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protocolSection identificationModule nctId: NCT06332859, orgStudyIdInfo id: FOR-0022, briefTitle: Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-10-14, completionDateStruct date: 2026-10-14, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pensionsversicherungsanstalt, class: OTHER, descriptionModule briefSummary: To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event., conditionsModule conditions: Takotsubo Cardiomyopathy, conditions: Acute Coronary Syndrome, conditions: Psychological Resilience, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Resilience training, outcomesModule primaryOutcomes measure: Resilience scale-13 (RS-13), primaryOutcomes measure: Brief Resilience scale - German Version (BRS), secondaryOutcomes measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), secondaryOutcomes measure: Patient Health Questionnaire-4 (PHQ-4), secondaryOutcomes measure: Maximal incremental exercise test, secondaryOutcomes measure: Work ability index (WAI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332846, orgStudyIdInfo id: KB-0012/06/10, briefTitle: Oral Health in Patients Hospitalized Because of Ischemic Stroke, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-10, primaryCompletionDateStruct date: 2021-11-15, completionDateStruct date: 2023-12-10, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pomeranian Medical University Szczecin, class: OTHER, descriptionModule briefSummary: Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI)., conditionsModule conditions: Oral Disease, conditions: Stroke, Ischemic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 118, type: ACTUAL, armsInterventionsModule interventions name: oral examination, interventions name: oral examination, outcomesModule primaryOutcomes measure: Oral health status, primaryOutcomes measure: Oral hygiene assessment, primaryOutcomes measure: Periodontal status- periodontal pockets, primaryOutcomes measure: Periodontal status-tooth mobility, primaryOutcomes measure: Periodontal status- bleeding, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pomeranian Medical University in Szczecin, city: Szczecin, zip: 70-111, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, hasResults: False
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protocolSection identificationModule nctId: NCT06332833, orgStudyIdInfo id: 235, briefTitle: Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pirogov Russian National Research Medical University, class: OTHER, descriptionModule briefSummary: Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed., conditionsModule conditions: Varicose Veins, conditions: Peripheral Arterial Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: availability of saphenous trunks as possible grafts, secondaryOutcomes measure: presence of varicose veins, secondaryOutcomes measure: type of previous invasive procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Veronika Golovina, status: RECRUITING, city: Moscow, state: Pirogov Russian National Research Medical University, zip: 109044, country: Russian Federation, contacts name: Veronika Golovina, MD, PHD, role: CONTACT, phone: +79776051708, email: nikuskin@inbox.ru, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06332820, orgStudyIdInfo id: 202401226RINB, briefTitle: In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease., conditionsModule conditions: Obstructive Airway Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Inspiratory capacity during exercise, secondaryOutcomes measure: Change of FEV1 and symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06332807, orgStudyIdInfo id: NGGT002-P-2301, briefTitle: AAV Gene Therapy Clinical Study in Adult Classic PKU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-22, primaryCompletionDateStruct date: 2030-12-30, completionDateStruct date: 2030-12-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: NGGT (Suzhou) Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years., conditionsModule conditions: Phenylketonurias, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: NGGT002, outcomesModule primaryOutcomes measure: Incidence and severity of Adverse Events (AEs), primaryOutcomes measure: Change from baseline in clinical laboratory values, primaryOutcomes measure: Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations, primaryOutcomes measure: Change from baseline in Plasma Phe Concentration, secondaryOutcomes measure: Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose, secondaryOutcomes measure: Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose, secondaryOutcomes measure: Change in PKU Profile of Mood States (POMS), secondaryOutcomes measure: Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332794, orgStudyIdInfo id: H-2201, briefTitle: Keep On Keep Up for Parkinson's, acronym: KOKU4PD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Northumbria University, class: OTHER, collaborators name: University of Manchester, collaborators name: Northumbria Healthcare NHS Foundation Trust, collaborators name: Newcastle University, collaborators name: Reason Digital, descriptionModule briefSummary: The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).The main aims of the study are to:1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app., conditionsModule conditions: Parkinson's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: KOKU4PD, outcomesModule primaryOutcomes measure: Usability of the KOKU app, secondaryOutcomes measure: Executive clock drawing task (CLOX 1, 2) (mean Change from baseline), secondaryOutcomes measure: Trail Making Test (mean Change from baseline), secondaryOutcomes measure: Freezing of Gait Questionnaire (mean Change from baseline), secondaryOutcomes measure: Falls Efficacy scale (mean Change from baseline), secondaryOutcomes measure: Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline), secondaryOutcomes measure: Mini-BESTest (mean Change from baseline), secondaryOutcomes measure: Two minute walk test, single and dual task (mean Change from baseline), secondaryOutcomes measure: EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline), secondaryOutcomes measure: Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline), secondaryOutcomes measure: Multidimensional Fatigue Inventory (MFI) (mean Change from baseline), secondaryOutcomes measure: Technology Acceptance questionnaire, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northumbria University, city: Newcastle upon Tyne, state: Tyne & Wear, zip: NE1 8ST, country: United Kingdom, contacts name: Gill Barry, PhD, role: CONTACT, phone: 01912277635, email: gill.barry@northumbria.ac.uk, contacts name: Julia Das, role: CONTACT, phone: 01912373343, email: julia.das@northumbria.ac.uk, geoPoint lat: 54.97328, lon: -1.61396, hasResults: False
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protocolSection identificationModule nctId: NCT06332781, orgStudyIdInfo id: 2126175, briefTitle: Intravesical Gentamicin to Prevent Recurrent UTI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Women and Infants Hospital of Rhode Island, class: OTHER, descriptionModule briefSummary: Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI), conditionsModule conditions: Recurrent Uti, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, interventions name: Nitrofurantoin, outcomesModule primaryOutcomes measure: UTIs, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, otherOutcomes measure: urobiome analysis, otherOutcomes measure: urobiome analysis, eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06332768, orgStudyIdInfo id: WEAN_2021, briefTitle: NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-09-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-03-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Northern State Medical University, class: OTHER, descriptionModule briefSummary: The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support., conditionsModule conditions: Mechanical Ventilation Complication, conditions: Weaning Failure, conditions: Acute Respiratory Distress Syndrome, conditions: High-flow Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized assignment, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Respiratory support, outcomesModule primaryOutcomes measure: Weaning failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City hospital # 1, city: Arkhangelsk, state: Arkhangelsk Region, zip: 163000, country: Russian Federation, geoPoint lat: 64.5401, lon: 40.5433, hasResults: False
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protocolSection identificationModule nctId: NCT06332755, orgStudyIdInfo id: LG-LRCL001, briefTitle: Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors, acronym: LB-LR1109, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: LG Chem, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options., conditionsModule conditions: Non-small Cell Lung Cancer(NSCLC), conditions: Head and Neck Squamous Cell Carcinoma(HNSCC), conditions: Renal Cell Carcinoma(RCC), conditions: Urothelial Carcinoma, conditions: Malignant Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: LB-LR1109, outcomesModule primaryOutcomes measure: MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events of LB-LR1109, secondaryOutcomes measure: Preliminary efficacy of LB-LR1109, secondaryOutcomes measure: Anti-tumor efficacy of LB-LR1109, secondaryOutcomes measure: Pharmacokinetic profile of LB-LR1109, secondaryOutcomes measure: Characterize PK of LB-LR1109, secondaryOutcomes measure: Immunogenicity of LB-LR1109, secondaryOutcomes measure: Quality of life of participants, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06332742, orgStudyIdInfo id: QXZS for DOR, briefTitle: Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Yun Chen, class: OTHER, descriptionModule briefSummary: A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction, conditionsModule conditions: Decreased Ovarian Reserve, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Traditional Chinese medicine syndrome score, primaryOutcomes measure: serum sex hormone levels, primaryOutcomes measure: serum AMH levels, primaryOutcomes measure: transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC), secondaryOutcomes measure: Seven items of thyroid function, secondaryOutcomes measure: natural pregnancy rate, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210023, country: China, contacts name: Chen Yun, role: CONTACT, phone: 8613675167221, email: 66teoyq@gmail.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06332729, orgStudyIdInfo id: EG,KFS,lab reserach 6, briefTitle: Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Mahmoud Reda Elsharkawy, class: OTHER, descriptionModule briefSummary: Summary:Inclusion Criteria:* Children aged four to eight years.* Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.* Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).* Ability to follow verbal commands and instructions.Exclusion Criteria:* Previous neurological or orthopedic surgery in the lower extremities.* Botox injection in the lower extremities within the past six months.* Fixed deformity in the joints of the lower limb.* Genu recarvatum secondary to surgery.* Severe hearing and visual defects.Materials for Subject Selection and Evaluation:* Modified Ashworth Scale for muscle tone assessment.* Gross Motor Functional Classification System (GMFCS) for functional activity classification.* Digital goniometer for measuring the angle of knee hyperextension.* Lafayette Manual Muscle Tester for quantifying muscle strength.Methods:* Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.* Evaluation of gross motor function using the GMFCS.* Assessment of genu recarvatum using a digital goniometer.* Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.* Assessment of range of motion in the knee joint using Kinovea software.* Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).Group A Treatment:- Designed physical therapy program combined with pulley therapy for muscle strengthening.Group B Treatment:- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: universal exercis unit, interventions name: functional electrical stimulation, outcomesModule primaryOutcomes measure: muscle strength using muscle tester device, primaryOutcomes measure: Range of motion using kinoviea software and digital goniometer, primaryOutcomes measure: range of motion for the joint using digital geniometer, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Physical Therapy, status: RECRUITING, city: Kafr Ash Shaykh, country: Egypt, contacts name: Mahmoud R Elsharkawy, bachelor, role: CONTACT, phone: 01021417889, email: mahmoud.elsharakawy1994@gmail.com, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06332716, orgStudyIdInfo id: KY20222234, briefTitle: Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Jianjun Yang,MD, class: OTHER, descriptionModule briefSummary: Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors., conditionsModule conditions: Gastrointestinal Tumors，3D Organoids，Drug Sensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time., outcomesModule primaryOutcomes measure: Progression-free survival（PFS）, secondaryOutcomes measure: Overall survival（OS）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: XijingH, status: RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Jianjun Yang, role: CONTACT, phone: 13756154175, email: yangjj@fmmu.edu.cn, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06332703, orgStudyIdInfo id: IACA, briefTitle: Acanthamoeba and Artificial Intelligence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model., conditionsModule conditions: Acanthamoeba Keratitis, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 151, type: ESTIMATED, outcomesModule primaryOutcomes measure: Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images., secondaryOutcomes measure: Correlation assessment between IVCM images and laboratory results., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06332690, orgStudyIdInfo id: 514.2021, briefTitle: OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Multimedica, class: OTHER, collaborators name: AbbVie, descriptionModule briefSummary: The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome., conditionsModule conditions: Diabetic Macular Edema, conditions: Macular Edema Due to Diabetes Mellitus, conditions: Retinal Vein Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: dexamethasone implant, outcomesModule primaryOutcomes measure: Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure), secondaryOutcomes measure: Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MultiMedica IRCCS Multimedica, status: RECRUITING, city: Milan, zip: 20123, country: Italy, contacts name: Stela Vujosevic, MD, role: CONTACT, phone: +39 02 85 99 4601, email: stela.vujosevic@multimedica.it, contacts name: GAbriele Piccoli, role: CONTACT, phone: +39 02 85 99 4601, email: gabriele.piccoli@multimedica.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06332677, orgStudyIdInfo id: TERS, briefTitle: Target of Suv420h1/2 in Hepatocytes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids., conditionsModule conditions: NAFLD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: study the cellular and molecular mechanisms of correlation between the SUV420H1/H2 methyltransferase and the progression of liver damage in mice (San Raffaele Institute) and to confirm these findings in human samples and in vitro 3D liver models., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: the main genes and expression by comparing the transcriptomic lipidomic profile, outcomesModule primaryOutcomes measure: the main genes and expression by comparing the transcriptomic lipidomic profile, primaryOutcomes measure: the main genes and expression by comparing the transcriptomic lipidomic profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, status: RECRUITING, city: Milano, zip: 20122, country: Italy, contacts name: Luca Vittorio Carlo Valenti, role: CONTACT, phone: 02 5503 6595, email: luca.valenti@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-26, uploadDate: 2024-03-14T09:56, filename: Prot_SAP_000.pdf, size: 703523, hasResults: False
