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protocolSection identificationModule nctId: NCT06309446, orgStudyIdInfo id: 381001BS, briefTitle: Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-14, primaryCompletionDateStruct date: 2020-02-19, completionDateStruct date: 2020-07-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, collaborators name: Bioskin GmbH, descriptionModule briefSummary: Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel., conditionsModule conditions: Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Zoralan Wound, outcomesModule primaryOutcomes measure: Wound healing efficacy (clinical), primaryOutcomes measure: Wound healing efficacy (global), primaryOutcomes measure: Cooling properties, secondaryOutcomes measure: Local tolerability (clinical), secondaryOutcomes measure: Local tolerability (global), secondaryOutcomes measure: Signs of infection, secondaryOutcomes measure: Time until 100% healing, secondaryOutcomes measure: Time until 75% healing, secondaryOutcomes measure: Presence of crusts, secondaryOutcomes measure: Questionnaire on product performance, secondaryOutcomes measure: Cosmetic outcome/acceptance, secondaryOutcomes measure: Photographic documentation of the wound - visual of the wound to support previous outcomes., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bioskin GmbH, city: Hamburg, zip: 20095, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
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protocolSection identificationModule nctId: NCT06309433, orgStudyIdInfo id: DXA-TKA, briefTitle: Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design, acronym: DXA-TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up., conditionsModule conditions: Periprosthetic Osteolysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: dual energy x-ray absorptiometry, outcomesModule primaryOutcomes measure: Periprosthetic bone mineral density measurement, primaryOutcomes measure: Periprosthetic bone mineral density measurement, primaryOutcomes measure: Periprosthetic bone mineral density measurement, primaryOutcomes measure: Periprosthetic bone mineral density measurement, secondaryOutcomes measure: Knee Society Score, secondaryOutcomes measure: Knee Society Score, secondaryOutcomes measure: Knee Society Score, secondaryOutcomes measure: Knee Society Score, secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, secondaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, secondaryOutcomes measure: Knee injury and Osteoarthritis Outcome Score, secondaryOutcomes measure: 36-Item Short Form Health Survey, secondaryOutcomes measure: 36-Item Short Form Health Survey, secondaryOutcomes measure: 36-Item Short Form Health Survey, secondaryOutcomes measure: 36-Item Short Form Health Survey, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stefano Zaffagnini, status: RECRUITING, city: Bologna, state: Italia, country: Italy, contacts name: Stefano Zaffagnini, MD, role: CONTACT, phone: 051 6366075, email: stefano.zaffagnini@unibo.it, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto ortoepdico rizzoli, status: RECRUITING, city: Bologna, zip: 40136, country: Italy, contacts name: Stefano Zaffagnini, Prof., role: CONTACT, phone: 00390516366111, email: stefano.zaffagnini@unibo.it, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06309420, orgStudyIdInfo id: 19E0566, briefTitle: Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-07, primaryCompletionDateStruct date: 2020-08-10, completionDateStruct date: 2020-08-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, descriptionModule briefSummary: The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts., conditionsModule conditions: Warts, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Cryogenic treatment of warts (Pixie CO2), interventions name: Cryogenic treatment of warts (Wortie®), outcomesModule primaryOutcomes measure: Percentage of subjects with clinical wart remission, secondaryOutcomes measure: Number of treatments, secondaryOutcomes measure: Efficacy of the freezing process (Surface Area), secondaryOutcomes measure: Diameter of the wart, secondaryOutcomes measure: Roughness of the wart, secondaryOutcomes measure: Thickness of the wart (For common warts only), secondaryOutcomes measure: Presence of small dark spot (For plantar warts only), secondaryOutcomes measure: Healing process of the wart, secondaryOutcomes measure: Local & general tolerance, eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dermscan Poland, city: Gdansk, zip: 80-288, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False
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protocolSection identificationModule nctId: NCT06309407, orgStudyIdInfo id: STUDY00024903, briefTitle: Dosimeter Location in Pain Physicians, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-23, primaryCompletionDateStruct date: 2023-04-21, completionDateStruct date: 2023-04-21, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event., conditionsModule conditions: RAD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants were randomized to wear either chest dosimeters only or chest and hand dosimeters for the duration of the study in order to measure differences in radiation readings by each dosimeter location., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Hand Dosimeters, interventions name: Standard Practice, outcomesModule primaryOutcomes measure: Radiation Readings, secondaryOutcomes measure: Number of Glove Breach Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health & Science University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06309394, orgStudyIdInfo id: INCB99280-102, briefTitle: A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-06-03, completionDateStruct date: 2024-06-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]INCB099280 in Healthy Male Participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ESTIMATED, armsInterventionsModule interventions name: INCB099280, outcomesModule primaryOutcomes measure: Total recovery of radioactivity from urine and feces., primaryOutcomes measure: Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion, secondaryOutcomes measure: Pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: PK for whole blood and plasma total radioactivity, secondaryOutcomes measure: Number of participants with Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309381, orgStudyIdInfo id: CEIm2.23, briefTitle: Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-08, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Doctor Peset, class: OTHER, descriptionModule briefSummary: Rebound pain after surgeries under peripheral nerve block is defined as the appearance of severe acute postoperative pain after regression of the sensory block. The incidence of this condition can reach up to 40-50% in patients undergoing ambulatory surgeries. Rebound pain represents a clinically significant issue that may outweigh the benefits of regional anaesthesia. This is particularly significant for painful outpatient surgeries, where inadequately managed pain can result in distress, potentially affecting patient satisfaction and recovery. It may also lead to unplanned utilization of healthcare resources or readmissions.Orthopaedic foot surgery is a prevalent outpatient surgery, potentially painful, where rebound may be a difficult challenge. However, to date, prospective studies focusing specifically on rebound pain in outpatient foot surgery are limited. Identifying conditions associated with rebound pain or at-risk patients could facilitate the development of preventive and treatment strategies, thereby enhancing pain management or relief. Younger age, female sex and bone surgery are non-modifiable factors associated with severe rebound pain. Perioperative intravenous dexamethasone has been identified as a modifiable independent risk factor associated with a reduced incidence of rebound pain. Regarding anaesthetic factors, the duration of the peripheral block has been proposed as a potentially modifiable factor influencing rebound pain; however, current evidence does not support this hypothesis.The goal of this prospective observational study is to evaluate the incidence of rebound pain specifically in outpatient orthopaedic foot surgery involving bone under popliteal sciatic nerve block and to assess the possible association between sensory block duration and the incidence of rebound pain., conditionsModule conditions: Rebound Pain, conditions: Sciatic Nerve Block, conditions: Foot Surgery, conditions: Outpatient Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of rebound pain., primaryOutcomes measure: Sensory block duration of the sciatic nerve block., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Av. de Gaspar Aguilar, 90, status: RECRUITING, city: Valencia, zip: 46017, country: Spain, contacts name: Javier Barrio, MD, PhD, role: CONTACT, phone: 0034646819882, email: jbarrio.ma@gmail.com, contacts name: Javier Barrio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06309368, orgStudyIdInfo id: 003875, briefTitle: Ostomy Primary Closure With 0.1% Betaine/0.1% Polyhexanide Wound Irrigation Compared to Pursestring Closure, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Nevada, Las Vegas, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are:1. Surgical site infection rates2. Patient quality of life3. Time to wound healingParticipants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above., conditionsModule conditions: Surgical Site Infection, conditions: Wound Surgical, conditions: Colorectal Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of the two treatment groups., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: No masking. This is a non-blinded randomized controlled trial, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation, interventions name: Pursestring Closure, outcomesModule primaryOutcomes measure: Surgical Site Infection Rates, secondaryOutcomes measure: Acceptability of wound and scar healing by patient, secondaryOutcomes measure: Acceptability of wound and scar healing by patient, secondaryOutcomes measure: Acceptability of wound and scar healing by patient, secondaryOutcomes measure: Acceptability of wound and scar healing by patient, secondaryOutcomes measure: Wound healing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89102, country: United States, contacts name: Abigail W Cheng, MD, role: CONTACT, phone: 916-695-4159, email: abigail.cheng@unlv.edu, contacts name: Lance Horner, MD, role: CONTACT, phone: 7755445456, email: lance.horner@unlv.edu, contacts name: Ovunc Bardakcioglu, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lance Horner, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Abigail W Cheng, MD, role: SUB_INVESTIGATOR, contacts name: Henry Krasner, BS, role: SUB_INVESTIGATOR, contacts name: Kavita Batra, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False
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protocolSection identificationModule nctId: NCT06309355, orgStudyIdInfo id: YR001-A03, briefTitle: Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Hangzhou Yirui Pharmaceutical Technology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis, conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: YR001 ointment, interventions name: Placebo, outcomesModule primaryOutcomes measure: The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50., secondaryOutcomes measure: all treatment-emergents AEs, secondaryOutcomes measure: Efficacy of YR001 Ointment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DelRicht Research, city: Baton Rouge, state: Louisiana, zip: 70809, country: United States, contacts name: Ira H Thorla, Doctor, role: CONTACT, geoPoint lat: 30.45075, lon: -91.15455, hasResults: False
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protocolSection identificationModule nctId: NCT06309342, orgStudyIdInfo id: VGRFOU-278257, briefTitle: Prevention of Lifestyle-related Disorders Based on Functional Examinations, acronym: PREVFUNKTION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Lena Bornhoft, class: OTHER, collaborators name: Vastra Gotaland Region, collaborators name: Göteborg University, descriptionModule briefSummary: The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life., conditionsModule conditions: Lifestyle-related Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Investigators performing the health and function examinations will not be informed about the group to which the participant is allocated. All examinations are performed identically for participants from both groups., whoMasked: INVESTIGATOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: PREVFUNKTION, interventions name: Control, outcomesModule primaryOutcomes measure: Change in objectively measured physical activity, primaryOutcomes measure: Change in objectively measured sedentary behaviour, secondaryOutcomes measure: Change in cardiovascular fitness, secondaryOutcomes measure: Change in motivation level, secondaryOutcomes measure: Proportion achieved goals, secondaryOutcomes measure: Change in fitness level, secondaryOutcomes measure: Change in strength upper extremity, secondaryOutcomes measure: Change in strength lower extremity, secondaryOutcomes measure: Change in strength trunk muscles, secondaryOutcomes measure: Change in balance, secondaryOutcomes measure: Change in mobility, secondaryOutcomes measure: Change in posture, secondaryOutcomes measure: Change in weight measures, secondaryOutcomes measure: Change in pain, secondaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in handgrip strength, secondaryOutcomes measure: Change in biceps strength, secondaryOutcomes measure: Change in leg strength, secondaryOutcomes measure: Change in calf strength, secondaryOutcomes measure: Change in ventral trunk strength, secondaryOutcomes measure: Change in dorsal trunk strength, secondaryOutcomes measure: Change in lower trunk strength, secondaryOutcomes measure: Change in static balance - 1, secondaryOutcomes measure: Change in static balance - 2, secondaryOutcomes measure: Change in static balance - 3, secondaryOutcomes measure: Change in dynamic balance, secondaryOutcomes measure: Change in mobility - 1, secondaryOutcomes measure: Change in mobility - 2, secondaryOutcomes measure: Change in mobility - 3, secondaryOutcomes measure: Change in hypermobility score, secondaryOutcomes measure: Change in neck mobility, secondaryOutcomes measure: Change in foot pronation, secondaryOutcomes measure: Change in habitual stance, secondaryOutcomes measure: Change in health-related quality of life assessed with EQ5D index, secondaryOutcomes measure: Change in health-related quality of life assessed with EQ5D VAS, secondaryOutcomes measure: Change in self-reported physical activity assessed with Swedish questionnaire, secondaryOutcomes measure: Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS), secondaryOutcomes measure: Change in self-reported sedentary time, secondaryOutcomes measure: Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire, secondaryOutcomes measure: Change in number of pain locations, secondaryOutcomes measure: Change in proportion smokers, secondaryOutcomes measure: Change in proportion acceptable level blood glucose, secondaryOutcomes measure: Change in proportion acceptable level serum cholesterol, secondaryOutcomes measure: Change in proportion acceptable level triglycerides, secondaryOutcomes measure: Change in proportion acceptable blood pressure, secondaryOutcomes measure: Change in proportion normal body mass index (BMI), secondaryOutcomes measure: Change in proportion acceptable waist circumference, secondaryOutcomes measure: Change in stress symptoms assessed with Stress and Crisis Inventory-93, secondaryOutcomes measure: Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Correlation between self-assessed and objectively measured fitness, secondaryOutcomes measure: Correlation between self-assessed and objectively measured fitness - 2, secondaryOutcomes measure: Correlation between self-assessed and objectively measured strength upper extremity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured strength lower extremity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured balance, secondaryOutcomes measure: Correlation between self-assessed and objectively measured physical activity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured physical activity - 2, eligibilityModule sex: ALL, minimumAge: 39 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309329, orgStudyIdInfo id: 1770023-2, briefTitle: Strength at Home - Parents RCT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: VISN 17 Center of Excellence, class: FED, collaborators name: United States Department of Defense, collaborators name: University of Texas at Austin, descriptionModule briefSummary: The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question\[s\]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources., conditionsModule conditions: Parent-Child Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Strength at Home Parents, interventions name: VA treatment as usual, outcomesModule primaryOutcomes measure: Parenting Stress Index total score, primaryOutcomes measure: Parenting Stress Index total score, primaryOutcomes measure: Parenting Stress Index total score, secondaryOutcomes measure: Laxness subscale on the Parenting Scale, secondaryOutcomes measure: Laxness subscale on the Parenting Scale, secondaryOutcomes measure: Laxness subscale on the Parenting Scale, secondaryOutcomes measure: Over reactivity subscale on the Parenting scale, secondaryOutcomes measure: Over reactivity subscale on the Parenting scale, secondaryOutcomes measure: Over reactivity subscale on the Parenting scale, otherOutcomes measure: PTSD Symptom Checklist score, otherOutcomes measure: PTSD Symptom Checklist score, otherOutcomes measure: PTSD Symptom Checklist score, otherOutcomes measure: Quick Inventory of Depressive Symptoms, otherOutcomes measure: Quick Inventory of Depressive Symptoms, otherOutcomes measure: Quick Inventory of Depressive Symptoms, otherOutcomes measure: Total Family Problems Score, otherOutcomes measure: Total Family Problems Score, otherOutcomes measure: Total Family Problems Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Texas Veterans Healthcare System, city: Temple, state: Texas, zip: 76504, country: United States, geoPoint lat: 31.09823, lon: -97.34278, hasResults: False
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protocolSection identificationModule nctId: NCT06309316, orgStudyIdInfo id: Grace-PCC, briefTitle: The Impact of Person Centred Care (PCC) in Grave's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Mental fatigue (MF) is prevalent after Graves' disease (GD), which is the most common form of hyperthyroidism. We have reported that 38% of patients, compared to 11% of control subjects, suffer from MF more than 1 year after successfully reversing of their hyperthyroidism and that MF is an entity of its own, separated from MF combined with anxiety or depression. The brain pathophysiology is unknown and there is no medical treatment, which requires patients to simply adapt to the situation. In the new national guideline for hyperthyroidism (Jan 2023), rehabilitation is recommended, but currently rarely offered to these patients. The problem is significant for patients, as illustrated by frequent media appeals. In this project, we hypothesise that person-centred care (PCC), which promotes positive coping strategies and increases self-efficacy by engaging patients as partners in their own care, improves MF, reduces sick leave, and lowers the recurrence rate of GD. In two work packages (WP), we will:WP1 Evaluate the effect of PCC eHealth intervention (telephone and digital platform) as an add-on to usual care vs usual care alone in a randomized controlled trial (RCT) of 220 patients on self-efficacy, days of sick-leave (composite score as primary outcome), MF, recurrence rate of disease, coping strategies, perceived stress, quality of life (QoL) and personality.WP2 Investigate the cost-effectiveness of the interventionPatients with GD have impaired long-term QoL. PCC could improve long-term outcomes of this autoimmune disease and may apply to other patient groups. This is in line with the societal aim to reduce mental illness., conditionsModule conditions: Graves Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Person-centred care (PCC), outcomesModule primaryOutcomes measure: Composite score of changes, secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: General Self-Efficacy Scale (GSE), secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Days of sick-leave, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Mental fatigue score, secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Coping Orientations to Problems Experienced (Brief cope), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Perceived Stress Scale (PSS-14), secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Personality Assessment Guardian NEO-FFI-3, secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Comprehensive psychopathological rating questionnaire (CPRS), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39), secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL)., secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: EuroQol- health questionnaire (EQ-5D), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Frenchay Activities Index (FAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI), secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid autoantibodies, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Levels of thyroid hormones, secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Clinical Activity Score (CAS), secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Severity score, secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Saltin-Grimby Physical Activity Scale (SGPAS), secondaryOutcomes measure: Composite score of changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Agneta Lindo, status: RECRUITING, city: Göteborg, zip: 413 45, country: Sweden, contacts name: Agneta Lindo, role: CONTACT, phone: +4676-6185481, email: agneta.lindo@vgregion.se, contacts name: Helena Filipsson Nyström, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06309303, orgStudyIdInfo id: RC 12/20, briefTitle: Kawasaki Disease During the COVID-19 Epidemic, acronym: KAWACOVID, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The common manifestations are: "middle aged" children (6-9 y/o) with a history of persistent high spiking fever in the last days, abdominal pain, diarrhea, skin rash and rapidly deteriorating clinical condition with the onset of shock, without clear signs of dehydration. Other less common features are arthralgia, cough, meningism, conjunctivitis and reddened, cracked lips. Labworks usually show high inflammatory markers, low lymphocyte counts, low sodium, and high troponin levels. Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities. Patients have been diagnosed as Kawasaki disease (typical or incomplete) and treated accordingly with IntraVenous ImmunoGlobulin (IVIG) and/or steroids. One patient refractory to such treatments responded successfully to intravenous Anakinra. All the patients reported a family history consistent with COVID-19, serology and naso-pharyngeal swabs were inconsistently positive. To date we are aware of at least 10 such cases. KSS is a rare and dreadful complication, with an estimated prevalence of 5% of patients with Kawasaki Disease (KD). Given the extreme rarity of this condition, the occurrence of so many cases in the last weeks points to a possible causative agent. As our hospitals are in high endemic area, SARS-COV2 seems the most obvious, although testing for such infection in patients returned conflicting results. It is not clear, at this moment, if this clinical entity is a proper KD triggered by SARS-COV2, or a systemic vasculitis with similar features of KD, secondary to SARS-COV2 infection. The aim of this nationwide study is to better define this clinical entity., conditionsModule conditions: Kawasaki Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Clinical evaluation, outcomesModule primaryOutcomes measure: Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection, secondaryOutcomes measure: Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Months, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Burlo Garofolo, city: Trieste, zip: 34137, country: Italy, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06309290, orgStudyIdInfo id: FAPESP-UFRO, briefTitle: Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy, acronym: PRE-RET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Universidad de La Frontera, class: OTHER, descriptionModule briefSummary: Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown., conditionsModule conditions: Prehabilitation, conditions: Breast Cancer, conditions: Postmenopause, conditions: Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation with resistance-exercise training, interventions name: Usual care program, outcomesModule primaryOutcomes measure: Change in skeletal muscle mass (measured via Computed tomography (CT) scan), secondaryOutcomes measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing), secondaryOutcomes measure: Change in hand grip strength (measured via JAMAR handheld dynamometer), secondaryOutcomes measure: Change in physical performance measured via Short physical performance battery, secondaryOutcomes measure: Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30), secondaryOutcomes measure: Change in points Brief fatigue inventory (BFI), secondaryOutcomes measure: Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA, secondaryOutcomes measure: Change in pathological complete response rate, secondaryOutcomes measure: Change quantification proteins, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Arturo López Pérez, city: Santiago, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile, city: Temuco, country: Chile, geoPoint lat: -38.73965, lon: -72.59842, hasResults: False
