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protocolSection identificationModule nctId: NCT06330259, orgStudyIdInfo id: new AMH assay, briefTitle: Does the AMH Concentration Depend on the Menstrual Cycle?, acronym: AMH, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-07-01, primaryCompletionDateStruct date: 2018-06-30, completionDateStruct date: 2019-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Basel, class: OTHER, collaborators name: Roche Diagnostics, descriptionModule briefSummary: During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum., conditionsModule conditions: Reproductive Sterility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: menstrual cycle monitoring, outcomesModule primaryOutcomes measure: AMH Elecsys Assay, secondaryOutcomes measure: Effect of handling of the serum on measured AMH concentrations, secondaryOutcomes measure: 3D ultrasound of both ovaries, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Christian De Geyter, city: Basel, zip: 4031, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
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protocolSection identificationModule nctId: NCT06330246, orgStudyIdInfo id: IRB300005280, secondaryIdInfos id: R01DK137784, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK137784, briefTitle: O. Formigenes Colonization in Calcium Oxalate Kidney Stone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: University of Texas Southwestern Medical Center, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this trial is to test if colonization with the gut bacteria Oxalobacter formigenes leads to a reduction in urinary oxalate excretion in patients with calcium oxalate kidney stone disease.The study will recruit adult participants with a history of calcium oxalate kidney stones who are not colonized with Oxalobacter formigenes.Participants will* ingest fixed diets containing low and moderately high amounts of oxalate for 4 days at a time* collect urine, blood and stool samples during the fixed diets* ingest a preparation of live Oxalobacter formigenes to induce colonization with Oxalobacter formigenes, conditionsModule conditions: Kidney Stone, conditions: Kidney Calculi, conditions: Urolithiasis, conditions: Urolithiasis, Calcium Oxalate, conditions: Nephrolithiasis, conditions: Nephrolithiasis, Calcium Oxalate, conditions: Oxalate Urolithiasis, conditions: Oxaluria, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Low oxalate fixed diets pre-colonization, interventions name: Moderately high oxalate fixed diets pre-colonization, interventions name: Colonization with Oxalobacter formigenes, interventions name: Low oxalate fixed diets post-colonization, interventions name: Moderately high oxalate fixed diets post-colonization, outcomesModule primaryOutcomes measure: Change in urinary oxalate excretion following colonization with Oxalobacter formigenes, secondaryOutcomes measure: Sustainability of colonization with Oxalobacter formigenes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Sonia Fargue, PhD, role: CONTACT, phone: 205-975-6932, email: sfargue@uab.edu, contacts name: Research Coordinator, role: CONTACT, phone: 2059345712, email: kidneystone@uabmc.edu, contacts name: Sonia Fargue, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: UTSW, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Naim Maalouf, MD, role: CONTACT, email: Naim.Maalouf@UTSouthwestern.edu, contacts name: Esperanza Jackson, role: CONTACT, email: Esperanza.Jackson@UTSouthwestern.edu, contacts name: Naim Maalouf, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06330233, orgStudyIdInfo id: YJiang, briefTitle: Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-07, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang Chinese Medical University, class: OTHER_GOV, collaborators name: The First Affiliated Hospital of Zhejiang Chinese Medical University, descriptionModule briefSummary: This study is designed to provide the treatment plan for moxibustion for diabetic peripheral neuropathy (DPN) and provide a reference for clinical moxibustion for DPN. The patients will be randomly assigned to three clinical centers each center 44, then they will be distributed equally into 4 groups, which include the conventional treatment group and the moxibustion different minutes (5 minutes, 10 minutes, 15 minutes) per point group. The conventional treatment group will receive mecobalamin tablets and alpha-lipoic acid tablets for four weeks in conjunction with the patient's daily treatment (basal drug treatment for patients with combined hypertension and hyperlipidaemia). The frequency of moxibustion treatment is twice a week for 4 weeks. The outcomes were evaluated in the baseline period (the day before grouping), the treatment period (end of the 8th treatment) and the follow-up period (2 weeks after the end of treatment). The results of this study are expected to confirm the optimal amount of moxibustion for the treatment of diabetic peripheral neuralgia and to observe the efficacy of moxibustion in the treatment of diabetic peripheral neuralgia. It provides a reference for the clinical therapeutic operation standardization of moxibustion., conditionsModule conditions: Diabetic Peripheral Neuropathy, conditions: Pain, conditions: Moxibustion, conditions: Randomized Controlled Trial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Moxibustion, outcomesModule primaryOutcomes measure: Electrophysiological examination of the tibial nerve of the lower limb, primaryOutcomes measure: Electrophysiological examination of the peroneal nerve of the lower limb, secondaryOutcomes measure: Total clinical effectiveness, secondaryOutcomes measure: Toronto Clinical Scoring System, secondaryOutcomes measure: Visual Analogue Scale, secondaryOutcomes measure: Traditional Chinese Medicine Syndrome Score Scale, secondaryOutcomes measure: regional temperature testing, secondaryOutcomes measure: infrared thermography testing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330220, orgStudyIdInfo id: 2010-015-1161, briefTitle: Visual Function Change in Wet Age-related Macular Degeneration Patients With Better Baseline Visual Acuity, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-10, primaryCompletionDateStruct date: 2022-02-28, completionDateStruct date: 2022-02-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: Although the number of wet AMD patients with the better visual acuity is increasing, the visual improvement in patients with the better vision may not be so significant after anti-vascular endothelial growth factor (VEGF) treatments because of 'ceiling effect'. The aim of current study is to investigate the improvement of visual function after aflibercept treatments using microperimetry in wet AMD patients with the better baseline visual acuity (≥20/40)., conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Aflibercept Injection [Eylea], outcomesModule primaryOutcomes measure: Retinal sensitivity change after aflibercept treatment using microperimetry in wet age-related macular degeneration patients, secondaryOutcomes measure: The correlation of OCT and OCT angiography parameters with retinal sensitivity change measured by microperimetry, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06330207, orgStudyIdInfo id: IRB202301471, secondaryIdInfos id: K99DE031723, type: NIH, link: https://reporter.nih.gov/quickSearch/K99DE031723, briefTitle: An Emergency Department (ED) Provider Centered Intervention for Non-Traumatic Dental Condition Management (NTDC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-08-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, collaborators name: National Institute of Dental and Craniofacial Research (NIDCR), descriptionModule briefSummary: The overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (NTDC) management in the emergency department (ED) through quantitative and qualitative methods. The first aim will determine the national variation in NTDC prescribing in the ED and subsequent ED/urgent care revisits and hospitalizations within 30-days of an index ED visit. Using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for NTDC and variation at the patient, provider, hospital and state levels. The second aim identifies ED providers' perceived barriers and facilitators to the management of NTDC in the ED. Using individual in depth interviews, ED providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for NTDC in the ED., conditionsModule conditions: Emergency Department Visit, conditions: Odontalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Clinical decision support tool, outcomesModule primaryOutcomes measure: Acceptability and feasibility, secondaryOutcomes measure: Prescribing behavior, otherOutcomes measure: Pilot trial outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330194, orgStudyIdInfo id: AID-study, briefTitle: Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Steno Diabetes Center Copenhagen, class: OTHER, collaborators name: Rigshospitalet, Denmark, descriptionModule briefSummary: The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).The main objective is:• To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal diseaseSecondary objectives are:• To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this populationParticipants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels., conditionsModule conditions: Dialysis, conditions: Chronic Kidney Disease, conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Mellitus, Type 1, conditions: Hemodialysis, conditions: Peritoneal Dialysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Design: Prospective, open-label, two-stage randomised-crossover study.Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5).Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels.All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks.CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: 2nd Generation Automated Insulin Delivery (AID) system, outcomesModule primaryOutcomes measure: Percent time in sensor glucose target range (3.9-10.0 mmol/L), secondaryOutcomes measure: Proportion of time spent <2.8 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.0 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.3 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.9 mmol/L, secondaryOutcomes measure: Proportion of time spent 3.9-7.8, secondaryOutcomes measure: Proportion of time spent >10.0 mmol/L, secondaryOutcomes measure: Proportion of time spent >13.9 mmol/L, secondaryOutcomes measure: Proportion of time spent >16.7 mmol/L, secondaryOutcomes measure: Glucose variability (SD and coefficient of variation), secondaryOutcomes measure: Mean glucose, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes, secondaryOutcomes measure: Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia, secondaryOutcomes measure: eGFR (estimated glomerular filtration rate), secondaryOutcomes measure: Potassium pre-dialysis, secondaryOutcomes measure: Urine albumine-to-creatinine ratio, secondaryOutcomes measure: Actigraph Metrics for sleep architecture, secondaryOutcomes measure: Sleep diary, secondaryOutcomes measure: Proportion of time Automode is active, secondaryOutcomes measure: Diabetic ketoacidosis, secondaryOutcomes measure: Severe hypoglycemia, secondaryOutcomes measure: Serious Adverse Event, secondaryOutcomes measure: Unanticipated Serious Adverse Device Event, secondaryOutcomes measure: Satisfaction with diabetes treatment, secondaryOutcomes measure: Satisfaction with diabetes treatment, secondaryOutcomes measure: Fear of hypoglycaemia, secondaryOutcomes measure: Hypoglycaemia awareness, secondaryOutcomes measure: Diabetes distress, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Sarcopenia, secondaryOutcomes measure: Semi-structured interview, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Frailty, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tobias Bomholt, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Tobias Bomholt, MD, PhD, role: CONTACT, phone: +4535457952, email: Tobias.bomholt@regionh.dk, contacts name: Christine Meyer Olesen, MD, role: CONTACT, phone: 21495144, email: clmolesen@gmail.com, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06330181, orgStudyIdInfo id: SC220178, secondaryIdInfos id: HT9425-23-1-1019, type: OTHER_GRANT, domain: Department of Depense, briefTitle: Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Texas A&M University, class: OTHER, collaborators name: United States Department of Defense, collaborators name: Immersive Experience Labs, descriptionModule briefSummary: The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury., conditionsModule conditions: Spinal Cord Injuries, conditions: Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of two intervention arms. Both groups receive the same number of sessions, duration of sessions, and measures procured., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: VR Game 1, interventions name: VR Game 2, outcomesModule primaryOutcomes measure: Change in Pain Intensity, secondaryOutcomes measure: Change in Pain Quality, secondaryOutcomes measure: Change in Pain Interference, secondaryOutcomes measure: Post treatment change, secondaryOutcomes measure: Change in mood, secondaryOutcomes measure: Change in quality of life, secondaryOutcomes measure: Neurological changes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas A&M University, status: RECRUITING, city: College Station, state: Texas, zip: 77843, country: United States, contacts name: Amanda Higgins, M.E.d, role: CONTACT, phone: 804-569-5965, email: sci@vrwalk.org, contacts name: Zina Trost, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.62798, lon: -96.33441, hasResults: False
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protocolSection identificationModule nctId: NCT06330168, orgStudyIdInfo id: 36264PR573/2/24, briefTitle: Paravertebral Calcitonin in Thoracotomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-04-10, completionDateStruct date: 2025-04-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy., conditionsModule conditions: Calcitonin, conditions: Paravertebral, conditions: Thoracotomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: triple, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: bupivacaine-calcitonin-fentanyl, interventions name: Bupivacaine-fentanyl, outcomesModule primaryOutcomes measure: morphine consumption, secondaryOutcomes measure: numerical rating scale scores, secondaryOutcomes measure: incidence of chronic pain, secondaryOutcomes measure: Side effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University Hospitals, status: RECRUITING, city: Tanta, state: Gharbiya, zip: 31527, country: Egypt, contacts name: Osama M Rehab, MD, role: CONTACT, phone: 01095210806, email: osamarehab@med.tanta.edu.eg, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06330155, orgStudyIdInfo id: 2024-01-032, briefTitle: A Genetic Study for Alzheimer Dementia: Case-control Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: MinYoung Kim, MD, PhD, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.The investigators want to identify genes that are importantly related to Alzheimer's dementia., conditionsModule conditions: Alzheimer Dementia (AD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: genetic analysis, secondaryOutcomes measure: Measurement of Korean version of mini-mental state examination (K-MMSE), secondaryOutcomes measure: Measurement of Clinical Dementia Rating (CDR), secondaryOutcomes measure: Measurement of Geriatric Depression Scale (GDSd), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330142, orgStudyIdInfo id: 2022-006, briefTitle: Hippotherapy Teenager-pediatric Radiotherapy, acronym: T-QAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Institut de cancérologie Strasbourg Europe, class: OTHER, descriptionModule briefSummary: This study proposes a horse-assisted therapy (HAT) approach to accompany children and young adults undergoing irradiation in the ICANS Radiotherapy Department.The aim of this new approach is to improve quality of life and reduce anxiety in children and adolescents treated with radiotherapy. The impact of equine-assisted therapy on quality of life and anxiety disorders will be described prospectively between the start and end of irradiation in children and parents who agree to inclusion., conditionsModule conditions: Radiotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Participation in 10 horse-assisted therapy sessions, outcomesModule primaryOutcomes measure: Evolution of quality of life between the beginning and the end of horse-assisted therapy (HAT) in children (self-questionnaire) treated with radiotherapy, secondaryOutcomes measure: Improving children's quality of life between the start and end of irradiation (hetero-questionnaire) by HAT, secondaryOutcomes measure: Decrease anxiety disorders between the beginning - child version and end of irradiation in children (self-questionnaire) with HAT, secondaryOutcomes measure: Decrease anxiety disorders between the beginning - parents' version and end of irradiation in children (self-questionnaire) with HAT, secondaryOutcomes measure: Assessing the acute side effects of radiotherapy at the start and end of irradiation, secondaryOutcomes measure: Study the relevance of the various equestrian activities proposed as a strategy for improving care through the horse, secondaryOutcomes measure: Evaluate participant's expectations and satisfaction with their care, secondaryOutcomes measure: Assess the medical electroradiology technician's (MERT's) impression of the child's well-being during irradiation, secondaryOutcomes measure: Assessing the impact of HAT on the child during irradiation according to the MERT, secondaryOutcomes measure: Evaluate the rider's impression of the child's well-being of the child during HAT sessions, secondaryOutcomes measure: Assessing the impact of an alternative activity on parents' satisfaction with care, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institut de Cancerologie Strasbourg Europe, city: Strasbourg, zip: 67033, country: France, contacts name: Valérie SARTORI, role: CONTACT, phone: 0368767223, email: v.sartori@icans.eu, contacts name: Manon VOEGELIN, role: CONTACT, phone: 0368767360, email: promotion-rc@icans.eu, contacts name: Laura BOINOT-FRITSCH, role: PRINCIPAL_INVESTIGATOR, contacts name: Georges NOEL, role: SUB_INVESTIGATOR, contacts name: Claire DOSSUN, role: SUB_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