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protocolSection identificationModule nctId: NCT06332664, orgStudyIdInfo id: 2023-2330, briefTitle: Early Nutrition Intervention for M1 Stage Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Xingchen Peng, class: OTHER, descriptionModule briefSummary: In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice., conditionsModule conditions: Nutrition, conditions: Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 194, type: ESTIMATED, armsInterventionsModule interventions name: Early Nutrition Intervention, outcomesModule primaryOutcomes measure: the incidence of cachexia, secondaryOutcomes measure: overall survival ；progression-free survival, secondaryOutcomes measure: Physical Fitness Status, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Nutritional risk and malnutrition status, secondaryOutcomes measure: Patient's emotional changes, secondaryOutcomes measure: Caregiver psychological burden, secondaryOutcomes measure: Patient's physical, social, and cognitive functioning, secondaryOutcomes measure: incidence of Sarcopenia, secondaryOutcomes measure: Nutritional risk and malnutrition status, secondaryOutcomes measure: Patient's emotional changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan Universit, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: XingChen Peng, Ph.D, role: CONTACT, phone: +8618980606753, email: pxx2014@163.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06332651, orgStudyIdInfo id: NL84684.091.23, briefTitle: Metabolic Availability in Older and Younger Men, acronym: YOMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Wageningen University, class: OTHER, descriptionModule briefSummary: The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men., conditionsModule conditions: Ageing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is a parallel intervention study. The intervention does not involve a drug or biologic product, however does involve an adaptation diet and a diet with measured amino acids dissolved in water, during the test day. We investigate the amino acid metabolic availability using the IAAO method., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Black beans, interventions name: Milk, interventions name: Sorghum, outcomesModule primaryOutcomes measure: Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method., eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wageningen University & Research, status: RECRUITING, city: Wageningen, state: Gelderland, zip: 6708PB, country: Netherlands, contacts name: Fenna Hinssen, MSc, role: CONTACT, phone: +031648043165, email: yoma@wur.nl, contacts name: Karen Fransen, MSc, role: CONTACT, phone: +031648043165, email: yoma@wur.nl, geoPoint lat: 51.97, lon: 5.66667, hasResults: False
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protocolSection identificationModule nctId: NCT06332638, orgStudyIdInfo id: IN_APA_124, briefTitle: PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: HK inno.N Corporation, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Tegoprazan 12.5mg, interventions name: Tegoprazan 25mg, interventions name: Famotidine 20mg, outcomesModule primaryOutcomes measure: Cmax of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: AUC0-t of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: AUC0-∞ of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: Tmax of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: t1/2β of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: CL/F of tegoprazan, primaryOutcomes measure: Vd/F of tegoprazan, primaryOutcomes measure: Css,max of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: Css,min of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: Css,avg of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: AUCtau,ss of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: Tmax,ss of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: t1/2β,ss of tegoprazan and tegoprazan's metabolite M1, primaryOutcomes measure: CLss/F of tegoprazan, primaryOutcomes measure: Vdss/F of tegoprazan, primaryOutcomes measure: Accumulation index of tegoprazan, primaryOutcomes measure: Fluctuation of tegoprazan, secondaryOutcomes measure: 24-hour, daytime and nighttime mean pH, secondaryOutcomes measure: 24-hour, daytime and nighttime median pH, secondaryOutcomes measure: 24-hour, daytime and nighttime TpH>3(%), secondaryOutcomes measure: 24-hour, daytime and nighttime TpH>4(%), secondaryOutcomes measure: 24-hour, daytime and nighttime Δ TpH>3(%), secondaryOutcomes measure: 24-hour, daytime and nighttime Δ TpH>4(%), secondaryOutcomes measure: 24-hour, daytime and nighttime Δ mean pH, secondaryOutcomes measure: 24-hour, daytime and nighttime Δ median pH, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Inje University Busan Paik Hospital, city: Busan, zip: 47392, country: Korea, Republic of, geoPoint lat: 35.10278, lon: 129.04028, hasResults: False
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protocolSection identificationModule nctId: NCT06332625, orgStudyIdInfo id: PNRR-MR1-2022-12375648, briefTitle: The Fingerprinting of Inherited Leukoencephalopathies: A New Brain Imaging, Genetic and Clinical Assessment, acronym: FIABA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2024-02-05, completionDateStruct date: 2025-11-22, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: Oasi Research Institute-IRCCS, collaborators name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, collaborators name: IRCCS Ospedale San Raffaele, descriptionModule briefSummary: Inherited leukoencephalopathies are a broad spectrum of genetically determined disorders, characterized by specific involvement of the white matter of the central nervous system. These pathologies are almost as common as other acquired white matter disorders, such as acute disseminated encephalomyelitis and multiple sclerosis. The onset can occur at any age, from prenatal life to adulthood, and the clinical picture is mostly progressive, but can also be non-evolving or, rarely, improve over time. Thanks to new diagnostic approaches, including next-generation genetic sequencing and recognition of magnetic resonance imaging patterns, in recent years the investigators have witnessed a significant increase in the number of genetically defined leukoencephalopathies. However, despite advances in genetic studies, inherited leukoencephalopathies include a large number of inherited white matter diseases in children and adults and remain of unknown cause in many patients (about 40%). This significant percentage of cases of unknown etiology represents a major challenge for public health, both in prognostic terms and, consequently, economically. However, even in leukoencephalopathies of genetically determined cause, the absence of specific biomarkers can be a limiting factor in the design and execution of clinical studies in search of promising therapies. As in other fields of neurology, the integration of clinical and genetic data with brain MRI data plays a fundamental role in the diagnostics of subjects affected by these pathologies. Currently, the methodologies commonly used in magnetic resonance imaging are qualitative, and evaluate brain lesions through the contrast between white and gray matter. The lack of specific biomarkers is therefore a limiting factor in the design of therapeutic challenges. In this regard, the development of new multiparametric quantitative magnetic resonance imaging (qMRI) methods could allow the investigators to identify new biomarkers to assess the etiology behind leukodystrophies, increasing diagnostic power and understanding the progression or improvement of leukoencephalopathy for both future trials and existing therapies. In this perspective, recent rapid "transient-state" magnetic resonance imaging methods, such as MR Fingerprinting (MRF), have proven effective in efficiently separating different components of brain tissue. These techniques consist of rapid and highly undersampled acquisitions performed by continuously changing the MR sequence parameters, thus obtaining a signal evolution that is unique for each combination of underlying tissue properties. Furthermore, if these techniques have already shown their validity at 3 Tesla, they could be even more informative in 7T MRI where the use of qMRI could provide more details thanks to the high image resolution.The project's objective is to evaluate and validate new and innovative quantitative magnetic resonance imaging (qMRI) methodologies at both clinical and ultra-high fields in inherited leukodystrophies and those of unknown etiology.This is a national, multi-institutional, multicenter exploratory study on the potential identification and predictability of early structural and metabolic markers in quantitative MRI at 3T and 7T in the diagnosis and follow-up of leukodystrophy and leukoencephalopathy in adults and during development.The study will include multiple sub-studies:1. A cross-sectional study in leukoencephalopathies at clinical fields.2. A longitudinal study in leukoencephalopathies at 3T: natural history and therapy outcomes.3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies., conditionsModule conditions: Leukoencephalopathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Brain quantitative magnetic resonance imaging, outcomesModule primaryOutcomes measure: Quantitative Susceptibilty Mapping, QSM, primaryOutcomes measure: Fractional Anisotropy, FA, primaryOutcomes measure: Mean Diffusivity, MD, primaryOutcomes measure: Relaxation times, primaryOutcomes measure: Myelin water fraction, MWF, primaryOutcomes measure: Neuromotor skills, primaryOutcomes measure: Neuromotor skills, secondaryOutcomes measure: Epilepsy symptoms, secondaryOutcomes measure: Electroencephalography features, secondaryOutcomes measure: Neuro-psychological profile, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Associazione Oasi Maria SS Troina, status: RECRUITING, city: Troina, state: Enna, zip: 94018, country: Italy, contacts name: Maurizio Elia, role: CONTACT, geoPoint lat: 37.78437, lon: 14.59605, locations facility: Ospedale San Raffaele, status: RECRUITING, city: Milano, zip: 20132, country: Italy, contacts name: Cristina Baldoli, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione Istituto Neurologico Carlo Besta, status: RECRUITING, city: Milano, zip: 20133, country: Italy, contacts name: Stefania Magri, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06332612, orgStudyIdInfo id: 8420224AROM, briefTitle: Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial, acronym: MROSF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Ziauddin University, class: OTHER, descriptionModule briefSummary: OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition, conditionsModule conditions: Oral Submucous Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. In Vitro (Cell Line) Study Design: Experimental in vitro study using OSF cell lines.Groups:* Metformin-treated* Control (untreated)* Vehicle control Clinical Trial Study Design: A pilot Randomized Controlled Trial (RCT) translating the in vitro findings into a clinical setting. It would be a single-blind, placebo-controlled designAll groups will undergo a 24-week intervention phase. Group 1 will receive standard treatment including topical cream betamethasone thrice daily and Pentoxifylline tablet 400 mg twice daily. Group 2 will receive Metformin 500 mg thrice daily. Group 3 will receive topical cream metformin thrice daily. All groups will be instructed to perform a stick mouth opening exercise twice daily, alternating sides, holding the stick for 10 minutes on each side, with a 10-minute rest in between. All groups will be single blinded to the intervention., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: It would be a single-blind, placebo-controlled design, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Metformin Hydrochloride, interventions name: betamethasone dipropionate, interventions name: Pentoxifylline, outcomesModule primaryOutcomes measure: Cell Viability, primaryOutcomes measure: Cytotoxicity, primaryOutcomes measure: Morphological Changes Cell Shape, primaryOutcomes measure: Morphological Change Cell Density, primaryOutcomes measure: Morphological Change Extracellular Matrix (ECM) Structure, primaryOutcomes measure: Cell Migration Assays, primaryOutcomes measure: Cell Invasion Assays, primaryOutcomes measure: Apoptosis Analysis, primaryOutcomes measure: Assess Signaling pathway with optimal metformin concentration, secondaryOutcomes measure: Clinical Oral Mucosal Characteristics, secondaryOutcomes measure: Patient Burning sensation pain, secondaryOutcomes measure: Patient Mouth Opening, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ziauddin University, city: Karachi, state: Sindh, zip: 74700, country: Pakistan, contacts name: Afifa Razi, FCPS OMFS, role: CONTACT, phone: +92 300 2247389, email: afifa.razi@zu.edu.pk, contacts name: Shumaila Usman, PhD, role: CONTACT, phone: +92 336 1882779, email: shumaila.usman@zu.edu.pk, contacts name: Afifa Razi, FCPS, role: PRINCIPAL_INVESTIGATOR, contacts name: Shumaila Usman, PhD, role: SUB_INVESTIGATOR, contacts name: Yamna Khurshid, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06332599, orgStudyIdInfo id: rjhy20240001, briefTitle: Minocycline for Helicobacter Pylori Rescue Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2034-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting., conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: BQT, interventions name: EBM4M4, interventions name: EBM3M3, interventions name: EBM2M4, interventions name: EBM2M3, outcomesModule primaryOutcomes measure: Helicobacter pylori eradication rate, secondaryOutcomes measure: Rate of adverse effects, secondaryOutcomes measure: Compliance rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, state: None Selected, zip: 200127, country: China, contacts name: Yu Huang, role: CONTACT, phone: 0198621791879, email: 15626211482@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06332586, orgStudyIdInfo id: 202311087RINA, briefTitle: The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-04, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: "Triage" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010., TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses., conditionsModule conditions: Triage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Diversified teaching, outcomesModule primaryOutcomes measure: Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taiwan, city: Taipei, zip: Taiwan, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06332573, orgStudyIdInfo id: 24-06, briefTitle: Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer, acronym: SEXOCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Hôpital Européen Marseille, class: OTHER, descriptionModule briefSummary: Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.Onco-sexology is one of the supportive care services validated by The French National Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the 2017-2030 national sexual health strategy plan.Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment)., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Onco-sexology support, interventions name: Onco-sexology support, outcomesModule primaryOutcomes measure: Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support, secondaryOutcomes measure: Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire, secondaryOutcomes measure: Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men), secondaryOutcomes measure: Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men), secondaryOutcomes measure: Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale "., secondaryOutcomes measure: Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale"., secondaryOutcomes measure: Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care, secondaryOutcomes measure: Rate of patients expressing sexual difficulties during the consultation of announcement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Européen Marseille, city: Marseille, country: France, contacts name: Myriam BENNANI, role: CONTACT, phone: 0413428351, email: m.bennani@hopital-europeen.fr, geoPoint lat: 43.29551, lon: 5.38958, hasResults: False