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protocolSection identificationModule nctId: NCT06309277, orgStudyIdInfo id: GLG-100X, briefTitle: A Clinical Study to Evaluate of Single and Multiple Oral Doses of GM-1020 in Patients With MDD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Gilgamesh Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The aim of this Phase 2a study in patients with MDD is to assess safety and tolerability and preliminary antidepressant efficacy., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: GM-1020, outcomesModule primaryOutcomes measure: Incidence of treatment emergent adverse events, secondaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS) Change from baseline to 72 hours, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MAC Clinical Research, status: RECRUITING, city: Manchester, country: United Kingdom, contacts name: Gregory, role: CONTACT, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
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protocolSection identificationModule nctId: NCT06309264, orgStudyIdInfo id: C5059-R, secondaryIdInfos id: I01RX005059, type: NIH, link: https://reporter.nih.gov/quickSearch/I01RX005059, briefTitle: Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans, acronym: SBA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, collaborators name: University of California, San Diego, collaborators name: NADI Inc., descriptionModule briefSummary: Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem. Many blast-exposed Veterans experience "functional hearing difficulties" (FHDs): problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram. VA audiologists have begun using low-gain hearing aids to treat FHDs, but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram. This study proposes a data-driven approach called speech-based audiometry (SBA), which optimizes hearing aid gains from a patient's responses to speech stimuli in aided conditions. This trial will assess the behavioral (speech recognition in noise, subjective listening difficulty) and neurophysiological (functional neuroimaging during a speech recognition task) benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs., conditionsModule conditions: Auditory Diseases, Central, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This study is a 2x2 randomized trial. Each subject receives a low-gain hearing aid. The randomized factors are:1. Fitting method. Half of the subjects have their hearing aids programmed using conventional methods based on the pure-tone audiogram. The remainder have their hearing aids programmed using the gain profile selected from speech-based audiometry.2. Daily hearing aid use. Half of the subjects will be assigned to use their hearing aids routinely in daily life for a six-week acclimatization period. The remaining half will be followed for the same six-week period but will use their hearing aids only to complete pre-post (mQuickSIN, fMRI) and weekly (DIN) laboratory assessments for speech recognition in noise. The daily use group will complete the same assessments.The factors are fully crossed such that there are four groups in the experiment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Factor 1 is single blind: Participants will not know which procedure is used to program their hearing aid, but the investigator/outcomes assessor will. Factor 2 is unblinded: Participants will know whether they are assigned to the daily hearing aid use group., whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Phonak Lumina P90, outcomesModule primaryOutcomes measure: Change in Modified Quick Speech-in-Noise Test (mQuickSIN) Score at 6 weeks, primaryOutcomes measure: Abbreviated Profile of Hearing Aid Benefit (APHAB), secondaryOutcomes measure: Change in Digits in Noise Test (DIN) Score at Weekly Intervals from Baseline to 6 weeks, otherOutcomes measure: Change in fMRI Activation at 6 weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: VA Loma Linda Healthcare System, Loma Linda, CA, city: Loma Linda, state: California, zip: 92357-1000, country: United States, contacts name: Maria I Rodriguez, role: CONTACT, phone: 909-583-6050, email: maria.Rodriguez9@va.gov, contacts name: Ernest M Alva, role: CONTACT, phone: (909) 825-7084, phoneExt: 1500, email: ernest.alva@va.gov, contacts name: Jonathan Venezia, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, locations facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA, city: Sepulveda, state: California, zip: 91343, country: United States, contacts name: Delia Karahalios, AuD, role: CONTACT, phone: 818-891-7711, phoneExt: 32752, email: delia.karahalios@va.gov, contacts name: Jamie Spector, AuD, role: CONTACT, phone: 8188917711, phoneExt: 7062, email: jamie.spector@va.gov, geoPoint lat: 34.16167, lon: -118.28285, locations facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA, city: West Los Angeles, state: California, zip: 90073-1003, country: United States, contacts name: Delia Karahalios, AuD, role: CONTACT, phone: 818-891-7711, phoneExt: 32752, email: delia.karahalios@va.gov, contacts name: Guneet Missan, AuD, role: CONTACT, phone: 3104783711, phoneExt: 40613, email: guneet.missan@va.gov, geoPoint lat: 34.0464, lon: -118.44813, hasResults: False
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protocolSection identificationModule nctId: NCT06309251, orgStudyIdInfo id: KetoSTrENgTH, briefTitle: Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Danone Nutricia SpA Società Benefit, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.The main question\[s\] it aims to answer are:* does KD support adequate growth?* does KD improve clinical symptoms?* how does KD impact quality of life? Participants will be followed up as per clinical practice, conditionsModule conditions: Drug Resistant Epilepsy, conditions: Autism Spectrum Disorder, conditions: Chronic Migraine, conditions: Brain Tumor, Pediatric, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: ketogenic diet (as per clinical practice), outcomesModule primaryOutcomes measure: Nutritional adequacy, secondaryOutcomes measure: Nutritional adequacy, secondaryOutcomes measure: % of responders to KD, secondaryOutcomes measure: Health related quality of life improvement through parent questionnaire, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: ASST Fatebenefratelli Sacco (PO "V. Buzzi"), status: RECRUITING, city: Milan, state: MI, zip: 20154, country: Italy, contacts name: Sara Olivotto, MD, role: CONTACT, email: sara.olivotto@asst-fbf-sacco.it, contacts name: Roberto Previtali, MD, role: CONTACT, email: roberto.previtali@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione "Istituto Neurologico Nazionale C. Mondino", status: RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, contacts name: Valentina De Giorgis, MD, role: CONTACT, email: valentina.degiorgis@mondino.it, contacts name: Carlo Alberto Quaranta, MD, role: CONTACT, email: carloalberto.quaranta01@universitadipavia.it, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Pediatrico Bambino Gesù, status: RECRUITING, city: Roma, state: RM, zip: 00165, country: Italy, contacts name: Antonella Diamanti, MD, role: CONTACT, email: antonella.diamanti@opbg.net, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06309238, orgStudyIdInfo id: LightBAR, briefTitle: Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial, acronym: LightBAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2048-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Carsten Dirksen, class: OTHER, collaborators name: University of Copenhagen, collaborators name: University of Southern Denmark, collaborators name: University of Oxford, collaborators name: University of Bristol, collaborators name: Copenhagen Trial Unit, Center for Clinical Intervention Research, descriptionModule briefSummary: With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions.Blinded outcome assessment will be employed for the primary outcome and anywhere else possible. When assessing clinical outcomes, the participants will be asked not to disclose their assigned intervention group to the outcome assessor. Further, they will be provided with a plain white t-shirt, or similar, to wear during clinical assessments to cover the presence of surgical scars.Statisticians and investigators drawing conclusions will be fully blinded. We will conduct the statistical analyses with the intervention groups coded as e.g., 'A' and 'B'. We will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Intensive weight loss intervention, interventions name: Bariatric surgery, outcomesModule primaryOutcomes measure: MetS-Z, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Gait speed, secondaryOutcomes measure: Short-Form-36, mental component score, otherOutcomes measure: SAE, otherOutcomes measure: Proportion of participants with at least one adverse events (AE) of special interest. Each of the AE will also be assessed individually exploratorily., otherOutcomes measure: Cardiometabolic health - metabolic syndrome, otherOutcomes measure: Cardiometabolic health - blood pressure, otherOutcomes measure: Cardiometabolic health - pulse, otherOutcomes measure: Cardiometabolic health - glucose, otherOutcomes measure: Cardiometabolic health - Hb1Ac, otherOutcomes measure: Cardiometabolic health - insulin, otherOutcomes measure: Cardiometabolic health - HOMA2-IR, otherOutcomes measure: Cardiometabolic health - lipids, otherOutcomes measure: Cardiometabolic health - eGFR, otherOutcomes measure: Cardiometabolic health - hsCRP, otherOutcomes measure: Cardiometabolic health - Fib-4, otherOutcomes measure: Cardiometabolic health - proteinuria, otherOutcomes measure: Cardiometabolic health - TSH, otherOutcomes measure: Weight and body composition - weight loss, otherOutcomes measure: Weight and body composition - waist circumference, otherOutcomes measure: Weight and body composition - body fat and lean body mass, otherOutcomes measure: Physical functioning - sedentary and active, otherOutcomes measure: Physical functioning - sit to stand test, otherOutcomes measure: Medication use, otherOutcomes measure: Micronutrient status, assessed as proportion of participants with deficiency, otherOutcomes measure: Bone mineral density (BMD) assessed by DXA, otherOutcomes measure: Sleep - ESS, otherOutcomes measure: Sleep - sleep and wake time, otherOutcomes measure: Sleep - sleep movement, otherOutcomes measure: Health-related quality of life and mental health - EQ-5D-5L, index score, otherOutcomes measure: Health-related quality of life and mental health - EQ-5D-5L, VAS, otherOutcomes measure: Health-related quality of life and mental health - SF-36, otherOutcomes measure: Health-related quality of life and mental health - EDE-Q, otherOutcomes measure: Health-related quality of life and mental health - WBIS-M, otherOutcomes measure: Health-related quality of life and mental health - MDI, otherOutcomes measure: Labour market attachment - WPAI, otherOutcomes measure: Labour market attachment - days of sick leave, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic range, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic events, otherOutcomes measure: Continuous glucose monitoring - glucose variability, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic symptoms, otherOutcomes measure: Pending additional funding: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs bariatric surgery, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - costs, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios, otherOutcomes measure: Long-term effects - mortality and major cardiovascular disease (CVD), otherOutcomes measure: Long-term effects - prescription patterns, otherOutcomes measure: Long-term effect - incident cancer, otherOutcomes measure: Long-term effect - surgical procedures, otherOutcomes measure: Long-term effect - fracture risk, otherOutcomes measure: Long-term effect - health economic and labour market attachment, employment status, otherOutcomes measure: Long-term effect - health economic and labour market attachment, salary, otherOutcomes measure: Long-term effect - health economic and labour market attachment, absence, otherOutcomes measure: Long-term effect - health economic and labour market attachment, sick leave, otherOutcomes measure: Long-term effect - health economic and labour market attachment, long-term sick leave, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Aarhus, Aarhus Universitets Hospital, status: NOT_YET_RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Jens Bruun, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, locations facility: The Department of Medicine and Department of Surgery, University Hospital of South West Jutland, status: NOT_YET_RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Claus Borg Juhl, role: CONTACT, geoPoint lat: 55.47028, lon: 8.45187, locations facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, status: RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Kirstine N Bojsen-Møller, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: The Department of Medicine and the Department of Surgery, Zealand University Hospital Køge, status: NOT_YET_RECRUITING, city: Køge, zip: 4600, country: Denmark, contacts name: Merethe Hansen, role: CONTACT, geoPoint lat: 55.45802, lon: 12.18214, locations facility: Department of Surgery, Viborg Regional Hospital, status: NOT_YET_RECRUITING, city: Viborg, zip: 8800, country: Denmark, contacts name: Peter Rask, role: CONTACT, geoPoint lat: 56.45319, lon: 9.40201, locations facility: Southmead Hospital, North Bristol NHS Trust, status: NOT_YET_RECRUITING, city: Bristol, zip: BS10 5NB, country: United Kingdom, contacts name: Dimitri Pournaras, role: CONTACT, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: James Byrne, role: CONTACT, geoPoint lat: 50.90395, lon: -1.40428, locations facility: Musgrove Park Hospital, Somerset Foundation NHS Trust, status: NOT_YET_RECRUITING, city: Taunton, zip: TA1 5DA, country: United Kingdom, contacts name: Richard Welbourn, role: CONTACT, geoPoint lat: 51.01494, lon: -3.10293, hasResults: False
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protocolSection identificationModule nctId: NCT06309225, orgStudyIdInfo id: BMDA-2301, briefTitle: Dose Adjusted Chemoradiotherapy in HPV-Associated Oropharynx Cancer of the Elderly, acronym: (DACHOC-E), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Omar Mahmoud, class: OTHER, descriptionModule briefSummary: Previous studies of this type of head and necl cancer have shown high rates of cancer control but result in many short and long term side effects when treated with high dose radiation and chemotherapy. Recently, investigators have noticed similar high rates of cancer control in small numbers of patients who receive less intensive treatments using lower doses of radiation, smaller radiation fields with chemotherapy. It is expected that the side effects of treatment with lower doses of radiation would be less.For this reason this study is looking at a different regimen of reducing the intensity of the treatment.The purpose of this study is to compare any good and bad effects of using lower dose smaller fields radiation therapy and chemotherapy with published outcomes. This study will allow the researchers to know whether these different approaches are better, the same, or worse than the usual approach. To be better, the study approach should result in the same survival rate of the usual approach (about 85 out of 100 patients alive and free of cancer at 2 years) but with less long-term side effects., conditionsModule conditions: Oropharynx Cancer, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Modified dose and fields intensity modulated radiotherapy, outcomesModule primaryOutcomes measure: Two-year progression free survival, secondaryOutcomes measure: Benefit and Tolerance of Treatment, secondaryOutcomes measure: Acute Toxicity, secondaryOutcomes measure: Late toxicity, secondaryOutcomes measure: Failure pattern, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 99 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309212, orgStudyIdInfo id: 2023-20/687, briefTitle: Assessing the Impact of COVID-19 on HMPV Incidence and Severity Among Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: Human metapneumovirus (HMPV) is primarily recognized as a childhood pathogen, but its impact on adults remains largely underestimated. This study investigates the prevalence, clinical characteristics, and post-COVID-19 trends of HMPV infection among adults in Istanbul, Turkey., conditionsModule conditions: The Prevalance of HMPV After COVID-19 Pandemic, conditions: The Importance of Accurate Diagnosis for HPMV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2197, type: ACTUAL, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: Prevalence of HMPV infection in adults pre- and post-COVID-19 pandemic, secondaryOutcomes measure: Comparison of HMPV with other respiratory viruses in adults, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acibadem University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06309199, orgStudyIdInfo id: 0855/66, briefTitle: Prevalence of FGIDs and Probiotics Study, acronym: PROOF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: This is a study to evaluate the prevalence of FGIDs in infants using the Thai version of Rome IV diagnostic questionnaire for functional gastrointestinal disorders in infants and evaluate the efficacy of Limosilactobacillus reuteri DSM 17938 to prevent FGIDs in infants., conditionsModule conditions: Functional Gastrointestinal Disorders, conditions: Infant Conditions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group received probiotics Control group received sunflower and MCT oil, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: These 2 groups was assigned using computer generate with block of 4 and ratio 1:1.The intervention and placebo were prepare in the same container with the same color, odor and blinded to investigators, participants and guardians., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 512, type: ESTIMATED, armsInterventionsModule interventions name: Biogaia, interventions name: Placebo, outcomesModule primaryOutcomes measure: The prevalence of functional gastrointestinal disorders in the treatment group, secondaryOutcomes measure: The prevalence of functional gastrointestinal disorders in the placebo group, otherOutcomes measure: Nutrition associated with functional gastrointestinal disorders in infants, otherOutcomes measure: Gut microbial profiles associated with functional gastrointestinal disorder in infants, otherOutcomes measure: The sleep quality assessed by Brief Infant Sleep Revise Questionnaire of BISQR, otherOutcomes measure: Stool metabolomic substances (i.e microbial conjugation of secondary bile acid, aminoacid) and the stool metabolites alteration, otherOutcomes measure: Fluid intake associated with functional gastrointestinal disorders in infants, otherOutcomes measure: Stress associated with functional gastrointestinal disorders in infants, otherOutcomes measure: Antibiotics associated with functional gastrointestinal disorders in infants, otherOutcomes measure: Economic status associated with functional gastrointestinal disorders in infants, otherOutcomes measure: Education of caregiver associated with functional gastrointestinal disorders in infants, eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309186, orgStudyIdInfo id: RC 30/2023, briefTitle: Empowerment and Burnout of Midwives at the End of Health Emergency From COVID-19, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: As the fifth wave of COVID-19 comes to an end and the pandemic's countermeasures expire, there is a need to assess the impact of the pandemic on health care providers, especially midwives, as the professionals deputed to promote and protect women's holistic health, in all phases, physiological and otherwise, of the life cycle. The midwife considers the person as a whole, in which the mind-body-culture components interact profoundly. Prevention and containment measures have impacted on midwifery clinical and nursing practices with the mandatory continuous use of personal protective equipments (PPE) and social distancing to protect the patient and the practitioner, effectively hindering the intimacy of the woman-midwife relationship. The impact assessment focuses on two dimensions: learning, investigated as perceived empowerment, and perceived malaise, investigated as burnout. Empowerment has a positive connotation, which can offset burnout, a syndrome that affects the physical, psychological and emotional health of midwives and can have significant negative implications on midwife turnover, patient safety and outcomes, and the efficiency of healthcare organisations., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of midwifes' burnout, outcomesModule primaryOutcomes measure: Evaluation of empowerment of midwives, primaryOutcomes measure: Number of midwives affected by burnout, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Martina Debelli, role: CONTACT, email: martina.debelli@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06309173, orgStudyIdInfo id: 0000-00000; ko23Hemkens, briefTitle: Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2, acronym: DreaMS_VS2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). Diagnosis is established by clinical assessment of persons with MS (PwMS), in combination with imaging and body fluid assessments. Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments.The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited. Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely, in real-world settings, with minimal disruption of patients' life.Using the investigators' self developed dreaMS software program the investigators previously identified digital biomarkers (DB) that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical, imaging, or body fluid assessments.This international, observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care, research, and regulatory decisions. Beyond this, the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies, including pragmatic trials, promoting new long-term international academic collaborations., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation of the digital features with the respective measurements of the clinical reference tests, primaryOutcomes measure: The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables, secondaryOutcomes measure: The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence, secondaryOutcomes measure: The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids), secondaryOutcomes measure: The ability of the digital biomarker to detect change of Patient Reported Outcomes, secondaryOutcomes measure: The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity), secondaryOutcomes measure: The relationship of the digital biomarkers with imaging and body fluid markers, secondaryOutcomes measure: The relationship of the digital biomarkers with Patient Reported Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309160, orgStudyIdInfo id: R324A230008, briefTitle: COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD, acronym: CAST, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ball State University, class: OTHER, collaborators name: University of Toledo, collaborators name: Indiana University, descriptionModule briefSummary: Purpose: The purpose of this project is to develop and test the COMPASS \[Collaborative Model for Competence and Success\] Across Settings (CAST) intervention to enhance the goal setting and attainment skills of autistic youth. Despite federal education law mandating transition services as part of the Individualized Education Program (IEP) for ensuring good outcomes for students with disabilities, current educational practices have been unable to demonstrate that autistic students experience positive postsecondary outcomes. There are existing, evidence-based interventions aimed at supporting positive outcomes for these students. However, these interventions have not systematically provided coaching support to the caregivers, students, and employment specialists. To address these issues, CAST will integrate three evidence-based interventions for supporting student transitions while providing this critical coaching support. By doing so, CAST aims to align the priorities and goals of interventions across home, school, and community settings to better support positive postsecondary outcomes for autistic students., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, conditions: Autistic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre-post; randomized control, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Independent observer evaluating goal attainment outcomes, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 297, type: ESTIMATED, armsInterventionsModule interventions name: COMPASS Across Settings (CAST), outcomesModule primaryOutcomes measure: Goal Attainment of IEP progress (Ruble et al., 2012; 2018)., primaryOutcomes measure: Attainment of Postsecondary Goals (Ruble et al., 2019), secondaryOutcomes measure: Fidelity Assessment of Initial CAST consultation (Ruble et al., 2018), secondaryOutcomes measure: Fidelity Assessment of CAST Coaching (Ruble et al., 2018), secondaryOutcomes measure: Organizational Connectedness, secondaryOutcomes measure: Transition Plan Quality (Ruble et al., 2019), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ball State University, status: RECRUITING, city: Muncie, state: Indiana, zip: 47306, country: United States, contacts name: Lisa Ruble, PhD, role: CONTACT, phone: 765-285-5702, email: laruble@bsu.edu, geoPoint lat: 40.19338, lon: -85.38636, hasResults: False
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protocolSection identificationModule nctId: NCT06309147, orgStudyIdInfo id: ALX-923-107, briefTitle: A Study to Assess the Safety of BMS-984923 Compared to Placebo, in People With Parkinson's, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Allyx Therapeutics, class: INDUSTRY, collaborators name: Michael J. Fox Foundation for Parkinson's Research, descriptionModule briefSummary: A Phase 1, randomized, double-blind, placebo-controlled study of BMS-984923 administered orally twice daily (BID) for 28 days in participants with Parkinson's disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, parallel, 3-arm, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Matching placebo, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: BMS-9894923, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Area under the curve for the first 24 hours of dosing (AUC24h) and at steady state as determined by pharmacokinetic modeling, otherOutcomes measure: To evaluate changes in α-synuclein, otherOutcomes measure: Change from baseline dopamine transporter, otherOutcomes measure: Assess changes in motor function, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke Clinical Research Institute, status: RECRUITING, city: Durham, state: North Carolina, zip: 27701, country: United States, contacts name: Alexis Schuettke, role: CONTACT, phone: 919-668-2842, email: alexis.schuettke@duke.edu, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06309134, orgStudyIdInfo id: R34AA030662, type: NIH, link: https://reporter.nih.gov/quickSearch/R34AA030662, briefTitle: The Healthy Families Bright Futures Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Colorado Springs, class: OTHER, collaborators name: University of Nebraska Lincoln, descriptionModule briefSummary: The goal of this clinical trial is to learn about an online group program (Healthy Families Bright Futures program) for LGBTQ+ teens and their caregivers. The main question\[s\] it aims to answer are: • is this program acceptable, appropriate, and feasible for LGBTQ+ youth and their caregivers • does the program affect teen (alcohol use, dating violence, alcohol use refusal self-efficacy, healthy communication self-efficacy) and caregiver (accepting behaviors, parenting self-efficacy, parenting behaviors) outcomes associated with risk for dating violence and alcohol use among LGBTQ+ teens. Participants will participate in a one-hour weekly online group for seven weeks with separate groups for teens and caregivers., conditionsModule conditions: Alcohol Drinking, conditions: Violence in Adolescence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned by algorithm to either complete the program or to waitlist. Allocation to conditions will be 50/50. Randomization will occur at the dyad level., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Healthy Families Bright Futures Program, outcomesModule primaryOutcomes measure: Measure of Adolescent Relationships and Harassment and Abuse - Victimization, primaryOutcomes measure: Measure of Adolescent Relationships and Harassment and Abuse - Perpetration, primaryOutcomes measure: Monitoring the future alcohol use intentions, primaryOutcomes measure: Monitoring the future alcohol use items, primaryOutcomes measure: Drinking Refusal Self-Efficacy Questionnaire- Shortened adolescent version, primaryOutcomes measure: Conflict Tactics Scale- 2 (SGM Specific IPV Perpetration), primaryOutcomes measure: Conflict Tactics Scale- 2 (SGM Specific IPV Victimization), primaryOutcomes measure: Program acceptability, appropriateness, and feasibility ratings (drawn from Weiner), secondaryOutcomes measure: PHQ-8 (modified for adolescents), secondaryOutcomes measure: LGBTQ+ teen perceived drinking norms, secondaryOutcomes measure: LGBTQ+ teen perceived dating violence norms, secondaryOutcomes measure: Sexual communication self-efficacy scale, secondaryOutcomes measure: Communication skills test (modified to assess self-efficacy), secondaryOutcomes measure: Short Internalized Homonegativity Scale., secondaryOutcomes measure: Self-Efficacy for Parenting Adolescents Scale, secondaryOutcomes measure: Parental Monitoring Short Scale, secondaryOutcomes measure: Parent Adolescent Communication Scale, secondaryOutcomes measure: Alabama Parenting Questionnaire- Short form, secondaryOutcomes measure: Social and Emotional Competencies Questionnaire, secondaryOutcomes measure: LGBTQ+ Microaggressions and Microaffirmations in Families, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Colorado Springs, city: Colorado Springs, state: Colorado, zip: 80918-3733, country: United States, contacts name: Heather Littleton, PhD, role: CONTACT, phone: 719-255-3108, email: hlittlet@uccs.edu, contacts name: Heather Littleton, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.83388, lon: -104.82136, hasResults: False
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protocolSection identificationModule nctId: NCT06309121, orgStudyIdInfo id: PIC-11-24, briefTitle: Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents, acronym: PostOb, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Fundació Sant Joan de Déu, class: OTHER, descriptionModule briefSummary: This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat., conditionsModule conditions: Obesity, Childhood, conditions: Obesity, Adolescent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Postbiotic ABB C3, interventions name: Placebo, interventions name: Follow-up Postbiotic ABB C3 (Optional), outcomesModule primaryOutcomes measure: Incidence of Adverse Events, primaryOutcomes measure: Change in adiposity (% fat body mass), primaryOutcomes measure: Change in blood glycated hemoglobin (HbA1c) levels, secondaryOutcomes measure: Change in adiposity (% fat body mass), secondaryOutcomes measure: Change in blood glycated hemoglobin (HbA1c) levels, secondaryOutcomes measure: Change in BMI z-score, secondaryOutcomes measure: Change in body composition, secondaryOutcomes measure: Change in insulin sensitivity, secondaryOutcomes measure: Change in lipid profile (triglycerides, cholesterol), secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in Beck Depression Inventory-II (BDI-2), secondaryOutcomes measure: Change in Beck Anxiety Inventory-II (BAI-2), otherOutcomes measure: Change in gut microbial abundance and diversity, otherOutcomes measure: Change in plasma metabolite concentrations, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Sant Joan de Déu, status: RECRUITING, city: Barcelona, zip: 08950, country: Spain, contacts name: Marta Ramon Krauel, MD PhD, role: CONTACT, phone: (+34) 932804000, phoneExt: 71263, email: marta.ramon@sjd.es, contacts name: Carles Lerin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06309108, orgStudyIdInfo id: 2022/68-04, secondaryIdInfos id: İUC, type: OTHER, domain: İUC, briefTitle: Bariatric Surgery and Patient Education, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2022-05-02, completionDateStruct date: 2023-07-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Obesity is a disease that poses a health risk and is increasing worldwide. Bariatric surgery is the most effective method used in the treatment of obesity. Preoperative health education for bariatric surgery patients is important to support surgery. There is not enough nursing research in the literature regarding training patients with two different materials before bariatric surgery. The purpose of the randomized controlled experimental study designed in light of this information was to determine the effect of education given to patients with two different materials before bariatric surgery on early complications. The rates of the study were determined by randomizing trial I, trial II, and control treatment in 66 rooms that met the interval and study screening criteria offered between May 2022 and June 2023 in the general surgery service of a university hospital. Data from the research; was collected with the Veria Total Form, Autar Risk Assessment Scale, Apfel Risk Score, Visual Comparison Scale-VAS (Visual Analog Scale-VAS), Training Satisfaction Survey, and Complication Monitoring Form. In the first face-to-face meeting in the experimental groups, we were given training by the researcher with the removable Training Booklet I and Training Booklet II and were monitored until discharge. No control group training was given., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Education, conditions: Patient Education, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In our study, patients who would undergo bariatric surgery were selected randomly., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ACTUAL, armsInterventionsModule interventions name: Education Booklet, interventions name: Augmented Reality Group, outcomesModule primaryOutcomes measure: Veria Total Form for sociodemographic features, secondaryOutcomes measure: Autar Risk Assessment Scale for DVT, otherOutcomes measure: Apfel Risk Score for nausea and vomiting, otherOutcomes measure: Visual Analog Scale-VAS for pain, otherOutcomes measure: Training Satisfaction Survey, otherOutcomes measure: Complication Monitoring Form to determine whether complications develop, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul University- Cerrahpasa Instutite Graduate Studies, city: İstanbul, state: Avcılar, zip: 34320, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06309095, orgStudyIdInfo id: AFSU_AhmetDemirhanUygun_001, briefTitle: Investigation of the Effect of Low Torque and Speed on Post-Operative Pain After Root Canal Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Afyonkarahisar Health Sciences University, class: OTHER, descriptionModule briefSummary: Root canal preparation is one of the most important stages in root canal treatment. Nowadays, the use of Nickel-Titanium(Ni-Ti) rotary instrument systems for root canal expansion is becoming very popular. The force required to rotate the Ni-Ti file is defined as the torque force and is considered a parameter for the stress produced within the canal. Ni-Ti rotary instruments can be used with a wide speed scale between 150 rpm (rotary per minute) and 40,000 rpm in conventional endodontic engines.Low torque and speed values mean low pressure applied by the instruments in the root canal. With low forces and vibrations, motor noise is generally negligible, and the instruments can easily shape most root canals in a reasonable amount of time and with minimal mechanical stress (in medium-easy canals). The use of lower torque values has been shown to reduce cyclic fatigue of Ni-Ti rotary tools. With reduced cyclic fatigue, the risk of instrument breakage in complex root canal morphologies is minimized and complications that may occur during root canal treatment are reduced. However, with low torque and speed values, cutting efficiency decreases and the process time increases as the instrument advances in the canal and during possible treatment. Decreasing cutting efficiency may also result in the operator applying force to move through the canal. With the applied force, the friction resistance within the canal increases and the heat produced increases. For this reason, it is thought that the risk of post-operative pain may increase during or after the procedure.The aim of this study is to investigate the incidence of post-operative pain and procedure time using the visual analog scale (VAS) among groups where low torque and speed values were applied during the use of the Ni-Ti rotary instrument system., conditionsModule conditions: Dental Pulp Necrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: use of VDW Silver Endodontic motor, outcomesModule primaryOutcomes measure: Visual analog scale, secondaryOutcomes measure: Preparation time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Afyonkarahisar Health Science University, city: Afyonkarahisar, zip: 03030, country: Turkey, contacts name: Ahmet D Uygun, Assoc. Prof., role: CONTACT, phone: +905057513705, email: ademirhan100@hotmail.com, contacts name: Betül Karaağaç, R.A., role: CONTACT, phone: +905347934602, email: karaagacbetull@gmail.com, geoPoint lat: 38.75667, lon: 30.54333, hasResults: False
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protocolSection identificationModule nctId: NCT06309082, orgStudyIdInfo id: DFU, briefTitle: Assessing Diabetic Foot Ulcer Microcirculation With High-frequency Contrast Enhanced Ultrasound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to investigate and validate the utility of high-frame-rate ultrasound imaging technology for dynamic observation of the blood perfusion process at the site of ulcer wounds in real-time, focusing on patients with Diabetic Foot Ulcers (DFU). The primary research questions it seeks to address are as follows:* What are the dynamic characteristics of vascular dynamics at the site of ulcer wounds in patients with DFU under high-frame-rate ultrasound imaging?* Is High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) technology feasible for effectively visualizing the microcirculation of ulcer wounds in patients with DFU? Participants will Undergo high-frame-rate ultrasound imaging for real-time observation of blood perfusion dynamics at the site of ulcer wounds.Researchers will compare ulcerated sites with normal sites to see whether the use of High-Frequency Contrast-Enhanced Ultrasound (H-CEUS) has any discernible impact on the visualization of microcirculation in ulcer wounds., conditionsModule conditions: Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: H-CEUS score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital the First Affiliated Hospital, city: Wenzhou, state: Zhejiang, zip: 325006, country: China, contacts name: Shihao Xu, role: CONTACT, phone: 13857766918, email: dcxshvip@wmu.edu.cn, contacts name: Shihao Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
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protocolSection identificationModule nctId: NCT06309069, orgStudyIdInfo id: LOCAL/2024/TP-01, secondaryIdInfos id: IRB 24.01.01, type: OTHER, domain: CHU de Nîmes, briefTitle: Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort, acronym: CCE Cohorte, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics., conditionsModule conditions: Calcified Cerebral Embolism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 79, type: ESTIMATED, armsInterventionsModule interventions name: None, purely observational study, outcomesModule primaryOutcomes measure: Calcified aortic brachiocephalic, primaryOutcomes measure: cardiovascular risk, primaryOutcomes measure: history of stroke, primaryOutcomes measure: Population, primaryOutcomes measure: Population, primaryOutcomes measure: history of surgical/endovascular cardiovascular intervention, primaryOutcomes measure: NIHSS, primaryOutcomes measure: calcified aortic arch, primaryOutcomes measure: calcified carotid, primaryOutcomes measure: atherosclerotic plaques, primaryOutcomes measure: calcified aortic valves, primaryOutcomes measure: calcified mitral valves, primaryOutcomes measure: CCE diameter, primaryOutcomes measure: density, primaryOutcomes measure: involved cerebral artery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nîmes, city: Nîmes, zip: 30029, country: France, contacts name: Teodora PARVU, role: CONTACT, phone: +33466685008, email: teodora.parvu@chu-nimes.fr, geoPoint lat: 43.83333, lon: 4.35, hasResults: False
