, orgStudyIdInfo id: CAR-CF, briefTitle: COVID-19 Antibody Responses In Cystic Fibrosis, acronym: CAR-CF, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-08, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Pilar Azevedo, class: OTHER, collaborators name: Queen's University, Belfast, collaborators name: European Cystic Fibrosis Society - Clinical Trial Network, collaborators name: Cystic Fibrosis Foundation, collaborators name: Medical University Innsbruck, descriptionModule briefSummary: Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed., conditionsModule conditions: COVID-19, conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: SARS-COV-2 seroprevalence, primaryOutcomes measure: Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF, primaryOutcomes measure: Longitudinal comparison of the detection, secondaryOutcomes measure: Serum proteomic and genomic responses of pwCF, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHLN, status: RECRUITING, city: Lisboa, zip: 1800-268, country: Portugal, contacts name: Celeste Barreto, role: CONTACT, contacts name: Ana Lopes, role: CONTACT, contacts name: Celeste Barreto, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, hasResults: False |
protocolSection identificationModule nctId: NCT06274827, orgStudyIdInfo id: GO 22- 881, briefTitle: Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-25, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-06-20, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: In shoulder rehabilitation, the inclusion of kinetic chain exercises is advocated in order to provide the necessary energy transfer to produce optimal force with minimal energy consumption. Closed kinetic chain (CKC) exercises are defined as exercises in which the distal segment is stabilized by encountering significant resistance while the proximal segment moves. In contrast, open kinetic chain (OKC) exercises allow the distal segment to move freely without any resistance. Recently, the importance of closed kinetic chain (CKC) exercises has increased in enhancing shoulder joint neuromuscular control by improving dynamic shoulder stability and joint position sense.The most current shoulder rehabilitation protocols include exercises for restoration of scapular muscle imbalances.There exist studies investigating the levels of scapular muscle activation during CKC exercises. Researchers have shown that most CKC exercises especially push-ups and plank variations with the shoulder in the 90° position, generally provide high SA activity and an optimal UT/SA ratio.In the literature, there is limited information on how the level of shoulder elevation affects scapular muscle activity and ratio during closed kinetic chain exercises in the prone position. To effectively prescribe CKC exercises commonly used in rehabilitation and athletic programs, a clear understanding of shoulder elevation changes muscle activity during these exercises is required.Our hypothesis is that glenohumeral joint elevation status will alter scapular muscle activation and activation rates., conditionsModule conditions: Shoulder Pain, conditions: Shoulder Injuries, conditions: Activation, Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All participants will complete each stage in a randomized order., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Superficial Electromyography, outcomesModule primaryOutcomes measure: Muscle activation recorded with surface electromyography (sEMG) during CKC, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, zip: 06430, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06274814, orgStudyIdInfo id: AP23.501.038, briefTitle: U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Egypt, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative., conditionsModule conditions: Breast Neoplasm Female, conditions: Analgesics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: U/S guided Rhomboid intercostal block (RIB), interventions name: U/S guided RIB combined with the sub-serratus plane block (RISS), outcomesModule primaryOutcomes measure: Total morphine consumption, primaryOutcomes measure: Visual Analog scale score postoperative, secondaryOutcomes measure: Intraoperative fentanyl consumption, secondaryOutcomes measure: Heart rate intraoperative, secondaryOutcomes measure: Timing of first rescue analgesia, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National cancer Insititute, status: RECRUITING, city: Cairo, zip: 11796, country: Egypt, contacts name: attef, lecturer, role: CONTACT, phone: +20225328286, email: [email protected], contacts name: ahmed soliman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06274801, orgStudyIdInfo id: GB002-3102, secondaryIdInfos id: 2023-506334-75, type: EUDRACT_NUMBER, briefTitle: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: GB002, Inc., class: INDUSTRY, descriptionModule briefSummary: This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study, conditionsModule conditions: Pulmonary Arterial Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Seralutinib, interventions name: Gereic Dry Powder Inhaler, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Changes in distance achieved on the Six-Minute Walk Test (6MWT), secondaryOutcomes measure: Changes in NT-proBNP, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, locations facility: Pulmonary Associates of Richmond, Inc., city: Richmond, state: Virginia, zip: 23230, country: United States, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False |
protocolSection identificationModule nctId: NCT06274788, orgStudyIdInfo id: OMEG-054-CP4, briefTitle: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fresenius Kabi, class: INDUSTRY, descriptionModule briefSummary: This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population, conditionsModule conditions: Parenteral Nutrition Associated Liver Disease (PNALD), conditions: Essential Fatty Acid Deficiency, conditions: Malnutrition, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Omegaven® (fish oil triglycerides) Injectable Emulsion, outcomesModule primaryOutcomes measure: Incidence of essential fatty acid deficiency (EFAD), secondaryOutcomes measure: Incidence of clinical EFAD, secondaryOutcomes measure: Time from treatment start to EFAD diagnosis, secondaryOutcomes measure: Incidence of adverse events (AEs)/serious adverse events (SAEs), secondaryOutcomes measure: Routine laboratory tests: Direct or conjugated bilirubin, secondaryOutcomes measure: Routine laboratory tests: triglycerides, secondaryOutcomes measure: Fatty acid profiles: α-linolenic acid, secondaryOutcomes measure: Fatty acid profiles: linoleic acid, secondaryOutcomes measure: Fatty acid profiles: arachidonic acid, secondaryOutcomes measure: Fatty acid profiles: mead acid, secondaryOutcomes measure: Fatty acid profiles: oleic acid, secondaryOutcomes measure: Fatty acid profiles: docosahexaenoic acid (DHA), secondaryOutcomes measure: Fatty acid profiles: eicosapentaenoic acid (EPA), secondaryOutcomes measure: Anthropometric measures: body weight, secondaryOutcomes measure: Anthropometric measures: body height/length, secondaryOutcomes measure: Anthropometric measures: head circumference, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274775, orgStudyIdInfo id: 23-12026811, briefTitle: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, descriptionModule briefSummary: The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures., conditionsModule conditions: Anxiety, conditions: Literacy, conditions: Satisfaction, Patient, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Educational Video, outcomesModule primaryOutcomes measure: Anxiety, as measured by the State Trait Anxiety Inventory, primaryOutcomes measure: Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale, primaryOutcomes measure: Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale, primaryOutcomes measure: Health literacy, as measured by 4 domains of The Health Literacy Questionnaire, primaryOutcomes measure: Patient satisfaction, as measured by a patient satisfaction survey, secondaryOutcomes measure: Quality of video intervention for intervention participants, as measured by a qualitative feedback survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Medicine, city: New York, state: New York, zip: 10065, country: United States, contacts name: Shari R. Lipner, MD, PhD, role: CONTACT, email: [email protected], contacts name: Rachel C Hill, BS, role: CONTACT, phone: 5024170984, email: [email protected], geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06274762, orgStudyIdInfo id: MARU-SBF-ROKÇ-01, briefTitle: Visually Impaired Women Model-based Cancer Education and Breast Self-examination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination., conditionsModule conditions: Breast Cancer Awareness and BSE in Visually Impaired Women, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Training and BSE application on a model, outcomesModule primaryOutcomes measure: Champion health belief model scale, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University, city: Istanbul, country: Turkey, contacts name: Marmara University, role: CONTACT, email: [email protected], contacts name: Seval Saraydemir Kıromeroglu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06274749, orgStudyIdInfo id: 10001930, secondaryIdInfos id: 001930-AG, briefTitle: Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute on Aging (NIA), class: NIH, descriptionModule briefSummary: Background:As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.Objective:To learn if UA improves levels of insulin and other hormones that help control blood glucose.Eligibility:People aged 55 years and older with a body mass index of 27 or higher.Design:Participants will have 6 clinic visits over 8 weeks.Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.Participants will have tests during the study including:Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.Imaging scans of the thigh; scans of the brain are optional...., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Urolithin A, interventions name: Placebo, outcomesModule primaryOutcomes measure: To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation., secondaryOutcomes measure: To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation., secondaryOutcomes measure: To determine if UA supplementation will alter gut microbiome composition., eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institute of Aging, Clinical Research Unit, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Josephine Egan, M.D., role: CONTACT, phone: 410-558-8414, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06274736, orgStudyIdInfo id: CLINP-001012, briefTitle: Safety and Performance of Motiva® Sizers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-10, primaryCompletionDateStruct date: 2027-04-10, completionDateStruct date: 2027-07-10, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Establishment Labs, class: INDUSTRY, descriptionModule briefSummary: The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook., conditionsModule conditions: Breast Implant; Complications, conditions: Breast Implantation; Methods, Safety and Performance, conditions: Mammaplasty, conditions: Breast Reconstruction, conditions: Breast Augmentation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Motiva Sizer, outcomesModule primaryOutcomes measure: Motiva Sizers Safety (complications), primaryOutcomes measure: Motiva Sizers Performance (satisfaction), secondaryOutcomes measure: Motiva Sizers Safety (reoperations), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Establishment Labs, status: RECRUITING, city: Coyol, state: Alajuela, zip: 20102, country: Costa Rica, geoPoint lat: 10.00126, lon: -84.26124, hasResults: False |
protocolSection identificationModule nctId: NCT06274723, orgStudyIdInfo id: STUDY00001220, secondaryIdInfos id: 1K99CA281094-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1, briefTitle: Responses to E-cigarette Message Source and Presentation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape., conditionsModule conditions: Vaping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Expert, interventions name: Peer, interventions name: 1 Sided, interventions name: 2 Sided, outcomesModule primaryOutcomes measure: Message acceptance, primaryOutcomes measure: Harm perceptions, secondaryOutcomes measure: Psychological reactance, secondaryOutcomes measure: Message liking, secondaryOutcomes measure: Source trust, secondaryOutcomes measure: Attitudes, secondaryOutcomes measure: Behavioral intentions to vape or try vaping, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-17, uploadDate: 2024-01-31T10:44, filename: SAP_000.pdf, size: 176839, hasResults: False |
protocolSection identificationModule nctId: NCT06274710, orgStudyIdInfo id: 23-5554, briefTitle: ODYSSEE Kidney Health Trial, acronym: ODYSSEE-KH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2026-04-13, completionDateStruct date: 2026-04-13, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: Scarborough General Hospital, collaborators name: The Ottawa Hospital, descriptionModule briefSummary: INTRODUCTIONSevere CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life.HYPOTHESESThe primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months).The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures.RECRUITMENTPatients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital.DESIGNODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked.ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account.ANALYSISSeparate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: ODYSSEE-KH, outcomesModule primaryOutcomes measure: Incidence of home RRT, secondaryOutcomes measure: Improvement of Home RRT, secondaryOutcomes measure: Improvement of RRT preparation with planned dialysis access, secondaryOutcomes measure: Incidence of annual hospitalization rate, secondaryOutcomes measure: Engagement with RRT education and CKD self-care counselling resources, secondaryOutcomes measure: Self-reported engagement in activities for living well, secondaryOutcomes measure: Self-reported assessment for health-related quality of life due to kidney disease, secondaryOutcomes measure: Self-reported assessment of people's aspirations and goals, secondaryOutcomes measure: Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning), secondaryOutcomes measure: Self-reported depression, secondaryOutcomes measure: Self-reported perceived social support, secondaryOutcomes measure: Self-reported psychological wellbeing, secondaryOutcomes measure: Self-reported anxiety, secondaryOutcomes measure: Self-reported feeling of value to self and others, secondaryOutcomes measure: Self-reported measure of psychological wellbeing and happiness, secondaryOutcomes measure: Self-reported measure of overall life experience, secondaryOutcomes measure: Self-reported measure of well-being, secondaryOutcomes measure: Self-reported readiness for change (motivation), secondaryOutcomes measure: Self-reported confidence in doing life activities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M2N 7A2, country: Canada, contacts name: Robert P Nolan, PhD, role: CONTACT, phone: (416) 340-4800, phoneExt: 6400, email: [email protected], contacts name: Karly Gunson, HBA, BHSc, role: CONTACT, phone: (416) 340-4800, phoneExt: 6400, email: [email protected], geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06274697, orgStudyIdInfo id: RECHMPL22_0391, secondaryIdInfos id: 2023-A01784-41, type: REGISTRY, domain: ID-RCB, briefTitle: Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites, acronym: COMADO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: phymedexp, descriptionModule briefSummary: The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease., conditionsModule conditions: Lower Extremity Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation by magnetic sensor, outcomesModule primaryOutcomes measure: Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery, secondaryOutcomes measure: Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other, secondaryOutcomes measure: Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, secondaryOutcomes measure: Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, secondaryOutcomes measure: Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, secondaryOutcomes measure: Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, secondaryOutcomes measure: Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Center, status: RECRUITING, city: Montpellier, country: France, contacts name: Gudrun BOGE, MD, role: CONTACT, phone: 467336279, phoneExt: 33, email: [email protected], contacts name: Gudrun BOGE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False |
protocolSection identificationModule nctId: NCT06274684, orgStudyIdInfo id: 2023-01100, briefTitle: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Geneva, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.The main question it aims to answer:- Is there a significant decrease on anxiety level thanks to VR-assistance?Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.Researchers will compare standardised anxiety scores with a control group., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Use of Virtual Reality Assistance during prostate biopsies, outcomesModule primaryOutcomes measure: Anxiety level, secondaryOutcomes measure: Anxiety level of the surgeon, secondaryOutcomes measure: Biopsies complications, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06274671, orgStudyIdInfo id: 23-24-09, briefTitle: Glymphatic MRI in Clinically Isolated Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Exeter, class: OTHER, descriptionModule briefSummary: The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS., conditionsModule conditions: Clinically Isolated Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic Resonance Imaging, outcomesModule primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI, primaryOutcomes measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS, secondaryOutcomes measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Exeter, city: Exeter, country: United Kingdom, contacts name: Edoardo R de Natale, MD, role: CONTACT, email: [email protected], geoPoint lat: 50.7236, lon: -3.52751, hasResults: False |
protocolSection identificationModule nctId: NCT06274658, orgStudyIdInfo id: STUDY00006517, briefTitle: The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, descriptionModule briefSummary: The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls., conditionsModule conditions: Autonomic Nervous System Disease, conditions: Spinal Cord Injuries, conditions: Cognition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High-intensity interval exercise, outcomesModule primaryOutcomes measure: Low frequency of systolic blood pressure variability, primaryOutcomes measure: High frequency of heart rate variability, primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Heart rate, secondaryOutcomes measure: Cerebral blood flow velocity, secondaryOutcomes measure: Symbol Digit Matched Test score, secondaryOutcomes measure: California Verbal Learning Test score, secondaryOutcomes measure: Color-Word Stroop Test score, secondaryOutcomes measure: Controlled Word Association Task score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University at Buffalo, South Campus, status: RECRUITING, city: Buffalo, state: New York, zip: 14214, country: United States, contacts name: Wenjie Ji, role: CONTACT, phone: 716-907-2508, phoneExt: 1, email: [email protected], geoPoint lat: 42.88645, lon: -78.87837, hasResults: False |
protocolSection identificationModule nctId: NCT06274645, orgStudyIdInfo id: IVUS CHIP China Registry, briefTitle: IVUS CHIP China Registry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI., conditionsModule conditions: Complex Higher Risk Indicated Patients Undergoing PCI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2020, type: ESTIMATED, armsInterventionsModule interventions name: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific, outcomesModule primaryOutcomes measure: Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints., secondaryOutcomes measure: Time-to-first-event analysis will be primarily used for clinical endpoints., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan Zhongshan Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Chenguang Li, Doctor, role: CONTACT, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06274632, orgStudyIdInfo id: 2023P001913, briefTitle: ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Baylor College of Medicine, collaborators name: University of Miami, descriptionModule briefSummary: The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization., conditionsModule conditions: HIV/AIDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ADELANTE, outcomesModule primaryOutcomes measure: 12-month viral suppression, secondaryOutcomes measure: Number of Emergency department visits, secondaryOutcomes measure: Number of Hospitalizations, secondaryOutcomes measure: 6-month viral suppression, secondaryOutcomes measure: Retention in care, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33146, country: United States, contacts name: Allan Rodriguez, MD, role: CONTACT, phone: 305-243-3711, email: [email protected], geoPoint lat: 25.77427, lon: -80.19366, locations facility: Baylor College of Medicine, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Thomas