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protocolSection identificationModule nctId: NCT06332560, orgStudyIdInfo id: NL86247.091.24, briefTitle: Pain in Endometriosis And the Relation to Lifestyle, acronym: PEARL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy.Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Anti-inflammatory diet (DI), interventions name: Cognitive behavioral therapy (CBT), outcomesModule primaryOutcomes measure: Change in Pain intensity assessed by the Numerical Rating Scale, primaryOutcomes measure: Change in inflammatory characteristics in menstruum, secondaryOutcomes measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30, secondaryOutcomes measure: Change in general Quality of Life assessed by the Short Form 36, secondaryOutcomes measure: Change in the composition of vaginal and intestinal microbiome, secondaryOutcomes measure: Change in Objective stress assessed by measuring scalp hair cortisol levels, secondaryOutcomes measure: Adherence and anti-inflammatory status of the diet, otherOutcomes measure: Change in sleep quality assessed by the PSQI, otherOutcomes measure: Change in physical activity level assessed by the IPAQ-SF, otherOutcomes measure: Change in Subjective stress assessed by the Perceived Stress Scale, otherOutcomes measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale, otherOutcomes measure: Changes in pain cognitions assessed by the pain catastrophizing Scale, otherOutcomes measure: Changes in Fatigue assessed by the checklist individual strength, otherOutcomes measure: Anti-inflammatory diet rating, eligibilityModule sex: FEMALE, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud University Medical Center, city: Nijmegen, country: Netherlands, contacts name: E Huijs, B, role: CONTACT, contacts name: A.W. Nap, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
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protocolSection identificationModule nctId: NCT06332547, orgStudyIdInfo id: TICVS, briefTitle: Transfusion in Cardiac Valve Surgery, acronym: TICVS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups., conditionsModule conditions: Cardiac Surgery With Cardiopulmonary Bypass, conditions: Valve Heart Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Restrictive Transfusion Strategy, interventions name: Liberal Transfusion Strategy, outcomesModule primaryOutcomes measure: A composite of postoperative morbidity and mortality, secondaryOutcomes measure: Rate of reoperation, secondaryOutcomes measure: Length of ICU Stays, secondaryOutcomes measure: Length of Postoperative Hospital Stay, secondaryOutcomes measure: Number of Blood Transfusion, secondaryOutcomes measure: Duration of mechanical ventilation, secondaryOutcomes measure: Postoperative thoracic fluid volume in the first 24 hours, secondaryOutcomes measure: Number of participants with postoperative atrial fibrillation, secondaryOutcomes measure: Number of participants with new-onset renal failure with dialysis, secondaryOutcomes measure: Number of participants with acute kidney injury, secondaryOutcomes measure: Number of participants with delirium, secondaryOutcomes measure: Hospitalization expense, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial People's Hospital, city: Guangzhou, state: Guangdong, zip: 510145, country: China, contacts name: Huang Huanlei, Phd, role: CONTACT, phone: 765 714 9765, email: hhuanlei@hotmail.com, contacts name: Huang huanlei, Phd, role: PRINCIPAL_INVESTIGATOR, contacts name: Zhao Junfei, Phd, role: PRINCIPAL_INVESTIGATOR, contacts name: He Biaochuan, Phd, role: PRINCIPAL_INVESTIGATOR, contacts name: Zhang Zhaolong, BD, role: PRINCIPAL_INVESTIGATOR, contacts name: Wang Zhenzhong, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Wang Qiuji, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06332534, orgStudyIdInfo id: M14-671, briefTitle: Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-26, primaryCompletionDateStruct date: 2032-03-22, completionDateStruct date: 2034-12-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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: Crohn's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Upadacitinib, outcomesModule primaryOutcomes measure: Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64, primaryOutcomes measure: Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12., primaryOutcomes measure: Number of Participants with Adverse Events, secondaryOutcomes measure: Achievement of clinical remission per PCDAI, secondaryOutcomes measure: Achievement of endoscopic response, secondaryOutcomes measure: Achievement of endoscopic remission, secondaryOutcomes measure: Achievement of clinical response per PCDAI, secondaryOutcomes measure: Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12, secondaryOutcomes measure: Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12, secondaryOutcomes measure: Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332521, orgStudyIdInfo id: 23CH296, secondaryIdInfos id: ANSM, type: OTHER, domain: 2024-A00286-41, briefTitle: Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment, acronym: BABYCRY_1000, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry., conditionsModule conditions: Newborn; Vitality, conditions: Premature Infants, conditions: Infant Development, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Acoustic signal analysis method, outcomesModule primaryOutcomes measure: Fundamental frequency f0 (Hz), primaryOutcomes measure: Bailey-4 quantitative scale, secondaryOutcomes measure: Percentage voiced frames, secondaryOutcomes measure: Harmonics of f0 (Hz), secondaryOutcomes measure: Median pitch f0 (Hz), secondaryOutcomes measure: Harmonicity (dB), secondaryOutcomes measure: Jitter (Percentage),, secondaryOutcomes measure: Q25 (Percentage), secondaryOutcomes measure: Median Cepstral Peak Prominence (CPP) (dB), eligibilityModule sex: ALL, maximumAge: 4 Days, stdAges: CHILD, contactsLocationsModule locations facility: Chu de Saint-Etienne, status: RECRUITING, city: Saint-Étienne, zip: 42055, country: France, contacts name: Hugues PATURAL, MD-PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06332508, orgStudyIdInfo id: 2022/00406, briefTitle: Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-30, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: National University Hospital, Singapore, class: OTHER, collaborators name: National University of Singapore, descriptionModule briefSummary: To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed electromagnetic fields (PEMFs), interventions name: Anthracycline-based chemotherapy, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0, secondaryOutcomes measure: Treatment response as assessed by clinical measurement of tumor size using calipers, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University Hospital, status: RECRUITING, city: Singapore, zip: 119074, country: Singapore, contacts name: Joline Si Jing Lim, role: CONTACT, phone: 69082222, email: joline_sj_lim@nuhs.edu.sg, contacts name: Joline Si Jing Lim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06332495, orgStudyIdInfo id: RC23_0573, secondaryIdInfos id: 2024-A00025-42, type: OTHER, domain: ANSM (IDRCB), briefTitle: Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers, acronym: RIDAECUBA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-03, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: the hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study., conditionsModule conditions: Nurse-Patient Relations, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Questioning the patient during hygiene care, outcomesModule primaryOutcomes measure: Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan., secondaryOutcomes measure: Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3, secondaryOutcomes measure: Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan., secondaryOutcomes measure: Assess patient discomfort on the bedpan, secondaryOutcomes measure: Assess alteration of skin condition at the seat of the patient using the bedpan, secondaryOutcomes measure: Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan., secondaryOutcomes measure: Assess the risk factors associated with the onset of pain when placing a bedpan., secondaryOutcomes measure: Assess the difficulty of positioning and removing the bedpan., secondaryOutcomes measure: Assess bedpan stability during use, secondaryOutcomes measure: Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, city: Nantes, state: Loire Atlantique, zip: 44093, country: France, contacts name: Pia SECHER-CAILLETEAU, role: CONTACT, email: pia.secher@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Cholet, city: Cholet, country: France, contacts name: Nelly DIXNEUF, role: CONTACT, phone: (+33) 2 41 49 69 85, email: nelly.dixneuf@ch-cholet.fr, geoPoint lat: 47.06667, lon: -0.88333, locations facility: CHU Laval, city: Laval, country: France, contacts name: ROMAIN CHAMPAGNE, role: CONTACT, phone: (+33) 672091548, email: Romain.CHAMPAGNE@chlaval.fr, geoPoint lat: 48.06667, lon: -0.76667, locations facility: CH Le Mans, city: Le Mans, country: France, contacts name: Emmanuelle Lecompte, role: CONTACT, phone: (+33) 681220543, email: gsicot@ch-lemans.fr, geoPoint lat: 48.0, lon: 0.2, locations facility: CHU Orleans, city: Orléans, country: France, contacts name: Guillaume FOSSAT, role: CONTACT, phone: (+33) 2 38.65.13.18, email: guillaume.fossat@chu-orleans.fr, geoPoint lat: 47.90289, lon: 1.90389, hasResults: False
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protocolSection identificationModule nctId: NCT06332482, orgStudyIdInfo id: M0303023RP, briefTitle: Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-30, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration., conditionsModule conditions: Prosthesis Durability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: digital impressions will be made for each patient,3 technique will be used to determine intermaxillary relation. Occlusal prematurties of final prosthesis will compared using occlusense device and all patients will be followed up for one year, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Implant supported screw retained prosthesis, outcomesModule primaryOutcomes measure: measurement of occlusal prematurity, primaryOutcomes measure: prosthestic complications, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University ,Faculty of dentistry, city: Mansoura, zip: P.O.Box:35516, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06332469, orgStudyIdInfo id: INSERT feasibility, briefTitle: Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation, acronym: INSERT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, descriptionModule briefSummary: The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention group gets immediate access to the 9 week program, and the waitlist control group gets access after a 9 week waiting period., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Internet based education and support program for patients awaiting kidney transplantation, outcomesModule primaryOutcomes measure: Kidney transplant understanding tool (K-TUT), primaryOutcomes measure: Self-care in chronic illness inventory v.4c, primaryOutcomes measure: The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G, primaryOutcomes measure: Pearlin Mastery Scale, primaryOutcomes measure: The Depression Anxiety Stress Scales 21 (DASS-21), primaryOutcomes measure: Acceptance of chronic health conditions scale (ACHC), primaryOutcomes measure: EQ-5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332456, orgStudyIdInfo id: ICM 2023-3169, briefTitle: Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography, acronym: RESIST, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Matthieu Pelletier-Galarneau, MD MSc, class: OTHER, descriptionModule briefSummary: The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases., conditionsModule conditions: Renal Microcirculation With Rubidium Positron Emission Tomography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Renal blood flow in units of mL/min/100g, secondaryOutcomes measure: Renal vascular resistance in units of mmHg/mL/min/100g, secondaryOutcomes measure: Correlation between renal vascular resistance measured with PET and measured with echography, secondaryOutcomes measure: Coefficient of repeatability of renal blood flow, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montreal Heart Institute, status: RECRUITING, city: Montréal, state: Quebec, zip: H1T 1C8, country: Canada, contacts name: Matthieu Pelletier-Galarneau, role: CONTACT, phone: 5143763330, phoneExt: 4418, email: matthieu.pelletier-galarneau@icm-mhi.org, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06332443, orgStudyIdInfo id: CER-CEMTL-2023-3086, briefTitle: Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty., acronym: RCT SEA vs SA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Maisonneuve-Rosemont Hospital, class: OTHER, collaborators name: Mina Wahba Morcos, collaborators name: Issam Tanoubi, collaborators name: Pierre Drolet, collaborators name: Ariane Clairoux, collaborators name: Veronique Brulotte, collaborators name: Marie-Eve Bélanger, collaborators name: Philippe Richebé, collaborators name: Karina Pellei, descriptionModule briefSummary: To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries., conditionsModule conditions: Knee Injuries and Disorders, conditions: Hip Injuries, conditions: Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a RCT with two parallel treatment groups: THA/TKA with single-shot SA group and THA/TKA with SED-EA group, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The group assignment will be given to the intraoperative anesthesia team by writing, by a research team member who will not participate in postoperative assessments. The intraoperative anesthesia team will not be blinded to the group assignment, but surgeons, patients, and assessors will be blinded. For the SA group, a sham epidural catheter will be placed on the patient's back by the anesthesia team in order to keep the surgeons, patients and assessors blind to the randomization group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Spinal anesthesia, interventions name: Sedation epidural anesthesia, outcomesModule primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Time needed by the anesthesiologist to perform the technique, secondaryOutcomes measure: Time needed for the SA or SED-EA to achieve adequate sensory block, secondaryOutcomes measure: Intraoperative blood loss, secondaryOutcomes measure: intraoperative muscle tension, secondaryOutcomes measure: Extra Lidocaine needed, secondaryOutcomes measure: Conversion to GA, secondaryOutcomes measure: Total dose of the sedation, secondaryOutcomes measure: Hemodynamic stability measured, secondaryOutcomes measure: Time to return of motor and sensory function, secondaryOutcomes measure: Post-operative nausea, secondaryOutcomes measure: PONV and anti-emetics, secondaryOutcomes measure: Urinary retention, secondaryOutcomes measure: Opioid consumption, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Failed discharded, secondaryOutcomes measure: Complications related to the technique performed., secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Maisonneuve Rosemont, status: RECRUITING, city: Montreal, state: Quebec, zip: H1T 2M4, country: Canada, contacts name: Serge Marquis, RN, role: CONTACT, phone: 5142523400, phoneExt: 5701, email: smarquis.hmr@ssss.gouv.qc.ca, contacts name: Janie Barry, MSc, role: CONTACT, phone: 5142523400, phoneExt: 4567, email: jbarry.hmr@ssss.gouv.qc.