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protocolSection identificationModule nctId: NCT06309056, orgStudyIdInfo id: MP-05-2024-3903, briefTitle: Neuromuscular Electrical Stimulation for Children With Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Sir Mortimer B. Davis - Jewish General Hospital, class: OTHER, descriptionModule briefSummary: This study aims to measure if using neuromuscular electrical stimulation (NMES) effectively improves swallowing, drooling (if applicable), feeding ability, physical growth and quality of life in children with severe dysphagia. This pilot study is for children aged over 18 months old with dysphagia. It aims to investigate a new approach to help children improve their swallowing function. Some published studies have shown that electrical stimulation to muscles involved in swallowing may help children with dysphagia.In this pilot study, NMES will be used. This procedure delivers electrical stimulation to make participants' muscles contract. Electrodes are placed on the skin, over the muscles that help with swallowing, and an electric current is delivered through wires which are connected to a small machine. The current is controlled through a small, handheld device. NMES will be applied to muscles involved in eating, drinking and swallowing. NMES will be applied to the participant alongside their regular treatment. No medications or treatments will be added, modified or discontinued as part of this study.The overall duration of the study per participant will last a total of nine months. For the first three months, the participant will receive the NMES twice a week. There will be no interventions or follow-up appointments scheduled for the following 6 months. Then, there will be a final follow-up meeting 9 months following the start of the intervention to evaluate for lasting changes., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients being followed at the Lethbridge-Layton-Mackay Rehabilitation Centre Salivation Management Clinic and the Dysphagia and Feeding Disturbance Clinic who meet inclusion criteria will be recruited. If caregivers/participants consent to the study, they will be enrolled in the intervention arm. Any potentially eligible participant who declines to participate in the study will be recruited as a control group. These participants will complete the questionnaires at the same timepoints as the interventional group and data from the medical charts will be included in the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: VitalStim, outcomesModule primaryOutcomes measure: Feeding Intake - Functional Oral Intake Scale, secondaryOutcomes measure: Penetration and Aspiration Scale, secondaryOutcomes measure: Quality of Life - Pediatric Quality of Life Inventory 4.0 Generic Core Scale for Toddlers, Young Children, Children 8-12 years old OR Teenagers., secondaryOutcomes measure: Body Mass Index (kg/m^2), eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309043, orgStudyIdInfo id: HLX05-001, briefTitle: A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. This study is divided into two parts., conditionsModule conditions: EGFR Overexpression, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 268, type: ESTIMATED, armsInterventionsModule interventions name: recombinant anti-EGFR human/murine chimeric monoclonal antibody injection, outcomesModule primaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: CL, secondaryOutcomes measure: λz, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06309030, orgStudyIdInfo id: ZRJY2023-QM21, briefTitle: Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Liu Longxiao, class: OTHER, descriptionModule briefSummary: The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs., conditionsModule conditions: Rheumatoid Arthritis, 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: 72, type: ESTIMATED, armsInterventionsModule interventions name: Bushen quhan zhiwang decoction, interventions name: Bushen quhan zhiwang decoction placebo, outcomesModule primaryOutcomes measure: disease activity score derivative for 28 joints (DAS28), secondaryOutcomes measure: patient reported outcomes（PRO）, secondaryOutcomes measure: visual analogue scale for pain, secondaryOutcomes measure: withdrawl mechanical threshold, secondaryOutcomes measure: erythrocyte sedimentation Rate（ESR）, secondaryOutcomes measure: C-reactive protein（CRP）, secondaryOutcomes measure: TCM symptom score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06309017, orgStudyIdInfo id: 23-01243, briefTitle: Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition specialist, interventions name: Ensure Surgery Immunonutrition shakes, outcomesModule primaryOutcomes measure: Length of hospital stay, primaryOutcomes measure: Proportion of patients who experienced postoperative major complications, secondaryOutcomes measure: Proportion of patients who participated in a nutritional intervention program before surgery, secondaryOutcomes measure: Proportion of patients who participated in a nutritional intervention program after surgery, secondaryOutcomes measure: Number of nutritional shakes completed, secondaryOutcomes measure: Percentage of nutritional shakes completed overall, secondaryOutcomes measure: Percentage of nutritional shakes completed pre-surgery, secondaryOutcomes measure: Percentage of nutritional shakes completed post-surgery, secondaryOutcomes measure: Proportion of patients who experienced any postoperative complications, secondaryOutcomes measure: Proportion of patients with 30 day readmission, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06309004, orgStudyIdInfo id: 2023-00741a, briefTitle: Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction, acronym: iACTforDGBI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Örebro University, Sweden, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to develop and test the iACTforDGBI intervention in a sample of Swedish individuals with DGBI (Disorders of Gut-Brain Interaction).The first substudy of this project (Substudy 1) aims to answer the following question: How can the design of iACTforDGBI be tailored to meet the specific needs of individuals with DGBI and clinically meaningful symptoms of anxiety and depression?Participants (individuals with symptoms compatible with a DGBI and anxiety and/or depression, and healthcare professionals working in DGBI) will be asked to: a) Evaluate a preliminary version of the iACTforDGBI intervention, consisting of self-guided online sessions. b) Participate in online focus-group interviews and provide information on their views of a preliminary version of the iACTforDGBi intervention, conditionsModule conditions: Clinically Meaningful Symptoms Levels of Symptoms of DGBI and Depression and/or Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Focus group interviews, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308991, orgStudyIdInfo id: IDU-SBF-SD-01, briefTitle: Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Izmir Democracy University, class: OTHER, descriptionModule briefSummary: The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants., conditionsModule conditions: Endotracheal Aspiration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Yakson touch, interventions name: Gentle Human Touch, interventions name: Routine care, outcomesModule primaryOutcomes measure: Neonatal Pain Agitation and Sedation Scale (N-PASS), primaryOutcomes measure: Change in Oxygen saturation, primaryOutcomes measure: Change in Heart rate, secondaryOutcomes measure: COMFORTneo Scale, eligibilityModule sex: ALL, minimumAge: 26 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Izmir Democracy University, city: Karabağlar, state: Izmir, zip: 35140, country: Turkey, geoPoint lat: 38.37396, lon: 27.1352, hasResults: False
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protocolSection identificationModule nctId: NCT06308978, orgStudyIdInfo id: FT819-102, briefTitle: FT819 in Moderate to Severe Active Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2042-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fate Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: FT819, interventions name: Fludarabine, interventions name: Cyclophosphamide, interventions name: Bendamustine, outcomesModule primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Number of participants with serious TEAEs, primaryOutcomes measure: Number of participants with adverse events of special interest (AESI), primaryOutcomes measure: Number of participants with TEAEs by severity, primaryOutcomes measure: Number of participants with dose-limiting toxicities (DLTs), primaryOutcomes measure: Recommend Phase 2 dose (RP2D) of FT819, secondaryOutcomes measure: Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time, secondaryOutcomes measure: Percentage of participants achieving DORIS clinical remission over time, secondaryOutcomes measure: Percentage of participants achieving lupus low disease activity state (LLDS) over time, secondaryOutcomes measure: Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time, secondaryOutcomes measure: Change in Physician Global Assessment (PGA) over time, secondaryOutcomes measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time, secondaryOutcomes measure: Change in estimated glomerular filtration rate (eGFR) over time, secondaryOutcomes measure: Change in urine creatinine over time, secondaryOutcomes measure: Change in urine protein over time, secondaryOutcomes measure: Change in protein to creatinine ratio over time, secondaryOutcomes measure: Concomitant lupus therapies prior to and following study intervention, secondaryOutcomes measure: Plasma concentration of FT819, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota Medical School, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: University of Nebraska Medical Center, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68198, country: United States, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False
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protocolSection identificationModule nctId: NCT06308965, orgStudyIdInfo id: Z-2023088, briefTitle: Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?, acronym: USP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ziekenhuis Oost-Limburg, class: OTHER, descriptionModule briefSummary: During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower., conditionsModule conditions: Tensor Fasciae Latae Syndrome, conditions: Arthroplasty Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a monocentric prospective randomized blinded clinical trial during a period of minimal 3 years or until 150% of sample size is included (100 patients)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants will be blinded and randomized into two cohorts. The selection and randomization protocol is as follows: participants eligible for the study are requested to participate and informed by the study nurse. If the patient agreed to participate, informed consent is obtained, and the patient is included in the study. At that time, the study nurse uses a mobile randomization application (Random, Dublin, Ireland) to allocate them either to the 'standard' (sacrificing the vessels) or 'vessel sparing' DAA.Weighted randomization (1:2) is applied to compensate for a dropout of patients planned for vessel sparing surgery, but in whom the vessels were damaged unintendedly. In case a bilateral procedure will be performed, each side is randomized individually.Surgery will be performed by the surgeon. Data collection before and after surgery is collected by personal assistant who is unaware of group assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Vessel technique, outcomesModule primaryOutcomes measure: a) Incidence of TFL tendinopathy, primaryOutcomes measure: b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS), primaryOutcomes measure: b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS), primaryOutcomes measure: b-3) Patient-reported outcome 3: Forgotten Joint Score, primaryOutcomes measure: b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS)., primaryOutcomes measure: c) Component placement (x-rays), secondaryOutcomes measure: Vessel sparing succesfull, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuis Oost-Limburg, city: Genk, state: Limburg, zip: 3600, country: Belgium, contacts name: Frans-Jozef Vandeputte, M.D., role: CONTACT, geoPoint lat: 50.965, lon: 5.50082, hasResults: False
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protocolSection identificationModule nctId: NCT06308952, orgStudyIdInfo id: 2024SL0006, briefTitle: Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery.At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients.Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees.However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad.Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation., conditionsModule conditions: Efficacy Endpoint: no New Cerebrovascular Adverse Events Within 1 Year, conditions: Safety Endpoint: no New Moderate or Serious Adverse Events Within 1 Year, conditions: All-cause Mortality Events (Within 1 Year), conditions: Incident Ischemic Stroke Events (Within 1 Year), conditions: New Hemorrhagic Stroke Events (Within 1 Year), conditions: New Stent Thrombosis Events (Within 1 Year), conditions: New Symptomatic Stenosis Events (Within 1 Year), conditions: Occurrence of In-stent Stenosis 12th ±1 Month Annual Angiographic Follow-up, conditions: Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up, conditions: Target Aneurysm Embolization Rate at 12±1 Month Annual Angiographic Follow-up (Raymond and OKM Classification), designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 386, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 20mg, outcomesModule primaryOutcomes measure: Efficacy endpoint: no new cerebrovascular adverse events within 1 year, secondaryOutcomes measure: Safety endpoint: no new moderate or serious adverse events within 1 year, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06308939, orgStudyIdInfo id: IRB-2024-198, briefTitle: Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: Eribulin, interventions name: Sintilimab, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Clinical Benefit Rate (CBR), secondaryOutcomes measure: Duration of Overall Response(DoR), secondaryOutcomes measure: Time to response (TTR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: adverse event(AE), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: zhejiangCH, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Ying Xi Shao, doctor, role: CONTACT, phone: 15824113524, email: 15824113524@163.com, contacts name: Jia Xiao Wang, doctor, role: CONTACT, contacts name: Jia Xiao Wang, doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06308926, orgStudyIdInfo id: MRG23ARDS, briefTitle: MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients, acronym: SUMMIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: MedRegen LLC, class: INDUSTRY, collaborators name: Vanderbilt University Medical Center, descriptionModule briefSummary: This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges., conditionsModule conditions: Acute Respiratory Distress Syndrome, conditions: Respiratory Failure, conditions: Respiratory Distress Syndrome, conditions: Respiratory Tract Diseases, conditions: Cytokine Storm, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: MRG-001 (Low-dose), interventions name: MRG-001 (High-dose), interventions name: Placebo, outcomesModule primaryOutcomes measure: Hemopoietic stem cell mobilization, primaryOutcomes measure: Organ Failure, secondaryOutcomes measure: Pharmacokinetics, secondaryOutcomes measure: Pharmacokinetics, secondaryOutcomes measure: Pharmacodynamics, secondaryOutcomes measure: Cytokine Changes, secondaryOutcomes measure: Respiratory-Free Days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308913, orgStudyIdInfo id: 2023-1722, secondaryIdInfos id: UW23121, type: OTHER, domain: UWCCC, secondaryIdInfos id: A534260, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 2/15/2024, type: OTHER, domain: UW Madison, secondaryIdInfos id: P50DE026787, type: NIH, link: https://reporter.nih.gov/quickSearch/P50DE026787, secondaryIdInfos id: P50CA278595-07, type: NIH, link: https://reporter.nih.gov/quickSearch/P50CA278595-07, briefTitle: Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: National Institute of Dental and Craniofacial Research (NIDCR), collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: INCB081776, interventions name: Pembrolizumab, interventions name: Palliative RT, outcomesModule primaryOutcomes measure: Incidence of Adverse Events (AEs), primaryOutcomes measure: Duration of Adverse Events, primaryOutcomes measure: Severity of Adverse Events, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DoR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UW Carbone Cancer Center, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
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protocolSection identificationModule nctId: NCT06308900, orgStudyIdInfo id: CL_SIMULATION_01, briefTitle: Non-technical Skills of Clinical Simulation in Physiotherapy Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.However, if we focus on physiotherapy, the use of clinical simulation is a very new field and therefore requires great research. The investigators still do not have the consistency or experience as in other health branches such as medicine or nursing, in which they have been using simulators for years for the learning of all their students.For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Clinical simulation, outcomesModule primaryOutcomes measure: Ottawa Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: David Hernández-Guillén, status: RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: David Hernández-Guillén, PT, PhD, role: CONTACT, phone: +34644217578, phoneExt: 51232, email: david.hernandez@uv.es, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06308887, orgStudyIdInfo id: 01, briefTitle: Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Kastamonu University, class: OTHER, descriptionModule briefSummary: Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection., conditionsModule conditions: Gonarthrosis, conditions: Meniscus; Degeneration, conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 31, type: ACTUAL, armsInterventionsModule interventions name: Triamcinolone Hexacetonide, interventions name: Dextrose 5% in water, outcomesModule primaryOutcomes measure: Visual Analogue Scale, secondaryOutcomes measure: Western Ontario and McMaster University Osteoarthritis Index, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gamze Gül Güleç, city: Kastamonu, zip: 37150, country: Turkey, geoPoint lat: 41.37805, lon: 33.77528, hasResults: False
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protocolSection identificationModule nctId: NCT06308874, orgStudyIdInfo id: JH-222-101, briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2023-02-17, completionDateStruct date: 2023-02-17, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: J2H Biotech, class: INDUSTRY, descriptionModule briefSummary: - Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects., conditionsModule conditions: Non-alcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Amg dose administration group, interventions name: Amg dose administration group- Placebo, interventions name: Bmg dose administration group, interventions name: Bmg dose administration group- Placebo, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: Emax, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: J2H Biotech, city: Suwon, state: Gyeonggi-do, zip: 16684, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False
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protocolSection identificationModule nctId: NCT06308861, orgStudyIdInfo id: JH-201-101, briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-12, primaryCompletionDateStruct date: 2021-06-25, completionDateStruct date: 2021-07-13, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: J2H Biotech, class: INDUSTRY, descriptionModule briefSummary: 1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial, conditionsModule conditions: Non-alcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Single administration Amg dose Group, interventions name: Single administration Bmg dose Group, interventions name: Single administration Cmg dose Group, interventions name: Single administration Dmg dose Group, interventions name: Single administration Emg dose Group, interventions name: Single administration Amg dose Group-Placebo, interventions name: Single administration Bmg dose Group-Placebo, interventions name: Single administration Cmg dose Group-Placebo, interventions name: Single administration Dmg dose Group-Placebo, interventions name: Single administration Emg dose Group-Placebo, interventions name: Multiple administration Amg dose group, interventions name: Multiple administration Bmg dose group, interventions name: Multiple administration Cmg dose group, interventions name: Multiple administration Dmg dose group, interventions name: Multiple administration Emg dose group, interventions name: Multiple administration Amg dose group - Placebo, interventions name: Multiple administration Bmg dose group - Placebo, interventions name: Multiple administration Cmg dose group - Placebo, interventions name: Multiple administration Dmg dose group - Placebo, interventions name: Multiple administration Emg dose group - Placebo, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: Emax, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: J2H Biotech, city: Suwon, state: Gyeonggi-do, zip: 16684, country: Korea, Republic of, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False
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protocolSection identificationModule nctId: NCT06308848, orgStudyIdInfo id: PR-22077, briefTitle: Microbiota Directed Food for Children With Severe Acute Malnutrition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Washington University School of Medicine, descriptionModule briefSummary: Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF., conditionsModule conditions: Severe Acute Malnutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial (Proof of concept study), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 256, type: ESTIMATED, armsInterventionsModule interventions name: Microbiota-Directed Food, interventions name: Ready-to-Use Therapeutic Food, outcomesModule primaryOutcomes measure: Mean change in Weight-for-Length Z-score (WLZ), secondaryOutcomes measure: Gut microbial community repair, secondaryOutcomes measure: Improvement in the levels of plasma protein biomarkers of healthy growth, secondaryOutcomes measure: Mean change in Weight-for-Age Z-score (WAZ), secondaryOutcomes measure: Mean change in Length-for-Age Z-score (LAZ), secondaryOutcomes measure: Mean change in body composition (% body fat mass and % fat-free mass), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Kurigram Study site, city: Kurigram, country: Bangladesh, contacts name: Md Hasan Hafizur Rahman, MPH, MBBS, role: CONTACT, phone: 01813333444, email: hasan.hafizur@icddrb.org, hasResults: False