P Giordano, MD, role: CONTACT, phone: 713-798-8918, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06274619, orgStudyIdInfo id: 23HH8541, secondaryIdInfos id: MISP 59717, type: OTHER_GRANT, domain: MSD, secondaryIdInfos id: 57276, type: REGISTRY, domain: CPMS, secondaryIdInfos id: 324970, type: OTHER, domain: IRAS, briefTitle: Novel Mucosal Correlates Of RSV Protection In Older Adults, acronym: CHIRP01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease.However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments., conditionsModule conditions: Respiratory Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: RSV A Memphis 37, outcomesModule primaryOutcomes measure: Number of solicited and unsolicited adverse events (AEs), primaryOutcomes measure: Infection rate, secondaryOutcomes measure: Nasal Viral Load, secondaryOutcomes measure: Antibody levels by serum neutralisation assay, secondaryOutcomes measure: Antibody levels by ELISA, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College London, city: London, zip: W12 0NN, country: United Kingdom, contacts name: Polly Fox, role: CONTACT, email: [email protected], contacts name: Christopher Chiu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06274606, orgStudyIdInfo id: HSR230106, briefTitle: Exercise Training Study Before Bariatric Surgery, acronym: BaSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.Researchers will compare the effects of walking before bariatric surgery on:* Insulin sensitivity (diabetes risk factor)* Health of blood vessels* Rate of complications after surgery* Weight* Body Fat* Fitness level, conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Group, outcomesModule primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Surgical outcomes - readmission within 30 days of surgery, secondaryOutcomes measure: Surgical outcomes - IV treatment as an outpatient, secondaryOutcomes measure: Surgical outcomes - emergency department visits, secondaryOutcomes measure: Surgical outcomes - time of surgery, secondaryOutcomes measure: Surgical outcomes - length of stay after surgery completion, secondaryOutcomes measure: Flow-mediated dilation (FMD), secondaryOutcomes measure: Pulse-wave analysis (PWA), secondaryOutcomes measure: Pulse-wave velocity (PWV), secondaryOutcomes measure: Body fat, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Bone mineral density, secondaryOutcomes measure: Visceral adiposity, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Blood Lipids, secondaryOutcomes measure: Plasma glucose, secondaryOutcomes measure: Plasma insulin, secondaryOutcomes measure: Hemoglobin A1c, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Quality of life (SF-36), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22902, country: United States, contacts name: Damon L Swift, PhD, role: CONTACT, phone: 434-924-1436, email: [email protected], contacts name: Emily E Grammer, MS, role: CONTACT, phone: 8508968401, email: [email protected], geoPoint lat: 38.02931, lon: -78.47668, hasResults: False |
protocolSection identificationModule nctId: NCT06274593, orgStudyIdInfo id: AP_JBD_MJ_003, briefTitle: Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma, acronym: OGA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl)., conditionsModule conditions: Glaucoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: OCT, outcomesModule primaryOutcomes measure: Compare the progression of vascular density (VD) in advanced glaucoma patients., primaryOutcomes measure: Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients., primaryOutcomes measure: Compare the progression of visual field in advanced glaucoma patients., secondaryOutcomes measure: CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jean-Baptiste Ducloyer, city: Nantes, zip: 44093, country: France, contacts name: Jean-Baptiste Ducloyer, MD, role: CONTACT, email: [email protected], geoPoint lat: 47.21725, lon: -1.55336, hasResults: False |
protocolSection identificationModule nctId: NCT06274580, orgStudyIdInfo id: 5916, briefTitle: Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ospedale Policlinico San Martino, class: OTHER, descriptionModule briefSummary: Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1., conditionsModule conditions: Subdural Hematoma, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: embolization of the middle meningeal artery, outcomesModule primaryOutcomes measure: Rate of incomplete hematoma resolution or surgical rescue, secondaryOutcomes measure: treatment complication, secondaryOutcomes measure: treatment successful, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274567, orgStudyIdInfo id: 2024P000348, briefTitle: Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-08-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: University of Pennsylvania, descriptionModule briefSummary: The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks., conditionsModule conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized allocation, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: We will use an active/placebo TMS coil. TMS operator and participant will be blinded to active versus sham. Investigator will be blinded to participant condition assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation (TMS), interventions name: Sham (placebo) TMS, outcomesModule primaryOutcomes measure: Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity), secondaryOutcomes measure: Affective Multisource Interference Task, secondaryOutcomes measure: Balloon Analogue Risk Task, eligibilityModule sex: ALL, minimumAge: 24 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Martinos Center for Biomedical Imaging, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, geoPoint lat: 42.37787, lon: -71.062, hasResults: False |
protocolSection identificationModule nctId: NCT06274554, orgStudyIdInfo id: 23-11026746, briefTitle: Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: The Leona M. and Harry B. Helmsley Charitable Trust, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole., conditionsModule conditions: Crohn's Disease, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double-blinded study, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Fluconazole, interventions name: Placebo, interventions name: IL-23 Therapy, outcomesModule primaryOutcomes measure: Proportion of subjects achieving clinical response, secondaryOutcomes measure: Proportion of subjects achieving clinical remission, secondaryOutcomes measure: Proportion of patients achieving endoscopic response or remission, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Medicine, city: New York, state: New York, zip: 10065, country: United States, contacts name: Grace Xiang, BS, role: CONTACT, phone: 646-697-0985, email: [email protected], contacts name: Randy Longman, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Dana Lukin, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Ellen Scherl, MD, role: SUB_INVESTIGATOR, contacts name: Iliyan Iliev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06274541, orgStudyIdInfo id: CTRIAL-IE 18-01, briefTitle: Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-03-22, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Cancer