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06332430, orgStudyIdInfo id: CW-202, briefTitle: Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Canwell Biotech Limited, class: INDUSTRY, descriptionModule briefSummary: A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas., conditionsModule conditions: Solid Tumor, conditions: Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: CAN2109, outcomesModule primaryOutcomes measure: Safety and tolerability, primaryOutcomes measure: Recommended Phase 2 Dose (RP2D), secondaryOutcomes measure: To determine the efficacy of CAN2109, secondaryOutcomes measure: To evaluate the pharmacodynamics of CAN2109, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Sun Yat-Sen Memorial Hospital, city: Guangzhou, state: Guangdong, zip: 510535, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06332417, orgStudyIdInfo id: REC/RCR&AHS/23/0364, briefTitle: Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, 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: Ba-Duan-Jin Based Deep Breathing Exercises, interventions name: FET (Forced Expiratory Technique), outcomesModule primaryOutcomes measure: 36-Item Short Form Survey (SF-36), primaryOutcomes measure: FEV1/FVC ratio, primaryOutcomes measure: Exercise Tolerance : 6 minute walk test, primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: Forced expiratory volume (FEV1), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Social Security Teaching Hospital, status: RECRUITING, city: Lahore, state: Punhab, zip: 42000, country: Pakistan, contacts name: Faisal Rehman, MBBS, role: CONTACT, phone: +924299230227, email: info@pessi.punjab.gov.pk, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06332404, orgStudyIdInfo id: B3002024000047, briefTitle: Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry, acronym: B-HNS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2034-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital., conditionsModule conditions: Obstructive Sleep Apnea, conditions: Sleep Apnea, conditions: Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA), outcomesModule primaryOutcomes measure: Delta apnea-hypopnea index (AHI) as measured by a polysomnography, secondaryOutcomes measure: % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h, secondaryOutcomes measure: Therapy adherence defined by the amount of hours therapy usage per night., secondaryOutcomes measure: Delta oxygen desaturation index (ODI) as measured by a polysomnography, secondaryOutcomes measure: Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire, secondaryOutcomes measure: Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire, secondaryOutcomes measure: Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antwerp University Hospital, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, contacts name: Dorine Van Loo, Msc, role: CONTACT, phone: +3238215780, email: dorine.vanloo@uza.be, contacts name: Olivier Vanderveken, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False
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protocolSection identificationModule nctId: NCT06332391, orgStudyIdInfo id: 202308349, secondaryIdInfos id: R01HL168752, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL168752, briefTitle: Paced Heart Rate Acceleration for Cardiac Conditioning, acronym: HeartExcel, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Denice Hodgson-Zingman, MD, class: OTHER, collaborators name: The Cleveland Clinic, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed., conditionsModule conditions: Heart Failure, Systolic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Subjects and outcomes assessors are blinded to study group (intervention vs. sham) but investigator is not. During intervention vs. sham, subjects do not have access to vital sign data and sham procedures follow intervention procedures exactly with the exception that no change in pacing rate is delivered. A blinding questionnaire is given to subjects to assess adequacy of blinding., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Exercise-similar cardiac pacing, interventions name: Sham cardiac pacing, outcomesModule primaryOutcomes measure: Change in left ventricular ejection fraction by echocardiogram, secondaryOutcomes measure: Quality of Life score on the Minnesota Living with Heart Failure questionnaire, secondaryOutcomes measure: Quality of Life score on the Kansas City Cardiomyopathy Questionnaire, secondaryOutcomes measure: 6-minute walk distance, secondaryOutcomes measure: Cardiopulmonary exercise test maximum oxygen consumption, secondaryOutcomes measure: Cardiopulmonary exercise test metabolic equivalents achieved, secondaryOutcomes measure: Cardiopulmonary exercise test peak power output achieved, secondaryOutcomes measure: Cardiopulmonary exercise test total exercise time, secondaryOutcomes measure: daily minutes of sedentary activity, secondaryOutcomes measure: daily minutes of low activity, secondaryOutcomes measure: daily minutes of moderate activity, secondaryOutcomes measure: daily minutes of vigorous activity, secondaryOutcomes measure: major adverse cardiac events, secondaryOutcomes measure: symptom score during the intervention/sham procedure, secondaryOutcomes measure: maximum achieved pacing rate during the intervention/sham procedure, secondaryOutcomes measure: presence of significant arrhythmia during the intervention/sham procedure, secondaryOutcomes measure: vital signs - systolic blood pressure during the intervention/sham procedure, secondaryOutcomes measure: vital signs - oxygen saturation in the blood during the intervention/sham procedure, secondaryOutcomes measure: tolerability - vital signs - cardiac output, secondaryOutcomes measure: vital signs - cardiac output during the intervention/sham procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332378, orgStudyIdInfo id: sHasan, briefTitle: Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Dr. Sobia Hasan, class: OTHER, descriptionModule briefSummary: The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..The main question it aims to answer are:1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.2. Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity., conditionsModule conditions: Diabetic Neuropathies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group 1 :Ball training, interventions name: Experimental group 2 :Frenkel Exercises, interventions name: Control Group, outcomesModule primaryOutcomes measure: One Leg Stance, primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Timed Up and Go Test:, primaryOutcomes measure: Diabetic Neuropathy Symptom Score, primaryOutcomes measure: Hemoglobin A1C, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332365, orgStudyIdInfo id: ID: 3938/2022, briefTitle: Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers, acronym: salivaLichen, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-03, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Pia Lopez Jornet, class: OTHER, descriptionModule briefSummary: Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus, conditionsModule conditions: Oral Lichen Planus, conditions: Oral Lichen Planus Related Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Acetonide triamcinolone 0.2% +hyaluronicacid 1%, interventions name: Corticoid Acetonide triamcinolone 0.2%, interventions name: Hyaluronic acid 1%, outcomesModule primaryOutcomes measure: Pain assessment scale, secondaryOutcomes measure: OHIP-14 questionnaire, secondaryOutcomes measure: reduction of clinical signs measure, secondaryOutcomes measure: Salivary level of oxidative stress biomarker, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pia Lopez Jornet, city: Murcia, zip: 30004, country: Spain, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
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protocolSection identificationModule nctId: NCT06332352, orgStudyIdInfo id: 00173470, briefTitle: Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears, acronym: PRP for ALT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2025-01-25, completionDateStruct date: 2026-01-25, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants., conditionsModule conditions: Acetabular Labrum Tear, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: PRP, outcomesModule primaryOutcomes measure: Pain & Function Improvements, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Harris Hip Scores (HHS), secondaryOutcomes measure: International Hip Outcome Tool (iHOT-12), secondaryOutcomes measure: EQ-5D (EuroQual 5D), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Utah - Department of Orthopaedics, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84108, country: United States, contacts name: Luke A Johnson, BS, role: CONTACT, phone: 801-213-3379, email: luke.a.johnson@utah.edu, contacts name: Daniel Cushman, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Derek Stokes, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06332339, orgStudyIdInfo id: HVTN 313, briefTitle: Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2026-11-11, completionDateStruct date: 2026-11-11, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.The main question\[s\] it aims to answer are:* Are these vaccine regimens safe and well tolerated?* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary., conditionsModule conditions: HIV, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 16055 NFL delta Gly4 trimer, interventions name: Trimer 4571, interventions name: Ad4-Env145NFL, 5 x 108 viral particles (vp), outcomesModule primaryOutcomes measure: Local reactogenicity signs and symptoms, primaryOutcomes measure: Systemic reactogenicity signs and symptoms, primaryOutcomes measure: Number of adverse events (AEs) reported for 30 days after receipt of any study product, primaryOutcomes measure: Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation, primaryOutcomes measure: Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc), primaryOutcomes measure: Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.), primaryOutcomes measure: Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.), secondaryOutcomes measure: Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086), secondaryOutcomes measure: Occurrence of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Magnitude of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Response Rate of serum antibody neutralization of HIV-1 strains, secondaryOutcomes measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells, secondaryOutcomes measure: Occurrence of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Magnitude of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Response Rate of serum IgG binding antibodies as measured by BAMA, secondaryOutcomes measure: Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations, secondaryOutcomes measure: Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination, secondaryOutcomes measure: Occurrence of serum IgG binding antibodies, secondaryOutcomes measure: Magnitude of serum IgG binding antibodies, secondaryOutcomes measure: Response Rate of serum IgG binding antibodies, secondaryOutcomes measure: Occurrence of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Magnitude of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Response Rate of serum antibody neutralization to tier 2 HIV-1 strains, secondaryOutcomes measure: Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Alabama CRS, status: NOT_YET_RECRUITING, city: Birmingham, state: Alabama, zip: 35222, country: United States, contacts name: Heather Logan, ANP, role: CONTACT, phone: 205-873-8686, email: heatherlogan@uabmc.edu, geoPoint lat: 33.52066, lon: -86.80249, locations facility: The Ponce de Leon Center CRS, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30308, country: United States, contacts name: Erika Patrick, MSN, role: CONTACT, phone: 404-616-6313, email: erpatri@emory.edu, geoPoint lat: 33.749, lon: -84.38798, locations facility: Brigham and Women's Hospital Vaccine CRS (BWH VCRS), status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jose Licona, MD, role: CONTACT, phone: 617-525-9433, email: jlicona@partners.org, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Columbia Partnership for Prevention and Control of HIV/AIDS CTU, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Mascha Elskamp, role: CONTACT, phone: 212-305-2201, email: Me2500@cumc.columbia.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Rochester HIV/AIDS CTU, status: NOT_YET_RECRUITING, city: Rochester, state: New York, zip: 14642, country: United States, contacts name: Catherine Bunce, RN MS, CCRC, role: CONTACT, phone: 585-275-5871, email: catherine_bunce@urmc.rochester.edu, geoPoint lat: 43.15478, lon: -77.61556, locations facility: University of Pennsylvania HIV Therapeutics and Prevention Clinical Trials Unit, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Debora Dunbar, MSN, CRNP, role: CONTACT, phone: 215-746-3713, email: ddunbar@pennmedicine.