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protocolSection identificationModule nctId: NCT06308835, orgStudyIdInfo id: APHP231652, briefTitle: Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU, acronym: STRESSréa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it., conditionsModule conditions: Post Intensive Care Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: questionnaires, outcomesModule primaryOutcomes measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom, primaryOutcomes measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom, primaryOutcomes measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom, primaryOutcomes measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GH Pitié Salpêtrière, city: Paris, zip: 75013, country: France, contacts name: Clémence Marois, MD, MSc, role: CONTACT, phone: 0142161858, phoneExt: 33, email: clemence.marois@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH Saint Anne, city: Paris, zip: 75014, country: France, contacts name: Camille Legouy, MD, role: CONTACT, phone: 0145656200, phoneExt: 33, email: c.legouy@ghu-paris.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06308822, orgStudyIdInfo id: NCI-2024-01151, secondaryIdInfos id: NCI-2024-01151, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-K1, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-K1, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-06-19, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well JNJ-42756493 (erdafitinib) works in treating patients with tumors that have more copies of the FGFR gene than is normal (amplification). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply., conditionsModule conditions: Advanced Lymphoma, conditions: Advanced Malignant Solid Neoplasm, conditions: Refractory Lymphoma, conditions: Refractory Malignant Solid Neoplasm, conditions: Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Erdafitinib, interventions name: Magnetic Resonance Imaging, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06308809, orgStudyIdInfo id: Shuzhen Ma, briefTitle: Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ma Shuzhen, class: OTHER, descriptionModule briefSummary: The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany., conditionsModule conditions: Adolescent Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Single (Participant)- Page 2 of 5 \[DRAFT\] -In order to avoid mutual interference between the experimental group and the control group, a blinding method needs to be used in the study. In this study, a single blind experiment will be conducted to blind the participating athletes.During the sample grouping process, participating athletes will not know the specific grouping situation., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: PNF training, outcomesModule primaryOutcomes measure: CAIT score, primaryOutcomes measure: Lower limb stability test, primaryOutcomes measure: Star offset balance test, primaryOutcomes measure: Muscle strength test, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308796, orgStudyIdInfo id: RADIOCARIES2023, briefTitle: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy, acronym: RADIOCARIES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Milan, class: OTHER, descriptionModule briefSummary: One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions., conditionsModule conditions: Caries,Dental, conditions: Head and Neck Cancer, conditions: Radiotherapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Application of CaP dental mousse, outcomesModule primaryOutcomes measure: Number of new cavitated caries per each patient (incidence of caries), secondaryOutcomes measure: Number of extracted teeth per patient (incidence of extracted teeth), secondaryOutcomes measure: Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis), secondaryOutcomes measure: Number of dental surfaces with caries or filling, and missed teeth, secondaryOutcomes measure: Rate of dentinal hypersensitivity per patient, secondaryOutcomes measure: Rate of dental surface with plaque per patient, secondaryOutcomes measure: Rate of bleeding gingival sites per patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Univeristy of Milan, status: RECRUITING, city: Milan, zip: 20142, country: Italy, contacts name: Elena M Varoni, PhD, role: CONTACT, phone: +3950319017, email: elena.varoni@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06308783, orgStudyIdInfo id: UFranciscoVitoriaRPGBREATH23, briefTitle: Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students, acronym: RPGBREATH23, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2024-07-17, completionDateStruct date: 2024-07-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Universidad Francisco de Vitoria, class: OTHER, descriptionModule briefSummary: Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.Objectives: Compare the effects of a diaphragmatic breathing self-management program with global postural reeducation on stress and sleep quality in university students.Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.Ethical considerations:The principles of the 1964 Declaration of Helsinki will be followed. The proposed interventions are non-invasive, based on the combination of mild physical activity tools, body awareness and relaxation techniques.The dependent variables to be measured are based on clinimetric aspects, without any harm to the participants.Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time., conditionsModule conditions: Stress, conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Diaphragmatic Breathing, interventions name: Global Postural Reeducation, outcomesModule primaryOutcomes measure: Stress, primaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Sleep Quality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308770, orgStudyIdInfo id: AC21137, briefTitle: Fatigue in Lupus Intervention Programmes (FLIP), acronym: FLIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Edinburgh, class: OTHER, collaborators name: Accord Clinical Research, descriptionModule briefSummary: Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in healthcare settings. Fatigue is more prevalent in SLE than other Rheumatic diseases. Management across the NHS is very variable ranging from a booklet to one to one appointments or, less often, a group intervention. Previous studies in other Rheumatic diseases have shown that a group cognitive behavioural approach can be effective in helping patients manage their fatigue. The COVID-19 pandemic changed the way healthcare is delivered in the NHS . Healthcare professionals had to find alternate solutions e.g. Virtual appointments.Our study aims to establish whether a virtual group Fatigue Management Programme and a fatigue booklet (Versus Arthritis and Lupus UK) is more effective at reducing the impact of fatigue in SLE participants than the fatigue booklet alone.The investigators will also compare a shortened 4-week to the standard 7-week programme to lessen the time commitment for participants and potentially reduce waiting times.The investigators will measure the effectiveness of the interventions through the use of Patient Reported Outcome Measures (PROMs) at several intervals whilst the participant is enrolled in the study.The pilot study will run in a single site in Edinburgh. The investigators aim to find a manageable, cost effective solution for the NHS and patients to address this frequently unmet need., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The pilot study for the FLIP trial is a single centre three arm, randomised controlled trial (RCT) comparing the effectiveness of a virtual group fatigue management intervention with standard care in SLE participants. Participants will self-enrol via a secure database and then be randomised electronically to one of the three interventions;1. Standard care (SC) - Lupus UK and Versus Arthritis Booklets2. SC and 4 week Fatigue management Programme (FMP)3. SC and 7 week FMP Results will be measured by comparing Patient Reported Outcome measures (PROMs) submitted before and after the intervention and, at 6 and 12 months., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The statistician who analyses the results will be blind to the intervention to which the participant was randomised., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: 4 week FMP, interventions name: 7 week FMP, outcomesModule primaryOutcomes measure: Modified Fatigue Impact Score (MFIS), secondaryOutcomes measure: Lupus quality of life questionnaire (LupusQoL), secondaryOutcomes measure: Pittsburgh Sleep quality Inventory ( PSQI), secondaryOutcomes measure: Visual Analog scale of fatigue impact (FI-VAS), secondaryOutcomes measure: Participant Health Questionnaire (PHQ4), secondaryOutcomes measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale, secondaryOutcomes measure: Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ), secondaryOutcomes measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308757, orgStudyIdInfo id: 495/2021/Sper/AOUBo, briefTitle: Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis, acronym: KETONASH, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-29, primaryCompletionDateStruct date: 2024-11-24, completionDateStruct date: 2026-12-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD)., conditionsModule conditions: NASH, conditions: NAFLD, conditions: Obesity, conditions: Liver Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Two-arms, 2: 1 randomization stratified by type 2 diabetes mellitus and gender, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Very-low-calorie ketogenic diet (VLCKD) with meal replacements, interventions name: Mediterranean low-calorie diet (LCD), outcomesModule primaryOutcomes measure: Change of at least one grade of liver fibrosis, primaryOutcomes measure: Change of histological features of NASH, secondaryOutcomes measure: Histological NIH NASH CRN Score, secondaryOutcomes measure: Histological FLIP/SAF changes, secondaryOutcomes measure: Biochemical test changes 1, secondaryOutcomes measure: Biochemical test changes 2, secondaryOutcomes measure: Biochemical test changes 3, secondaryOutcomes measure: Biochemical test changes 4, secondaryOutcomes measure: Biochemical test changes 5, secondaryOutcomes measure: Biochemical test changes 6, secondaryOutcomes measure: Biochemical test changes 7, secondaryOutcomes measure: Biochemical test changes 8, secondaryOutcomes measure: Biochemical test changes 9, secondaryOutcomes measure: Biochemical test changes 10, secondaryOutcomes measure: Biochemical test changes 11, secondaryOutcomes measure: Biochemical test changes 12, secondaryOutcomes measure: Biochemical test changes 13, secondaryOutcomes measure: Fibrosis-4 test (FIB-4 ) variation, secondaryOutcomes measure: NAFLD Fibrosis Score (NFS) change, secondaryOutcomes measure: FAST (FibroScan-AST) score variation, secondaryOutcomes measure: Fatty Liver Index (FLI) modification, secondaryOutcomes measure: Changes in LSM, secondaryOutcomes measure: Variation of steatosis by CAP, secondaryOutcomes measure: Body Mass Index (BMI) improvement, secondaryOutcomes measure: Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale), secondaryOutcomes measure: Compliance to VLCKD evaluated by VAS (Visual Analogue Scale), secondaryOutcomes measure: Variation of steatosis by ultrasound assessment, secondaryOutcomes measure: Questionnaires 1, secondaryOutcomes measure: Questionnaires 2, secondaryOutcomes measure: Questionnaires 3, secondaryOutcomes measure: Questionnaires 4, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, status: RECRUITING, city: Bologna, zip: 40138, country: Italy, contacts name: Federico Ravaioli, role: CONTACT, phone: +393333176759, email: f.ravaioli@unibo.it, contacts name: Sofia Penazza, role: CONTACT, phone: 0512142477, email: sofia.penazza2@unibo.it, contacts name: Federico Ravaioli, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Maria Letizia Petroni, Professor, role: SUB_INVESTIGATOR, contacts name: Fabio Piscaglia, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: Silvia Ferri, MD, role: SUB_INVESTIGATOR, contacts name: Simona Leoni, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-23, uploadDate: 2024-02-19T03:31, filename: Prot_SAP_000.pdf, size: 368757, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-14, uploadDate: 2024-02-19T03:32, filename: ICF_001.pdf, size: 47308, hasResults: False
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protocolSection identificationModule nctId: NCT06308744, orgStudyIdInfo id: 2021-5212-4387, briefTitle: A Large Multi-site Study on Self-administered Mindfulness, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-23, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Swansea University, class: OTHER, collaborators name: Université Grenoble-Alpes, collaborators name: University of Utah, collaborators name: Seeburg University, collaborators name: Ludwig-Maximilians - University of Munich, collaborators name: University of Houston, collaborators name: Loyola Marymount University, collaborators name: Ashland University, collaborators name: The College at Brockport, collaborators name: Medical University of South Carolina, collaborators name: Australian National University, collaborators name: The University of Queensland, collaborators name: University of North Florida, collaborators name: University of Wuerzburg, collaborators name: Iowa State University, collaborators name: Goldsmiths, University of London, collaborators name: Pennsylvania Western University, collaborators name: University of Konstanz, collaborators name: Springfield College, collaborators name: Glendale Community College, collaborators name: St. Olaf College, collaborators name: University of Limerick, collaborators name: Northumbria University, collaborators name: Wittenberg University Ohio, collaborators name: University of Edinburgh, collaborators name: University of California, Merced, collaborators name: University of Southern Indiana, collaborators name: Pace University, collaborators name: Toronto Metropolitan University, collaborators name: Wayne State University, collaborators name: Memorial University of Newfoundland, collaborators name: University College, London, collaborators name: DigiPen Institute of Technology Redmond, collaborators name: University of Canberra, collaborators name: University of Northern Iowa, collaborators name: Idaho State University, collaborators name: Behavioural Science Institute, collaborators name: Radboud University Medical Center, collaborators name: Eastern Oregon University, collaborators name: Charles University, Czech Republic, collaborators name: University of Milano Bicocca, collaborators name: Spiessens Coaching Solutions Ltd, descriptionModule briefSummary: The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found \[evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises\] with an estimated mean effect size of \[xx/xx\]. This means that... or The investigators recommend that... \[recommendation will be provided\]., conditionsModule conditions: Body Scan Meditation, conditions: Loving-Kindness Meditation, conditions: Mindful Breathing Meditation, conditions: Mindful Walking Meditation, conditions: Control Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The current multi-site project followed the route of a parallel randomized controlled trial. Each participant was randomly allocated to either an experimental condition corresponding to a 15-minute audio listening of one of four different mindfulness exercises (i.e., mindful walking, mindful breathing, body scan and loving kindness meditation) or to a control condition (i.e., listening to a 15-minute audio story excerpt). Participants who were assigned to the control group randomly listened to an excerpt of one of the three stories that the investigators selected for the present study., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants were not aware of the experimental condition in which they were randomly allocated. Data collection was performed blind to the experimental conditions, but data analysis was not performed blind. However, given that all analyses were pre-registered, it is unlikely that the lack of blinding in data analysis introduced bias., whoMasked: PARTICIPANT, enrollmentInfo count: 2239, type: ACTUAL, armsInterventionsModule interventions name: Body-scan meditation, interventions name: Mindful Breathing meditation, interventions name: Loving Kindness meditation, interventions name: Mindful Walking, interventions name: Listening of a story, outcomesModule primaryOutcomes measure: Stress, secondaryOutcomes measure: Emotion dimensions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Swansea University, city: Swansea, state: Wales, UK, zip: SA2 8PP, country: United Kingdom, geoPoint lat: 51.62079, lon: -3.94323, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-03-22, uploadDate: 2024-03-05T01:50, filename: Prot_SAP_000.pdf, size: 606904, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-11-05, uploadDate: 2024-03-05T01:51, filename: ICF_001.pdf, size: 240389, hasResults: False
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protocolSection identificationModule nctId: NCT06308731, orgStudyIdInfo id: 23-26, briefTitle: Exercise-Induced Rates of Fat Oxidation With and Without Ingestion of a Caffeine-Based Energy Drink, acronym: EDX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Lindenwood University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink., conditionsModule conditions: Substrate Oxidation, conditions: Energy Expenditure, conditions: Reaction Time, conditions: Cognition, conditions: Exercise Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind, placebo controlled, crossover design, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: All energy drink supplements are provided in identical, unlabeled cans, using a randomization code., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine-Based Energy Drink, interventions name: Placebo, outcomesModule primaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise., secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise., secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on exercise performance, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on reaction time, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on trail making test performance, secondaryOutcomes measure: Impact of a caffeine-based energy drink ingestion on Cognition, otherOutcomes measure: Impact of a caffeine-based energy drink ingestion on adverse events, otherOutcomes measure: Impact of a caffeine-based energy drink ingestion on heart rate, otherOutcomes measure: Impact of a caffeine-based energy drink ingestion on blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Exercise and Performance Nutrition Laboratory, status: RECRUITING, city: Saint Charles, state: Missouri, zip: 63301, country: United States, contacts name: Anthony M Hagele, MS, role: CONTACT, phone: 636-949-4785, email: ahagele@lindenwood.edu, contacts name: Joesi M Krieger, MS, role: CONTACT, phone: 636-949-4785, email: jkrieger@lindenwood.edu, contacts name: Chad M Kerksick, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.78394, lon: -90.48123, hasResults: False
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protocolSection identificationModule nctId: NCT06308718, orgStudyIdInfo id: FBX-101-LTFU, briefTitle: Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Forge Biologics, Inc, class: INDUSTRY, descriptionModule briefSummary: This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101., conditionsModule conditions: Krabbe Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: FBX-101, outcomesModule primaryOutcomes measure: Long Term safety as assessed by incidence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) that are attributed to FBX-101, secondaryOutcomes measure: Efficacy as assessed by change of gross motor function measured longitudinally by Peabody Developmental Motor Scale (PDMS-2), secondaryOutcomes measure: Efficacy as assessed by change of gross motor function measured longitudinally by Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), secondaryOutcomes measure: Efficacy as assessed by change of gross motor function measured longitudinally by Gross Motor Function Measure 88 (GMFM-88), secondaryOutcomes measure: Efficacy as assessed by change of fine motor function measured longitudinally by Mullen Scales of Early Learning (MSEL), secondaryOutcomes measure: Efficacy as assessed by change of fine motor function measured longitudinally by Beery VMI Sixth Edition (VMI), secondaryOutcomes measure: Efficacy as assessed by change of fine motor function measured longitudinally by Bayley Scales of Infant Development (Bayley-III), secondaryOutcomes measure: Efficacy as assessed by change of fine motor function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3), secondaryOutcomes measure: Efficacy as assessed by change of cognitive function measured longitudinally by Mullen Scales of Early Learning (MSEL), secondaryOutcomes measure: Efficacy as assessed by change of cognitive function measured longitudinally by the Differential Ability Scale II (DAS-II), secondaryOutcomes measure: Efficacy as assessed by change of cognitive function measured longitudinally by Bayley Scales of Infant Development (Bayley-III), secondaryOutcomes measure: Efficacy as assessed by change of adaptive behaviour function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3)., secondaryOutcomes measure: Efficacy as assessed by change of language function measured longitudinally by Mullen Scales of Early Learning (MSEL)., secondaryOutcomes measure: Efficacy as assessed by change of language function measured longitudinally by Clinical Evaluation of Language Fundamentals Fifth Edition (CELF-5), secondaryOutcomes measure: Efficacy as assessed by change of language function measured longitudinally by Bayley Scales of Infant Development (Bayley-III), secondaryOutcomes measure: Efficacy as assessed by change of language function measured longitudinally by Vineland Adaptive Behavior Scale (Vineland 3)., secondaryOutcomes measure: Efficacy as assessed by change of quality of life measured longitudinally by the Pediatric Quality of Life (PedsQL) Generic Core Scales with Family Impact Module and Multidimensional Fatigue Scale, secondaryOutcomes measure: Efficacy as assessed by change of developmental milestones such as language and motor skills as measured longitudinally by an specific Developmental Milestones questionnaire, secondaryOutcomes measure: Efficacy as assessed by change of hearing function measured longitudinally by Auditory Brainstem Responses (ABRs), secondaryOutcomes measure: Efficacy as assessed by change of hearing function measured longitudinally by Behavior Audiometry (BAUD), secondaryOutcomes measure: Efficacy as assessed by change of peripheral nerve conduction velocity measured longitudinally by Nerve Conduction Velocity (NCV) assessments, secondaryOutcomes measure: Efficacy as assessed by change of Fractional Anisotropy (FA) as measured longitudinally by brain Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI), secondaryOutcomes measure: Efficacy as assessed by change of visual function as measured longitudinally by visual evoked potentials (VEP), secondaryOutcomes measure: Efficacy as assessed by change of visual function as measured longitudinally by visual acuity, secondaryOutcomes measure: Efficacy as assessed by change of whole blood donor chimerism, secondaryOutcomes measure: Efficacy as assessed by change of psychosine in whole blood and plasma, secondaryOutcomes measure: Efficacy as assessed by change of Galactosylceramidase (GALC) levels in plasma and Cerebrospinal Fluid (CSF), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308705, orgStudyIdInfo id: 2022-19, briefTitle: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2023-10-18, completionDateStruct date: 2023-10-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is a single-center interventional study with an IVD medical device.The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests., conditionsModule conditions: Strongyloides Stercoralis Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: InBios Strongy Detect TM IgG ELISA, outcomesModule primaryOutcomes measure: Result of the SsIR/NIE ELISA, secondaryOutcomes measure: Seroconversion, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, city: Negrar, state: Verona, zip: 37024, country: Italy, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06308692, orgStudyIdInfo id: 2022-11, briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM., conditionsModule conditions: Drug Resistant Bacterial Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: ARES PCR, outcomesModule primaryOutcomes measure: PCR results, secondaryOutcomes measure: Gene mutations, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierantonio Orza, role: SUB_INVESTIGATOR, contacts name: Francesca Perandin, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06308679, orgStudyIdInfo id: BE 001-24, briefTitle: A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Pharma Nueva, class: INDUSTRY, descriptionModule briefSummary: Objectives:Primary:to evaluate the bioequivalence of two formulations of Empagliflozin tablets, test formulation and reference innovator formulation, after a single oral dose administration in healthy Thai subjects under fasting conditionsSecondary:To examine the pharmacokinetics and safety of test and reference formulationsStudy Design:A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions, conditionsModule conditions: Healthy Vollunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 10 mg tablets, interventions name: JARDIANCE®, outcomesModule primaryOutcomes measure: Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Empagliflozin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308666, orgStudyIdInfo id: 46091, briefTitle: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use, acronym: FOX, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-07-18, completionDateStruct date: 2024-07-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Waterloo, class: OTHER, collaborators name: Alcon Research, descriptionModule briefSummary: The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day)., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Delefilcon A contact lenses, outcomesModule primaryOutcomes measure: Subjective Rating of Comfort After 8 Hours or More of Digital Device Use, primaryOutcomes measure: Subjective Rating of Dryness After 8 Hours or More of Digital Device Use, primaryOutcomes measure: Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Ocular Research & Education, status: RECRUITING, city: Waterloo, state: Ontario, zip: N2L 3G1, country: Canada, contacts name: Jill Woods, McOptom, role: CONTACT, phone: 519-888-4567, phoneExt: 36743, email: jwoods@uwaterloo.ca, contacts name: Lyndon Jones, PhD, FCoptom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.4668, lon: -80.51639, hasResults: False