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protocolSection identificationModule nctId: NCT06330129, orgStudyIdInfo id: Pegasus01_Val, briefTitle: Validity and Reliability of Trunk Strength Device, acronym: PEGASUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Schulthess Klinik, class: OTHER, collaborators name: Balgrist Campus AG, descriptionModule briefSummary: The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition., conditionsModule conditions: Trunk Muscle Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: CTT Pegasus, outcomesModule primaryOutcomes measure: maximal isometric trunk muscle strength, secondaryOutcomes measure: MRI muscle morphology, secondaryOutcomes measure: Electromyography (EMG) activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330116, orgStudyIdInfo id: 2023-05348-01, briefTitle: Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea, acronym: SNORT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-28, completionDateStruct date: 2025-03-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Region Västerbotten, class: OTHER_GOV, collaborators name: Interreg, collaborators name: Umeå University, descriptionModule briefSummary: Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro or serving as controls. Participants in Köge will be randomized to either training with Exciteosa, group training, or controls.The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment., conditionsModule conditions: Sleep Apnea, Obstructive, conditions: Snoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 141 consecutive adult subjects, 71 men and 70 women, referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sights, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the 3 different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Patients in Umeå will be randomized to either training with IQoro or serving as controls. Patients in Köge will be randomized to either training with Exciteosa group training, or controls., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 141, type: ESTIMATED, armsInterventionsModule interventions name: IQoro, interventions name: eXciteosa, interventions name: Grouptraining, outcomesModule primaryOutcomes measure: Apnea-hyponpnea index (AHI), secondaryOutcomes measure: Questionnaries, secondaryOutcomes measure: Snoring, secondaryOutcomes measure: Tounge strenght, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zealand University Hospital, city: Köge, state: Sjaelland, zip: 4600, country: Denmark, geoPoint lat: 55.45802, lon: 12.18214, locations facility: Skåne University Hospital, city: Lund, state: Skåne, zip: 22100, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Region Västerbotten, city: Umeå, state: Västerbotten, zip: 901 85, country: Sweden, geoPoint lat: 63.82842, lon: 20.25972, hasResults: False
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protocolSection identificationModule nctId: NCT06330103, orgStudyIdInfo id: RayongH, briefTitle: Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Rayong Hospital, class: OTHER, collaborators name: Chulalongkorn University, descriptionModule briefSummary: Assessing the Efficacy of Artificial Intelligence in Left Ventricular Function Screening Using Parasternal Long Axis View Cardiac Ultrasound Video ClipsABSTRACT BACKGROUND: Echocardiography serves as a fundamental diagnostic procedure for managing heart failure patients. Data from Thailand's Ministry of Public Health reveals that there is a substantial patient population, with over 100,000 admissions annually due to this condition. Nevertheless, the widespread implementation of echocardiography in this patient group remains challenging, primarily due to limitations in specialist resources, particularly in rural community hospitals. Although modern community hospitals are equipped with ultrasound machines capable of basic cardiac assessment (e.g., parasternal long axis view), the demand for expert cardiologists remains a formidable obstacle to achieving comprehensive diagnostic capabilities. Leveraging the capabilities of Artificial Intelligence (AI) technology, proficient in the accurate prediction and processing of diverse healthcare data types, offers a promising for addressing this prevailing issue. This study is designed to assess the effectiveness of AI in evaluating cardiac performance from parasternal long axis view ultrasound video clips obtained via the smartphone application.OBJECTIVES: To evaluate the effectiveness of artificial intelligence in screening cardiac function from parasternal long axis view cardiac ultrasound video clips obtained through the smartphone application., conditionsModule conditions: Heart Failure, conditions: Heart Failure With Reduced Ejection Fraction, conditions: Cardiac Failure, conditions: Echocardiography, conditions: Artificial Intelligence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 923 samples that were evaluated for LVEF by certified cardiologists, 739 clips were used to train AI, while the remaining 184 clips were used to test if AI could process the results correctly. Artificial intelligence aims to classify cardiac function into three groups: Reduced EF, Mildly Reduced EF, and Preserved LV., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 923, type: ACTUAL, armsInterventionsModule interventions name: Easy EF, outcomesModule primaryOutcomes measure: efficiency of AI in screening left ventricular cardiac function by use smartphone application, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rayong Hospital, city: Rayong, zip: 066, country: Thailand, geoPoint lat: 12.68095, lon: 101.25798, hasResults: False
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protocolSection identificationModule nctId: NCT06330090, orgStudyIdInfo id: NL84688.091.23, secondaryIdInfos id: 101040534, type: OTHER_GRANT, domain: European Research Council, briefTitle: COgnitive Dynamics in Early Childhood, acronym: CODEC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this accelerated longitudinal observational cohort study is to advance our understanding of cognitive variability in children aged 7 to 10 at first measurement. The CODEC study aims to integrate experience sampling methods, longitudinal designs, deep phenotyping cohorts, and state-of-the-art statistical methodologies to investigate three core questions:1. How does cognitive variability differ between individuals?2. What are the neural, psychological, and environmental mechanisms that underlie cognitive variability?3. What are the long-term consequences and outcomes associated with differences in cognitive variability?, conditionsModule conditions: Cognitive Change, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Reaction times from the vocabulary cognitive task, primaryOutcomes measure: Reaction times from the exploration cognitive task, primaryOutcomes measure: Reaction times from the Working Memory cognitive task, primaryOutcomes measure: Reaction times from the speed cognitive task, primaryOutcomes measure: Reaction times from the fluid reasoning cognitive task, primaryOutcomes measure: Mood score on smiley slider, primaryOutcomes measure: Sleep score on smiley slider, primaryOutcomes measure: MP-RAGE MRI sequence baseline, primaryOutcomes measure: Functional MRI sequence of low time constraint reasoning task at baseline, primaryOutcomes measure: gaze direction during reasoning task at baseline, primaryOutcomes measure: pupil dilation during reasoning task at baseline, primaryOutcomes measure: Naturalistic viewing fMRI at baseline, primaryOutcomes measure: Naturalistic viewing fMRI at follow-up, primaryOutcomes measure: Functional MRI sequence of high time constraint reasoning task at follow-up, primaryOutcomes measure: gaze direction during reasoning task at baseline at follow-up, primaryOutcomes measure: pupil dilation during reasoning task at baseline at follow-up, primaryOutcomes measure: Functional MRI sequence of low time constraint reasoning task at follow-up, primaryOutcomes measure: Sparse MP2-Rage MRI sequence baseline, primaryOutcomes measure: Diffusion weighted imaging MRI sequence baseline, primaryOutcomes measure: MP-RAGE MRI sequence follow up, primaryOutcomes measure: Sparse MP2-Rage MRI sequence follow up, primaryOutcomes measure: Diffusion weighted imaging MRI sequence follow up, primaryOutcomes measure: Total score for Highly Sensitive Child scale at baseline, primaryOutcomes measure: Total score for Strengths and difficulties questionnaire at baseline, primaryOutcomes measure: Total score for BRIEF-2 questionnaire at baseline, primaryOutcomes measure: Total score for BRIEF-2 questionnaire at follow-up, primaryOutcomes measure: Total score for Strengths and difficulties questionnaire at follow-up, primaryOutcomes measure: Total score for Mind Excessively Wandering Scale scale at baseline, primaryOutcomes measure: Originality score for the Alternative Uses Tasks at baseline, primaryOutcomes measure: Originality score for the Alternative Uses Tasks at follow-up, primaryOutcomes measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at baseline, primaryOutcomes measure: Total score for Parent-reported Socio-demographic questionnaire at baseline, primaryOutcomes measure: Total score for Parent-reported Socio-demographic questionnaire at follow-up, primaryOutcomes measure: Total score for Mind Excessively Wandering Scale scale at follow-up, primaryOutcomes measure: Total score for Parent-reported Mind Excessively Wandering Scale scale at follow-up, primaryOutcomes measure: Total score for Highly Sensitive Child scale at follow-up, secondaryOutcomes measure: motivation rating for cognitive tasks, secondaryOutcomes measure: Decibel of background noise during cognitive testing, secondaryOutcomes measure: Academic school result baseline, secondaryOutcomes measure: Academic school result follow-up, secondaryOutcomes measure: Parent reaction times on cognitive battery at baseline, secondaryOutcomes measure: Parent reaction times on cognitive battery at follow-up, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330077, orgStudyIdInfo id: APHP200027, secondaryIdInfos id: 2021-003584-99, type: EUDRACT_NUMBER, briefTitle: Ifenprodil as a ReMyelinating repurpOsed Drug in Multiple Sclerosis, acronym: MODIF-MS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Multiple sclerosis (MS) is the most frequently acquired demyelinating disease and the first cause of non-traumatic chronic disability in young adults. Major progress has been achieved in the treatment of MS through the development of therapies targeting the adaptative immune system, which drastically reduce the relapse rate, with various efficiency and safety profiles (Ontaneda, 2015). However, these drugs generally fail to prevent disability worsening along the disease course, and we are now assisting to a shift in therapeutic objectives from the development of new immune drugs towards the identification of therapeutic strategies that could prevent neurodegeneration by promoting myelin regeneration (Stangel, 2017; Stankoff, 2016), in order to prevent neurological disability in MS (Irvine and Blakemore, 2008; Patrikios, 2006; Duncan I, 2017, Bodini, 2016).Among the first candidate compounds developed to promote remyelination was the anti Lingo1 antibody, which enhance remyelination (Mi, 2009). Medium and large throughput screening of drug libraries subsequently identified several chemical classes of compounds with strong promyelinating properties, such as the antifongic drug miconazole (Najm, 2015) or the muscarinic antagonist clemastine (Wei, 2014). A recent innovative trial has investigated the effect of clemastine, compared to placebo, in a small sample of subjects (25 patients per group) and showed that clemastine could significantly improve the optic nerve conduction speed which reflecting myelin integrity and functionality (Green, 2017).Our preclinical research has allowed us to identify ifenprodil as a powerful drug to promote myelin repair in vitro and in vivo across species. In parallel our team recently pioneered and optimized a PET imaging approach for quantifying remyelination in the whole brain, that allowed to enhance the sensitivity to detect the myelin repair process, and showed that patients are characterized by heterogeneous profiles of spontaneous remyelination profiles that are closely linked to disability accrual (Bodini, 2016)., conditionsModule conditions: Multiple Sclerosis, conditions: Remitting Relapsing Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ifenprodil, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in P100 latency according to visual evoked potential., secondaryOutcomes measure: Proportion of voxels within white matter lesions classified as remyelinating, secondaryOutcomes measure: Proportion of remyelinating voxels extracted in cortical regions from magnetization transfer imaging (MTR) acquisitions, secondaryOutcomes measure: Change in amplitude of P100 on to visual evoked potential, secondaryOutcomes measure: Change in retinal nerve fibre layer (RNFL) and ganglion cell complex (GCC) thickness on OCT, secondaryOutcomes measure: Change in blood concentration of NfL fragments, secondaryOutcomes measure: Change in the brain atrophy rate, secondaryOutcomes measure: The correlation between the change in the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions, secondaryOutcomes measure: The comparison of the proportion of remyelinating voxels extracted in white matter lesions from [18F]florbetaben PET acquisitions, secondaryOutcomes measure: Incidence of adverse drug reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Neurologique Pierre WERTHEIMER - HCL, city: Bron, zip: 69677, country: France, contacts name: Françoise DURAND DUBIEF, MD, role: CONTACT, phone: 04 72 35 75 22, email: françoise.durand-dubief@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Groupe Hospitalier Pitié Salpêtrière - APHP, city: Paris, zip: 75013, country: France, contacts name: Bruno STANKOFF, MD, role: CONTACT, email: bruno.stankoff@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06330064, orgStudyIdInfo id: DS7300-203, secondaryIdInfos id: 2023-509632-26, type: OTHER, domain: EU CTR, briefTitle: A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Daiichi Sankyo, class: INDUSTRY, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: This study is designed to assess the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); non-squamous non-small cell lung cancer (NSCLC); and urothelial carcinoma (UC)., conditionsModule conditions: Recurrent or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Ifinatamab deruxtecan, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) as Assessed by Investigator, secondaryOutcomes measure: Number of Dose-limiting Toxicities in the HCC Cohort, secondaryOutcomes measure: Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetic Parameter Maximum Concentration (CMax) for I DXd, total anti-B7-H3 antibody, and DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (TMax) for I DXd, total anti-B7-H3 antibody, and DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Half-life (t1/2) for I DXd, total anti-B7-H3 antibody, and DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Minimum Concentration (Ctrough) for I DXd, total anti-B7-H3 antibody, and DXd, secondaryOutcomes measure: Pharmacokinetic Parameter Area Under the Curve (AUC) for I DXd, total anti-B7-H3 antibody, and DXd, secondaryOutcomes measure: Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline), secondaryOutcomes measure: Percentage of Participants Who Have Treatment-emergent ADA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Alliance, Inc., status: RECRUITING, city: Westbury, state: New York, zip: 11590, country: United States, geoPoint lat: 40.75566, lon: -73.58763, hasResults: False
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protocolSection identificationModule nctId: NCT06330051, orgStudyIdInfo id: KY 2023-184-02, briefTitle: The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China, acronym: IMPROVE-II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: This study intends to construct the goal-oriented integrated intervention model for AIS in-hospital procedure through the spatiotemporal positioning and the P-D-C-A cycle for continuous improvement (FAST model). Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: After 2 months of baseline information collection,10 hospitals will be seleted and then randomly assigned to the control and intervention groups according to hospital level and baseline DNT to reduce the imbalance between the two groups. We will not indicate to any hospital the grouping type of other hospitals. If the selected hospital is unable to complete the study for some reason during the operation, the hospital with conditions to carry out the replacement will be selected from the hospitals of the same region, the same level and the same scale., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: improvement acute reperfusion treatment quality for stroke through spatiotemporal computing, outcomesModule primaryOutcomes measure: The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset., secondaryOutcomes measure: The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset., secondaryOutcomes measure: The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset., secondaryOutcomes measure: The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset., secondaryOutcomes measure: Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy., secondaryOutcomes measure: Proportion of patients with 90-day favorable functional outcome., secondaryOutcomes measure: Proportion of patients with 90-day independent functional outcome., secondaryOutcomes measure: in-hospital mortality, secondaryOutcomes measure: 90-day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330038, orgStudyIdInfo id: SMC 2024-01-065, briefTitle: Anesthesia and Non-small Cell Lung Cancer Recurrence, acronym: GASTIVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: Seoul National University Hospital, collaborators name: Asan Medical Center, collaborators name: Severance Hospital, collaborators name: Seoul St. Mary's Hospital, collaborators name: Korea University Guro Hospital, collaborators name: DongGuk University, collaborators name: Inha University Hospital, collaborators name: Konkuk University Medical Center, collaborators name: Ewha Womans University, collaborators name: Chungnam National University Hospital, collaborators name: University of Virginia, collaborators name: Memorial Sloan Kettering Cancer Center, collaborators name: Yale University, collaborators name: Mayo Clinic, collaborators name: University of Texas Southwestern Medical Center, collaborators name: University Hospitals Coventry and Warwickshire NHS Trust, collaborators name: Khon Kaen University, collaborators name: King Chulalongkorn Memorial Hospital, collaborators name: The Affiliated Hospital of Qingdao University, collaborators name: Beijing Hospital, collaborators name: All India Institute of Medical Sciences, New Delhi, descriptionModule briefSummary: There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials., conditionsModule conditions: Non-small Cell Lung Cancer, conditions: Surgery, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 5384, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, interventions name: Inhaled anesthetics, outcomesModule primaryOutcomes measure: Recurrence free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330025, orgStudyIdInfo id: 69HCL23_1180, briefTitle: Exploring Food Rejection Dispositions as Potential Risk Factors for Undernutrition in Hospitalized Children Aged 2 to 8, acronym: MEDIALIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Undernutrition affects over 30% of hospitalized children in France, with 10% severely malnourished yet only half of the cases are diagnosed. Undernutrition deteriorates children's health during hospital stays, weakening immunity and hindering recovery. Children suffering from acute malnutrition can stay in the hospital 45% longer than non-malnourished patients.One of the primary causes of malnutrition is the reduction in children's food intake. Several researchers have emphasized that the young age of patients is associated with reduced food intake. For example, data on 923 children aged 1 day to 16 