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06332326, orgStudyIdInfo id: E-10840098-772.02-4966, briefTitle: Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-23, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH)., conditionsModule conditions: Vestibular Diseases, conditions: Vestibular Vertigo, conditions: Vertigo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 40 patients diagnosed with UHV were included. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: non-invasive vagus nerve stimulation, interventions name: vestibular rehabilitation, outcomesModule primaryOutcomes measure: Modified-CTSIB, primaryOutcomes measure: Semitandem test, primaryOutcomes measure: tandem test, primaryOutcomes measure: one-leg standing test, primaryOutcomes measure: Unterberger test, primaryOutcomes measure: VAS Visual Analogue Scale (dizziness severity), primaryOutcomes measure: Dynamic visual acuity test, secondaryOutcomes measure: Dizziness Handicap Inventory Scale, secondaryOutcomes measure: Tampa Kinesiophobia Scale, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HAD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: tuğba türk kalkan, MD, role: CONTACT, phone: +905334956459, email: tugbatrkk@gmail.com, contacts name: tugba türk kalkan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06332313, orgStudyIdInfo id: 2023/10/05, briefTitle: Erector Spina Plane Block Volume Comparison, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-12, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2024-12-05, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded, conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: erector spina plane block, outcomesModule primaryOutcomes measure: The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332300, orgStudyIdInfo id: ADBL-LC-003, briefTitle: An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, class: OTHER, descriptionModule briefSummary: This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Adebelimumab+Famitinib + FOLFIRI+Ariely, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: iPFS, secondaryOutcomes measure: iDoR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shengcun Fang, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: Shengcun Fang, PhD, role: CONTACT, phone: +86 13404163638, email: Fang1984@aliyun.com, contacts name: Jian Zhang, Master, role: CONTACT, phone: +86 13095457871, email: 919939410@qq.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06332287, orgStudyIdInfo id: 2023-NSCLC, briefTitle: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Jiangsu Province Nanjing Brain Hospital, class: OTHER, descriptionModule briefSummary: To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。, conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Trilaciclib, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: combination of Trilaciclib and Pemetrexed, outcomesModule primaryOutcomes measure: Duration of severe neutropenia (DSN), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Incidence of grade 3 and 4 hematologic toxicity, secondaryOutcomes measure: Incidence of G-CSF treatment, secondaryOutcomes measure: Incidence of platelet transfusion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fang Shencun, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 210029, country: China, contacts name: fang S cun, M.D., role: CONTACT, phone: 83728558, phoneExt: 025, email: fang1984@aliyun.com, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
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protocolSection identificationModule nctId: NCT06332274, orgStudyIdInfo id: 2023-503316-33-00, secondaryIdInfos id: 2023/3720, type: OTHER, domain: CSET number, briefTitle: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease, acronym: UMBRELLA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Gustave Roussy, Cancer Campus, Grand Paris, class: OTHER, collaborators name: BeiGene, collaborators name: C2i Genomics, descriptionModule briefSummary: Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage.UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \[MRD(-)\]., conditionsModule conditions: Cancer, conditions: Lung Cancer, conditions: Colo-rectal Cancer, conditions: Pancreas Cancer, conditions: Soft Tissue Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a double-blinded, randomized, placebo-controlled, multi-center, national, Phase 3 biology-driven trial designed to investigate the impact of systemic treatment with tislelizumab or placebo following detection of MRD minimum 3 months and maximum 4.5 months after completion of curative-intent therapy., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 717, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Blood sampling, interventions name: Placebo, outcomesModule primaryOutcomes measure: Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival), secondaryOutcomes measure: Estimation of DFS in subjects without MRD, secondaryOutcomes measure: Estimation of overall survival (OS), secondaryOutcomes measure: Percentage of MRD (+) subject's completion of standard curative-intent therapy, secondaryOutcomes measure: Time between detection of MRD and detection of relapse at imaging., secondaryOutcomes measure: Percentage of subjects with MRD assessment failure., secondaryOutcomes measure: Estimation of the time to become MRD (-) for MRD(+) patients, secondaryOutcomes measure: Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30, secondaryOutcomes measure: Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L, secondaryOutcomes measure: Cost effectiveness analysis: incremental cost, secondaryOutcomes measure: Cost effectiveness analysis: QALY, secondaryOutcomes measure: Cost effectiveness analysis: ICER, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gustave Roussy, city: Villejuif, state: Val De Marne, zip: 94800, country: France, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False
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protocolSection identificationModule nctId: NCT06332261, orgStudyIdInfo id: 2024-BB-01, briefTitle: Standardized Assessment in Depression Treatment in Routine Psychiatric Services, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Region Stockholm, descriptionModule briefSummary: The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.The main questions it aims to answer are:* Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?* What are the present conditions for implementing measurement-based care in depression treatment in this setting?Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics., conditionsModule conditions: Major Depressive Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale, secondaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale-Self Assessment, secondaryOutcomes measure: The Patient Health Questionnaire-9, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stockholm Health Care Services, Region Stockholm, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06332248, orgStudyIdInfo id: 2014/1023-31/4 & 2014/274-31/5, briefTitle: Possible Effects of the Dietary Supplement Magnesium Compared to Placebo, statusModule overallStatus: COMPLETED, startDateStruct date: 2014-09-15, primaryCompletionDateStruct date: 2015-05-20, completionDateStruct date: 2015-05-28, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Dan Hasson, class: OTHER, collaborators name: Stiftelsen Stressmottagningen, collaborators name: AFA Insurance, descriptionModule briefSummary: The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:* Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?* Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc., conditionsModule conditions: Health Promotion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants received either 375 mg nutritional supplement magnesium or placebo pill., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1013, type: ACTUAL, armsInterventionsModule interventions name: Magnesium, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time x group difference in HealthWatch-11 (questionnaire), secondaryOutcomes measure: Intervention compliance measure 1 (objective, number of pills left), secondaryOutcomes measure: Intervention compliance measure 2 (subjective, marked days in calendar), otherOutcomes measure: Time x group difference in Oldenburg Burnout Inventory (questionnaire), otherOutcomes measure: Time x group difference in Karolinska Sleep Questionnaire, otherOutcomes measure: Time x group difference in Pure Tone Audiogram (clinical hearing test), otherOutcomes measure: Time x group difference in Speech in noise test (clinical hearing test), otherOutcomes measure: Time x group difference in Uncomfortable loudness level (clinical hearing test), otherOutcomes measure: Time x group difference in single questionnaire item assessing sick leave, otherOutcomes measure: Time x group difference in single questionnaire item assessing sickness presenteeism, otherOutcomes measure: Time x group difference in prevalence of pain (questionnaire), otherOutcomes measure: Time x group difference in pain frequency (questionnaire), otherOutcomes measure: Time x group difference in pain discomfort (questionnaire), otherOutcomes measure: Time x group difference in pain intensity (questionnaire), otherOutcomes measure: Time x group difference in functional impairment due to pain (questionnaire), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332235, orgStudyIdInfo id: KMUHIRB-F(I)-20220023, briefTitle: Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-18, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University Chung-Ho Memorial Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms., conditionsModule conditions: Human Trichinellosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Silodosin 8 mg, outcomesModule primaryOutcomes measure: Assessment criteria Efficacy, primaryOutcomes measure: Assessment criteria Safety, secondaryOutcomes measure: Assessment criteria Efficacy, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, status: RECRUITING, city: Kaohsiung, state: Sanmin District, zip: 807, country: Taiwan, contacts name: Chen Yu Chen, MS, role: CONTACT, phone: 0911884597, email: jennis7995@hotmail.com, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06332222, orgStudyIdInfo id: 1987, briefTitle: Recovery With Tart Cherry Supplementation Following a Marathon., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-10-11, completionDateStruct date: 2023-10-11, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Northumbria University, class: OTHER, collaborators name: Iprona Lana SpA, descriptionModule briefSummary: The goal of this clinical trial is to compare recovery in healthy, active runners.The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:* muscle function* inflammation* soreness following a marathon run.Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:* maximal voluntary contractions* counter movement jumps* visual analog scales to assess soreness* blood samples, conditionsModule conditions: Exercise Recovery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Tart Cherry, interventions name: Placebo, outcomesModule primaryOutcomes measure: Maximal Voluntary Contraction, secondaryOutcomes measure: Counter Movement Jump, secondaryOutcomes measure: Active Muscle Soreness, secondaryOutcomes measure: Serum Concentration of High-Sensitive C-Reactive Protein, secondaryOutcomes measure: Serum Concentration of Creatine Kinase, secondaryOutcomes measure: Perceptual Measures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northumbria University, city: Newcastle Upon Tyne, state: Tyne And Wear, zip: NE1 8ST, country: United Kingdom, geoPoint lat: 54.97328, lon: -1.61396, hasResults: False
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protocolSection identificationModule nctId: NCT06332209, orgStudyIdInfo id: Pro00135303, secondaryIdInfos id: U66RH31458, type: OTHER_GRANT, domain: Telehealth Center of Excellence, briefTitle: Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, descriptionModule briefSummary: The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery., conditionsModule conditions: Post-Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Trauma Focused Cognitive Behavioral Therapy, outcomesModule primaryOutcomes measure: Traumatic Stress Symptoms, primaryOutcomes measure: Traumatic Stress Symptoms, secondaryOutcomes measure: Anxiety and Depression Symptoms, secondaryOutcomes measure: Anxiety and Depression Symptoms, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06332196, orgStudyIdInfo id: L-IEI, briefTitle: Immunodeficiency and Cancer: Identification of Congenital Immune System Defects Underlying Paediatric Lymphomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-18, primaryCompletionDateStruct date: 2025-06-18, completionDateStruct date: 2025-10-18, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas., conditionsModule conditions: Immune Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients diagnosed with non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma (HL) aged and patients with previous lymphoma and signs of immunodeficiency, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Analysis of biological sample and clinical data, outcomesModule primaryOutcomes measure: To unravel inborn error of immunity behind Lymphoid neoplasm in children, secondaryOutcomes measure: Identification of lymphoma-specific biomarkers, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: AOU Malpighi IRCCS, status: ACTIVE_NOT_RECRUITING, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Eleonora Gambineri, role: CONTACT, email: eleonora.gambineri@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: AOU Pisana, status: ACTIVE_NOT_RECRUITING, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Ospedale Pediatrico Bambin Gesù IRCCS, status: ACTIVE_NOT_RECRUITING, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06332183, orgStudyIdInfo id: ECDGWAS, briefTitle: GWAS and EWAS in Patients With Erdheim-Chester Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-07-17, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Augusto Vaglio, class: OTHER, descriptionModule briefSummary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments., conditionsModule conditions: Erdheim-Chester Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Presence of polymorphisms, outcomesModule primaryOutcomes measure: Polymorphisms and genetic variants correlated with disease development, primaryOutcomes measure: Methylation in Erdheim-Chester disease, primaryOutcomes measure: Gene expression in Erdheim-Chester disease, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Pitié Salpetrière, status: RECRUITING, city: Paris, country: France, contacts name: Julien Haroche, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Augusto Vaglio, role: CONTACT, email: augusto.vaglio@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milano, country: Italy, contacts name: Lorenzo Dagna, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: AOU Parma, status: RECRUITING, city: Parma, country: Italy, contacts name: Davide Martorana, role: CONTACT, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Genetics Lab, CSIC, status: RECRUITING, city: Granada, country: Spain, contacts name: Javier Martin, role: CONTACT, geoPoint lat: 37.18817, lon: -3.60667, hasResults: False