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protocolSection identificationModule nctId: NCT06308653, orgStudyIdInfo id: PSIL301, briefTitle: Psilocybin for Major Depressive Disorder (MDD), acronym: uAspire, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Usona Institute, class: OTHER, descriptionModule briefSummary: Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo.The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to receive Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo under double-blind conditions. After the initial 6-week Double-blind Period, all participants will proceed into a 1-year Follow-up Period. During this 1-year Follow-up Period, eligible participants who meet pre-determined criteria may be offered open-label Psilocybin 25 mg in the context of a "Set and Setting" (SaS) Protocol., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The following roles will be blinded to the treatment group assignment in the Double-blind Period during the trial: Participant, Investigator, Site Personnel, Facilitators, Efficacy Raters (including Site Raters, Participant Raters, and Central Raters), Contract Research Organization (CRO) Staff, and Sponsor.All roles other than the Sponsor, CRO, and Ethics Committees will also be blinded to the randomization ratio and Patient Health Questionnaire-9 (PHQ-9) score for re-administration eligibility.The Central MADRS Rater will also be blinded to all aspects of the protocol and trial visit for each participant.Blinded trial site personnel will complete administration of the IP.Full blinding of trial personnel, Sponsor, and participants will be maintained until database lock at the conclusion of the trial., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin 25 mg, interventions name: Inactive Placebo, interventions name: Psilocybin 5 mg, interventions name: Psychosocial Support, outcomesModule primaryOutcomes measure: Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Trial Day 43, secondaryOutcomes measure: Change in central rater Clinical Global Impression-Severity (CGI-S) total score from Baseline to Trial Day 43, secondaryOutcomes measure: Change in on-site rater administered Sheehan Disability Scale (SDS) score from Baseline to post-dose Day 43, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mountain View Clinical Research, status: RECRUITING, city: Denver, state: Colorado, zip: 80209, country: United States, contacts name: Brian Johnson, role: CONTACT, phone: 720-941-9363, phoneExt: 703, email: Brian@mtnresearch.com, contacts name: David Weiss, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Innovative Clinical Research, Inc., status: RECRUITING, city: Lauderhill, state: Florida, zip: 33319, country: United States, contacts name: Shelbie Bobrow, role: CONTACT, phone: 954-769-1397, email: sbobrow@segaltrials.com, contacts name: Louis Sotolongo, role: CONTACT, phone: 954-769-1397, email: lsotolongo@segaltrials.com, contacts name: Rishi Kakar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.14036, lon: -80.21338, locations facility: Cedar Clinical Research, status: RECRUITING, city: Draper, state: Utah, zip: 84020, country: United States, contacts name: Jane Bjorklund, role: CONTACT, phone: 801-369-4219, email: jane.bjorklund@numinus.com, contacts name: Reid Robison, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.52467, lon: -111.86382, locations facility: Cedar Clinical Research, Inc., status: RECRUITING, city: Murray, state: Utah, zip: 84107, country: United States, contacts name: Jane Bjorklund, role: CONTACT, phone: 801-369-4219, email: jane.bjorklund@numinus.com, contacts name: Paul Thielking, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.66689, lon: -111.88799, hasResults: False
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protocolSection identificationModule nctId: NCT06308640, orgStudyIdInfo id: ORTH 11-23 2097, briefTitle: Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molarsThe patients will be selected according to the following criteria:1. Patient with full permanent dentition.2. Good oral hygiene.3. None of the patients had received any orthodontic treatment.4. Class II molar relationship.5. Minimal or no crowding in the mandibular arch.6. Non-extraction treatment plan with molar distalization.7. Low angle cases.8. No medical problems or active periodontal disease.Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization., conditionsModule conditions: Class II Malocclusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The purpose of this study is to evaluate and compare the treatment effects of two bone supported protocols for bilateral distalization of maxillary molars in patients exhibiting class II pattern using Fast Back appliance and modified Leaf Spring Self-Activated Expander, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Insertion of the device intraorally, outcomesModule primaryOutcomes measure: 3D Dental and skeletal Cephalometric Measurements, primaryOutcomes measure: 2D Dental and skeletal Cephalometric Measurements, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Tanta, state: Gharbia, zip: 6620010, country: Egypt, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06308627, orgStudyIdInfo id: K2022-03-074, briefTitle: A One-year Trajectory of Depression Status Changes in Elderly Patients With MCI and SD: a Longitudinal Cohort Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the one-year trajectory of changes in depression status in elderly patients with mild cognitive impairment and subthreshold depression, and to explore relevant risk factors for predicting changes in depression status. This one-year prospective longitudinal follow-up study involved 400 (expected) subjects who met the diagnostic criteria for mild cognitive impairment combined with subthreshold depression in the elderly, and their depressive status was assessed using the Geriatric Depression Scale (GDS). Follow up monitoring of depression status at 6 and 12 months. Obtain factors related to changes in depressive status (such as age, gender, education level, cognitive function, anxiety level, sleep status, social support, psychological resilience, social network, etc.). By studying the longitudinal trajectory of depression status in elderly patients with mild cognitive impairment and subthreshold depression, a multi state Markov model with time and state discreteness is constructed, namely: State 1 (normal); State 2 (subliminal depression); State 3 (mild depression); State 4 (moderate depression); State 5 (severe depression). Deeply explore and analyze the impact of certain factors and indicators on the transition between states, and estimate the probability of transition between states., conditionsModule conditions: Mild Cognitive Impairment, conditions: Subthreshold Depression, conditions: Older Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Depressive state, secondaryOutcomes measure: General information of patients, secondaryOutcomes measure: Cognitive, secondaryOutcomes measure: Cognitive, secondaryOutcomes measure: Activity of Daily Living, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Social Function, secondaryOutcomes measure: Social Function, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Resilience, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian provincial hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350000, country: China, contacts name: Hong Li, role: CONTACT, phone: 18120826271, email: leehong99@126.com, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06308614, orgStudyIdInfo id: MIT-Do001-C206, briefTitle: Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Estetra, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is investigating estetrol (E4) in women after menopause, suffering from sexual arousal disorder. The main question it aims to answer is: is 20 mg estetrol monohydrate effective in the treatment of sexual arousal disorder in women after their menopause. Participants will visit the clinic 7 times and complete a daily diary while receiving estetrol or placebo for 12 weeks. Placebo is a pill that looks the same as estetrol but has no active ingredient. Researchers will compare estetrol and placebo to see if estetrol has an effect on the sexual arousal of the participants., conditionsModule conditions: Sexual Dysfunction, Physiological, 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: 76, type: ESTIMATED, armsInterventionsModule interventions name: 20 mg estetrol monohydrate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline to Week 12 in feeling concerned by difficulties with sexual arousal, assessed by FSDS-DAO Item 14., primaryOutcomes measure: Change from Baseline to Week 12 in the Sexual Function Questionnaire 28 (SFQ-28) Arousal-Sensation Domain (Questions 6 to 9)., secondaryOutcomes measure: Change from Baseline to Week 12 in arousal and lubrication assessed by Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction (SexFS) measures (PROMISSexFS Questionnaire)., secondaryOutcomes measure: Change from Baseline to Week 12 in sexual function assessed by FSDS-DAO - total score., secondaryOutcomes measure: Change from Baseline to Week 12 in sexual function assessed by Percentage of Satisfying Sexual Events (SSE) - captured in arousal electronic diary (ediary)., secondaryOutcomes measure: Change from Baseline to Week 12 in sexual function assessed by SFQ-28 - total score., secondaryOutcomes measure: Change from Baseline to Week 12 in sexual function assessed by PROMIS-SexFS., secondaryOutcomes measure: Patient Global Impression of Change (PGIC) at Week 12., secondaryOutcomes measure: Change from Baseline to Week 12 in severity of sexual arousal disorder as assessed by Patient Global Impression of Severity (PGIS)., otherOutcomes measure: Frequency of treatment emergent adverse events (TEAEs) (including treatment-emergent serious adverse events [TESAEs])., otherOutcomes measure: Blood pressure (systolic and diastolic) at each measured time point., otherOutcomes measure: Respiratory rate at each measured time point., otherOutcomes measure: Heart rate at each measured time point., eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85032, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Tucson, state: Arizona, zip: 85715, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92111, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33173, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: New Port Richey, state: Florida, zip: 34652, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 28.24418, lon: -82.71927, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32801, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Estetra Study Site, status: RECRUITING, city: West Palm Beach, state: Florida, zip: 33409, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 26.71534, lon: -80.05337, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Sandy Springs, state: Georgia, zip: 30328, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 33.92427, lon: -84.37854, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Omaha, state: Nebraska, zip: 68114, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Las Vegas, state: Nevada, zip: 89109, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Albuquerque, state: New Mexico, zip: 87102, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 35.08449, lon: -106.65114, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Englewood, state: Ohio, zip: 45322, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 39.87756, lon: -84.30217, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Memphis, state: Tennessee, zip: 38119, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Memphis, state: Tennessee, zip: 38120, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 35.14953, lon: -90.04898, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77061, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Estetra Study Site, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77074, country: United States, contacts role: CONTACT, email: clinical.trials@mithra.com, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06308601, orgStudyIdInfo id: 23-12.1T/60, briefTitle: The Effect of Laughter Yoga on Loneliness, Anger and Salivary Cortisol Levels in Visually Impaired Individuals, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-16, primaryCompletionDateStruct date: 2024-06-04, completionDateStruct date: 2024-06-27, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Purpose: This project aimed to examine the effects of laughter yoga, which is accepted as an international nursing initiative, on loneliness, anger and salivary cortisol levels in visually impaired individuals. When the national and international literature was examined, no project was found that measured the results of laughter yoga as an intervention for visually impaired individuals. For this reason, planning an original project in this field aims to contribute to the literature. Thanks to the evidence obtained, laughter yoga, an innovative approach, can be disseminated in institutions and organizations serving visually impaired individuals as an evidence-based practice that can improve the social skills of individuals.Scope and Target Audience: The project will be carried out with visually impaired individuals receiving services in the Disabled Persons Department within the Atatürk Provincial Public Library located in Konak district of Izmir. In this section, services are provided to 250 members who actively use the library and to visually impaired people from all over Turkey.Method and Expected Result: The project was planned in a randomized controlled, pre-test post-test, single-blind follow-up consultancy design. With this initiative, a social rehabilitation environment will be provided for visually impaired individuals by taking an approach based on respect, understanding and awareness. Laughter yoga is expected to reduce the level of anger and loneliness in visually impaired individuals. At the same time, laughter yoga is expected to reduce cortisol levels, which are known to increase when faced with stress factors, and increase serotonin, which is associated with happiness and vitality, and endorphine, known as the body's natural painkiller. With laughter yoga sessions, a social environment will be created where visually impaired individuals will have an active and independent experience. Thanks to the expected evidence, laughter yoga can be popularized both in visually impaired individuals and in individuals with other disabilities. Within the scope of protecting and improving health, laughter yoga can be planned to be carried out as a routine nursing practice in disabled centers. Thus, by creating an environment where visually impaired individuals and nurses come together, a more accessible health service will be provided to individuals with special needs., conditionsModule conditions: Nursing Caries, conditions: Laughter, conditions: Visual Impairment, conditions: Loneliness, conditions: Anger, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Research Population: The population of this research is the visually impaired individuals who received service from the Disabled Department within the Ataturk Provincial Public Library in Konak district of Izmir province between 2023-2024.Research Sample: In the research, "G. Using the "Power-3.1.9.7" program, the sample size of the study was calculated at a 95% confidence level before the data collection phase. The standardized effect size was found to be 0.90 when calculated based on the mean and standard deviation values of previous studies. As a result, the minimum number of samples was calculated as 28 for each group with a 95% confidence level, 0.05 alpha value, 0.90 intervention effect size and 95% theoretical power. It is aimed to reach 56 people in total. Considering that there will be a 20% case loss in experimental studies in the literature (Pan, et al., 2019), the number of samples was determined as 60 (30 interventions; 30 controls)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Statistical evaluation of the research results will be made by an expert other than the researcher., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Laughter yoga, outcomesModule primaryOutcomes measure: salivary cortisol test, primaryOutcomes measure: UCLA(University of California, Los Angeles) Loneliness Scale, primaryOutcomes measure: Trait Anger Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ege University, city: Bornova, state: İ̇zmi̇r, zip: 35030, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, hasResults: False
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protocolSection identificationModule nctId: NCT06308588, orgStudyIdInfo id: 2024-0054, secondaryIdInfos id: NCI-2024-02121, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL., conditionsModule conditions: Philadelphia Chromosome-Positive, conditions: Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Blinatumomab, interventions name: Asciminib, 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: Nicholas Short, MD, role: CONTACT, phone: 713-563-4485, email: nshort@mdanderson.org, contacts name: Nicholas Short, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06308575, orgStudyIdInfo id: 2023-0771, secondaryIdInfos id: NCI-2024-02155, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Elevar Therapeutics, descriptionModule briefSummary: To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied., conditionsModule conditions: Metastatic Olfactory Neuroblastoma, conditions: Recurrent Olfactory Neuroblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Rivoceranib, 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: Luana Guimaraes De Sousa, MD, role: CONTACT, phone: 832-728-7849, email: lgsousa@mdanderson.org, contacts name: Luana Guimaraes De Sousa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06308562, orgStudyIdInfo id: 23-010717, briefTitle: Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Fuzzy Wale Compression Stockinet, outcomesModule primaryOutcomes measure: Surgical site infection, primaryOutcomes measure: Wound dehiscence, primaryOutcomes measure: Days on negative pressure wound therapy, primaryOutcomes measure: Pain control, primaryOutcomes measure: Time to prosthetic fitting, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Vascular Research Team, role: CONTACT, phone: 507-538-7425, contacts name: Matthew Melin, M.D., role: CONTACT, phone: (507) 266-6717, email: Melin.Matthew@mayo.edu, contacts name: Matthew Melin, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06308549, orgStudyIdInfo id: 2023.0714, briefTitle: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY), acronym: MyREMEDY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Maartje de Wit, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: King's College London, collaborators name: University of Malaga, collaborators name: Forschungsinstitut der Diabetes Akademie Mergentheim, descriptionModule briefSummary: In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany., conditionsModule conditions: Type 1 Diabetes, conditions: Diabetes Distress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: MyDiaMate, outcomesModule primaryOutcomes measure: Diabetes Distress, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Psychological self-efficacy in relation to diabetes, secondaryOutcomes measure: Social Engagement, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Time in/above/below range, secondaryOutcomes measure: Events of ketoacidosis/severe hypoglycaemia, otherOutcomes measure: MyDiaMate usage data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim, city: Bad Mergentheim, state: Baden-Württemberg, zip: 97980, country: Germany, contacts name: Dominic Ehrmann, role: CONTACT, phone: +4979319613839, email: info@fidam.de, contacts name: Dominc Ehrmann, role: PRINCIPAL_INVESTIGATOR, contacts name: Gina Lehmann, role: SUB_INVESTIGATOR, contacts name: Norbert Hermanns, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.4925, lon: 9.77361, locations facility: Amsterdam UMC, city: Amsterdam, state: Noord-Holland, zip: 1081HV, country: Netherlands, contacts name: Theresa Mohr, MSc, role: CONTACT, phone: +31205669111, email: myremedy@amsterdamumc.nl, contacts name: Maartje de Wit, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Theresa Mohr, MSc., role: SUB_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Universidad de Málaga, city: Málaga, zip: 29071, country: Spain, contacts name: Maria Teresa Anarte, role: CONTACT, phone: +34952131313, email: info@uma.es, contacts name: Maria Teresa Anarte, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: King's College London, city: London, zip: WC2R 2LS, country: United Kingdom, contacts name: Kirsty Winkley, Dr., role: CONTACT, phone: +4402078365454, email: MyREMEDY@kcl.ac.uk, contacts name: Kirsty Winkly, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06308536, orgStudyIdInfo id: KY-2023-045, briefTitle: Application of Concentrated Growth Factors in Alveolar Ridge Preservation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-09, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: To explore the role of CGF in the regeneration or preservation of soft and hard tissues during tooth extraction site preservation surgery., conditionsModule conditions: Alveolar Ridge Preservation, conditions: Concentrated Growth Factor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: bone powder + collagen membrane, interventions name: bone powder + collagen membrane + CGF membrane, interventions name: bone powder mixed wih CGF gel + collagen membrane + CGF membrane, interventions name: bone powder + CGF membrane, outcomesModule primaryOutcomes measure: the width of keratinized gingiva, primaryOutcomes measure: the horizontal width (from buccal to lingual at the alveolar top ) of gingiva, primaryOutcomes measure: the horizontal bone resorption of alveolar crest, primaryOutcomes measure: the vertical bone resorption of alveolar crest, primaryOutcomes measure: the average gray value of alveolar bone, secondaryOutcomes measure: Landry wound healing index, secondaryOutcomes measure: reduction in membrane exposure area, secondaryOutcomes measure: pain score, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine, status: RECRUITING, city: Yiwu, state: Zhejiang Procince, zip: 310000, country: China, contacts name: Genying Zhuang, Master, role: CONTACT, phone: 13758195143, email: 20918620@zju.edu.cn, geoPoint lat: 29.31506, lon: 120.07676, hasResults: False