years indicates that patients under 8 years old are at a higher risk of undernutrition than older children.The MEDIC project aims to investigate if increased food rejection dispositions contribute to reduced food intake in hospitalized children. Food rejections are typically observed between 2 and 8 years. Some children are more challenging and eat only a few different foods, while others try everything. Around the age of 2, children become more selective about the foods they consume. This is largely due to two common dispositions in young children: food neophobia and food pickiness. Food neophobia is defined as the reluctance to eat or even try foods that appear new, whereas food pickiness is defined as the rejection of a substantial number of familiar foods, including foods previously tasted. Both pickiness and neophobia have been associated with a significant reduction in food consumption (especially of vegetables), a decrease in food variety, and less enjoyment derived from food. A study showed that children aged 2 to 5 were twice as likely to be underweight if they were picky eaters.Studies have shown that the socioeconomic status has a significant impact on food rejection in children. For instance, longitudinal studies reveal a higher proportion of picky eaters in low-income families. Parental education was also found to be inversely associated with children's food rejection levels.The MEDIC project seeks to assess health inequalities by studying the impact of food rejection dispositions on the nutritional status of children in pediatric services. A qualitative study supports the notion that food rejection is heightened during the hospitalization: half of the parents of hospitalized children interviewed reported that foods accepted outside the hospital were rejected in the ward. Parents indicated that their child's food preferences were more limited, and they only alternated between a few foods after entering the hospital. According to the majority of interviewed nurses, children refuse any food other than that provided by parents.The research hypotheses of the MEDIC project focus on understanding the moderating effects of food rejection dispositions and socioeconomic backgrounds on children's food intake during hospitalization. Two hypotheses are formulated: (H1) the pre-hospitalization food rejection levels predict the amount of food consumed during the hospital stay, and (H2) children from disadvantaged socioeconomic backgrounds are more likely to refuse food during their hospital stay than those from more advantaged backgrounds. To test these hypotheses, parents of children aged 2 to 8 will complete questionnaires on food rejection dispositions upon admission, and food consumption (in grams and calories) will be assessed through weighing and photographs of meal trays taken 48 hours (± 24 hours) post-admission. The project aims to shed light on the complexities of childhood malnutrition, addressing social inequalities and contributing valuable insights for interventions and public health policy., conditionsModule conditions: Undernutrition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Children between 2 and 8 years, without medical treatments or pathologies impacting food intake and his parents, outcomesModule primaryOutcomes measure: Grams of hospital meals consumed by the patients at lunch, primaryOutcomes measure: Calories of hospital meals consumed by the patients at lunch, 48 hours after their admission to the hospital., eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Femme Mère Enfant de Lyon, city: Bron, zip: 69677, country: France, contacts name: Noël PERETTI, MD, role: CONTACT, phone: +33 (0)4.72.35.70.50, email: noel.peretti@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
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protocolSection identificationModule nctId: NCT06330012, orgStudyIdInfo id: GeoMx_Breast, briefTitle: The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients., conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: GeoMx data analysis with clinical outcome, outcomesModule primaryOutcomes measure: Spatial transcriptomic analysis, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ji-Yeon Kim, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Ji-Yeon Kim, role: CONTACT, phone: 82-2-3410-3459, email: jyeon25@skku.edu, contacts name: MIRYOUNG HONG, role: CONTACT, phone: 82-2-2148-7147, email: ring7629@naver.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06329999, orgStudyIdInfo id: CMG-sAML-001, briefTitle: A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, collaborators name: Huadong Hospital, collaborators name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, collaborators name: Huashan Hospital, collaborators name: Army Medical Center of PLA, collaborators name: Sun Yat-sen University, collaborators name: RenJi Hospital, collaborators name: Shanghai Jiading District Central Hospital, collaborators name: The Second Affiliated Hospital of Dalian Medical University, collaborators name: First Hospital of China Medical University, collaborators name: Dalian Municipal Central Hospital, collaborators name: Shanghai Zhongshan Hospital, collaborators name: Shanghai Pudong Hospital, collaborators name: Shanghai Public Health Clinical Center, collaborators name: Xuhui Central Hospital, Shanghai, collaborators name: The Affiliated People's Hospital of Ningbo University, collaborators name: Taizhou First People's Hospital, collaborators name: Wenzhou People's Hospital, descriptionModule briefSummary: The goal of this clinical trial\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\]. The main questions it aims to answer are:* Evaluation of the efficacy* Evaluation of the safety, conditionsModule conditions: Recurrent Adult Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome, conditions: Adult Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: CMGV, outcomesModule primaryOutcomes measure: CRc, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: RFS, secondaryOutcomes measure: MRD-, secondaryOutcomes measure: Adverse Event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: xiaoqian Xu, Doctor, role: CONTACT, phone: 13816205940, email: Ellenxxq@qq.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06329986, orgStudyIdInfo id: SEDPTC20240109, briefTitle: Crossover RCT of TAMER Lenses in Myopia Control, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Eye Disease Prevention and Treatment Center, class: OTHER, descriptionModule briefSummary: This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses., conditionsModule conditions: Myopia, conditions: Progressive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: TAMER Lens Spectacle, interventions name: SV lenses, outcomesModule primaryOutcomes measure: Spherical Equivalent change, secondaryOutcomes measure: Axial Length change, secondaryOutcomes measure: Spherical Equivalent change, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Shanghai Eye Disease Prevention and Treatment Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200041, country: China, contacts name: Xiangui He, role: CONTACT, phone: 021-62982727-817, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06329973, orgStudyIdInfo id: 2023-237, briefTitle: Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2028-02-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Henan Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies, conditionsModule conditions: Metastatic Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Fruquintinib in combination with Sintilimab and CAPEOX, outcomesModule primaryOutcomes measure: Objective response rate, primaryOutcomes measure: Maximum tolerated dose, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Disease Control Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450008, country: China, contacts name: Xiaobing Chen, role: CONTACT, phone: +8613937100233, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06329960, orgStudyIdInfo id: 2024PHB019-001(3), briefTitle: Dorsal Scapular Nerve Injection Combined With Muscle Needle Release, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Ultrasound-guided perineural injection (PIT) of 5% dextrose (D5W) hydrodissection has been widely used in the treatment of peripheral entrapment neuropathies. However, there are few studies investigating the efficacy of PIT using D5W HD for dorsal scapular nerve (DSN) entrapment. Generally, the DSN entrapment causes the stiffness of the major and minor rhomboideus(2). In clinical practice, the investigators observed that ultrasound-guided PIT using D5W HD combined with needle release of major and minor rhomboideus significantly relieved the pain of scapular region. Therefore, the investigators aimed to evaluate the 6-month efficacy of this procedure for the participants with DSN entrapment., conditionsModule conditions: Dorsal Scapular Nerve Entrapment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-guided injection combined with needle release, outcomesModule primaryOutcomes measure: visual analogue scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiaan Zhu, city: Beijing, country: China, contacts name: Jiaan Zhu, role: CONTACT, email: canzhujia@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06329947, orgStudyIdInfo id: HMPL-012-SPRING-P106, briefTitle: A Phase II Study of Surufatinib Combined With PD-L1 and mFOLFOX6 as Second-line Treatment for Advanced PRAD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Rui-hua Xu, MD, PhD, class: OTHER, descriptionModule briefSummary: To preliminarily evaluate whether there is a survival benefit of surufatinib in combination with Caralizumab and mFOLFOX6 in the second-line treatment of advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer, conditionsModule conditions: Advanced Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Surufatinib in combination with Caralizumab and mFOLFOX6, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: quality of life (QoL), secondaryOutcomes measure: adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SunYat-senUniversity Cancer Center, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-12-12, uploadDate: 2024-03-18T20:39, filename: Prot_000.pdf, size: 1380851, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-12, uploadDate: 2024-03-18T20:39, filename: ICF_001.pdf, size: 541718, hasResults: False
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protocolSection identificationModule nctId: NCT06329934, orgStudyIdInfo id: XXZY-003, briefTitle: Refined Nursing in Rehabilitation Training, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Xinxiang Central Hospital, class: OTHER, descriptionModule briefSummary: This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications., conditionsModule conditions: Brain Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: Establishment of a hierarchical monitoring and management team, interventions name: Assessment of pressure injury, interventions name: Communication, interventions name: Intervention for pressure ulcer, interventions name: Rehabilitation training, interventions name: introduction of the current patient's condition to family members, interventions name: maintaining appropriate temperature and humidity in the ward, interventions name: careful observation of vital signs in patients, outcomesModule primaryOutcomes measure: GCS scores, primaryOutcomes measure: GCS scores, primaryOutcomes measure: cognitive function scores, primaryOutcomes measure: cognitive function scores, primaryOutcomes measure: functional independence scores, primaryOutcomes measure: functional independence scores, primaryOutcomes measure: Newcastle Satisfaction with Nursing Scale (NSNS), primaryOutcomes measure: Newcastle Satisfaction with Nursing Scale (NSNS), primaryOutcomes measure: incidence of adverse reactions, primaryOutcomes measure: incidence of adverse reactions, eligibilityModule sex: ALL, minimumAge: 33 Years, maximumAge: 43 Years, stdAges: ADULT, contactsLocationsModule locations facility: Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study, city: Xinxiang, state: Henan, zip: 453000, country: China, geoPoint lat: 35.19033, lon: 113.80151, hasResults: False
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protocolSection identificationModule nctId: NCT06329921, orgStudyIdInfo id: 232192, briefTitle: Inpatient Monitoring of Unfractionated Heparin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Vanderbilt University Medical Center, class: OTHER, descriptionModule briefSummary: Unfractionated heparin (UFH) is the most widely used intravenous (IV) anticoagulant for treating and preventing thromboembolic disease (e.g., blood clots ). UFH must be closely monitored and adjusted in the hospital. There are two assays used to monitor UFH: 1) the activated partial thromboplastin time (PTT) and 2) the chromogenic anti-factor Xa assay (anti-Xa). This study aims to compare PTT and anti-Xa methods for monitoring UFH in a pragmatic, randomized controlled trial to determine which helps patients reach a therapeutic anticoagulation range faster., conditionsModule conditions: Blood Clot, conditions: Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be performed as a pragmatic, randomized controlled clinical trial with parallel group assignment., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: PTT protocol, interventions name: anti-Xa protocol, outcomesModule primaryOutcomes measure: Time to therapeutic anticoagulation range, secondaryOutcomes measure: Measurements in therapeutic anticoagulation range, secondaryOutcomes measure: Coagulation laboratory measurements, secondaryOutcomes measure: New thrombotic events, secondaryOutcomes measure: New clinically relevant bleeding events, secondaryOutcomes measure: New coagulation events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Benjamin Tillman, MD, role: CONTACT, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
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protocolSection identificationModule nctId: NCT06329908, orgStudyIdInfo id: TSLG-001, briefTitle: DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Zhen-Yu Ding, class: OTHER, descriptionModule briefSummary: This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single arm, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: LG002, outcomesModule primaryOutcomes measure: The safety of Neo-DCVac combined with ICIs., secondaryOutcomes measure: The efficacy of Neo-DCVac combined with ICIs., secondaryOutcomes measure: The efficacy of Neo-DCVac combined with ICIs., otherOutcomes measure: Synergistic anti-tumor mechanism., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Si Chuan, zip: 610000, country: China, contacts name: Zhengyu Ding, MD, role: CONTACT, phone: 18980601957, email: dingzhenyu@scu.edu.cn, contacts name: Qing Li, MD, role: CONTACT, phone: 18702848178, email: liqing@scu.edu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06329895, orgStudyIdInfo id: 22252, briefTitle: A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-05-23, completionDateStruct date: 2024-05-23, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.Researchers think that BAY2927088 inhibits drug transporters such as P-gp (P-glycoprotein) and breast cancer resistance protein (BCRP). Drug transporters are proteins that help in the movement of certain drugs into, through, and out of the body's cells. Dabigatran is a drug used in the treatment of blood clots in a vein and rosuvastatin is a drug used in the treatment of high cholesterol in the blood.The main purpose of this study is to find out how BAY2927088, taken as multiple doses, affects the levels of dabigatran and rosuvastatin in the blood of healthy participants. For this, researchers will measure the following for dabigatran and rosuvastatin, when given with and without BAY2927088:* Area under the curve (AUC): a measure of the total amount of the drug in participants' blood over time* Maximum observed concentration (Cmax): the highest amount of the drug in participants' bloodIn this study, participants will take the following treatments:* Dabigatran in the morning of Day 1 and 9.* Rosuvastatin in the morning of Day 3 and 12.* BAY2927088 two times a day in the morning and evening of Days 6 to 15.Participants will be in this study for about 8 weeks with 3 visits to the study clinic.Participants will visit the study clinic:* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study* once on the day before the treatment starts and will stay in the clinic until Day 16 of the treatment* once, 7 to 10 days after last dose of BAY2927088, for a health check-upDuring the study, the doctors and their study team will:* do physical examinations* collect blood samples from the participants to measure the levels of dabigatran, rosuvastatin and of BAY2927088* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)* ask the participants questions about how they are feeling and what adverse events they are havingAn adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment., conditionsModule conditions: Advanced Non-small Cell Lung Cancer, conditions: EGFR Mutation, conditions: HER2 Mutation, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: BAY2927088, interventions name: Dabigatran etexilate, interventions name: Rosuvastatin, outcomesModule primaryOutcomes measure: Cmax of unconjugated dabigatran when given with and without BAY2927088, primaryOutcomes measure: AUC of unconjugated dabigatran when given with and without BAY2927088, primaryOutcomes measure: Cmax of rosuvastatin when given with and without BAY2927088, primaryOutcomes measure: AUC of rosuvastatin when given with and without BAY2927088, secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Severity of TEAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: PAREXEL International Early Phase Clinical Unit (London), status: RECRUITING, city: Harrow, zip: HA1 3UJ, country: United Kingdom, geoPoint lat: 51.57142, lon: -0.33371, hasResults: False