Trials Ireland, class: NETWORK, descriptionModule briefSummary: A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics., conditionsModule conditions: Serous Ovarian Tumor, conditions: Endometrioid Carcinoma Ovary, conditions: Fallopian Tube Cancer, conditions: Primary Peritoneal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Somatic and Germline BRCA1/2 Testing, outcomesModule primaryOutcomes measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience., primaryOutcomes measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience., primaryOutcomes measure: The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials)., primaryOutcomes measure: The impact on patient management by use of clinical genetics counselling sessions., primaryOutcomes measure: The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model), secondaryOutcomes measure: The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland, secondaryOutcomes measure: Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease., secondaryOutcomes measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used., secondaryOutcomes measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy., secondaryOutcomes measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials, secondaryOutcomes measure: Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease., secondaryOutcomes measure: Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease., secondaryOutcomes measure: Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mater Misericordiae University Hospital / Mater Private Hospital, city: Dublin, state: Leinster, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: St James's Hospital, city: Dublin, state: Leinster, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Bon Secours, city: Cork, state: Munster, country: Ireland, geoPoint lat: 51.89797, lon: -8.47061, locations facility: Cork University Hospital, city: Cork, state: Munster, country: Ireland, geoPoint lat: 51.89797, lon: -8.47061, locations facility: University Hospital Limerick, city: Limerick, state: Munster, country: Ireland, geoPoint lat: 52.66472, lon: -8.62306, hasResults: False |
protocolSection identificationModule nctId: NCT06274528, orgStudyIdInfo id: 202301150, briefTitle: DORA and LP in Alzheimer's Disease Biomarkers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2029-03-11, completionDateStruct date: 2029-03-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Pharmacist, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 201, type: ESTIMATED, armsInterventionsModule interventions name: Lemborexant 10 mg, interventions name: Lemborexant 20mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo, secondaryOutcomes measure: Number of participants with treatment-related adverse events, secondaryOutcomes measure: Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181, secondaryOutcomes measure: Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42), secondaryOutcomes measure: Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42), secondaryOutcomes measure: Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217)., secondaryOutcomes measure: Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217)., otherOutcomes measure: Measure changes of cerebrospinal TREM2 (exploratory), otherOutcomes measure: Measure changes of cerebrospinal NPTX2 (exploratory), otherOutcomes measure: Measure changes of cerebrospinal NfL (exploratory), otherOutcomes measure: Measure changes of blood plasma NfL (exploratory), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University in St. Louis, School of Medicine, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Cristina Toedebusch, BS, role: CONTACT, phone: 314-747-0646, email: [email protected], contacts name: Chloe Meehan, BS, MA, role: CONTACT, phone: 314-273-0878, email: [email protected], contacts name: Brendan P. Lucey, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: J. Philip Miller, Ph.D., role: SUB_INVESTIGATOR, contacts name: Jason Hassenstab, Ph.D., role: SUB_INVESTIGATOR, contacts name: David Carr, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
protocolSection identificationModule nctId: NCT06274515, orgStudyIdInfo id: WO44977, briefTitle: A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies, acronym: REMERGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-01-28, completionDateStruct date: 2027-01-28, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hoffmann-La Roche, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Tissue and Blood Draw, outcomesModule primaryOutcomes measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2), primaryOutcomes measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3), primaryOutcomes measure: Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1), primaryOutcomes measure: Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1), primaryOutcomes measure: Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1), primaryOutcomes measure: Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie, status: RECRUITING, city: Essen, zip: 45136, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: I.R.S.T Srl IRCCS; Oncologia Medica, status: RECRUITING, city: Meldola, state: Emilia-Romagna, zip: 47014, country: Italy, geoPoint lat: 44.12775, lon: 12.0626, locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Rome, state: Lazio, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06274502, orgStudyIdInfo id: deep learning, briefTitle: Automated Detection and Diagnosis of Pathological DRGs in PHN Patients Using Deep Learning and Magnetic Resonance, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: Here, this study aimed to develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning. This study retrospectively analyzed the DRG images of all patients with postherpetic neuralgia who underwent magnetic resonance neuroimaging examinations in our radiology department from January 2021 to February 2022. After image post-processing, the You Only Look Once (YOLO) version 8 was selected as the target algorithm model. Model performance was evaluated using metrics such as precision, recall, Average Precision, mean average precision and F1 score., conditionsModule conditions: Deep Learning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 41, type: ACTUAL, armsInterventionsModule interventions name: YOLOv8, outcomesModule primaryOutcomes measure: Develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06274489, orgStudyIdInfo id: GSN000500, briefTitle: A Study to Evaluate Setanaxib in Patients With Alport Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2025-01-27, completionDateStruct date: 2025-01-27, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Calliditas Therapeutics AB, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period., conditionsModule conditions: Alport Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Setanaxib, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of patients with Serious Adverse Events (SAEs), primaryOutcomes measure: Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs), secondaryOutcomes measure: The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample, secondaryOutcomes measure: Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample, secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss), secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss), secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss), otherOutcomes measure: Percentage of patients with clinically significant changes in heart rate, otherOutcomes measure: Percentage of patients with clinically significant changes blood pressure, otherOutcomes measure: Percentage of patients with clinically significant changes in 12-lead electrocardiogram (ECG), otherOutcomes measure: Percentage of patients with clinically significant changes in physical examination, otherOutcomes measure: Percentage of patients with clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function, otherOutcomes measure: Percentage of patients with clinically significant changes in hearing audiometric testing (bone- and air-conduction), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Fakultni Nemocnice Hradec Kralove, status: RECRUITING, city: Hradec Králové, country: Czechia, contacts name: Roman Safranek, role: CONTACT, geoPoint lat: 50.20923, lon: 15.83277, locations facility: Fakultni Nemocnice Olomouc, status: RECRUITING, city: Olomouc, country: Czechia, contacts name: Karel Krejci, role: CONTACT, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Institut Klinicke a Experimentalni Mediciny, status: RECRUITING, city: Praha, country: Czechia, contacts name: Ondrej Viklicky, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Vseobecna Fakultni Nemocnice v Praze, status: RECRUITING, city: Praha, country: Czechia, contacts name: Vladimir Tesar, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Hospital Clinic Barcelona, status: RECRUITING, city: Barcelona, state: L'eixample, zip: 08036, country: Spain, contacts name: Marc Xipell Font, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario 12 de Octubre, status: RECRUITING, city: Madrid, state: Usera, zip: 28041, country: Spain, contacts name: Enrique Morales, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Vall d'Hebron, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Irene Agraz Pamplona, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Reina Sofia, status: RECRUITING, city: Córdoba, zip: 14004, country: Spain, contacts name: Cristina Rabasco, role: CONTACT, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital Universitario Virgen de las Nieves, status: RECRUITING, city: Granada, zip: 18014, country: Spain, contacts name: Rafael Jose Esteban de la Rosa, role: CONTACT, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Royal Free London NHS Foundation Trust, status: RECRUITING, city: London, zip: NW3 2QG, country: United Kingdom, contacts name: Daniel Gale, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Great Ormond Street Hospital for Children, status: NOT_YET_RECRUITING, city: London, zip: WC1N 3JH, country: United Kingdom, contacts name: Zainab Arslan, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Manchester Children's Hospital, status: RECRUITING, city: Manchester, zip: M13 9WL, country: United Kingdom, contacts name: Rachel Lennon, role: CONTACT, geoPoint lat: 53.48095, lon: -2.23743, locations facility: Nottingham City Hospital, status: RECRUITING, city: Nottingham, country: United Kingdom, contacts name: Matthew Hall, role: CONTACT, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False |
protocolSection identificationModule nctId: NCT06274476, orgStudyIdInfo id: 2020/9/9, briefTitle: Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement, acronym: implant, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-09, primaryCompletionDateStruct date: 2019-12-09, completionDateStruct date: 2020-01-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically., conditionsModule conditions: Atrophic Maxillary Ridge and Mandibular Ridge, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: maxillary and mandibular atrophic ridge, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: double, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: implant placement, outcomesModule primaryOutcomes measure: implant success, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohamed yahia Sharaf, city: Zagazig, state: Sharkia, zip: 44715, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False |
protocolSection identificationModule nctId: NCT06274463, orgStudyIdInfo id: 2023-11-035, briefTitle: A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Bundang CHA Hospital, class: OTHER, descriptionModule briefSummary: To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease., conditionsModule conditions: Brain Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Exercise therapy including a trunk stabilization exercise program, outcomesModule primaryOutcomes measure: Trunk Impairment Scale, primaryOutcomes measure: Berg Balance Scale, secondaryOutcomes measure: Joint angle, secondaryOutcomes measure: Joint moment, secondaryOutcomes measure: Joint power, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06274450, orgStudyIdInfo id: C2202112, briefTitle: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-06, primaryCompletionDateStruct date: 2022-09-02, completionDateStruct date: 2022-09-02, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Botanee Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink., conditionsModule conditions: Skin Laxity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: skin care product, interventions name: Drinks with active ingredients Rosa Roxburghii and Pomegranate, outcomesModule primaryOutcomes measure: Changes in the skin hydration, primaryOutcomes measure: Changes in the skin glossiness, primaryOutcomes measure: Changes in the skin firmness, primaryOutcomes measure: Changes in the skin elasticity, primaryOutcomes measure: Changes in the individual type angle, primaryOutcomes measure: Changes in the melanin content, primaryOutcomes measure: Changes in the proportion of crow's feet area, primaryOutcomes measure: Changes in the proportion of fine lines under the eye, primaryOutcomes measure: Changes in the CIE RGB of skin tone, primaryOutcomes measure: Changes in the grade of Pigmentation, primaryOutcomes measure: Skin condition Assessment after 4-week application, primaryOutcomes measure: Skin condition Assessment after 8-week application, secondaryOutcomes measure: Changes in the satisfaction with the quality of life, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai China-norm Quality Technical Service Co ，Ltd, city: Shanghai, state: Shanghai, zip: 200072, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06274437, orgStudyIdInfo id: BND-35-001, briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Biond Biologics, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: BND-35, interventions name: Nivolumab, interventions name: Cetuximab, outcomesModule primaryOutcomes measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), primaryOutcomes measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs, primaryOutcomes measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT), primaryOutcomes measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1, primaryOutcomes measure: Part 2: Incidence of TEAEs and SAEs, secondaryOutcomes measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1, secondaryOutcomes measure: Part 1: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough), secondaryOutcomes measure: Part 1: Time of maximum observed serum concentration (Tmax), secondaryOutcomes measure: Part 1: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Part 1: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Part 1: Incidence of anti-drug antibodies (ADA), secondaryOutcomes measure: Part 2: Progression Free Survival (PFS), secondaryOutcomes measure: Part 2: PFS rate, secondaryOutcomes measure: Part 2: Duration of Response, secondaryOutcomes measure: Part 2: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough), secondaryOutcomes measure: Part 2: Time of maximum observed serum concentration (Tmax), secondaryOutcomes measure: Part 2: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Part 2: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Part 2: Incidence of anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rambam Health Care Campus, city: Haifa, zip: 3109601, country: Israel, contacts name: Ruth Perets, role: CONTACT, contacts role: CONTACT, phone: +97247776234, email: [email protected], geoPoint lat: 32.81841, lon: 34.9885, locations facility: Hadassah University Medical Center, city: Jerusalem, zip: 91120, country: Israel, contacts name: Jonathan Cohen, role: CONTACT, contacts role: CONTACT, phone: +97226776781, email: [email protected], geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center, city: Petah Tikva, zip: 49100, country: Israel, contacts name: Solomon Shtemer, role: CONTACT, contacts role: CONTACT, phone: +97239378110, email: [email protected], geoPoint lat: 32.08707, lon: 34.88747, locations facility: Sheba Medical Center, city: Ramat Gan, zip: 52621, country: Israel, contacts name: Gal Strauss, role: CONTACT, phone: +97235304498, email: [email protected], geoPoint lat: 32.08227, lon: 34.81065, locations facility: Tel Aviv Sourasky Medical Center, city: Tel Aviv, zip: 6423906, country: Israel, contacts name: Ravit Geva, role: CONTACT, phone: +97236973193, email: [email protected], geoPoint lat: 32.08088, lon: 34.78057, hasResults: False |
protocolSection identificationModule nctId: NCT06274424, orgStudyIdInfo id: HUS/211/2016 and HUS/2699/2018, briefTitle: Hair Cortisol and Symptoms in Children With Psychopathology During CBT, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-07-01, primaryCompletionDateStruct date: 2019-10-01, completionDateStruct date: 2019-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Helsinki University Central Hospital, class: OTHER, descriptionModule briefSummary: This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study., conditionsModule conditions: Child Behavior Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: The Friends Program, outcomesModule primaryOutcomes measure: Hair Cortisol Concentration, primaryOutcomes measure: Parent- and teacher rated internalizing and externalizing symptoms, primaryOutcomes measure: Child-rated internalizing symptoms, primaryOutcomes measure: Parent-rated sleep disturbance symptoms, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 13 Years, stdAges: CHILD, hasResults: False |
protocolSection identificationModule nctId: NCT06274411, orgStudyIdInfo id: KS2024014, briefTitle: Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention, acronym: ESCORT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Beijing Anzhen Hospital, class: OTHER, descriptionModule briefSummary: The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI, conditionsModule conditions: ECMO, conditions: High-risk PCI, 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: 176, type: ESTIMATED, armsInterventionsModule interventions name: Standby cannulated ECMO, interventions name: Prophylactic ECMO, outcomesModule primaryOutcomes measure: Composite rate of 8 major adverse events, secondaryOutcomes measure: Platelet drop, secondaryOutcomes measure: Duration of ECMO support, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Hemoglobin drop, secondaryOutcomes measure: Serum interleukin-6 concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Liangshan Wang, MD, role: CONTACT, phone: 86-13811363372, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06274398, orgStudyIdInfo id: RITE Study, briefTitle: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study, acronym: RITE PrEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Eastern Virginia Medical School, class: OTHER, collaborators name: CONRAD, collaborators name: Emory University, collaborators name: Centers for Disease Control and Prevention, descriptionModule briefSummary: This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days., conditionsModule conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Placebo-controlled, Double-blind, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: TAF/EVG rectal insert, interventions name: Matching placebo rectal insert, outcomesModule primaryOutcomes measure: Frequency and intensity of Adverse Events, primaryOutcomes measure: Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood, primaryOutcomes measure: PK (Cmax) in rectal secretions, primaryOutcomes measure: PK (Cmax) in rectal mucosal tissue, secondaryOutcomes measure: PK (Cmax) in cervicovaginal secretions, secondaryOutcomes measure: PK (Cmax) in cerviocovaginal mucosal tissues, secondaryOutcomes measure: Cytokine Profiles, secondaryOutcomes measure: Microbiome Profiles, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Emory Clinic, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Cassie Grimsley Ackerley, MD, MSc, role: CONTACT, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, hasResults: False |
protocolSection identificationModule nctId: NCT06274385, orgStudyIdInfo id: 2311010178, briefTitle: The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery., acronym: BET_RSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Drexel University, class: OTHER, descriptionModule briefSummary: Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery., conditionsModule conditions: Nutraceuticals, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Betalain-rich concentrate (AltRed), interventions name: Placebo, outcomesModule primaryOutcomes measure: Repeated Sprint Performance, secondaryOutcomes measure: Neuromuscular Fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Drexel University - Health Sciences Building, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19102, country: United States, contacts name: Arun Ramakrishnan, PhD, role: CONTACT, phone: 215-553-7018, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, hasResults: False |