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protocolSection identificationModule nctId: NCT06308523, orgStudyIdInfo id: AP303-PK-02, briefTitle: A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Alebund Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: AP303 150 μg, interventions name: Placebo 150 μg, interventions name: AP303 300 μg, interventions name: Placebo 300 μg, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: Tmax, primaryOutcomes measure: AUC0-24h, primaryOutcomes measure: AUC0-last, primaryOutcomes measure: AUC0-inf, primaryOutcomes measure: AUC0-t, primaryOutcomes measure: t1/2, primaryOutcomes measure: CL/F, primaryOutcomes measure: V/F, primaryOutcomes measure: Cav, primaryOutcomes measure: Ctrough, primaryOutcomes measure: Rac, primaryOutcomes measure: Incidence and severity of adverse events, primaryOutcomes measure: Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Effect of AP303 on ECG parameters, primaryOutcomes measure: Vital signs, primaryOutcomes measure: Effect of AP303 on physical examination result, primaryOutcomes measure: body weight, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Fasting lipid profile, secondaryOutcomes measure: Serum creatinine, secondaryOutcomes measure: eGFR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308510, orgStudyIdInfo id: MEC-2024tba, briefTitle: Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: collection additional peritoneal lavage fluid, outcomesModule primaryOutcomes measure: Sensitivity mFast-SeqS, secondaryOutcomes measure: DFS, secondaryOutcomes measure: Concordance detection rates peritoneal dissemination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, city: Rotterdam, zip: 3015GD, country: Netherlands, contacts name: Jessie Huizer, Drs, role: CONTACT, phone: +31107034523, email: t.j.huizer@erasmusmc.nl, contacts name: Niels Guchelaar, role: CONTACT, email: n.guchelaar@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06308497, orgStudyIdInfo id: 2024-Q10PREGNANT, briefTitle: Adjunctive Periodontal Treatment With Coenzyme Q10 in Association With Probiotics for Pregnant Women, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-10-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess if probiotic supplementation can be effective in reducing periodontal clinical parameters in a 6-month study on pregnant patients., conditionsModule conditions: Periodontal Diseases, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-arm parallel design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Products will be concealed., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic Treatment, interventions name: Standard Treatment, outcomesModule primaryOutcomes measure: Change in Plaque Index, primaryOutcomes measure: Change in Recession (R), primaryOutcomes measure: Change in Clinical Attachment Loss (CAL), primaryOutcomes measure: Change in Bleeding on Probing (BoP), primaryOutcomes measure: Change in Probing Pocket Depth (PPD), primaryOutcomes measure: Change in API - Approximal Plaque Index, primaryOutcomes measure: Change in Plaque Control Record (PCR%), primaryOutcomes measure: Change in Papillary Marginal Gingival Index (PMGI), primaryOutcomes measure: Change in modified Marginal Gingival Index (mMGI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06308484, orgStudyIdInfo id: TRR265 C02 FP2, briefTitle: Neuromodulation and Mindfulness Patients With AUD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: Medical School Berlin, descriptionModule briefSummary: Our primary objective is to integrate tVNS and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for detoxified alcohol-dependent patients (AD). We aim to determine whether neuromodulation can enhance mindfulness-based relapse prevention compared to mindfulness practice alone. In this context, we will investigate potential changes in the interaction of top-down control and cue reactivity, as well as assess the severity of AUD. Measurements of drinking behavior, cravings, and abstinence rates will be conducted up to three months post-treatment. Our second objective is to examine the causal role of frontal midline theta oscillations (FMΘ) in MBRP and cognitive control. To achieve this, we will first establish closed-loop amplitude-modulated transcranial alternating current stimulation (CLAM-tACS) to selectively modulate FMΘ oscillations during MBRP meditation exercises in AUD patients (2)., conditionsModule conditions: Alcohol Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous vagus nerve stimulation, interventions name: Closed-loop AM-tACS, outcomesModule primaryOutcomes measure: Cognitive Control, primaryOutcomes measure: Interoception, primaryOutcomes measure: Cue-Reactivity, secondaryOutcomes measure: Heartrate, secondaryOutcomes measure: Heartrate Variability, secondaryOutcomes measure: Mindfulness, secondaryOutcomes measure: Alcohol consumption, secondaryOutcomes measure: Dependence Severity (Alcohol Dependence Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Charité - Berlin University of Medicine, status: RECRUITING, city: Berlin, zip: 10117, country: Germany, contacts name: Rosenthal, role: CONTACT, phone: 0049 30 450 517040, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
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protocolSection identificationModule nctId: NCT06308471, orgStudyIdInfo id: ege üniversitesi, briefTitle: Effect of Baby Massage on Oral Motor Skills of Premature Babies, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: This experimental research was conducted in a single-blind, block randomized controlled design type.The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).Comparative results were evaluated statistically., conditionsModule conditions: Infant, Premature, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Baby massage was applied to the intervention group (20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (20)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Professional nurses who evaluate nutrition do not know which group they belong to in the study.They do not know which group the premature babies are in due to their age., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Baby massage was applied to the intervention group (n=20) of the study, interventions name: Oral stimulation, outcomesModule primaryOutcomes measure: time for first oral feeding, primaryOutcomes measure: time for full oral feeding, secondaryOutcomes measure: discharge time, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Ege University, city: Izmir, state: Bornova, zip: 35040, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06308458, orgStudyIdInfo id: P.T.REC/012/003966, briefTitle: Breather Exerciser Trainer on Diaphragmatic Mobility And Thickness, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-30, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Adly A Adam, class: OTHER, descriptionModule briefSummary: The purpose of this study is to the effect of the breather exerciser trainer on diaphragmatic mobility and thickness in elderly., conditionsModule conditions: Aging Well, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective pre/ posttreatment, randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double masking (Investigator, Outcomes assessor, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Breather Exerciser Trainer, interventions name: Conventional Breathing Exercise, outcomesModule primaryOutcomes measure: Diaphragmatic thickness in millimeters, primaryOutcomes measure: Diaphragmatic mobility in centimeters, secondaryOutcomes measure: Functional Capacity, secondaryOutcomes measure: Geriatric Quality of life Questionnaire, secondaryOutcomes measure: Geriatric Quality of Life, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06308445, orgStudyIdInfo id: RC31/23/0388, briefTitle: Safety Study for the Use of Rapamycin in Children With Familial Adenomatous Polyposis, acronym: RAPA-4-PAF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2029-08, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: The hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (FAP). Rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. Researchers aim to assess the safety profile of rapamycin in FAP adolescents using a 2 low dose regimen., conditionsModule conditions: Familial Adenomatous Polyposis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Rapamycin, outcomesModule primaryOutcomes measure: Evaluation of the safety profile of two doses of rapamycin in adolescents with Familial Adenomatous Polyposis., secondaryOutcomes measure: Evaluation of the effect of rapamycin on the number of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis, secondaryOutcomes measure: Evaluation of the effect of rapamycin on the size of polyps, on the entire colon and by segments (rectum, left colon, transverse colon and right colon) in adolescents suffering from Familial Adenomatous Polyposis., secondaryOutcomes measure: Evaluation of the effect of rapamycin on the size of the largest polyp in each segment (rectum, left colon, transverse colon and right colon) in adolescents with Familial Adenomatous Polyposis, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHU Bordeaux Hôpital Pellegrin, city: Bordeaux, zip: 33076, country: France, contacts name: Raphael Enaud, Dr, role: CONTACT, phone: +33 5 56 79 98 24, email: raphael.enaud@chu-bordeaux.fr, contacts name: Raphaël ENAUD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Montpellier Hôpital Arnaud de Villeneuve, city: Montpellier, zip: 34295, country: France, contacts name: Laura Kollen, Dr, role: CONTACT, phone: +33 4 67 33 67 33, email: l-kollen@chu-montpellier.fr, contacts name: Laura KOLLEN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: APHP Hôpital Robert Debré, city: Paris, zip: 75019, country: France, contacts name: Jérôme VIALA, Pr, role: CONTACT, phone: +33 1 40 03 36 83, email: jerome.viala@aphp.fr, contacts name: Jérôme VIALA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Toulouse Hôpital des Enfants, city: Toulouse, zip: 31300, country: France, contacts name: Emmanuel Mas, Pr, role: CONTACT, phone: +33 5 34 55 84 45, email: mas.e@chu-toulouse.fr, contacts name: Emmanuel MAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06308432, orgStudyIdInfo id: UCAMCFE-00036, briefTitle: Sweat Rate Measurement With a Sensor (Wearable) in Different Climatic Conditions With Road Cyclists., acronym: CYSU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-04-12, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Universidad Católica San Antonio de Murcia, class: OTHER, descriptionModule briefSummary: Controlled, double-blind, crossover clinical trial with six parallel arms depending on the combination of temperature and humidity (22º and 40% humidity, 35º 40% humidity and 35º and 65% humidity), with two differents intensity, to investigate and validate the physiological use of a sensor in recreational road cyclists., conditionsModule conditions: Sweat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Low intensity, interventions name: Low temperature, interventions name: Low Humidity, interventions name: High intensity, interventions name: High temperature, interventions name: High humidity, outcomesModule primaryOutcomes measure: Sweat, secondaryOutcomes measure: Microcapillary Blood, secondaryOutcomes measure: Heart Rate, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Temperature on the forehead, secondaryOutcomes measure: Temperature in the ear, secondaryOutcomes measure: Sleep efficiency, secondaryOutcomes measure: Karolinska drowsiness scale, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Catholic University of Murcia, status: RECRUITING, city: Murcia, zip: 30107, country: Spain, contacts name: Fco Javier López Román, role: CONTACT, phone: 968278523, email: jlroman@ucam.edu, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
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protocolSection identificationModule nctId: NCT06308419, orgStudyIdInfo id: 2023-0900, secondaryIdInfos id: NCI-2024-01751, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2029-02-01, completionDateStruct date: 2031-02-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Aadi Bioscience, descriptionModule briefSummary: To find a recommended dose of gemcitabine and nab-sirolimus that can be given in combination to participants with advanced leiomyosarcomas or soft-tissue sarcomas., conditionsModule conditions: Leiomyosarcoma, conditions: Soft-tissue Sarcomas, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Gemcitabine, interventions name: Nab-Sirolimus, 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: Elise Nassif, MD, role: CONTACT, phone: 281-460-0607, email: efnassif@mdanderson.org, contacts name: Gracy Zacharian, BSN,MSN,RN, role: CONTACT, phone: (713) 792-2669, email: gzachari@mdanderson.org, contacts name: Elise Nassif, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06308406, orgStudyIdInfo id: HRS-1167-201-Bev, briefTitle: A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer., conditionsModule conditions: Recurrent Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab； HRS-1167, outcomesModule primaryOutcomes measure: The number of subjects with dose-limiting toxicity (DLT), primaryOutcomes measure: Determination of Recommended Phase II dose (RP2D), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time To Response(TTR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of University of Science and Technology of China, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230002, country: China, contacts name: Ying Zhou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Lingying Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Cancer Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Hong Zheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Cancer Hospital, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Yu Huang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The First Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400016, country: China, contacts name: Junying Tang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Guangxi Medical University Affiliated Tumor Hospital, status: NOT_YET_RECRUITING, city: Nanning, state: Guangxi, zip: 530022, country: China, contacts name: He Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The Fourth Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050001, country: China, contacts name: Hui Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Harbin Medical University Cancer Hospital, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150001, country: China, contacts name: Ge Lou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.75, lon: 126.65, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Qinglei Gao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410013, country: China, contacts name: Jing Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Liaoning Cancer Hospital, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110042, country: China, contacts name: Danbo Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Qilu Hospital of Shandong University, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Hualei Bu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong First Medical University Affiliated Cancer Hospital, status: NOT_YET_RECRUITING, city: Jinan, state: Shangdong, zip: 250117, country: China, contacts name: Liang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanxi Provincial Cancer Hospital, status: NOT_YET_RECRUITING, city: Taiyuan, state: Shanxi, zip: 030006, country: China, contacts name: Hongwei Zhao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Sichuan Cancer Hospital, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610042, country: China, contacts name: Guonan Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Tianjin Cancer Hospital, status: NOT_YET_RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Ke Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Yunnan Cancer Hospital, status: NOT_YET_RECRUITING, city: Kunming, state: Yunnan, zip: 650118, country: China, contacts name: Hongying Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Zhejiang Cancer Hospital, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Tao Zhu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06308393, orgStudyIdInfo id: RSP61418, briefTitle: Randomized, Double-blind, Placebo-controlled Study of RSS0393 Ointment in Healthy and Psoriatic Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects, conditionsModule conditions: Healthy, conditions: Psoriatic Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: RSS0393 ointment；Placebo, outcomesModule primaryOutcomes measure: The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）, primaryOutcomes measure: The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects）, primaryOutcomes measure: Measurement of blood examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of urine examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of Blood Chemistry examination（Multiple dose in patients ）, primaryOutcomes measure: Measurement of coagulation function examination（Multiple dose in patients ）, secondaryOutcomes measure: AUC0-t （Single dose in healthy subjects）, secondaryOutcomes measure: AUC0-∞（Single dose in healthy subjects）, secondaryOutcomes measure: Tmax（Single dose in healthy subjects）, secondaryOutcomes measure: Cmax（Single dose in healthy subjects）, secondaryOutcomes measure: t1/2（Single dose in healthy subjects）, secondaryOutcomes measure: CL/F（Single dose in healthy subjects）, secondaryOutcomes measure: Vz/F（Single dose in healthy subjects）, secondaryOutcomes measure: AUC0-t （Multiple dose in healthy subjects）, secondaryOutcomes measure: AUC0-∞（Multiple dose in healthy subjects）, secondaryOutcomes measure: Tmax（Multiple dose in healthy subjects）, secondaryOutcomes measure: Cmax（Multiple dose in healthy subjects）, secondaryOutcomes measure: t1/2（Multiple dose in healthy subjects）, secondaryOutcomes measure: CL/F（Multiple dose in healthy subjects）, secondaryOutcomes measure: Vz/F（Multiple dose in healthy subjects）, secondaryOutcomes measure: Absolute change in PASI score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: The percentage change in PASI score relative to baseline（（Multiple dose in patients ）, secondaryOutcomes measure: The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ）, secondaryOutcomes measure: The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ）, secondaryOutcomes measure: The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ）, secondaryOutcomes measure: Absolute change in BSA score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: The percentage change in BSA score relative to baseline（Multiple dose in patients ）, secondaryOutcomes measure: Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ）, secondaryOutcomes measure: Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06308380, orgStudyIdInfo id: UCV/2022-2023/158, briefTitle: Effectiveness of Rehabilitation Protocol in Patients With Shortened Posterior Leg Muscles, acronym: EREPSOLM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-03-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Fundación Universidad Católica de Valencia San Vicente Mártir, class: OTHER, descriptionModule briefSummary: The goal of this clinical study is to develop a specialized rehabilitation exercise protocol designed for patients diagnosed with foot pathologies and calf muscle shortening, regardless of their choice to undergo minimally invasive ultrasound-guided surgery. The primary focus is to assess disparities in outcomes, particularly in the recovery of ankle mobility degrees. Additionally, for patients opting for minimally invasive ultrasound-guided surgery, the study aims to evaluate the resumption of both sporting activities and daily routines using the aforementioned specific rehabilitation protocol.The primary questions this study aims to answer are:* How does the proposed rehabilitation protocol impact ankle mobility recovery for patients with foot pathologies and calf muscle shortening?* What are the differences observed in the return to sporting activities and daily life among patients undergoing minimally invasive ultrasound-guided surgery, following the prescribed protocol?Participants enrolled in this study will be engaged in:Undertaking the specified rehabilitation exercises tailored for foot pathologies and calf muscle shortening.Those opting for minimally invasive ultrasound-guided surgery will follow the same rehabilitation protocol post-surgery to assess its impact on their return to normal activities.If there exists a comparison group:Researchers will compare participants who undergo minimally invasive ultrasound-guided surgery against those who choose other treatment options to discern any differential effects on ankle mobility recovery and resumption of activities., conditionsModule conditions: Equinus Deformity of Foot, conditions: Gastrocnemius Equinus, conditions: Contracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Specific protocol of rehabilitation exercise, interventions name: Short gastrocnemius surgery., outcomesModule primaryOutcomes measure: Gait Analysis, primaryOutcomes measure: Baropodometric examination, secondaryOutcomes measure: Passive ankle mobility, secondaryOutcomes measure: Short Form Health Survey 36 score, secondaryOutcomes measure: Foot Function Index, secondaryOutcomes measure: American Orthopedic Foot and Ankle Score, secondaryOutcomes measure: Halasi score, otherOutcomes measure: Olerud and Molander ankle score., otherOutcomes measure: Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Podologia Avançada, status: RECRUITING, city: Granollers, state: Barcelona, zip: 08401, country: Spain, contacts name: Lluis Castillo-Sanchez, Dr, role: CONTACT, phone: 610143173, email: info@podologiaavanzadabcn.com, contacts name: Lluis Castillo, Dr, role: SUB_INVESTIGATOR, contacts name: Cristina Razzano, role: PRINCIPAL_INVESTIGATOR, contacts name: Simone Moroni, role: SUB_INVESTIGATOR, geoPoint lat: 41.60797, lon: 2.28773, locations facility: Clinica Mayral foot center, status: RECRUITING, city: Barcelona, state: Barcelon, zip: 08029, country: Spain, contacts name: Jordi Mayral, role: CONTACT, phone: (+34) 93 339 78 41, email: barcelona@clinicamayral.com, contacts name: Jordi Mayral, role: SUB_INVESTIGATOR, contacts name: Cristina Razzano, role: PRINCIPAL_INVESTIGATOR, contacts name: Simone Moroni, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Clinicas UCV, status: RECRUITING, city: Valencia, state: València, zip: 46001, country: Spain, contacts name: Pablo Vera-Ivars, Dr., role: CONTACT, phone: 963 92 06 24, email: clinicas.ucv@ucv.es, contacts name: Cristina Mico-Salcedo, role: CONTACT, phone: 963 92 06 24, email: clinicas.ucv@ucv.es, contacts name: Javier Ferrer-Torregrosa, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Vicente-Mampel, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06308367, orgStudyIdInfo id: XWTEBS, briefTitle: The Therapeutic Effect of Betaine in Syringomyelia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia.Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage., conditionsModule conditions: Syringomyelia, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: Betaine, interventions name: Placebo, outcomesModule primaryOutcomes measure: ASIA Score, secondaryOutcomes measure: syringomyelia remission, secondaryOutcomes measure: Electrophysiology results, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Klekamp and Sammi syringomyelia scale, secondaryOutcomes measure: modified Japanese Orthopaedic Association Scores (mJOA), secondaryOutcomes measure: xuanwu syringomyelia scale, secondaryOutcomes measure: Incidence of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fengzeng Jian, status: RECRUITING, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Yuan Chenghua, role: CONTACT, email: yuanchenghua@ccmu.edu.cn, contacts name: Jian Fengzeng, role: CONTACT, email: jianfengzeng@xwh.ccmu.edu.cn, contacts name: jian guan, dr, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06308354, orgStudyIdInfo id: CRC dataset, briefTitle: Colorectal Cancer Dataset in Xijing Hospital From 2011, statusModule overallStatus: RECRUITING, startDateStruct date: 2011-01-01, primaryCompletionDateStruct date: 2048-01-01, completionDateStruct date: 2048-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: To compare the differences of clinical pathological, treatment and prognosis in the guided subgroups in colorectal cancer, the investigator enrolled all the colorectal cancer patients who underwent surgery and were hospitalized in the Xijing hospital., conditionsModule conditions: Prognostic Cancer Model, conditions: Chemotherapy, conditions: Nutrition Related Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: overall survival, primaryOutcomes measure: DFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fourth Military Medical University, status: RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Jipeng Li, role: CONTACT, phone: +86-029-84771533, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06308341, orgStudyIdInfo id: REC/RCR&AHS/23/0295, briefTitle: Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-05-19, completionDateStruct date: 2024-05-28, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality technique + Motor Imagery technique + Routine Physical Therapy, interventions name: Virtual Reality + Routine Physical Therapy, interventions name: Motor Imagery +Routine Physical Therapy, outcomesModule primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Fugal-Meyer Scale, primaryOutcomes measure: Barthel Index, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, email: Kashif.shaffi@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308328, orgStudyIdInfo id: NFEC-2024-090, briefTitle: A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC., conditionsModule conditions: Radiation-induced Oropharyngeal Mucositis, conditions: Swallowing-induced Breakthrough Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 718, type: ESTIMATED, outcomesModule primaryOutcomes measure: The AUC of the predictive model, secondaryOutcomes measure: The accuracy of the predictive model, secondaryOutcomes measure: The sensitivity of the predictive model, secondaryOutcomes measure: The specificity of the predictive model, secondaryOutcomes measure: The positive predictive value of the predictive model, secondaryOutcomes measure: The negative predictive value of the predictive model, secondaryOutcomes measure: The F1 score of the predictive model, secondaryOutcomes measure: The important predictors of severe oropharyngeal mucositis in the predictive model, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Ronghui Zheng, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang hospital, Southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jian Guan, Ph.D., role: CONTACT, phone: 86+13632102247, email: guanjian5461@163.com, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Yimin Liu, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-sen University Cancer Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Linglong Tang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Yong Bao, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Yuebei People's Hospital, status: NOT_YET_RECRUITING, city: Shaoguan, state: Guangdong, country: China, contacts name: Suming Pan, role: CONTACT, geoPoint lat: 24.8, lon: 113.58333, locations facility: Peking University Shenzhen Hospital, status: NOT_YET_RECRUITING, city: Shenzhen, state: Guangdong, country: China, contacts name: Min Chen, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The Fifth Affiliated Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Zhuhai, state: Guangdong, country: China, contacts name: Siyang Wang, role: CONTACT, geoPoint lat: 22.27694, lon: 113.56778, locations facility: Fudan University Shanghai Cancer Center, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Xueguan lv, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Sichuan Cancer Hospital, status: NOT_YET_RECRUITING, city: Chendu, state: Sichuan, country: China, contacts name: Wenjun Liao, role: CONTACT, hasResults: False
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protocolSection identificationModule nctId: NCT06308315, orgStudyIdInfo id: REC/RCR&AHS/23/0297, briefTitle: Effects of Rhythmic Balance Auditory Vision Training And Strength Training With Autism Spectrum Disorder., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Autism, a complex neurodevelopmental disorder that is marked by limited interests, and challenges in communication and social interactions and problem includes difficulties in understanding and responding to social cues, repetitive behaviors, intense focus on specific interests, and challenges with verbal and nonverbal communication. Rhythmic Balance Auditory Vision Training (RBAVT) a therapeutic approach which helps in improving coordination and balance in individuals with various neurological conditions. Strength training enhance physical health and muscle development. Thus, the purpose of this study is to compare the effects of rhythmic balance auditory vision training and strength training on motor function and cognition in children with autism spectrum disorder., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Rhythmic balance visual auditory exercise + Routine physical therapy, interventions name: Strength Training + Routine Physical Therapy, outcomesModule primaryOutcomes measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), secondaryOutcomes measure: Wisconsin Card Sorting Test (WCST), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, email: Kashif.shaffi@riphah.edu.pk, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308302, orgStudyIdInfo id: REC/RCR&AHS/23/0355, briefTitle: Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD)., conditionsModule conditions: COPD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: Group A (Inspiratory Muscles Training + Aerobic Interval Training), interventions name: Group B (Expiratory Muscles Training +Aerobic Interval Training), outcomesModule primaryOutcomes measure: Modified Medical Research Council (mMRC) Dyspnea Scale, primaryOutcomes measure: 6 Minute Walk Test, primaryOutcomes measure: Karnofsky Performance Scale (KPS), primaryOutcomes measure: Fatigue Severity Scale (FSS), primaryOutcomes measure: FEV1, primaryOutcomes measure: FVC, primaryOutcomes measure: FEV1/FVC, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308289, orgStudyIdInfo id: REC/RCR&AHS/23/0361, briefTitle: Combined Effects of Global Posture Re-education and Active Cycle of Breathing Technique in COPD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The randomized controlled trial will involve 30 participants, with Group A receiving GPRM and ACBT, while Group B follows the conventional COPD model that includes ACBT only.Assessments of heart rate, physical fitness, and quality of life will contribute to a nuanced understanding of joint function, informing future COPD treatment paradigms., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Global Posture Re-education, interventions name: Active Cycle of Breathing Technique, outcomesModule primaryOutcomes measure: SF- 36 Questionnaire, primaryOutcomes measure: FEV1/FVC ratio, primaryOutcomes measure: 6-minute walk test, primaryOutcomes measure: Photogrammetry, primaryOutcomes measure: Forced expiratory volume (FEV1), primaryOutcomes measure: Forced vital capacity (FVC), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Social Security Hospital, status: RECRUITING, city: Gujranwala, state: Punjab, zip: 52200, country: Pakistan, contacts name: Akhtar Hunjra, Phd, role: CONTACT, phone: 03041049249, email: ms.sshgw@pessi.punjab.gov.pk, contacts name: Komal Munir, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 32.15567, lon: 74.18705, hasResults: False
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protocolSection identificationModule nctId: NCT06308276, orgStudyIdInfo id: REC/RCR&AHS/23/0363, briefTitle: Effects of Aerobic Versus Resistance Training in Post Percutaneous Coronary Intervention Obese Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The randomized clinical trial (RCT) endeavors to enroll 50 participants, divided equally into aerobic exercise and resistance exercise groups. The study employs rigorous tools such as blood pressure measurement, SF-36 questionnaire, and the Six-Minute Walk Test (6MWT) to assess VO2max., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic Training, interventions name: Resistance Training, outcomesModule primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Six Minute Walk Test, primaryOutcomes measure: SF 36 Questionnaire, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sialkot Medical and Physiotherapy Center, status: RECRUITING, city: Sialkot, state: Punjab, zip: 51310, country: Pakistan, contacts name: Fasih Ahmed Rehmani, MS-OMPT, role: CONTACT, phone: 03348005240, email: Fasih12190@gmail.com, contacts name: Teenat Fatima, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 32.49268, lon: 74.53134, hasResults: False
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protocolSection identificationModule nctId: NCT06308263, orgStudyIdInfo id: MS201924_0003, secondaryIdInfos id: 2022-502940-10-00, type: OTHER, domain: EU trial number, briefTitle: M1774 Human Mass Balance Study (DDRIVER Solid Tumors 303), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-11-26, completionDateStruct date: 2025-11-26, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, class: INDUSTRY, descriptionModule briefSummary: This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. Thereafter, participants may enter an optional extension phase (Period 2) where participants will receive M1774 until disease progression or other criteria for study intervention discontinuation are met., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: M1774 [14C]M1774 microtracer, interventions name: M1774, outcomesModule primaryOutcomes measure: Period 1: Percent Urinary Recovery (feurine) Of Total Radioactivity (TRA) Over the Entire Period Of Collection, primaryOutcomes measure: Period 1: Percent Fecal Recovery (fefeces) Of TRA Over the Entire Period Of Collection, primaryOutcomes measure: Period 1: Percent Total Recovery in Urine and Feces (fetotal) Of TRA Over the Entire Period of Collection, primaryOutcomes measure: Period 1: Maximum Observed Plasma Concentration (Cmax) Of M1774, primaryOutcomes measure: Period 1: Time to Reach Maximum Plasma Concentration (Tmax) Of M1774, primaryOutcomes measure: Period 1: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) Of M1774, primaryOutcomes measure: Period 1: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) Of M1774, primaryOutcomes measure: Period 1: Apparent Terminal Half-Life (t1/2) Of M1774, primaryOutcomes measure: Period 1: Apparent Total Body Clearance (CL/F) Of M1774, primaryOutcomes measure: Period 1: Apparent Volume of Distribution (Vz/F) Of M1774, primaryOutcomes measure: Period 1: Maximum Observed Concentration (Cmax) of TRA in Plasma and Whole Blood, primaryOutcomes measure: Period 1: Time to Reach Maximum Concentration (tmax) of TRA in Plasma and Whole blood, primaryOutcomes measure: Period 1: Area Under Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of TRA in Plasma and Whole Blood, primaryOutcomes measure: Period 1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of TRA in Plasma and Whole Blood, primaryOutcomes measure: Period 1: Apparent Terminal Half-Life (t1/2) of TRA in Plasma and Whole Blood, secondaryOutcomes measure: Period 1,2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Abnormal Laboratory Parameters, abnormal Vital Signs and abnormal 12-Lead Electrocardiogram (ECG) Findings, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely, status: RECRUITING, city: Budapest, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, locations facility: Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály, status: NOT_YET_RECRUITING, city: Budapest, country: Hungary, geoPoint lat: 47.49801, lon: 19.03991, hasResults: False
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protocolSection identificationModule nctId: NCT06308250, orgStudyIdInfo id: REC/RCR&AHS/23/0294, briefTitle: Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism., conditionsModule conditions: Bell Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: MIME THERAPY, interventions name: ACTION OBSERVATION THERAPY, outcomesModule primaryOutcomes measure: Sunny Brook Facial Grading System, primaryOutcomes measure: Facial Disability Index, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, email: kashif.shaffi@riphah.edu.pk, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308237, orgStudyIdInfo id: REC/RCR&AHS/23/0293, briefTitle: Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Mild cognitive impairment affects older adults and it includes memory and attentions deficits, and problem-solving difficulties in activities of daily living. Resisted exercises is considered a viable strategy to improve balance and motor function in older population. Balance exercises comprises proprioceptive, visual and motor learning to a larger degree and has positive effects on memory and spatial cognition and improves balance and motor function. This study aims to determine the effects of resisted and balance exercises on cognition and motor function in patients with mild cognitive impairment., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: RESISTED EXERCISES, interventions name: BALANCE EXERCISES, outcomesModule primaryOutcomes measure: MoCA (Montreal Cognitive Assessment ), primaryOutcomes measure: Mini-Balance Evaluation Systems Test (BESTest)., primaryOutcomes measure: Timed UP and GO Test (TUG) :, primaryOutcomes measure: Computerized battery test (CBT), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, email: kashif.shaffi@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308224, orgStudyIdInfo id: REC/RCR&AHS/23/0290, briefTitle: Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-24, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The study aims to determine the comparative effects of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients with Stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single-blinded as the assessor of the study would be kept blind of the treatment groups to which the patient would be allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Modified-Otago Exercises, interventions name: Tai-Chi Exercises, outcomesModule primaryOutcomes measure: Berg Balance Scale (BBS), primaryOutcomes measure: Timed Up and Go (TUG), primaryOutcomes measure: Motor Assessment Scale (MAS), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Riphah International University, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, contacts name: Muhammad Kashif, PhD-PT, role: CONTACT, phone: 03333125303, email: kahif.shaffi@riphah.edu.pk, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308211, orgStudyIdInfo id: REC/RCR&AHS/23/0289, briefTitle: Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient would be allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY, interventions name: MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY, outcomesModule primaryOutcomes measure: Berg balance scale (BBS), primaryOutcomes measure: FUGL-MEYER ASSESMENT (FMA), primaryOutcomes measure: FUNCTIONAL INDEPENDENCE MEASURE (FIM), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Muhammad Kashif, status: RECRUITING, city: Lahore, state: Punjab, zip: 54660, country: Pakistan, contacts name: Muhammad Kashif, Phd, role: CONTACT, phone: 03333125303, email: kashif.shaffi@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06308198, orgStudyIdInfo id: M24-008, briefTitle: A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-22, completionDateStruct date: 2025-03-22, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires., conditionsModule conditions: Glabellar Lines, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AGN-151586, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown, primaryOutcomes measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown, primaryOutcomes measure: Number of Participants with Adverse Events (AEs), secondaryOutcomes measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL, secondaryOutcomes measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL, secondaryOutcomes measure: Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time, secondaryOutcomes measure: Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time, secondaryOutcomes measure: Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time, secondaryOutcomes measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown, secondaryOutcomes measure: Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown, secondaryOutcomes measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time, secondaryOutcomes measure: Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time, secondaryOutcomes measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown, secondaryOutcomes measure: Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL, secondaryOutcomes measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL, secondaryOutcomes measure: Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL, secondaryOutcomes measure: Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Hospital /ID# 256084, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Dermatology Hospital of Southern Medical University /ID# 256172, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510091, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhongda Hospital Southeast University /ID# 255937, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Xianyang Hospital of Yan'an University /ID# 256774, status: RECRUITING, city: Xianyang, state: Shaanxi, zip: 712000, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669, status: RECRUITING, city: Kaohsiung, zip: 807, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06308185, orgStudyIdInfo id: EPINEO, briefTitle: Neonatal Seizures: Semiology, Etiology, Therapy and Prognosis Correlations, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Epileptic seizures in newborns (often called "neonatal convulsions") represent the most frequent neurological problem in newborns (1-3/1000 newborns). The type of seizure and their etiology is very varied and therefore the therapeutic protocol also requires adaptations with a personalization of the therapeutic approach according to the characteristics of the case according to principles of precision medicine in particular for forms of neonatal epilepsy compared to epileptic seizures acute symptomatic. In recent years it has been highlighted that the clinical characterization and instrumental characterization, in particular electroencephalographic, of epileptic seizures represents an important biomarker that allows the choice of therapy to be oriented appropriately. In the literature there is a lack of single-center studies that relate the type of crisis according to the new ILAE 2017 classification (Fisher 2017) and its proposal for neonatal adaptation (Pressler 2021) with the etiology, type of therapy and outcome neurological after a few years.The primary aim of the study is to evaluate the correlation between the type of seizure determined according to the ILAE classification (clinical variables), the EEG findings of the epileptic seizures and the specific etiology of the epileptic seizures.The secondary aim is to evaluate the correlation between seizure type and etiology with effective therapy, length of hospitalization and neurobehavioral development outcome. The study design is a retrospective observational on the population of neonates managed at our center in the last decade., conditionsModule conditions: Neonatal Seizure, conditions: Epilepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: observational study, outcomesModule primaryOutcomes measure: Seizure Type and etiology correlation, primaryOutcomes measure: EEG and etiology correlation, secondaryOutcomes measure: Etiology and and effective drug correlation, secondaryOutcomes measure: Etiology and neurobehavioral outcome correlation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06308172, orgStudyIdInfo id: CSI/2021, briefTitle: Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups, conditionsModule conditions: Cesarean Section; Dehiscence, conditions: Uterine Bleeding, conditions: Uterus; Scar, conditions: Uterus Abnormal, conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Patients are recruited and randomly assigned to either the "single-layer" or "double-layer" arm of the study. The randomization process occurs on the day of the cesarean section. Following randomization, patients are informed about their assigned group, and the cesarean section procedure is then carried out., enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Hysterotomy closure, outcomesModule primaryOutcomes measure: Intermenstrual bleeding reduction (days), secondaryOutcomes measure: Intra-operatory time, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Analgesics, secondaryOutcomes measure: Post-operatory recovery time, secondaryOutcomes measure: Time to full patient mobilization, secondaryOutcomes measure: Isthmocele, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano, status: RECRUITING, city: Milan, state: Mi, zip: 20122, country: Italy, contacts name: Giuseppe Perugino, MD, role: CONTACT, phone: 3383030553, email: giuseppe.perugino@policlinico.mi.it, contacts name: Floriana Carbone, MD, role: SUB_INVESTIGATOR, contacts name: Ottavio Cassardo, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06308159, orgStudyIdInfo id: LT02-101, briefTitle: An Open-label Study of a Gene Therapy Product in Beta-Thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Lantu Biopharma, class: INDUSTRY, descriptionModule briefSummary: This is an interventional study to evaluate the safety and efficacy of autologous Hematopoietic Stem Cells (HSCs) transduced with lentiviral vector encoding functional hemoglobin subunit beta (HBB) gene in patients with transfusion-dependent beta-thalassemia., conditionsModule conditions: Beta-Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Vebeglogene autotemcel, outcomesModule primaryOutcomes measure: Time and duration of the subject's hemoglobin (Hb)≥9.0 g/dL without receiving red blood cell infusion, secondaryOutcomes measure: The prevalence and severity of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: The reduction of red blood cells (RBCs) transfusion requirement after product infusion compared to previous transfusion records, secondaryOutcomes measure: Number of days required to achieve successful neutrophil and platelet engraftment, secondaryOutcomes measure: Vector copy number (VCN) in peripheral blood over time, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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