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protocolSection identificationModule nctId: NCT06329882, orgStudyIdInfo id: 14789, briefTitle: Doxycycline in Type II Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mostafa Bahaa, class: OTHER, descriptionModule briefSummary: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden, conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: open label, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Sitagliptin 100mg, interventions name: Doxycyclin, outcomesModule primaryOutcomes measure: Change in glycemic profile, primaryOutcomes measure: Change in glycemic profile, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06329869, orgStudyIdInfo id: 202401158MIFD, briefTitle: Sacituzumab Govitecan for Advanced Esophageal Squamous Cell Carcinoma, acronym: SG-ESCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: The goal of this clinical trial is to investigate the efficacy and safety of sacituzumab govitecan in patients with advanced esophageal squamous cell carcinoma., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab govitecan, outcomesModule primaryOutcomes measure: Overall objective response rates (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], otherOutcomes measure: Biomarkers-related endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329856, orgStudyIdInfo id: 202301218RIND, briefTitle: Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline.Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying., conditionsModule conditions: Terminal Cancer, conditions: Hospice, conditions: Palliative Medicine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1270, type: ESTIMATED, armsInterventionsModule interventions name: Administering of artificial hydration, outcomesModule primaryOutcomes measure: Likert scale on alteration of administer artificial hydration to the terminal cancer patient and principles of clinical ethics, primaryOutcomes measure: Distributive statistics, primaryOutcomes measure: Disagreement score according to the Interpercentile Range Adjusted for Symmetry (IPRAS) for survey results, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329843, orgStudyIdInfo id: Intermountain, briefTitle: Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Picterus AS, class: INDUSTRY, collaborators name: Intermountain Medical Center, descriptionModule briefSummary: The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy., conditionsModule conditions: Neonatal Jaundice, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Picterus Jaundice Pro (JP), outcomesModule primaryOutcomes measure: Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP., secondaryOutcomes measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy., secondaryOutcomes measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy., secondaryOutcomes measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy., secondaryOutcomes measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy., eligibilityModule sex: ALL, minimumAge: 12 Hours, maximumAge: 192 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Intermountain Health, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Timothy M Bahr, MS MD, role: CONTACT, phone: 801-602-6523, email: Tim.Bahr@imail.org, contacts name: Kimberlee W Lewis, MS RN, role: CONTACT, phone: 801.507.7675, email: [kimberlee.weaverlewis@imail.org, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06329830, orgStudyIdInfo id: 2023-GAR-001, briefTitle: 177Lu-PSMA, Niraparib/AA Plus Prednisone for Prostate Cancer, acronym: LUNAAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Rohan Garje, class: OTHER, collaborators name: Janssen Scientific Affairs, LLC, descriptionModule briefSummary: The purpose of this research study is to test the safety and possible side effects of Lutetium-177 (177Lu)-Prostate-Specific Membrane Antigen (PSMA)-617 along with niraparib and abiraterone acetate plus prednisone when it is given to people diagnosed with metastatic castration-resistant prostate cancer (prostate cancer that has spread to other parts of the body and does not improve with hormonal therapies) at different dose levels. Once an optimal dose is selected, the researchers want to find out what how well these treatments work to improve survival and control the growth of the tumor., conditionsModule conditions: Metastatic Prostate Cancer, conditions: Castration-resistant Prostate Cancer, conditions: Metastatic Castration-resistant Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-PSMA-617, interventions name: Niraparib abiraterone acetate, interventions name: Prednisone, outcomesModule primaryOutcomes measure: Determination of the recommended phase 2 dose (RP2D), primaryOutcomes measure: Prostatic-specific antigen (PSA)-50 response rate, secondaryOutcomes measure: Radiographic progression-free survival (rPFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: PSA-80 response rate, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Objective response rate (ORR), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Miami Cancer Institute, city: Miami, state: Florida, zip: 33176, country: United States, contacts name: Rohan Garje, M.D., role: CONTACT, phone: 786-596-2000, email: rohan.garje@baptisthealth.net, contacts name: Leslie Castaneda, role: CONTACT, phone: (786) 596-2000, email: leslie.castaneda@baptisthealth.net, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
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protocolSection identificationModule nctId: NCT06329817, orgStudyIdInfo id: A/28/ER/532/23, briefTitle: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Pak Emirates Military Hospital, class: OTHER, descriptionModule briefSummary: One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia., conditionsModule conditions: Inguinal Hernia Bilateral, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Incidence of regurgitation in two different position., outcomesModule primaryOutcomes measure: Prevention of aspiration pneumonia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: PEMH, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 44000, country: Pakistan, contacts name: PEMH, role: CONTACT, phone: +923317055191, email: rabbiafatimasattar555@gmail.com, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
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protocolSection identificationModule nctId: NCT06329804, orgStudyIdInfo id: RM_01-11-21b, briefTitle: The Dose Response Effect of Isometric Handgrip Training Frequency on Blood Pressure in Normotensive Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Swansea University, class: OTHER, collaborators name: National Taiwan Normal University, descriptionModule briefSummary: It is estimated by WHO (2021) that 1.4 billion individuals across the globe have high blood pressure with only 14% of people managing these elevated levels. Simple and effective lifestyle strategies are required to help people improve their blood pressure and/or attenuate increases in blood pressure with ageing. Exercise is one possible strategy: in previous research, several different types of exercise have been shown to have effects on blood pressure (Blackwell et al., 2017). However, many individuals do not adhere to currently recommended levels of exercise (150 mins of moderate intensity exercise per week), due to a combination of the required time commitment, lack of motivation, and the associated levels of effort / exertion and discomfort (Korkiakangas et al 2009). Thus, there is a need to investigate alternative exercise interventions which will overcome these barriers but remain effective at improving blood pressure (Herrod, Lund, \& Phillips, 2021).Low intensity isometric hand grip training (IHGT) has been shown to result in large decreases in rest-ing blood pressure in younger and older age groups, in both men and women, and in individuals with normal as well as elevated baseline blood pressure (Badrov et al, 2013; Bentley et al., 2018; Millar et al., 2014). In this research, IHGT has typically involved performing 4 x 2 IHGT holds at 30% of maximal voluntary contraction, 3 times a week, over a 4-8-week intervention (Millar et al, 2014). Interestingly, there are very few studies that have investigated the effect of changing different protocol parameters on the adaptations in blood pressure, and the minimal effective dose of IHGT is unknown. One important modifiable parameter is training frequency and it is unknown whether reducing the frequency of IHGT will reduce the efficacy for improving blood pressure. Therefore, the aim of this randomised controlled trial is to compare the effect of IHGT with a frequency of 2 or 4 sessions/week on resting blood pressure., conditionsModule conditions: Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Isometric Handgrip Exercise Training (IHGT), outcomesModule primaryOutcomes measure: Resting Systolic Blood Pressure, secondaryOutcomes measure: Resting Diastolic Blood Pressure, secondaryOutcomes measure: Resting Mean Arterial Blood Pressure, otherOutcomes measure: Ratings of perceived exertion, otherOutcomes measure: Affective Valence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Taiwan Normal University, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Yung-Chih Chen, PhD, role: CONTACT, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Swansea University, status: RECRUITING, city: Swansea, country: United Kingdom, contacts name: Richard Metcalfe, role: CONTACT, phone: 01792205678, phoneExt: 4779, email: r.s.metcalfe@swansea.ac.uk, geoPoint lat: 51.62079, lon: -3.94323, hasResults: False
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protocolSection identificationModule nctId: NCT06329791, orgStudyIdInfo id: AZ202401, briefTitle: A Phase 3 Study to Evaluate AZR-MD-001 in Patients With Abnormal Meibomian Gland Function and Dry Eye Disease (DED), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Azura Ophthalmics, class: INDUSTRY, collaborators name: ORA, Inc., descriptionModule briefSummary: This study is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study designed to evaluate the treatment of abnormal meibomian gland function and associated symptoms of DED using either AZR-MD-001 0.5% ophthalmic ointment or its vehicle. Study drug (either AZR-MD-001 or vehicle) will be dosed twice-weekly at bedtime for up to 12 months., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AZR-MD-001, interventions name: Vehicle, outcomesModule primaryOutcomes measure: Change from baseline in Meibomian Glands Yielding Liquid Secretion, primaryOutcomes measure: Change from baseline in Total Ocular Surface Disease Index Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arizona Eye Center, city: Chandler, state: Arizona, zip: 85225, country: United States, contacts name: Erin Fox, role: CONTACT, phone: 714-559-8435, email: michael.depenbusch@doctrials.com, geoPoint lat: 33.30616, lon: -111.84125, locations facility: Global Research Management, Inc, city: Glendale, state: California, zip: 91204, country: United States, contacts name: Logi El-Harazi, role: CONTACT, email: logi@grmclinical.com, geoPoint lat: 34.14251, lon: -118.25508, locations facility: Eye Research Foundation, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Linda Wirta, role: CONTACT, email: linda.wirta@drwirta.com, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Pankratz Eye Institute, city: Columbus, state: Indiana, zip: 47203, country: United States, contacts name: Kristin Slevin, role: CONTACT, email: Kslevin@pankratzeye.com, geoPoint lat: 39.20144, lon: -85.92138, locations facility: The Eye Care Institute/Butchertown Clinical Trials, city: Louisville, state: Kentucky, zip: 40206, country: United States, contacts name: Danielle Gulock, role: CONTACT, email: dgulock@eyecareinstitute.com, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Ophthalmology Associates, city: Saint Louis, state: Missouri, zip: 63131, country: United States, contacts name: Maggie Thompson, role: CONTACT, email: maggiethompson@eyecare-partners.com, geoPoint lat: 38.62727, lon: -90.19789, locations facility: NC Eye Associates, city: Apex, state: North Carolina, zip: 27502, country: United States, contacts name: Ashley Cooper, role: CONTACT, email: acooper@nceyeassociates.com, geoPoint lat: 35.73265, lon: -78.85029, locations facility: Oculus Research, Inc., city: Garner, state: North Carolina, zip: 27529, country: United States, geoPoint lat: 35.71126, lon: -78.61417, locations facility: CORE, city: Shelby, state: North Carolina, zip: 28150, country: United States, contacts name: Winnie Simmons, role: CONTACT, email: winniesimmons.core@gmail.com, geoPoint lat: 35.29235, lon: -81.53565, locations facility: Scott & Christie and Associates, PC, city: Cranberry Township, state: Pennsylvania, zip: 16066, country: United States, geoPoint lat: 40.68496, lon: -80.10714, locations facility: Advancing Vision Research (AVR) - Goodlettsville, city: Goodlettsville, state: Tennessee, zip: 37072, country: United States, contacts name: Megan Medlin, role: CONTACT, email: meganm@avrteam.com, geoPoint lat: 36.32311, lon: -86.71333, locations facility: Total Eye Care, city: Memphis, state: Tennessee, zip: 38119, country: United States, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Advancing Vision Research (AVR) - Smyrna, city: Smyrna, state: Tennessee, zip: 37167, country: United States, contacts name: Megan Medlin, role: CONTACT, email: meganm@avrteam.com, geoPoint lat: 35.98284, lon: -86.5186, locations facility: Piedmont Eye Center, city: Lynchburg, state: Virginia, zip: 24502, country: United States, contacts name: Jennifer Frederick, role: CONTACT, email: jfrederick@piedmonteye.com, geoPoint lat: 37.41375, lon: -79.14225, hasResults: False
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protocolSection identificationModule nctId: NCT06329778, orgStudyIdInfo id: 50884b, briefTitle: Home-Based Child Care Toolkit for Nurturing School-Age Children Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-27, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mathematica Policy Research, Inc., class: OTHER, collaborators name: Department of Health and Human Services, descriptionModule briefSummary: The goal of this observational study is to build psychometric evidence for the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit) provider questionnaire. The main objectives of the study are to: 1) assess the reliability of the HBCC-NSAC Toolkit provider questionnaire, 2) assess the evidence for its validity compared to other existing measures of HBCC quality, and 3) examine invariance across subgroups (that is, look for the absence of any differential item functioning \[DIF\]). HBCC provider participants will complete a questionnaire in the HBCC-NSAC Toolkit. A subset of providers will also participate in an observation of their child care setting. Parents or guardians of children receiving care from HBCC providers will complete a survey., conditionsModule conditions: Child Development, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 316, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The Home-Based Child Care Toolkit for Nurturing School-Age Children provider questionnaire, primaryOutcomes measure: Emlen Scales, primaryOutcomes measure: Multicultural Teaching Competency Scale, primaryOutcomes measure: Family Child Care Program Quality Assessment (FCC PQA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mathematica Policy Research, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20002, country: United States, contacts name: Ashley Kopack Klein, role: CONTACT, phone: 202-484-9220, email: lakopackklein@mathematica-mpr.com, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False
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protocolSection identificationModule nctId: NCT06329765, orgStudyIdInfo id: HR- 4380, briefTitle: CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-07, primaryCompletionDateStruct date: 2025-04-04, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Marquette University, class: OTHER, collaborators name: Medical College of Wisconsin, descriptionModule briefSummary: The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped., conditionsModule conditions: Stroke, conditions: Hemiplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group pretest-posttest, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Exercise with CUped - a motor-assisted, split crank pedaling device and undergo 50 m of gait training., outcomesModule primaryOutcomes measure: Paretic limb use in walking, primaryOutcomes measure: Paretic limb use in pedaling, primaryOutcomes measure: Interlimb coordination in walking, primaryOutcomes measure: Interlimb coordination in pedaling, primaryOutcomes measure: Motorized intervention during pedaling split-crank (i.e., bilateral uncoupled) pedaling, primaryOutcomes measure: Absences, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Muscle activity - timing, secondaryOutcomes measure: Muscle activity - amplitude, secondaryOutcomes measure: Physiological response to exercise - Blood pressure, secondaryOutcomes measure: Physiological response to exercise - Heart rate, secondaryOutcomes measure: Physiological response to exercise - Rate of perceived exertion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marquette University, status: RECRUITING, city: Milwaukee, state: Wisconsin, zip: 53201, country: United States, contacts name: SHEILA M SCHINDLER-IVENS, PhD, role: CONTACT, phone: 414-288-7282, email: sheila.schindler-ivens@marquette.edu, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
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protocolSection identificationModule nctId: NCT06329752, orgStudyIdInfo id: Not available yet, briefTitle: Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department, acronym: AnkleMan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: IRCCS Policlinico S. Matteo, class: OTHER, descriptionModule briefSummary: The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures.The trial aims to assess:* The acceptability of sciatic nerve block* The technical feasibility of sciatic nerve block* The technical success of sciatic nerve block* The analgesic efficacy of sciatic nerve blockIn addition to that, this study aims to* Describe patient-reported and physician-reported satisfaction* Assess the Adverse Event rate at 48 hours post intervention, conditionsModule conditions: Ankle Fractures, conditions: Leg Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Interventional, single-arm, feasibility trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-guided Sciatic Nerve block (20 mL of 2% Lidocaine), outcomesModule primaryOutcomes measure: To assess the technical feasibility of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures., secondaryOutcomes measure: Technical success of US-guided sciatic nerve block, secondaryOutcomes measure: Analgesic efficacy of US-guided sciatic nerve block, secondaryOutcomes measure: Patient-reported and physician-reported satisfaction, otherOutcomes measure: Safety Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emergency Department, IRCCS Fondazione Policlinico San Matteo, city: Pavia, zip: 27100, country: Italy, contacts name: Santi Di Pietro, role: CONTACT, phone: 3463153244, email: santi.dipietro@unipv.it, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06329739, orgStudyIdInfo id: NeuroPsico_Dopa&PD, briefTitle: Genetics in Parkinson's Disease: Behavioral and Cognitive Outcomes, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-14, primaryCompletionDateStruct date: 2031-12-14, completionDateStruct date: 2031-12-14, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: The genetic landscape of Parkinson's disease (PD) is characterised by rare high penetrance pathogenic variants causing familial disease, genetic risk factor variants driving PD risk in a significant minority in PD cases and high frequency, low penetrance variants, which contribute a small increase of the risk of developing sporadic PD. This knowledge has the potential to have a major impact in the clinical care of people with PD.The goal of this observational study is to evaluate the impact of genetic mutation on behavior and cognition in PD patients.Patients will be assessed over time using test, questionnaire and standardised clinica scales. An initial assessment and annual follow-up assessments will be carried out for 5 years.Researchers will compare data collected from patients with genetic mutation versus patients without mutation., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Clinical examinations and clinical scales administration, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment, primaryOutcomes measure: Beck Depression Inventory, primaryOutcomes measure: State-Trait Anxiety Inventory, primaryOutcomes measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Parkinson's