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protocolSection identificationModule nctId: NCT06332170, orgStudyIdInfo id: HS-20093-103, briefTitle: ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2028-05-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Hansoh BioMedical R&D Company, class: INDUSTRY, descriptionModule briefSummary: HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 610, type: ESTIMATED, armsInterventionsModule interventions name: HS-20093, interventions name: Adebrelimab, interventions name: Cisplatin/ Carboplatin, interventions name: Cetuximab, interventions name: Enzalutamide, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) for combination-treatments, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), secondaryOutcomes measure: Objective response rate (ORR) determined by investigators, secondaryOutcomes measure: Disease control rate (DCR) determined by investigators, secondaryOutcomes measure: Duration of response (DoR) determined by investigators, secondaryOutcomes measure: Progression-free survival (PFS) determined by investigators according to RECIST 1.1, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3, secondaryOutcomes measure: Time to PSA progression (TTPP), secondaryOutcomes measure: Prostate-specific cancer antigen (PSA) response rate, secondaryOutcomes measure: Time to first subsequent therapy (TFST), secondaryOutcomes measure: Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor, secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax) of HS-20093, secondaryOutcomes measure: Terminal half-life (T1/2) of HS-20093 following the first dose, secondaryOutcomes measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093, secondaryOutcomes measure: Percentage of participants with antibodies to HS-20093 in serum, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06332157, orgStudyIdInfo id: 2023-ke-715-1, briefTitle: Postoperative Quality of Recovery After General Anesthesia With Remimazolam, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Beijing Chao Yang Hospital, class: OTHER, descriptionModule briefSummary: 126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome., conditionsModule conditions: Anesthesia Recovery Period, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Remimazolam besylate, interventions name: Propofol Injection Emulsion, outcomesModule primaryOutcomes measure: 15-item quality of recovery scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332144, orgStudyIdInfo id: 1R56DC020208-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R56DC020208-01A1, briefTitle: Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning, acronym: PLAUSL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-13, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Northeastern University, class: OTHER, collaborators name: University of Delaware, collaborators name: Boston University, collaborators name: Cornell University, descriptionModule briefSummary: The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;2. how children's brains automatically learn patterns from speech and prints;3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.First-grade students will participate in the study twice across three months.During Time 1, children will complete* a battery of language, reading, and cognitive assessments* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth., conditionsModule conditions: Autism Spectrum Disorder, conditions: Language Development, conditions: Literacy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Structural vs. Random sequences of stimuli, interventions name: Intact vs. Degraded speech, interventions name: Repeating 5-syllable nonwords or 2-syllable nonwords, interventions name: Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data., outcomesModule primaryOutcomes measure: Language Composite Score, primaryOutcomes measure: Reading Composite Score, primaryOutcomes measure: Language/Literacy Disorder Status, primaryOutcomes measure: Neural similarity between language and statistical learning tasks, primaryOutcomes measure: Orthographic statistical sensitivity, primaryOutcomes measure: Phonological statistical sensitivity, secondaryOutcomes measure: Linguistic SL composite scores, secondaryOutcomes measure: Neural sensitivity to statistical regularities during the statistical learning tasks, otherOutcomes measure: Neural activation to statistical regularities during the language tasks, eligibilityModule sex: ALL, minimumAge: 72 Months, maximumAge: 90 Months, stdAges: CHILD, contactsLocationsModule locations facility: Northeastern University, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Brynn Siles, BS, role: CONTACT, phone: 617-830-1530, email: plausl.project@gmail.com, contacts name: Zhenghan Qi, MD/PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Boston University, status: ENROLLING_BY_INVITATION, city: Boston, state: Massachusetts, zip: 02215, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06332131, orgStudyIdInfo id: UPCC07623, briefTitle: Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Abramson Cancer Center at Penn Medicine, class: OTHER, descriptionModule briefSummary: This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system., conditionsModule conditions: Melanoma, conditions: Coronary Microvascular Dysfunction, conditions: Cardiotoxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of new abnormal myocardial blood flow reserve (MBFR), secondaryOutcomes measure: Incidence of major cardiovascular events, secondaryOutcomes measure: Coronary calcium score, secondaryOutcomes measure: All cause mortality, secondaryOutcomes measure: Cardiovascular specific mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Abramson Cancer Center at University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06332118, orgStudyIdInfo id: avf ice massage, briefTitle: The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Erzurum Technical University, class: OTHER, descriptionModule briefSummary: The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured., conditionsModule conditions: Hemodialysis Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The research is quasi-experimental and relationship-seeking in a pretest-posttest format., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: ice massage group, outcomesModule primaryOutcomes measure: Pain score, secondaryOutcomes measure: Ecchymosis degree, secondaryOutcomes measure: Hematoma degree, secondaryOutcomes measure: Patient satisfaction score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ercan Bakır, city: Erzurum, state: Yakutiye, zip: 25010, country: Turkey, contacts name: Ercan Bakır, PhD, role: CONTACT, phone: 05444252111, email: ercan.bakir@erzurum.edu.tr, contacts name: Ercan Bakır, PhD, role: CONTACT, phone: 05443047186, email: e.bakir02@gmail.com, geoPoint lat: 39.90861, lon: 41.27694, locations facility: Ercan Bakır, city: Erzurum, state: Yakutiye, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06332105, orgStudyIdInfo id: CUK001, briefTitle: Evaluation of Low Phenylalanine Formulas, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Ajinomoto Co., Inc., class: INDUSTRY, collaborators name: Birmingham Children's Hospital, collaborators name: Great Ormond Street Hospital for Children NHS Foundation Trust, descriptionModule briefSummary: Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes., conditionsModule conditions: Phenylketonurias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 2-stage, 15-week randomized crossover trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: Glytactin, interventions name: L-AA, outcomesModule primaryOutcomes measure: Change in blood Phe in, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Birmingham Women and Children's Hospital, city: Birmingham, state: West Midlands, zip: B4 6NH, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Great Ormond Street Hospital for Children, city: London, zip: WC1N 3JH, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06332092, orgStudyIdInfo id: FID-007-003, briefTitle: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma, acronym: HNSCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fulgent Pharma LLC., class: INDUSTRY, descriptionModule briefSummary: The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: FID007, outcomesModule primaryOutcomes measure: ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST), secondaryOutcomes measure: BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST), secondaryOutcomes measure: Duration of Response (DoR) measurement, secondaryOutcomes measure: Progression-free Survival (PFS) measurement, secondaryOutcomes measure: Overall Survival (OS) measurement, secondaryOutcomes measure: Disease Control Rate (DCR) analysis, secondaryOutcomes measure: Adverse Events (AEs) graded according to the CTCAE version 5.0, secondaryOutcomes measure: Vital Signs safety assessments, secondaryOutcomes measure: Clinical Laboratory safety assessments, secondaryOutcomes measure: ECGs safety assessment, secondaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Terminal/elimination half-life (t1/2), secondaryOutcomes measure: Clearance (CL), secondaryOutcomes measure: Volume of Distribution (Vd), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gabrail Cancer Center Research, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, contacts name: Nashat Gabrail, MD, role: CONTACT, geoPoint lat: 40.79895, lon: -81.37845, hasResults: False
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protocolSection identificationModule nctId: NCT06332079, orgStudyIdInfo id: HAITI 2023-505356-22-00, briefTitle: Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients, acronym: HAITI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Gruppo Oncologico del Nord-Ovest, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).A total of 23 patients will be enrolled in each cohort., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: 166Holmium TARE, interventions name: Cetuximab, interventions name: Panitumumab, interventions name: 5-Fluorouracil, interventions name: Bevacizumab, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) Rate, secondaryOutcomes measure: Overall Toxicity rate, secondaryOutcomes measure: Grade 3/ Grade 4 Toxicity rate, secondaryOutcomes measure: Post-treatment Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Dose-response relationships, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Pisana, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Beatrice Borelli, MD, PhD, role: CONTACT, phone: +39050992192, email: b.borelli89@gmail.com, contacts name: Gianluca Masi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Beatrice Borelli, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06332066, orgStudyIdInfo id: 0046-24-COM, briefTitle: Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Shalvata Mental Health Center, class: OTHER, collaborators name: Clalit Health Services, descriptionModule briefSummary: In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain., conditionsModule conditions: Mental Health Therapists, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Oxytocin nasal spray, outcomesModule primaryOutcomes measure: Attunement and Responsiveness towards patients, secondaryOutcomes measure: Attachment with Therapist, secondaryOutcomes measure: Working Alliance with Therapist, secondaryOutcomes measure: Patient Symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mental Health Clinic, Teradion, city: Misgav, country: Israel, contacts name: Ayelet Nir,, M.A., role: CONTACT, phone: 972-4-6025050, email: ayeletni1@clalit.org.il, contacts name: Galit, role: CONTACT, phone: 972-4-6026050, geoPoint lat: 32.86017, lon: 35.26165, hasResults: False
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protocolSection identificationModule nctId: NCT06332053, orgStudyIdInfo id: SY-5007-I-03, briefTitle: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Shouyao Holdings (Beijing) Co. LTD, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin)., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: SY-5007, interventions name: Itraconazole, interventions name: SY-5007, interventions name: Rifampin, outcomesModule primaryOutcomes measure: Cmax for SY-5007, primaryOutcomes measure: Tmax for SY-5007, primaryOutcomes measure: AUC0-t for SY-5007, primaryOutcomes measure: AUC0-∞ for SY-5007, primaryOutcomes measure: t½ for SY-5007, primaryOutcomes measure: CL/F for SY-5007, primaryOutcomes measure: Vz/F for SY-5007, secondaryOutcomes measure: Safety of SY-5007, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Li Zheng, role: CONTACT, phone: 86-28-85423655, email: zhengli@wchscu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06332040, orgStudyIdInfo id: 22-500-243-50-35, briefTitle: Gentamicin Bladder Instillation on CAUTI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2026-10-08, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: St. Joseph's Hospital and Medical Center, Phoenix, class: OTHER, descriptionModule briefSummary: Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs., conditionsModule conditions: Catheter Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, outcomesModule primaryOutcomes measure: CAUTI as primary outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Jpseph's Hospital and Medical Center, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85013, country: United States, contacts name: Kristina Kupanoff, PhD, role: CONTACT, phone: 602-406-5192, email: Kristina.Kupanoff@Commonspirit.org, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