protocolSection identificationModule nctId: NCT06274372, orgStudyIdInfo id: FCV,V-2202, briefTitle: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2024-08-06, completionDateStruct date: 2024-08-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Derince Training and Research Hospital, class: OTHER, descriptionModule briefSummary: It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations., conditionsModule conditions: Laparoscopic Surgeries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: flow controlled ventilation, interventions name: volume controlled ventilation, outcomesModule primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effectcs of flow controlled ventiletion on respiratory parameters, primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effects of flow controlled ventilation on heamodynamic parameters, primaryOutcomes measure: effectcs of flow controlled ventiletion on respiratory parameters, secondaryOutcomes measure: respiratory related complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli Derince Training and Research Hospital, city: Derince, state: Kocaeli, zip: 41900, country: Turkey, hasResults: False |
protocolSection identificationModule nctId: NCT06274359, orgStudyIdInfo id: 21-3985, briefTitle: Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Denver Health and Hospital Authority, class: OTHER, descriptionModule briefSummary: While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases., conditionsModule conditions: Influenza, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Digital storytelling, outcomesModule primaryOutcomes measure: Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary), secondaryOutcomes measure: Intervention Feasibility, secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Intervention Appropriateness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denver Health Eastside Clinic, city: Denver, state: Colorado, zip: 80205, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Denver Health Park Hill Clinic, city: Denver, state: Colorado, zip: 80207, country: United States, geoPoint lat: 39.73915, lon: -104.9847, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-26, uploadDate: 2024-01-30T11:52, filename: ICF_000.pdf, size: 298169, hasResults: False |
protocolSection identificationModule nctId: NCT06274346, orgStudyIdInfo id: ahmedU, briefTitle: Effect of Retro Walking Versus Isometric Multi-angular Exercises on Pain and Functional Performance in Knee Osteoarthritis in Geriatric Population, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-11-10, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: Osteoarthritis is a leading musculoskeletal cause of disability in elderly persons all over the world and a major cause of physical limitations and reduced quality of life (1). Its onset is around 40 years of age and it is estimated that over 80% of people over 55 have evidence of radiographic changes in the knee due to osteoarthritis. It has been estimated that the incidence has increased by the increase in life expectancy and it has been identified as a frequent cause for health services demand in patients over 65(2).The common clinical manifestations of knee OA include pain, stiffness, joint enlargement, crepitus, muscle weakness, deformity, impaired proprioception, reduced joint motion, and disability(3).Patients with knee Osteoarthritis seems to develop their own gait pattern and try to unload the affected structures during gait. More over patients with less severe knee osteoarthritis develop a gait pattern that differs from patients with severe osteoarthritis and control group of patients (4).Isometric exercises are types of strength training in which the joint angle and muscle length do not change during contraction, and therefore this approach can be advantageous in the early stages of knee rehabilitation in cases where the range of motion is restricted due to pain (13). No physical work is performed during isometric exercise. Intensity and duration combination reflects the energy consumption of an isometric contraction (14). In addition, muscle strength increases in isometric exercise are specific to the angle applied. It was also concluded that isometric exercise performed at different angles should be especially considered as an alternative strength training since it induces the most noticeable and fastest increase in muscle moment (15). A study was conducted to investigate the effects of isometric quadriceps exercise on muscle strength, pain, and function in knee osteoarthritis, it was concluded that isometric quadriceps exercise program showed beneficial effects on quadriceps muscle strength, pain, and functional disability in patients with osteoarthritis of the knee (16).Another study was conducted to assess the effectiveness of Isometric exercise and counseling on level of pain among patients with Knee osteoarthritis, the authors concluded that Isometric exercise and counseling program has significantly reduced pain, stiffness and improved physical function and the authors recommended that Isometric exercise and counselling should be adopted as a routine care in the hospitals treating patients with knee osteoarthritis (17) Thus, we hypothesized that a less intensive walking program such as retro walking program could provide an additional benefit more than those experienced by forward walking program in the previous studies. Therefore, the primary aim of the present study was to compare the effect of retro walking versus isometric multiangular exercises group on knee pain and function in geriatric people.Materials and MethodsThis randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from June 2023 to November 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.Subjects:Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. In each case, the diagnosis of knee OA was based on the criteria specified by the American College of Rheumatology.We recorded the height, weight, and medical history, and lower extremity dominance, level of education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4), conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were randomly assigned into two groups through computer software. We put sixty patients on the software program and the program assigned them randomly. s exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given. Second group was treated by retrowalking exercises in addition to physical therapy interventions including short wave diathermy and strengthening exercise such as static quadriceps exercise, dynamic quadriceps exercise, straight leg raise, prone knee bending, side lying hip abduction, prone hip extension with 5 seconds hold and a rest interval of 2 seconds for 10 repetitions for each exercise for a period of 4 weeks, 3 days per week was given., which were given 3 times/week for 4 consecutive weeks., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Sixty male and female geriatric patients had chronic knee osteoarthritis were chosen the outpatient clinic of faculty of physical therapy, Delta University for science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4)., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Multiangular Isometric exercise, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Functional assessment:, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Delta University For Science and Technology, city: Gamasa, state: Almansourah, zip: 38733, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False |
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