Disease Questionnaire-8, primaryOutcomes measure: Minnesota Multiphasic Personality Inventory 2-RF, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Francesca Mameli, role: CONTACT, phone: 0255033621, email: francesca.mameli@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06329726, orgStudyIdInfo id: NeuroPsico_DBS&PD, briefTitle: Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-13, primaryCompletionDateStruct date: 2031-12-15, completionDateStruct date: 2032-12-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.Researchers will compare data collected from patients with DBS versus patients with best medical therapy., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Clinical examinations and clinical scales administration, outcomesModule primaryOutcomes measure: Long-term characterization of DBS-STN on cognitive outcomes, primaryOutcomes measure: Beck Depression Inventory, primaryOutcomes measure: State-Trait Anxiety Inventory, primaryOutcomes measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Parkinson's Disease Questionnaire-8, primaryOutcomes measure: Minnesota Multiphasic Personality Inventory 2-RF, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, state: Lombardia, zip: 20135, country: Italy, contacts name: Eleonora Zirone, Dr, role: CONTACT, phone: 0255038671, phoneExt: 0039, email: eleonora.zirone@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06329713, orgStudyIdInfo id: 2024-03/11, briefTitle: Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique., conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Group I: 30 Min Interval Time, interventions name: Group II: 60 Min Interval Time, outcomesModule primaryOutcomes measure: Difference between total local anaesthetic consumption, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atatürk University, status: RECRUITING, city: Erzurum, country: Turkey, contacts name: Ayşenur Dostbil, role: CONTACT, phone: +905333677796, email: adostbil@hotmail.com, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06329700, orgStudyIdInfo id: ParSparInLivAtrophy, briefTitle: Parenchymal Sparing Hepatectomy in Post-chemotherapy Liver Atrophy, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-05-01, primaryCompletionDateStruct date: 2019-12-31, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero Universitaria Maggiore della Carita, class: OTHER, descriptionModule briefSummary: Major hepatectomy in patients with colorectal liver metastases (CLM) and post-chemotherapy liver atrophy is associated with increased complications. Whether the performance of parenchymal-sparing hepatectomy (PSH) in those patients can be safer is unknown. The aim of this study was to assess the clinical impact of post-chemotherapy liver atrophy on patients undergoing PSH for CLM. For this purpose, the occurrence of liver atrophy was recorded and then computed against the occurrence of postoperative morbidity and mortality., conditionsModule conditions: Colorectal Cancer Stage IV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: Hepatectomy, outcomesModule primaryOutcomes measure: Postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329687, orgStudyIdInfo id: OPP-010, briefTitle: A Study Evaluating the Safety of the Nasal Pump, statusModule overallStatus: TERMINATED, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Oyster Point Pharma, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to determine the safety of the Tyrvaya nasal pump., conditionsModule conditions: Dry Eye, conditions: Kerato Conjunctivitis Sicca, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Tyrvaya Nasal Pump, outcomesModule primaryOutcomes measure: Incidence of Adverse Events, otherOutcomes measure: Tear Film Break up Time, otherOutcomes measure: Eye Dryness Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: United States, California, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, hasResults: False
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protocolSection identificationModule nctId: NCT06329674, orgStudyIdInfo id: 20DM30203, briefTitle: Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-27, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2023-06-13, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: AJU Pharm Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2, conditionsModule conditions: Type2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 235, type: ACTUAL, armsInterventionsModule interventions name: AJU-A51, interventions name: A51R2, interventions name: A51R3, interventions name: AJU-A51 Placebo, interventions name: A51R2 Placebo, outcomesModule primaryOutcomes measure: Changes in HbA1c, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06329661, orgStudyIdInfo id: CYS-007, briefTitle: A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Novaliq GmbH, class: INDUSTRY, descriptionModule briefSummary: The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED), conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Cyclosporine ophthalmic solution, 0.1% (VEVYE), interventions name: Saline solution, 0.6%, outcomesModule primaryOutcomes measure: Change from baseline in corneal ECD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329648, orgStudyIdInfo id: DECIDE, briefTitle: Distributed Learning of Edic and CardIac Dose Effects in Lung Cancer, acronym: DECIDE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2028-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, descriptionModule briefSummary: Cardiac dose was not a major concern in lung radiotherapy patients until the results of the RTOG (Radiation Therapy Oncology Group) 0617 trial, which showed an association between cardiac dose and survival. Since then, many papers have studied the association between cardiac (substructure) dose and either survival or cardiac toxicity. Ideally, cardiac toxicity would be separated from survival. However, scoring cardiac toxicity prospectively was not standard practice, and retrospective scoring is challenging because of the overlap of cardiac toxicity symptoms and lung cancer (treatment) symptoms. Therefore in real world cohorts, cardiac toxicity is usually not scored properly and most larger studies pragmatically consider overall survival as primary endpoint, and the relation between cardiac dose and cardiac toxicity is not well established for lung cancer patients.Cardiac toxicity might not be the only factor in decreased survival; toxicity of the immune system might be a competing risk or a major contributing factor, where dose to the heart is a surrogate for dose to blood. Dose to the immune system is defined as EDIC (Effective Dose to circulating Immune Cells), comprising heart dose, lung dose and body dose combined. As EDIC dose and cardiac dose partly overlap, a large cohort with substantial variation will be required to disentangle the two effects. Such vast amounts of routine care data are immediately available in many radiotherapy centers all over the world. The problem we face is not the lack of routine care data, but making such data available for analysis. DECIDE adopts a federated learning approach, which implies that data does not have to be centralized within a single institution to be fit for use. We aim to include an unprecedentedly large-scale cohort of 20,000 patients.In this proposal, we need to add on scientific and technological innovations that exploit the existing federated learning framework to scale up to supporting \>25 simultaneously connected partners. We will be training (generalized) linear epidemiological models as well as new computer vision-based models for outcome predictions. As cause-specific survival (cardiac toxicity or immune toxicity) is unavailable or unreliable in major studies, we will use the more pragmatic endpoint of survival. By elucidating the clinical contributions of whole heart dose, cardiac substructure dose and EDIC dose in combination with known clinical risk factors, the desired impact is to change clinical practice for lung cancer radiotherapy and improve survival., conditionsModule conditions: NSCLC, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Optimize EDIC dose, secondaryOutcomes measure: cardiac toxicity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329635, orgStudyIdInfo id: 2023070K, briefTitle: Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital Of Guizhou Medical University, class: OTHER, descriptionModule briefSummary: To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage., conditionsModule conditions: Aneurysmal Subarachnoid Hemorrhage, conditions: Vasospasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The assigned "intervention" will be performed only by a separate unblinded dedicated physician who signs the confidential agreement. The attending/investigating physician and patient are blinded to the intervention assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 396, type: ESTIMATED, armsInterventionsModule interventions name: Intrathecal Nicardipine, interventions name: No intervention, outcomesModule primaryOutcomes measure: Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6, secondaryOutcomes measure: Extended Glasgow Outcome Score (GOS-E)., secondaryOutcomes measure: Modified Rankin Scale ordinal shift with mRS 5 and 6 combined, secondaryOutcomes measure: Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6, secondaryOutcomes measure: Hamilton Depression Rating Scale (HAM-D) score, secondaryOutcomes measure: Hamilton Anxiety Rating Scale (HAM-A) score, secondaryOutcomes measure: Mini-Mental State Examination (MMSE) score, secondaryOutcomes measure: Montreal Cognitive Assessment (MoCA) scale score, secondaryOutcomes measure: Change of National Institutes of Health Stroke Scale (NIHSS) score, secondaryOutcomes measure: Cerebrospinal fluid shunt surgery rate, secondaryOutcomes measure: Overall mortality rate, secondaryOutcomes measure: Rate of CSF infection, secondaryOutcomes measure: Rate of any type of new intracranial hemorrhage., secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Serious Adverse Event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329622, orgStudyIdInfo id: KY2023-972, briefTitle: Effect of Ketosteril on Sarcopenia in Patients With Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: The investigators hypothesize that Ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. Therefore, this study intends to take patients with CKD stage 3-4 and sarcopenia as the research object, give Ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of Ketosteril prescription for improving sarcopenia in patients with CKD., conditionsModule conditions: Chronic Kidney Disease, conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: low-protein diet + Ketosteril, interventions name: low-protein diet, outcomesModule primaryOutcomes measure: skeletal muscle mass index (SMI), secondaryOutcomes measure: changes in eGFR(ml/min/1.73m2), secondaryOutcomes measure: serum albumin(g/l), secondaryOutcomes measure: grip strength(kg), secondaryOutcomes measure: BMI(kg/m2), secondaryOutcomes measure: 6m walking speed(s), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nephrology, Huashan hospital, city: Shanghai, zip: 200040, country: China, contacts name: Mengjing Wang, role: CONTACT, phone: +8613764676029, email: fiyona27@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06329609, orgStudyIdInfo id: ClA-333, briefTitle: Airvo 3 Respiratory Rate Validation Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fisher and Paykel Healthcare, class: INDUSTRY, descriptionModule briefSummary: This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring., conditionsModule conditions: COPD, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Airvo 3 with respiratory rate algorithm, outcomesModule primaryOutcomes measure: Respiratory rate, secondaryOutcomes measure: Respiratory rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Element Boulder, city: Louisville, state: Colorado, zip: 80027, country: United States, contacts name: Monica Rabanal, MSc, BSN, role: CONTACT, email: monica.rabanal@element.com, contacts name: Blair Holman, MS, role: CONTACT, phone: +1 651 379 5549, email: Blair.Holman@element.com, contacts name: Monica Rabanal, MSc, BSN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.97776, lon: -105.13193, hasResults: False
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protocolSection identificationModule nctId: NCT06329596, orgStudyIdInfo id: H-55146, secondaryIdInfos id: D43TW012274, type: NIH, link: https://reporter.nih.gov/quickSearch/D43TW012274, briefTitle: Microbiome Alterations With Xylitol (MAX) in Pregnancy, acronym: MAX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Baylor College of Medicine, class: OTHER, collaborators name: Fogarty International Center of the National Institute of Health, collaborators name: University of Washington, collaborators name: Baylor College of Medicine Children's Foundation Malawi, descriptionModule briefSummary: The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi., conditionsModule conditions: Dysbiosis, conditions: Inflammation Gum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Participants, data collectors (i.e. dental officers, study staff members, clinical officers), and data analysts will be blinded (triple-blinded) to group allocation throughout the study., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Xylitol gum, interventions name: Sorbitol gum, outcomesModule primaryOutcomes measure: Periodontal disease at 28-30 weeks of pregnancy, secondaryOutcomes measure: Periodontal disease at 6 weeks postpartum, secondaryOutcomes measure: Alterations in the maternal oral microbiome communities delivery, secondaryOutcomes measure: Alterations in the maternal vaginal microbiome communities, secondaryOutcomes measure: Inflammatory mediator changes in the maternal gingival crevicular fluid at, secondaryOutcomes measure: Alterations within the infants' oral microbiome communities, secondaryOutcomes measure: Alterations within the infants' gut microbiome communities, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Area 25 Health Center, city: Lilongwe, country: Malawi, contacts name: Benjamin Shayo, role: CONTACT, phone: +265980888996, email: benjamin.shayo@bcm.edu, geoPoint lat: -13.96692, lon: 33.78725, hasResults: False
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protocolSection identificationModule nctId: NCT06329583, orgStudyIdInfo id: 23-012635, briefTitle: Establishing Pressures at the EGJ During Diaphragmatic Breathing Using High-resolution Esophageal Manometry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the EGJ as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm., conditionsModule conditions: Gastroesophageal Reflux, conditions: Dysphagia, conditions: Esophageal Motility Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: diaphragmatic breathing, outcomesModule primaryOutcomes measure: Pressure at the esophagogastric junction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329570, orgStudyIdInfo id: NF-2023-03, briefTitle: Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: NaviFUS Corporation, class: INDUSTRY, collaborators name: NaviFUS US LLC, descriptionModule briefSummary: This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide., conditionsModule conditions: Glioblastoma Multiforme, conditions: Glioblastoma, conditions: Glioma, conditions: Brain Tumor, conditions: Neoplasms, conditions: Neoplasms, Nerve Tissue, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: NaviFUS System, interventions name: Lumason, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Adverse Events (AEs), secondaryOutcomes measure: 6-month Progression-Free Survival (PFS-6), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: One-year Survival Rate, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Local Disease Control on the MRI Images, secondaryOutcomes measure: Corticosteroid Consumption, secondaryOutcomes measure: Quality of life (QoL) assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22903, country: United States, contacts name: Jason Sheehan, M.D., Ph.D., role: CONTACT, phone: 434-924-8129, email: JPS2F@uvahealth.org, contacts name: Arthur Lung, Ph.D., role: CONTACT, phone: 02-25860560, phoneExt: 180, email: arthur.lung@navifus.com, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False
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protocolSection identificationModule nctId: NCT06329557, orgStudyIdInfo id: 23-007188, briefTitle: Optimizing the Patient Experience Through Provider Coaching or Communication Intervention, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction., conditionsModule conditions: Patient Satisfaction, conditions: Communication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Intervention 1, outcomesModule primaryOutcomes measure: To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06329544, orgStudyIdInfo id: STUDY-23-01572, secondaryIdInfos id: 1R01DK137968-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DK137968-01, briefTitle: High Fructose Diet, the Gut Microbiome, and Metabolic Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, collaborators name: Metabolic Solutions Inc., collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period.The research team aims to:1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk.2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model.The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes.The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D.The research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children., conditionsModule conditions: MASLD, conditions: Type 2 Diabetes, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study will be a double-blinded (participants and select study personnel), randomized controlled crossover dietary intervention design., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: All participants undergo both treatment arms but will be blinded to the order., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fructose, interventions name: glucose, outcomesModule primaryOutcomes measure: Liver proton density fat fraction (PDFF), primaryOutcomes measure: Degree of fibrosis, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Morningside, city: New York, state: New York, zip: 10025, country: United States, contacts name: Ryan Walker, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06329531, orgStudyIdInfo id: 2022-0992, secondaryIdInfos id: NCI-2024-02555, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Validation of the Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS) Tool for Use in a Physical Medicine Rehabilitation Clinic, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-04-22, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To compare the results of the SOCS-OTS to another standardized screening measure that is currently being used by rehabilitation services at MD Anderson Cancer Center and to ensure that the SOCS-OTS correctly identifies those individuals needing OT services in cancer care., conditionsModule conditions: Cancer, conditions: Occupational Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Screen of Cancer Survivorship - Occupational Therapy Services (SOCS-OTS), outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Ekta Gupta, MD, role: CONTACT, phone: 713-745-2327, email: egupta@mdanderson.org, contacts name: Ekta Gupta, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06329518, orgStudyIdInfo id: HHC-2024-0064, briefTitle: Rezafungin PK in Patients on ECMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hartford Hospital, class: OTHER, collaborators name: Melinta Therapeutics, LLC, descriptionModule briefSummary: Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum echinocandin, Rezafungin, in critically ill patients receiving ECMO, conditionsModule conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Rezafungin, outcomesModule primaryOutcomes measure: Rezafungin Clearance, secondaryOutcomes measure: Rezafungin Area Under the Curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hartford Hospital, city: Hartford, state: Connecticut, zip: 06102, country: United States, geoPoint lat: 41.76371, lon: -72.68509, hasResults: False