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protocolSection identificationModule nctId: NCT06332027, orgStudyIdInfo id: Soh-Med-24-03-03MD, briefTitle: Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation., conditionsModule conditions: Infertility, Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: Hystro-Salpingo-Foam-Sonography (HYFOSY), outcomesModule primaryOutcomes measure: the accuracy of HyFoSy in the assessment of tubal patency, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag University Hospital, city: Sohag, country: Egypt, contacts name: Magdy M Amin, Professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06332014, orgStudyIdInfo id: 20210123, briefTitle: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-07-29, completionDateStruct date: 2026-07-29, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Prolia, outcomesModule primaryOutcomes measure: Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12, secondaryOutcomes measure: Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12, secondaryOutcomes measure: Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12, secondaryOutcomes measure: Percent change from baseline in total hip and femoral neck BMD at month 6 and 12, secondaryOutcomes measure: Percent change from baseline in lumbar spine BMD at month 6, secondaryOutcomes measure: Number of participants with adverse events (AE), eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06332001, orgStudyIdInfo id: IEO 1403, briefTitle: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition., conditionsModule conditions: Neoplasm Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, interventions name: Control Group, outcomesModule primaryOutcomes measure: Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition., secondaryOutcomes measure: Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IEO Istituto Europeo di Oncologia, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Giuseppe Petralia, role: CONTACT, email: giuseppe.petralia@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331988, orgStudyIdInfo id: IEO 1341, briefTitle: Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer, acronym: MITICO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-21, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2029-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Relapse free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Davide Ciardiello, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331975, orgStudyIdInfo id: IEO 0836, briefTitle: Radiomics and Radiogenomics of Non-small Cell Lung Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-06-12, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-09-14, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up, conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule interventions name: Radiomic signature, outcomesModule primaryOutcomes measure: Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status, primaryOutcomes measure: Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS), primaryOutcomes measure: Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331962, orgStudyIdInfo id: B-ER-112-010, briefTitle: Digestive Tract Cancer and CIPN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-19, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, collaborators name: National Cheng Kung University, descriptionModule briefSummary: According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy., conditionsModule conditions: Digestive Tract Cancer, conditions: Chemotherapy-induced Peripheral Neuropathy, conditions: Remote Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: remote home-based exercise therapy group, interventions name: supervised exercise therapy group, interventions name: regular care group, outcomesModule primaryOutcomes measure: Basic information, primaryOutcomes measure: gene, primaryOutcomes measure: body height, primaryOutcomes measure: body weight, primaryOutcomes measure: body mass index, primaryOutcomes measure: blood data, primaryOutcomes measure: Questionnaire of Quality of Life, primaryOutcomes measure: Questionnaire of Chemotherapy-Induced Peripheral Neuropathy, secondaryOutcomes measure: Muscle Strength, secondaryOutcomes measure: Dynamic Balance, secondaryOutcomes measure: Sensation Test, secondaryOutcomes measure: Cardiovascular Endurance, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Physical Therapy, National Cheng-Kung University, status: RECRUITING, city: Tainan, zip: 701, country: Taiwan, contacts name: Cheng-Feng Lin, Ph.D, role: CONTACT, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False
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protocolSection identificationModule nctId: NCT06331949, orgStudyIdInfo id: TR TOKAT02, briefTitle: Video Supported Training on Non-Stress Test Application to Pregnant Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hilal Özbek, class: OTHER, descriptionModule briefSummary: Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided, conditionsModule conditions: First Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: video assisted training, outcomesModule primaryOutcomes measure: State-Trait Anxiety Scale, primaryOutcomes measure: Prenatal Attachment Inventory (PAI), secondaryOutcomes measure: State-Trait Anxiety Scale, secondaryOutcomes measure: Prenatal Attachment Inventory (PAI), otherOutcomes measure: State-Trait Anxiety Scale, otherOutcomes measure: Prenatal Attachment Inventory (PAI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331936, orgStudyIdInfo id: Shenzhen Project, briefTitle: Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: City University of Hong Kong, class: OTHER, collaborators name: International Social Service Hong Kong Branch, descriptionModule briefSummary: The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session., conditionsModule conditions: Emotion Regulation, conditions: Parent-Child Relations, conditions: Happiness, conditions: Positive Affect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Children will be randomly assigned to two groups: intervention and waitlist control groups. Children in the waitlist control group will receive experimental intervention after treatment for the experimental group finishes., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: At the recruitment phase, the participants and the social workers who lead the intervention will not know which arm the participants will be assigned. A cluster of approximately 10 participants formed a group based on their attendance date in the intervention program. This group will be randomly assigned to one of the two intervention arms through pre-prepared randomization list calculated by random allocation software., whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Emotion regulation, outcomesModule primaryOutcomes measure: 10-item Emotional Management Strategy Questionnaire, primaryOutcomes measure: 10-item Positive and Negative Affect Schedule, primaryOutcomes measure: Patient Health Questionnaire-9, primaryOutcomes measure: Generalized Anxiety Disorder Scale, primaryOutcomes measure: Subjective Happiness Scale, primaryOutcomes measure: Connor-Davidson Resilience Scale 10-Item, primaryOutcomes measure: Child-Parent Relationship Scale, primaryOutcomes measure: Family Harmony Scale, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: City University of Hong Kong, status: RECRUITING, city: Hong Kong, country: China, contacts name: Nancy Xiaonan YU, Ph.D., role: CONTACT, phone: (852)34429436, email: nancy.yu@cityu.edu.hk, geoPoint lat: 22.39407, lon: 114.13737, hasResults: False
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protocolSection identificationModule nctId: NCT06331923, orgStudyIdInfo id: U1111-1305-0484, briefTitle: Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beijing Tsinghua Chang Gung Hospital, class: OTHER, collaborators name: Peking University International Hospital, collaborators name: Wang Jing Hospital, collaborators name: ZhuHai Hospital, collaborators name: Beijing Hospital, collaborators name: Siyang County Hospital of Traditional Chinese Medicine, collaborators name: Second Hospital of Shanxi Medical University, collaborators name: Henan Provincial Chest Hospital, collaborators name: Fuzhou First Hospital, collaborators name: Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital, collaborators name: The First Affiliated Hospital of Anhui University of Chinese Medicine, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: Mindong Hospital of Ningde, collaborators name: The Fifth Hospital of Xiamen, collaborators name: People's Hospital of Ningxia Hui Autonomous Region, collaborators name: The First People's Hospital of Changzhou, collaborators name: The Fifth hospital of Deyang, collaborators name: Suzhou Municipal Hospital, collaborators name: Tang-Du Hospital, collaborators name: Yiyang Central Hospital, collaborators name: First Affiliated Hospital of Xinjiang Medical University, collaborators name: Peng Ding Shan Shi Zhong Yi Yi Yuan, collaborators name: Yueyang Central Hospital, collaborators name: The First People's Hospital of Lianyungang, collaborators name: Haimen District Traditional Chinese Medicine Hospital, collaborators name: The 910th Hospital, collaborators name: The Second Affiliated Hospital of Zhejiang Chinese Medical University, collaborators name: Beijing Tiantan Hospital, collaborators name: Affiliated Hospital of Jiangsu University, collaborators name: Liaocheng People's Hospital, collaborators name: Beijing Chao Yang Hospital, collaborators name: Jilin City Hospital of Chemical Industry, collaborators name: Creen Hospital-465, collaborators name: Wuhan Central Hospital, collaborators name: Air Force Military Medical University, China, collaborators name: Shanghai Tong Ren Hospital, collaborators name: Beijing Anzhen Hospital, collaborators name: Emergency General Hospital, collaborators name: Beijing Tongren Hospital, collaborators name: Civil Aviation General Hospital, collaborators name: Peking University Shougang Hospital, collaborators name: The First Affiliated Hospital of Anhui Medical University, collaborators name: Chinese PLA Central Hospital, descriptionModule briefSummary: The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are:* To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery.* To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model.Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge.The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after surgery., conditionsModule conditions: Comprehensive Complication Index, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10168, type: ESTIMATED, armsInterventionsModule interventions name: Continuous glucose monitoring (CGM) device, outcomesModule primaryOutcomes measure: Comprehensive complication index, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Morality, secondaryOutcomes measure: The length of the stay in the intensive care unit, secondaryOutcomes measure: The length of hospital stay, secondaryOutcomes measure: The overall hospitalization cost, secondaryOutcomes measure: Perioperative glucose level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhifeng Gao, status: RECRUITING, city: Beijing, state: Beijing, zip: 102218, country: China, contacts name: Zhifeng Gao, MD, role: CONTACT, phone: 18756235568, email: btchgzf@hotmail.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06331910, orgStudyIdInfo id: TITNCUES, briefTitle: Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers, conditionsModule conditions: Neurotrophic Keratopathy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: insulin eye drops, outcomesModule primaryOutcomes measure: Decrease in ulcer size and the increase in visual acuity ., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06331897, orgStudyIdInfo id: Bronchial asthma, briefTitle: Bronchial Asthma & Its Exacerbation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Our goals is to assess :1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio \& platelet indices \&CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation, conditionsModule conditions: Bronchial Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation, chest imaging, pulmonary function tests, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331884, orgStudyIdInfo id: PCZ_Phase1, briefTitle: Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: 4TEEN4 Pharmaceuticals GmbH, class: INDUSTRY, descriptionModule briefSummary: Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects., conditionsModule conditions: Safety and Tolerability, 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: 24, type: ESTIMATED, armsInterventionsModule interventions name: AK1967 (Procizumab), interventions name: Placebo, outcomesModule primaryOutcomes measure: Reported number of adverse events from baseline (start of Procizumab administration) up until the last follow-up visit after Procizumab administration, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Radboud University Medical Center, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525, country: Netherlands, contacts name: Peter Pickkers, MD, PhD, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
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protocolSection identificationModule nctId: NCT06331871, orgStudyIdInfo id: 2004202111621, briefTitle: Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Universidad Rey Juan Carlos, class: OTHER, descriptionModule briefSummary: The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain.This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).The intervention and follow-up period of the participants took place over 12 weeks., conditionsModule conditions: Ultrasound-Guided Percutaneous Electrical Nerve Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 70 patients with shoulder pain undergoing arthroscopic surgery were recruited. They were divided into two groups at random; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and two sessions of ultrasound-guided percutaneous nerve stimulation (US-PENS) were added (n=35)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence., interventions name: Manual physiotherapy protocol based on available evidence., outcomesModule primaryOutcomes measure: The Numeric Pain Rating Scale (NPRS), primaryOutcomes measure: Disabilities of the Arm, Shoulder and Hand (DASH), primaryOutcomes measure: The Shoulder Pain and Disability Index (SPADI), primaryOutcomes measure: GONIOMETRY, primaryOutcomes measure: DINAMOMETRY, primaryOutcomes measure: PAIN THRESHOLD ON PRESSURE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Cemtro, status: RECRUITING, city: Madrid, zip: 28049, country: Spain, contacts name: MARIO J ABRIL SERVÁN, role: CONTACT, phone: +34636707810, email: MASERVAN@HOTMAIL.COM, contacts name: FERNANDO GARCÍA SANZ, role: CONTACT, phone: +34917355757, email: fisioterapiaclub@clinicacemtro.com, contacts name: MARIO J ABRIL SERVÁN, role: PRINCIPAL_INVESTIGATOR, contacts name: ADRIÁN CASES, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06331858, orgStudyIdInfo id: KutahyaHSU-DRGOKPINARDROMER-43, briefTitle: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-03-29, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA)., conditionsModule conditions: Knee Osteoarthritis, conditions: Pain, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1. STUDY GROUP2. CONTROL GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Before and after the treatment, all patients were evaluated by a blind evaluator in terms of physical examination, pain and functionality, physical performance, quality of life and gait parameters., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: hip device-assisted concentric abductor strengthening (HDACAS), interventions name: knee device-assisted concentric flexor-extensor strengthening (KDACFES), outcomesModule primaryOutcomes measure: Western Ontario and McMaster Universities (WOMAC), primaryOutcomes measure: The Lequesne Algofunctional index, primaryOutcomes measure: TIME UP AND GO TEST, primaryOutcomes measure: 30 SECOND CHAIR TEST, primaryOutcomes measure: 40 METER SELF PACED WALK TEST, primaryOutcomes measure: SIX MINUTES WALK TEST, primaryOutcomes measure: STAIR CLIMB TEST, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: Mini Osteoarthritis Knee and Hip Quality of Life Scale, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kutahya Health Sciences University, status: RECRUITING, city: Kutahya, zip: 43100, country: Turkey, contacts name: Hasan Huseyin Gokpinar, Ass. Prof., role: CONTACT, phone: +905052842222, email: hasanhuseyin.gokpinar@ksbu.edu.tr, contacts name: Ömer Özyümlü, role: CONTACT, phone: +905442024671, email: omer.ozyumlu@gmail.com, geoPoint lat: 39.42417, lon: 29.98333, locations facility: Kutahya Health Sciences University, status: RECRUITING, city: Kutahya, zip: 43100, country: Turkey, contacts name: Hasan Huseyin Gokpinar, Ass. Prof., role: CONTACT, phone: +905052842222, email: hasanhuseyin.gokpinar@ksbu.edu.tr, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False