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protocolSection identificationModule nctId: NCT06329505, orgStudyIdInfo id: 111-085-B, briefTitle: Impact of Extracorporeal Membrane Oxygenation Care Strategy Application Development, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Pei-Hung Liao, class: OTHER, descriptionModule briefSummary: The objective of this study was to develop an educational training App for ECMO care, and to apply a blended learning approach to improve the knowledge and skills of nurses., conditionsModule conditions: Learning Problem, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, outcomesModule primaryOutcomes measure: Comparison of knowledge and skills of nurses between groups after the intervention For 6 months., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Taipei university of nursing and health science, city: Taipei, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06329492, orgStudyIdInfo id: 23-007937, briefTitle: Autologous Alpha-2 Macroglobulin Rich Plasma, Safety and Efficacy in Symptomatic Moderate Knee Osteoarthritis, acronym: A2MRP, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine the effectiveness and safety of autologous alpha-2 macroglobulin rich plasma (A2MRP) injections in the treatment of knee osteoarthritis (OA)., conditionsModule conditions: Osteoarthritis, conditions: OA, conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group cohort of 20 subjects, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Autologous Alpha-2 Macroglobulin Rich Plasma (A2MRP), outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Visual Analog Scale (VAS) for Pain, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Pain interference, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-Computer adaptive test (CAT): Physical function, secondaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score (KOOS):, secondaryOutcomes measure: Procedure Recommendation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06329479, orgStudyIdInfo id: 1926B, briefTitle: A Feasibility Trial for Circadian Rest-activity Rhythm Disorders in Cancer (RALI), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, descriptionModule briefSummary: Circadian rest-activity rhythm disorders are common in patients with cancer, particularly in advanced disease. A recent international e-Delphi study has outlined recommendations for the assessment and reporting of the disorder and subsequently an observation study is underway assessing a cohort of patients with advanced cancer. Affected patients are eligible to enter a feasibility study assessing a non-pharmacological multi-modal intervention., conditionsModule conditions: Circadian Rhythm Disorders, conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive behavioural therapy for Insomnia (CBT-I), interventions name: Bright Light Therapy, interventions name: Individualised activity plan, interventions name: Clincial review, outcomesModule primaryOutcomes measure: Acceptability and usability of a multi-modal non-pharmacological intervention, primaryOutcomes measure: Adherence to interventions, primaryOutcomes measure: Adverse events, primaryOutcomes measure: Completion rates of research assessments, primaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Symptom assessment, secondaryOutcomes measure: Quality of Life assessment, secondaryOutcomes measure: Daytime Sleepiness, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Physical activity assessment, secondaryOutcomes measure: Physical activity and sleep assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Our Lady's Hospice & Care Services, status: RECRUITING, city: Dublin, zip: D6W RY72, country: Ireland, contacts name: Craig Gouldthorpe, role: CONTACT, phone: +3534986235, email: gouldthc@tcd.ie, geoPoint lat: 53.33306, lon: -6.24889, locations facility: St James's Hospital, status: RECRUITING, city: Dublin, zip: D6W RY72, country: Ireland, contacts name: Craig Gouldthorpe, role: CONTACT, phone: +3534986235, email: gouldthc@tcd.ie, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
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protocolSection identificationModule nctId: NCT06329466, orgStudyIdInfo id: 0000-0002-4205-669X, briefTitle: The Effect of Emotional Freedom Technique (EFT) on Pain Intensity and Menstruation Symptoms, acronym: EFT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-28, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-07-25, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Gulay Coskun, class: OTHER, collaborators name: Mersin University, descriptionModule briefSummary: The most important indicator of the fertility period, which has an important place in a woman's life, is the menstrual cycle, which begins with menarche and continues until menopause. In this natural process that takes place every month physiologically, some women experience significant pain \[1\]. This condition, defined as dysmenorrhea (painful menstruation), is classified in two ways as primary dysmenorrhea (PD) and secondary dysmenorrhea (SD) \[2,3\]. PD is the most common women's health problem, especially in adolescents and young adults (10-20 years of age) \[1,5\].When studies on the incidence and severity of primary dysmenorrhea are examined, the incidence of PD is seen at rates ranging from 40-90% \[5-8\].The main goal of the treatment approach to PD, which negatively affects women's quality of life in many ways, is to relieve the woman by reducing the pain. Emotional Freedom Technique (EFT) is one of the non-pharmacological and integrated treatment methods for women with primary dysmenorrhea. This practice, which is also referred to as EFT stroke/touch in most sources, is based on expressing the problem by touching the energy meridian points of the body, as in acupuncture and acupressure.Considering the results of the studies, it can be said that EFT is effective in the management of pain and the negative effects caused by the restrictions in the life of the person (social and daily living activities, etc.) \[27-30\]. Thanks to EFT, it is thought that women will contribute to the reduction of the fear and anxiety of experiencing pain just before menstruation and the anxiety that their life will be limited due to this.Studies investigating the effect of EFT on pain have reported that it is effective in coping with pain \[33-35\]. However, no randomized controlled study was found in the literature search for the application of EFT in high school students with dysmenorrhea. For this reason, it is thought that if EFT is applied in this age period with a high incidence of dysmenorrhea, important findings can be achieved in terms of parameters such as pain intensity and menstrual symptoms, and it will contribute to the literature by shedding light on similar studies. \[36\]. Therefore, in this study, it was aimed to determine the effect of the emotional freedom technique applied to high school students with primary dysmenorrhea on pain severity and menstruation symptoms., conditionsModule conditions: Dysmenorrhea Primary, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: intervention (EFT) group, outcomesModule primaryOutcomes measure: Mcgill Pain Scale, primaryOutcomes measure: Menstruation Symptom Scale, primaryOutcomes measure: VAS pain scale, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mersin University, city: Yenişehir, state: Mersin, zip: 33343, country: Turkey, geoPoint lat: 40.26444, lon: 29.65306, hasResults: False
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protocolSection identificationModule nctId: NCT06329453, orgStudyIdInfo id: 2000033081, briefTitle: Intestinal Immunity in Neurologic Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to ascertain the functional profiles of the immune cells within the gastrointestinal tract and to determine how these cells contribute to autoimmune and neurologic diseases., conditionsModule conditions: Multiple Sclerosis, conditions: Parkinson Disease, conditions: REM Sleep Behavior Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Colon Tissue Biopsy, outcomesModule primaryOutcomes measure: Characterization of immune cells from the gastrointestinal mucosa, secondaryOutcomes measure: Evaluate spatial transcriptomics of intestinal tissue, secondaryOutcomes measure: Characterize the microbiome at different anatomic sites within the gastrointestinal tract, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale MS Clinic, status: RECRUITING, city: North Haven, state: Connecticut, zip: 06473, country: United States, contacts name: Cynthia Marques, role: CONTACT, phone: 203-287-6100, email: cynthia.marques@yale.edu, contacts name: Dimitri Duvilaire, role: CONTACT, phone: 2032876100, email: dimitri.duvilaire@yale.edu, contacts name: Erin Longbrake, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.39093, lon: -72.85954, hasResults: False
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protocolSection identificationModule nctId: NCT06329440, orgStudyIdInfo id: 2023/880, briefTitle: Comparison of Supraclavicular and Costoclavicular Brachial Plexus Blocks in Adult Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-05, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: Hemidiaphragmatic paresis is a common side effect of brachial plexus blocks such as supraclavicular or infraclavicular block techniques. It has been shown that diaphragma thickness is affected at some extent in supraclavicular block and also in costoclavicular block which is accepted as an infraclavicular approach. However, these two approaches have not been extensively investigated before in terms of the diaphragmatic paresis. Here, it is aimed to compare these two methods considering their effects on diaphragma thickness in inspirium and in expirium. Moreover, the performance properties such as motor and sensory block onset, needle visualization time, needle visualization difficulty, postoperative pain scores, and lastly the perfusion index which is known to be reflecting vasodilation will be investigated., conditionsModule conditions: Diaphragm Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasonographic measurement of diaphragm thickness, outcomesModule primaryOutcomes measure: Diaphragm thickness fraction (centimeters), secondaryOutcomes measure: Diaphragm thickness at the end of expirium (centimeters)., secondaryOutcomes measure: Diaphragm thickness at the end of inspirium (centimeters)., secondaryOutcomes measure: Perfusion index change, secondaryOutcomes measure: Motor and sensory block onset time, secondaryOutcomes measure: Postoperative pain scores (0-10), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University Istanbul Faculty of Medicine, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Meltem Savran Karadeniz, MD, Assoc Prof, role: CONTACT, email: mskaradeniz@gmail.com, contacts name: Ozgur Selek, MD, role: CONTACT, phone: 00905057883600, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06329427, orgStudyIdInfo id: IRB00098063, briefTitle: Dragon Ambient eXperience (DAX) Copilot Evaluation, acronym: DAX, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Hieu Nguyen, MS - Biostatician, collaborators name: McKenzie Isreal, MPH - project manager, collaborators name: Casey Stephens, MPH - Health services researcher, descriptionModule briefSummary: AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods., conditionsModule conditions: Automated Clinical Documentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 238, type: ACTUAL, armsInterventionsModule interventions name: Dragon Ambient eXperience (DAX) Copilot, outcomesModule primaryOutcomes measure: Total EHR time, primaryOutcomes measure: Work outside of work, primaryOutcomes measure: Time on encounter note documentation, primaryOutcomes measure: Completed appointment rate, primaryOutcomes measure: Same day closure rate, primaryOutcomes measure: Note length, primaryOutcomes measure: Gross revenue per visit, primaryOutcomes measure: wRVU per visit, secondaryOutcomes measure: Provider satisfaction, secondaryOutcomes measure: Provider interview, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atrium Health Navicent, city: Macon, state: Georgia, zip: 31201, country: United States, geoPoint lat: 32.84069, lon: -83.6324, locations facility: Atrium Health Floyd, city: Rome, state: Georgia, zip: 30165, country: United States, geoPoint lat: 34.25704, lon: -85.16467, locations facility: Atrium Health, city: Charlotte, state: North Carolina, zip: 28203, country: United States, geoPoint lat: 35.22709, lon: -80.84313, locations facility: Scotland Health Care System, city: Laurinburg, state: North Carolina, zip: 28352, country: United States, geoPoint lat: 34.77405, lon: -79.46282, locations facility: Atrium Health Wake Forest Baptist, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06329414, orgStudyIdInfo id: 00164631, briefTitle: Acceptability and Feasibility of Transcranial Magnetic Stimulation (TMS) for Depression in Multiple Sclerosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The goal of this single-arm, observational pilot study is to learn about the safety, feasibility, preliminary efficacy of TMS for the treatment of depression in people with MS. Participants will receive outpatient TMS treatment over the course of 5-6 weeks. Participants will complete validated questionnaires and exams before, during, and after treatment., conditionsModule conditions: Multiple Sclerosis, conditions: Major Depressive Disorder, conditions: Treatment Resistant Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 12, type: ESTIMATED, outcomesModule primaryOutcomes measure: Feasibility of TMS treatment for MDD, per participant retention rates., primaryOutcomes measure: Safety and tolerability, to be evaluated by side effects and adverse events over the course of treatment., secondaryOutcomes measure: Depression response rates (50% reduction in symptoms) will be measured using MADRS scores before and after treatment., secondaryOutcomes measure: Depression remission rates will be measured using MADRS scores before and after treatment., secondaryOutcomes measure: MS lesion burden on MRI will be compared before and after treatment to determine impact of TMS on white matter disease burden., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah Health, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84108, country: United States, contacts name: Kathleen Shangraw, MD, role: CONTACT, phone: 801-583-2500, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06329401, orgStudyIdInfo id: AP01-007, briefTitle: A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Avalyn Pharma Inc., class: INDUSTRY, collaborators name: DevPro Biopharma, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 versus placebo on top of standard of care in participants with PPF over 52 weeks., conditionsModule conditions: Progressive Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: AP01, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID), secondaryOutcomes measure: To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL), secondaryOutcomes measure: To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52), secondaryOutcomes measure: To evaluate the change from baseline in quantitative lung fibrosis score., otherOutcomes measure: To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Newport Native MD, Inc., status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Paradigm Clinical Research - Redding, status: NOT_YET_RECRUITING, city: Redding, state: California, zip: 96001, country: United States, geoPoint lat: 40.58654, lon: -122.39168, locations facility: Clinical Site Partners, LCC, status: NOT_YET_RECRUITING, city: Leesburg, state: Florida, zip: 34748, country: United States, geoPoint lat: 28.81082, lon: -81.87786, locations facility: Renstar Medical Research, status: NOT_YET_RECRUITING, city: Ocala, state: Florida, zip: 34470, country: United States, geoPoint lat: 29.1872, lon: -82.14009, locations facility: Clinical Site Partners, status: NOT_YET_RECRUITING, city: Winter Park, state: Florida, zip: 32789, country: United States, geoPoint lat: 28.6, lon: -81.33924, locations facility: Accellacare, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Southeastern Research Center, status: NOT_YET_RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Lowcountry Lung and Critical Care, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29406, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
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protocolSection identificationModule nctId: NCT06329388, orgStudyIdInfo id: CSD-SFRI-013, briefTitle: Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-18, primaryCompletionDateStruct date: 2023-07-07, completionDateStruct date: 2023-08-11, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: TruHeight Vitamins, class: INDUSTRY, collaborators name: San Francisco Research Institute, descriptionModule briefSummary: This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device., conditionsModule conditions: Growth Disorders, conditions: Dietary Exposure, conditions: Child Development, conditions: Bone Development Abnormal, conditions: Body Weight, conditions: Child Malnutrition, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: TruHeight Growth Protein Shake, outcomesModule primaryOutcomes measure: Change in Height, secondaryOutcomes measure: Change in Type X Collagen Concentration in Urine, secondaryOutcomes measure: Change in Body Composition, secondaryOutcomes measure: Incidence of Adverse Events, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: SF Research Institute, city: San Francisco, state: California, zip: 94127, country: United States, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
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protocolSection identificationModule nctId: NCT06329375, orgStudyIdInfo id: 72967, briefTitle: Food Insecurity Reduction & Strategy Team, acronym: FIRST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-02-05, completionDateStruct date: 2025-02-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Food Insecurity, conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. Patients in the intervention group will be provided the following two resources in addition to SOC:1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge),2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition program, outcomesModule primaryOutcomes measure: Food insecurity at 30-days post initial discharge, secondaryOutcomes measure: Food insecurity at 60- and 90- days post post initial discharge, secondaryOutcomes measure: Measures of diabetes stress, secondaryOutcomes measure: Measures of hypoglycemia, secondaryOutcomes measure: Measures of medication adherence, secondaryOutcomes measure: Hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329362, orgStudyIdInfo id: 2-7-23, briefTitle: Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-31, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Royal College of Surgeons of Edinburgh, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density., conditionsModule conditions: Alveolar Bone Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Minimally invasive implantation, interventions name: Open flap procedure for ridge expansion., outcomesModule primaryOutcomes measure: Implant stability., primaryOutcomes measure: CBCT assessment, secondaryOutcomes measure: Postoperative Pain, secondaryOutcomes measure: Operation Time, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Cairo University, status: RECRUITING, city: Cairo, zip: 35855, country: Egypt, contacts name: Bassem Emad, MDs, role: CONTACT, phone: +201001113474, email: bassem_26@hotmail.com, contacts name: Emad Deif, Prof, role: CONTACT, phone: +201222331938, email: daif_emad@yahoo.com, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Future Dental Academy GmbH, status: RECRUITING, city: Flonheim, state: Rheinland - Pfalz, zip: D-55237, country: Germany, contacts name: Armin Nadjet, A.Prof, role: CONTACT, phone: +4915115253692, email: nedjat@t-online.de, contacts name: Rainer Zoppke, role: CONTACT, phone: +491778339601, email: Rainer.Zoppke@champions-implants.com, geoPoint lat: 49.785, lon: 8.04, hasResults: False
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protocolSection identificationModule nctId: NCT06329349, orgStudyIdInfo id: EK VP57/0/2023, briefTitle: Metabolic Flexibility to Predict Lifestyle Interventions Outcomes, acronym: MEPHISTO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Ministry of Health, Czech Republic, collaborators name: EXCELES LX22NPO5104, CarDia, descriptionModule briefSummary: Weight loss is a cornerstone of diabetes (T2D) management, yet in clinical practice, its delivery is limited by its perceived burdensome nature and variability in response. Personalization of the interventions to increase their success rate is an unmet clinical need. The proposed project MEPHISTO (Whole body and gut microbiome metabolic flexibility to predict lifestyle intervention outcomes) would aim to identify predictive features related to successful weight loss upon sequential exercise and diet intervention in people living with obesity. To this end, the study aims to conduct a clinical trial where the investigators would implement state-of-the-art physiological phenotyping of metabolic flexibility at the whole-body level and at the level of the gut in persons with obesity before and after exercise and diet + exercise intervention to identify predictive signatures of successful weight loss, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 randomized cross-over, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Combined Exercise + Diet, outcomesModule primaryOutcomes measure: Change in metabolic flexibility (MetFlex (ΔRQ 200-0)), primaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Glucose tolerance relate to primary outcomes changes, secondaryOutcomes measure: HbA1c relate to primary outcomes changes, secondaryOutcomes measure: Insulin sensitivity relate to primary outcomes changes, otherOutcomes measure: Microbiome composition relate to weight loss: exploratory outcome, otherOutcomes measure: Metabolomic signatures relate to weight loss: exploratory outcome, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospital Kralovske Vinohrady, status: RECRUITING, city: Prague, zip: 10034, country: Czechia, contacts name: Jan Gojda, PhD, role: CONTACT, phone: +420267163031, email: jan.gojda@lf3.cuni.cz, contacts name: Katerina Koudelkova, MD, role: CONTACT, phone: +420267163031, email: katerina.koudelkova@fnkv.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Third Medical Faculty,Charles University, status: RECRUITING, city: Prague, zip: 10084, country: Czechia, contacts name: Michaela Šiklová, PhD, role: CONTACT, phone: +420267102222, email: michaela.siklova@lf3.cuni.cz, contacts name: PhD, role: CONTACT, phone: +420267163031, email: jan.gojda@lf3.cuni.cz, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Faculty of Sports Science, status: RECRUITING, city: Prague, zip: 16000, country: Czechia, contacts name: Michal Šteffl, PhD, role: CONTACT, phone: +420220172072, email: michal.steffl@ftvs.cuni.cz, contacts name: Tomáš Větrovský, PhD, role: CONTACT, phone: +420220172072, email: tomas.vetrovsky@ftvs.cuni.cz, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
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protocolSection identificationModule nctId: NCT06329336, orgStudyIdInfo id: STUDY00019653, secondaryIdInfos id: UL1TR002319, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR002319, briefTitle: Parenting Support for Justice Involved Families, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: Together with the Community Care Team of King County Community Partnership for Transition Solutions (KCCPTS), the investigators propose to collaborate in adapting parenting intervention(s) to support the well-being and effective parenting of parents re-entering the community, as well as that of their children's primary caregiver. The aim is promoting the well-being of the parents/caregivers and their children, fostering positive child development, and ultimately, preventing the intergenerational transmission of adversity. The KCCPTS Community Care Team includes re-entry navigators who have lived experience of adversity and incarceration, bringing their unique insights regarding the re-entry experience, from both personal and professional experiences. This study will evaluate a task-sharing approach to offering formerly incarcerated parents and their families a parenting support intervention. That is, re-entry navigators will be trained to deliver evidence-based parenting interventions. This increases the feasibility and accessibility of the program, particularly because facilitators have shared experiences and trusted connections with their clients. This project proposes four main activities: 1) conduct focus groups with parents re-entering the community to better understand their parenting needs, 2) work with KCCPTS re-entry navigators to incorporate information from their experience and the focus group to adapt a parenting intervention, 3) train re-entry navigators to deliver the program, and 4) conduct a preliminary evaluation of the impact of the program on parents' well-being and parenting when the program is delivered by KCCPTS re-entry navigators. If this preliminary evaluation shows promise in supporting parent well-being and parenting effectiveness, the investigators will seek funding to conduct a larger, more rigorous evaluation., conditionsModule conditions: Parenting, conditions: Well-Being, Psychological, conditions: Mental Health Wellness 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Social Emotional Competence for Children and Parents, outcomesModule primaryOutcomes measure: Parenting Behavior Inventory - Very short Form, primaryOutcomes measure: PHQ-9 Depressive Symptoms, primaryOutcomes measure: GAD-7 Anxiety Symptoms, primaryOutcomes measure: Brief Resilience Scale, primaryOutcomes measure: Self-Compassion Scale - Short Form, primaryOutcomes measure: Strengths and Difficulties Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329323, orgStudyIdInfo id: 23CX8477, briefTitle: SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours, acronym: SUMMER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.The main question\[s\] it aims to answer are:1. To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)2. To understand the imaging profile of MOGCTs compared to that of BOGCTs3. To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease4. To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI5. To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aimsParticipants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass., conditionsModule conditions: Germ Cell Ovarian Cancer, conditions: Germ Cell Tumor, conditions: Germ Cell Cancer, conditions: Germ Cell Neoplasia, conditions: Ovary Cancer, conditions: Ovary Neoplasm, conditions: Ovarian Cancer, conditions: Ovarian Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Blood test, interventions name: Pathology specimen miRNA expression, outcomesModule primaryOutcomes measure: Difference in microRNA expression (plasma) between benign and malignant masses, primaryOutcomes measure: Difference in microRNA expression (serum) between benign and malignant masses, primaryOutcomes measure: microRNA expression (plasma), primaryOutcomes measure: microRNA expression (serum), secondaryOutcomes measure: Quantitative measure of circulating miRNA before treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA before treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA after treatment, secondaryOutcomes measure: Quantitative measure of circulating miRNA after treatment, secondaryOutcomes measure: Performance of segmentation model on ultrasound images, secondaryOutcomes measure: Performance of segmentation model on MRI images, secondaryOutcomes measure: Performance of classification model on ultrasound images, secondaryOutcomes measure: Performance of classification model on MRI images, eligibilityModule sex: FEMALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329310, orgStudyIdInfo id: XEL-CR-14, briefTitle: Xeltis Hemodialysis Access Conduit: aXess-E Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Xeltis, class: INDUSTRY, descriptionModule briefSummary: A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation., conditionsModule conditions: End Stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: aXess-E conduit, outcomesModule primaryOutcomes measure: Primary Patency rate, primaryOutcomes measure: Freedom from device-related SAE, secondaryOutcomes measure: Implantation success rate, secondaryOutcomes measure: Primary patency rate, secondaryOutcomes measure: Primary assisted patency rate, secondaryOutcomes measure: Secondary patency rate, secondaryOutcomes measure: Functional patency rate, secondaryOutcomes measure: Time (expressed in months) to first intervention and to access abandonment, secondaryOutcomes measure: Rate of access-related interventions required to achieve/maintain patency, secondaryOutcomes measure: Freedom from device-related SAE, secondaryOutcomes measure: Rate of access site infections, secondaryOutcomes measure: Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment, secondaryOutcomes measure: Time to first cannulation, secondaryOutcomes measure: Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329297, orgStudyIdInfo id: NUR23-1005 INPTCGM1, briefTitle: Continuous Glucose Monitoring in Inpatients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Parkview Health, class: OTHER, descriptionModule briefSummary: The purpose of this study is to contribute to current research regarding the feasibility and accuracy of CGM in the hospital setting for both the medical and cardiovascular intensive care (ICU) patient populations., conditionsModule conditions: Hyperglycemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: CGM monitor, outcomesModule primaryOutcomes measure: CGM vs point of care test (POCT) glucose, secondaryOutcomes measure: Slow downward trend arrow on CGM device, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329284, orgStudyIdInfo id: RC 31.1.2024, briefTitle: Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-09-15, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils., conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Newly pregnant normotensive (NT) women with singleton fetus, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: ELISA, outcomesModule primaryOutcomes measure: Severity of Pre-Eclampsia (PE), eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Banha University, city: Banhā, state: El- Qalyobia, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False
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protocolSection identificationModule nctId: NCT06329271, orgStudyIdInfo id: 113022-E, briefTitle: After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-04-29, completionDateStruct date: 2025-04-29, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Far Eastern Memorial Hospital, class: OTHER, descriptionModule briefSummary: Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.Patients and methods:For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded., conditionsModule conditions: Bony Weight Bearing Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Early-Weight bearing, outcomesModule primaryOutcomes measure: Harris Hip Functional score, primaryOutcomes measure: Harris Hip Functional score, primaryOutcomes measure: Harris Hip Functional score, primaryOutcomes measure: Harris Hip Functional score, primaryOutcomes measure: Harris Hip Functional score, secondaryOutcomes measure: Visual analog pain score, secondaryOutcomes measure: Visual analog pain score, secondaryOutcomes measure: Visual analog pain score, secondaryOutcomes measure: Visual analog pain score, secondaryOutcomes measure: Visual analog pain score, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Far-Eastern Memorial Hospital, status: RECRUITING, city: New Taipei City, zip: 220, country: Taiwan, contacts name: Yen Cheng Chen, role: CONTACT, phone: 886919207805, email: sstteevveepp@gmail.com, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False
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protocolSection identificationModule nctId: NCT06329258, orgStudyIdInfo id: PTC09, briefTitle: Combination of Sotyktu and Enstilar for Plaque Psoriasis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-06, primaryCompletionDateStruct date: 2023-11-13, completionDateStruct date: 2023-11-13, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Psoriasis Treatment Center of Central New Jersey, class: OTHER, descriptionModule briefSummary: combination deucravacitinib and enstilar foam, conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Enstilar, interventions name: Deucravacitinib, outcomesModule primaryOutcomes measure: Psoriasis Area and Severity Index 75 at week 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schweiger Derm Group, city: East Windsor, state: New Jersey, zip: 08520, country: United States, geoPoint lat: 40.268, lon: -74.54043, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-08-30, uploadDate: 2024-03-14T10:41, filename: Prot_SAP_000.pdf, size: 834542, hasResults: False
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protocolSection identificationModule nctId: NCT06329245, orgStudyIdInfo id: brainpro2022, briefTitle: Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2029-07-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Fudan University, class: OTHER, collaborators name: ShanghaiTech University, descriptionModule briefSummary: The goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (ASD). The main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of ASD are. Participants will receive developmental and social communicational assessments (Griffiths Mental Developmental Scales, Peabody Developmental Motor Scales, The Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist), resting-state EEG and MRI in a natural sleeping state., conditionsModule conditions: Autism or Autistic Traits, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Do not take any interventions, outcomesModule primaryOutcomes measure: clinical diagnosis, primaryOutcomes measure: neurodevelopmental outcome, primaryOutcomes measure: Prosocial behaviors, primaryOutcomes measure: nuclear magnetic resonance imaging(MRI), primaryOutcomes measure: Event related potentials (ERPs), eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 18 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329219, orgStudyIdInfo id: wIRA, briefTitle: Water-filtered Infrared-A Radiation in Patients With Hand Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial is to evaluate the effects of water-filtered Infrared-A radiation on patients suffering from hand osteoarthritis. The main questions it aims to answer are:* Does water-filtered Infrared-A radiation reduce pain and improve the function of finger joints over time?* Are patients satisfied with the treatment results when compared to those who were on a wait-list?, conditionsModule conditions: Hand Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: water-filtered Infrared-A radiation, outcomesModule primaryOutcomes measure: Pain in the finger joints on visual analogue scale, secondaryOutcomes measure: Hand Dynamometer, secondaryOutcomes measure: Disabilities of Arm, Shoulder and Hand (DASH) questionnaire, secondaryOutcomes measure: Pain Self-Efficacy Questionnaire, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Short Form (SF)-36 Health Survey (SF-36), secondaryOutcomes measure: Functional Index for Hand OsteoArthritis (FIHOA), secondaryOutcomes measure: Tolerability of the intervention, secondaryOutcomes measure: Pain medication (number per day), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - Universitätsmedizin Berlin at the Department of Internal and Integrative Medicine, Immanuel Krankenhaus Berlin, status: RECRUITING, city: Berlin-Wannsee, state: Berlin, zip: 14109, country: Germany, contacts name: Miriam Rösner, role: CONTACT, phone: +49 30 80505 682, email: naturheilkunde.studien@immanuel.de, geoPoint lat: 52.41915, lon: 13.15531, hasResults: False
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protocolSection identificationModule nctId: NCT06329206, orgStudyIdInfo id: GH2616-101, briefTitle: A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-04-25, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, collaborators name: Zhejiang Cancer Hospital, collaborators name: Henan Cancer Hospital, collaborators name: Hubei Cancer Hospital, collaborators name: The First Affiliated Hospital of Zhengzhou University, descriptionModule briefSummary: This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: GH2616 Tablets, outcomesModule primaryOutcomes measure: Safety assessment, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Time to achieve Cmax (Tmax), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Zhejiang, country: China, contacts name: ZHENGBO SONG, DOCTORATE, role: CONTACT, phone: +8613857153345, email: zjccgcp_phase1@126.com, hasResults: False
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protocolSection identificationModule nctId: NCT06329193, orgStudyIdInfo id: CBU-FTR-ES-O4, briefTitle: Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players., conditionsModule conditions: Anxiety, conditions: Exercise, conditions: Athletic Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Mid-Season Camp Period Loading, outcomesModule primaryOutcomes measure: Sports Injury Anxiety, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Flexibility, secondaryOutcomes measure: Dynamic balance, secondaryOutcomes measure: Single-leg jump, secondaryOutcomes measure: Agility, secondaryOutcomes measure: Sprint, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 22 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06329180, orgStudyIdInfo id: 26.02.2024, briefTitle: Exercise in Mental Illness Questionnaire: French Validation, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, descriptionModule briefSummary: The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days., conditionsModule conditions: Exercise, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 42, type: ESTIMATED, outcomesModule primaryOutcomes measure: Intra-class-correlation coefficients (ICC 3,1, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Psychiatrique Chêne aux Haies, city: Mons, country: Belgium, geoPoint lat: 50.45413, lon: 3.95229, hasResults: False
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protocolSection identificationModule nctId: NCT06329167, orgStudyIdInfo id: 2024-HS-012, briefTitle: Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, descriptionModule briefSummary: This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery., conditionsModule conditions: Lower Extremity Lymphedema, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Daphnetin, interventions name: Aescuven, outcomesModule primaryOutcomes measure: The difference in the circumference of the lower limbs, primaryOutcomes measure: Gynaecological Cancer Lymphedema Questionnaire, primaryOutcomes measure: Fibrinogen content, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the 1st hospital of Jilin University, status: RECRUITING, city: Chang Chun, state: Jilin, country: China, contacts name: Xiaosen Li Li, role: CONTACT, phone: +8618343116682, email: xiaosensen@jlu.edu.cn, geoPoint lat: 42.74694, lon: 126.24667, hasResults: False
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protocolSection identificationModule nctId: NCT06329154, orgStudyIdInfo id: PJ-KS-KY-2024-03(X), briefTitle: Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-01-27, completionDateStruct date: 2025-02-27, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Yong Liu, MD, class: OTHER, descriptionModule briefSummary: This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries., conditionsModule conditions: Rotator Cuff Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal shock wave therapy, interventions name: conventional rehabilitation therapy, outcomesModule primaryOutcomes measure: Change from Baseline Visual Analogue Scale at 4 weeks, primaryOutcomes measure: Change from Baseline Range of Motion at 4 weeks, primaryOutcomes measure: Change from Baseline Constant-Murley Score at 4 weeks, primaryOutcomes measure: Change from Baseline Isokinetic muscle strength testing at 4 weeks, primaryOutcomes measure: Change from Baseline Magnetic resonance imaging at 4 weeks, primaryOutcomes measure: Change from Baseline Musculoskeletal ultrasound at 4 weeks, secondaryOutcomes measure: Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks, secondaryOutcomes measure: Change from Baseline Shoulder Pain and Disability Index at 4 weeks, secondaryOutcomes measure: Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks, secondaryOutcomes measure: Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks, secondaryOutcomes measure: Change from Baseline Pittsburgh sleep quality index at 4 weeks, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116011, country: China, contacts name: yong liu, role: CONTACT, phone: 18098876656, email: fuwa52008@126.com, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False
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protocolSection identificationModule nctId: NCT06329141, orgStudyIdInfo id: HSG4112-P2-03, briefTitle: A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Glaceum, class: INDUSTRY, descriptionModule briefSummary: 1. Study Objective - To assess the efficacy and safety of vutiglabridin in early Parkindson's disease patients2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in early Parkinson's disease patients.3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Vutiglabridin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change From Baseline in MDS-UPDRS Part III Subscore, secondaryOutcomes measure: Change From Baseline in MDS-UPDRS Part III Subscore, secondaryOutcomes measure: Change From Baseline in MDS-UPDRS Part II + Part III, secondaryOutcomes measure: Change From Baseline in CGI-C score, secondaryOutcomes measure: Change From Baseline in K-NMSS score, secondaryOutcomes measure: Change From Baseline in Modified Hoehn-Yahr stage, secondaryOutcomes measure: Change From Baseline in PET SNBR (Specific to Non-specific Binding Ratio) in the putamen, acudate and nucleus, secondaryOutcomes measure: Drop-out rate due to taking anti-parkinson drug, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329128, orgStudyIdInfo id: 2022/04, briefTitle: Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Hasan Kalyoncu University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were divided in two groups. One groups will get electrotherapy, exercise(home programme) and manuel therapy intervention. One group will be the control group. Control group will get electrotherapy and exercise (home programme)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Study Group, interventions name: Active Comparator: Control Group, outcomesModule primaryOutcomes measure: The pain, primaryOutcomes measure: Functional status, primaryOutcomes measure: The quality of Life, primaryOutcomes measure: Lower extremity functional strength and balance test, primaryOutcomes measure: Functional mobility, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hasan Kalyoncu University, city: Gaziantep, state: Şahinbey, zip: 27100, country: Turkey, geoPoint lat: 37.05944, lon: 37.3825, hasResults: False
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protocolSection identificationModule nctId: NCT06329115, orgStudyIdInfo id: 2024/23, briefTitle: Investigation of the Effectiveness of Regular Physical Activity in University Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Hasan Kalyoncu University, class: OTHER, descriptionModule briefSummary: In our study, university students who coded the course from various faculties and departments within the scope of a university-wide free elective course, after regular physical activity; It was aimed to examine the effects on lifelong learning, physical activity, fatigue, sleepiness, depression, anxiety and stress levels, quality of life and walking distances and physiological expenditure indices., conditionsModule conditions: Regular Physical Activity, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will be included in an 8-week regular exercise program. Evaluations will be made before and after exercise., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Exercise training, outcomesModule primaryOutcomes measure: Lifelong learning, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Fatique, primaryOutcomes measure: Daytime sleepiness, primaryOutcomes measure: Depression, anxiety and stress, primaryOutcomes measure: Quality of life measurement, primaryOutcomes measure: Physiological expenditure indices, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hasan Kalyoncu University, city: Gaziantep, state: Şahinbey, zip: 27100, country: Turkey, geoPoint lat: 37.05944, lon: 37.3825, hasResults: False
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protocolSection identificationModule nctId: NCT06329102, orgStudyIdInfo id: 93628, briefTitle: Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen, acronym: RCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, collaborators name: Intuitive Surgical, descriptionModule briefSummary: Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power., conditionsModule conditions: Right Sided Colon Cancer, conditions: Right Colectomy, conditions: Lymphadenectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Surgical access, outcomesModule primaryOutcomes measure: Surgical complications defined by Calvien Dindo II to V, secondaryOutcomes measure: Surgical quality described by the specimen quality and number of lymph nodes harvested, secondaryOutcomes measure: Oncological quality will be measured by overall survival and recurrence, secondaryOutcomes measure: Quality of life after surgery measured with the 15D instrument, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5009, country: Norway, contacts name: Frank Pfeffer, Prof, role: CONTACT, phone: 48180021, phoneExt: 0047, email: frank.pfeffer@helse-bergen.no, contacts name: Havard Forsmo, PhD, role: CONTACT, phone: 48276232, phoneExt: 0047, email: havard.mjorud.forsmo@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
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protocolSection identificationModule nctId: NCT06329089, orgStudyIdInfo id: HCB/2023/0840, briefTitle: Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer, acronym: RENATA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries. The main questions it aims to answer are:* What is the rate of identification of the sentinel lymph node, and how does it vary among patients with different histories of axillary surgeries?* How can we describe and understand the drainage pathways, including those from the armpit on the same side as the cancer, the area near the breastbone, and the opposite armpit?Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer. They will also receive standard treatments, including surgery and adjuvant therapies as recommended by their healthcare team., conditionsModule conditions: Recurrent Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 97, type: ESTIMATED, armsInterventionsModule interventions name: Reoperative Sentinel Lymph Node Biopsy, outcomesModule primaryOutcomes measure: Re-Sentinel Lymph node harvesting rate, primaryOutcomes measure: Drainage pathways description, secondaryOutcomes measure: Complications rate, secondaryOutcomes measure: Axillary metastasis rate, secondaryOutcomes measure: Correlation Between Axillary and Internal Mammary Chain Infiltration, secondaryOutcomes measure: Quality of life in recurrent breast cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic de Barcelona, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Ines Torras Caral, role: CONTACT, phone: 93 227 54 00, phoneExt: 2499, email: itorras@clinic.cat, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06329076, orgStudyIdInfo id: BAM_lab_eyetracking_04, briefTitle: Losartan Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Electronic Science and Technology of China, class: OTHER, descriptionModule briefSummary: The main aim of the present study is to investigate the effects of orally administered losartan on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Randomized placebo-controlled double-blind between-subject design, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Losartan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after losartan administration, secondaryOutcomes measure: First saccade latency(ms) for threatening versus non-threatening stimuli after losartan administration, secondaryOutcomes measure: Fixation duration(ms) for threatening versus non-threatening stimuli after losartan administration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Electronic Science and Technology of China, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Weihua Zhao, Dr, role: CONTACT, phone: 86-28-61830811, email: zarazhao.uestc@outlook.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06329063, orgStudyIdInfo id: BAM_lab_eyetracking_03, briefTitle: Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Electronic Science and Technology of China, class: OTHER, descriptionModule briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Randomized placebo-controlled double-blind between-subject design, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vasopressin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Ratio of judged-time-to-collision to actual-time-to-collision for threatening versus non-threatening stimuli after oral vasopressin administration, secondaryOutcomes measure: First saccade latency(ms) for threatening versus non-threatening stimuli after oral vasopressin administration, secondaryOutcomes measure: Fixation duration(ms) for threatening versus non-threatening stimuli after oral vasopressin administration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Electronic Science and Technology of China, status: RECRUITING, city: Chendu, state: Sichuan, country: China, contacts name: Weihua Zhao, Dr, role: CONTACT, phone: 86-28-61830811, email: zarazhao.uestc@outlook.com, hasResults: False
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protocolSection identificationModule nctId: NCT06329050, orgStudyIdInfo id: BAM_lab_eyetracking_02, briefTitle: The Effects of Losartan on Attention Control: An Eye-tracking Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Electronic Science and Technology of China, class: OTHER, descriptionModule briefSummary: The main aim of the present study is to investigate the effects of orally administered Losartan on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Losartan, interventions name: Placebo, outcomesModule primaryOutcomes measure: Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration, primaryOutcomes measure: Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration, secondaryOutcomes measure: Saccade/antisaccade latency for different facial emotions after losartan administration, secondaryOutcomes measure: Error rate of saccade/antisaccade for different facial emotions after losartan administration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Electronic Science and Technology of China, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 611731, country: China, contacts name: Weihua Zhao, Dr, role: CONTACT, phone: 86-28-61830811, email: zarazhao.uestc@outlook.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06329037, orgStudyIdInfo id: BAM_lab_eye-tracking_01, briefTitle: The Effects of Oral Vasopressin on Attention Control: An Eye-tracking Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Electronic Science and Technology of China, class: OTHER, descriptionModule briefSummary: The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized placebo-controlled double-blind between-subject design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vasopressin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Saccade/antisaccade latency difference between social and non-social stimuli after oral vasopressin administration, primaryOutcomes measure: Error rate of saccade/antisaccade for social versus non-social stimuli after oral vasopressin administration, secondaryOutcomes measure: Saccade/antisaccade latency for different facial emotions after oral vasopressin administration, secondaryOutcomes measure: Error rate of saccade/antisaccade for different facial emotions after oral vasopressin administration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Electronic Science and Technology of China, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 611731, country: China, contacts name: Weihua Zhao, Dr, role: CONTACT, phone: 86-28-61830811, email: zarazhao.uestc@outlook.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06329024, orgStudyIdInfo id: myofascial dysphagiapoststrok, briefTitle: The Impact of Myofascial Release Therapy on Dysphagia in Post-stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Myofascial Release Therapy in Dysphagic Stroke Survivors. The main question it aims to answer is:• Can Myofascial Release Therapy improve swallowing function in Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Myofascial Release Therapy. The study lasts 21 days for each patient. Researchers will compare the Functional Oral Intake Scale, Penetration-Aspiration Scale, Swallowing Quality of Life to see if the Myofascial Release Therapy can help improve the situation., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation treatment, interventions name: Myofascial Release Therapy, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, secondaryOutcomes measure: Patient health questionnaire-9, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06329011, orgStudyIdInfo id: TDC+IOE, briefTitle: Combining Transcranial Direct Current Stimulation With Intermittent Oral to Esophageal Tube for Stroke-related Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Transcranial direct current stimulation, interventions name: Placebo Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Penetration Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Swallowing Quality of Life Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Body weight, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328998, orgStudyIdInfo id: Intra-articular Injection, briefTitle: Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint DysfunctionThe main question it aims to answer is:• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction, conditionsModule conditions: Temporomandibular Joint Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Routine rehabilitation treatment, interventions name: Intra-articular Injection, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Friction Index, secondaryOutcomes measure: The Visual Analog Scale, secondaryOutcomes measure: The maximum mouth opening limit, secondaryOutcomes measure: Mann Assessment of Swallowing Ability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328985, orgStudyIdInfo id: IOETraumatic Brain Injury, briefTitle: Intermittent Oro-esophageal Tube Feeding in Traumatic Brain Injury Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric tube feeding, outcomesModule primaryOutcomes measure: Concentration of hemoglobin, primaryOutcomes measure: Concentration of albumin, primaryOutcomes measure: Concentration of prealbumin, primaryOutcomes measure: body mass index, secondaryOutcomes measure: Decannulation of tracheostomy tube-placement duration, secondaryOutcomes measure: Decannulation of tracheostomy tube-Successful removal, secondaryOutcomes measure: Level of consciousness, secondaryOutcomes measure: Feeding Amount, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06328972, orgStudyIdInfo id: IOE-Cerebral Palsy, briefTitle: Intermittent Multifunctional Nutrition Tube in Cerebral Palsy and Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: systemic therapy, interventions name: Intermittent Oro-Esophageal Tube Feeding, interventions name: Persistent Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: The Oral Motor Assessment Scale, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Total Protein, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: Prealbumin, secondaryOutcomes measure: body weight, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale for Infants, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06328959, orgStudyIdInfo id: IOE- Pierre Robin, briefTitle: Effect of Oral Feeding in Infants With Pierre Robin Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared., conditionsModule conditions: Pierre Robin Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: intermittent oro-esophageal tube feeding, interventions name: gastric tube feeding, outcomesModule primaryOutcomes measure: Number of patients diagnosed as the pulmonary infection "Positive", secondaryOutcomes measure: Concentration of total protein, secondaryOutcomes measure: Concentration of hemoglobin, secondaryOutcomes measure: Concentration of albumin, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: The Functional Oral Intake Scale for Infants, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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