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protocolSection identificationModule nctId: NCT06331845, orgStudyIdInfo id: NPC012, briefTitle: Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fujian Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC)., conditionsModule conditions: Metastatic Nasopharyngeal Carcinoma, conditions: Intermittent Systematic Chemotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Gemcitabine, interventions name: Cisplatin, interventions name: Paclitaxel protein-bound, interventions name: Capecitabine, interventions name: Tislelizumab, outcomesModule primaryOutcomes measure: progression-free survival, secondaryOutcomes measure: progression-free survival 2, secondaryOutcomes measure: overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331832, orgStudyIdInfo id: 2323-EAP, secondaryIdInfos id: 2021-002339-44, type: EUDRACT_NUMBER, briefTitle: Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL, statusModule overallStatus: NO_LONGER_AVAILABLE, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: IGM Biosciences, Inc., class: INDUSTRY, descriptionModule briefSummary: Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial., conditionsModule conditions: Relapsed/Refractory Non-Hodgkin Lymphomas, designModule studyType: EXPANDED_ACCESS, armsInterventionsModule interventions name: IGM2323, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Charles Gairdner Hospital, city: Nedlands, state: Western Australia, country: Australia, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Samsung Medical Center, city: Seoul, state: Gangnam-gu, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: START-Madrid Centro Integral Oncologico Clara Campal, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06331819, orgStudyIdInfo id: 7-3-2024, briefTitle: Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms., acronym: VasOSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Jordan Collaborating Cardiology Group, class: OTHER, descriptionModule briefSummary: The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital. The main aims are:* To prospectively obtain demographic and clinical information of patients referred for a sleep study.* To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition.* To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders.* To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking., conditionsModule conditions: Obstructive Sleep Apnea, conditions: Vasovagal Syncope, conditions: Smoking, conditions: Acanthosis Nigricans, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: In-lab polysomnography, interventions name: Continuous positive airway pressure, outcomesModule primaryOutcomes measure: Clinical association between obstructive sleep apnea and presence of facial pigmentation, primaryOutcomes measure: Clinical association between obstructive sleep apnea and severity of facial pigmentation, primaryOutcomes measure: Relation between obstructive sleep apnea and vasovagal symptoms, primaryOutcomes measure: Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms, secondaryOutcomes measure: Relation between obstructive sleep apnea and the effect of treatment on facial discolouration, secondaryOutcomes measure: Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms, secondaryOutcomes measure: Relation between obstructive sleep apnea and the effect of treatment on smoking habits, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Jordan, status: RECRUITING, city: Amman, zip: 11942, country: Jordan, contacts name: Asma Btoosh, MD, role: CONTACT, phone: 00962797684137, email: asmaalbtoosh@gmail.com, contacts name: Rand M Zaqqa, role: PRINCIPAL_INVESTIGATOR, contacts name: Ayah M Zaqqa, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maisa Mansoor, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Asma Btoosh, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Salah Salah, role: SUB_INVESTIGATOR, geoPoint lat: 31.95522, lon: 35.94503, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-07, uploadDate: 2024-03-07T14:03, filename: Prot_000.pdf, size: 82683, hasResults: False
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protocolSection identificationModule nctId: NCT06331806, orgStudyIdInfo id: IEO 398, briefTitle: Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment, conditionsModule conditions: Cardiomyopathy Due to Drug, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of myocardial fibrosis, outcomesModule primaryOutcomes measure: Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2), primaryOutcomes measure: Evaluation of blood levels of Galectin-3 (Gal-3), primaryOutcomes measure: Evaluation of Enhanced Liver Fibrosis score (ELF), primaryOutcomes measure: Evaluation of CMR imaging marker of fibrosis, secondaryOutcomes measure: Evaluation of response to heart failure treatment, secondaryOutcomes measure: Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP), secondaryOutcomes measure: Evaluation of levels of cytochrome C, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Daniela Cardinale, MD, role: CONTACT, email: daniela.cardinale@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331793, orgStudyIdInfo id: IEO 1849, briefTitle: Pulsed Electromagnetic Fields for Analgesia Post Mastectomy, acronym: Algocare, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs., conditionsModule conditions: Female Breast Cancer, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization 1:1, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Active AlgoCare, interventions name: Non-active AlgoCare, outcomesModule primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Need for analgesic drugs, secondaryOutcomes measure: Patient reported pain characteristics, secondaryOutcomes measure: Number of participants with other symptoms, secondaryOutcomes measure: Need for other drugs, secondaryOutcomes measure: Wound healing timing, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Daniele Sances, MD, role: CONTACT, phone: +390257489618, email: daniele.sances@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331780, orgStudyIdInfo id: WS10370, secondaryIdInfos id: 2023-A02153-42, type: OTHER, domain: ANSM (France), briefTitle: Refractive Status and Accommodation Response Under Different Experimental Conditions., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Essilor International, class: INDUSTRY, descriptionModule briefSummary: Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected., conditionsModule conditions: Accommodation Disorder, conditions: Accommodative Fatigue, conditions: Accommodative Inertia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Visual acuity, interventions name: Objective refraction, interventions name: Objective monocular accommodation amplitude measurement, interventions name: Subjective monocular accommodation amplitude measurement with the "Push-Up" method, interventions name: Subjective monocular accommodation facility measurement with the "Rock" method:, interventions name: CISS Questionnaire, interventions name: Difficulty assessment questionnaire, interventions name: Subjective evaluation questionnaire, outcomesModule primaryOutcomes measure: Accommodative response measured with closed-field aberrometer with different target displacement methods, primaryOutcomes measure: Accommodative response measured with closed-field aberrometer with different displayed targets, primaryOutcomes measure: Objective refraction measured with closed-field aberrometer and two camera exposure times, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Essilor International - Ci&T 2, status: RECRUITING, city: Créteil, zip: 94000, country: France, contacts name: Jérôme Gillet, role: CONTACT, phone: +33 (0)1 49 80 63 40, email: gilletj@essilor.fr, geoPoint lat: 48.78333, lon: 2.46667, hasResults: False
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protocolSection identificationModule nctId: NCT06331767, orgStudyIdInfo id: 2024P000654, briefTitle: Development of a Multilevel HIV Prevention Intervention for the Emergency Department, acronym: mSYNC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits., conditionsModule conditions: HIV, conditions: Drug Use, conditions: Mental Health, conditions: Psychological Distress, conditions: Social Marginalization, conditions: Problems With Access to Health Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: mSYNC, outcomesModule primaryOutcomes measure: Acceptability, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Acceptability, primaryOutcomes measure: Appropriateness, primaryOutcomes measure: Appropriateness, primaryOutcomes measure: Appropriateness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06331754, orgStudyIdInfo id: ATMANHEALTH001, briefTitle: Technology-Enabled Remote Hypertension Management To Advance Health Equity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-09-17, completionDateStruct date: 2026-03-17, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Atman Health, Inc, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: non-blinded pragmatic cluster-randomized controlled trial with a single intervention, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Technology-enabled blood pressure management, outcomesModule primaryOutcomes measure: Difference in SBP change, secondaryOutcomes measure: HEDIS proportion, secondaryOutcomes measure: Difference in DBP change, otherOutcomes measure: Home measured change in SBP and DBP, otherOutcomes measure: Patient satisfaction, otherOutcomes measure: Provider satisfaction, otherOutcomes measure: Mean time required per patient for provider, otherOutcomes measure: Mean time required per patient for navigator, otherOutcomes measure: Proportion of patients measuring blood pressure at directed frequency, otherOutcomes measure: Resource utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331741, orgStudyIdInfo id: 0403, briefTitle: Collagen for Treatment of Musculoskeletal Injuries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: I.M. Sechenov First Moscow State Medical University, class: OTHER, descriptionModule briefSummary: The purpose of the study:Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales, conditionsModule conditions: Anterior Cruciate Ligament Injuries, conditions: Hallux Rigidus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Main group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction with collagen membrane augmentation; Reference group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction without collagen membrane augmentation; Main group for HR (Hallux Rigidus): 5 patients with Hallux Rigidus, who undergo resection arthroplasty with introduction of collagen membrane Reference group: none, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane, interventions name: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group), interventions name: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity, outcomesModule primaryOutcomes measure: The International Knee Documentation Committee score, primaryOutcomes measure: The Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Modified Lysholm scale, primaryOutcomes measure: Anterior Cruciate Ligament OsteoArthritis Score, primaryOutcomes measure: American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score, primaryOutcomes measure: 36-Item Short Form Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery, status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Marina M Lipina, MD, PhD, role: CONTACT, phone: +79253122096, email: marina.lipina@icloud.com, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06331728, orgStudyIdInfo id: IGNX-T1, briefTitle: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: IgGenix Australia Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents., conditionsModule conditions: Peanut Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: IGNX001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and Severity of Treatment Emergent Adverse Events, primaryOutcomes measure: Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions, primaryOutcomes measure: Number of Participants with Clinically significant Changes from Baseline - Hematology, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - Chemistry, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations, secondaryOutcomes measure: Concentration of IGNX001 in the Plasma, secondaryOutcomes measure: Measurement of Area under the Plasma/Serum Concentration Curve (AUC), secondaryOutcomes measure: Peak Serum Concentration (Cmax), secondaryOutcomes measure: Time to Peak Serum Concentration (Tmax), secondaryOutcomes measure: Elimination Half-life (t1/2), secondaryOutcomes measure: Changes Over Time to Anti-drug Antibodies, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06331715, orgStudyIdInfo id: ML1005, briefTitle: Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Megalabs, class: INDUSTRY, descriptionModule briefSummary: An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition., conditionsModule conditions: Bioequivalence, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Palbociclib 125mg, outcomesModule primaryOutcomes measure: AUC 0-t, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331702, orgStudyIdInfo id: CDBJEIV2023001, briefTitle: Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Liaoning Chengda Biotechnology CO., LTD, class: INDUSTRY, descriptionModule briefSummary: This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately., conditionsModule conditions: Japanese Encephalitis, conditions: Measles, conditions: Mumps, conditions: Rubella, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 396, type: ESTIMATED, armsInterventionsModule interventions name: Vero cell-drived inactive Japanese encephalitis vaccine, interventions name: Measles-Mumps-Rubella Vaccine, outcomesModule primaryOutcomes measure: Antibody Titer for Post Vaccination, primaryOutcomes measure: Seroconversion Rate for Post Vaccination, secondaryOutcomes measure: Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination, secondaryOutcomes measure: Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination, secondaryOutcomes measure: Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination, eligibilityModule sex: ALL, minimumAge: 8 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Jiangsu Provincial Center for Disease Control and Prevention, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Zhiguo Wang, Master, role: CONTACT, phone: +86 18118996978, email: 120714991@QQ.com, contacts name: Zhiguo Wang, Master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06331689, orgStudyIdInfo id: HP-epidemıology, briefTitle: EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE, acronym: Hip fractures, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2021-04-01, completionDateStruct date: 2021-07-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation., conditionsModule conditions: Hip Fracture, conditions: Mortality Rate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 68, type: ACTUAL, outcomesModule primaryOutcomes measure: mortalite ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kütahya Health Sciences University, city: Kütahya, zip: 43100, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False
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protocolSection identificationModule nctId: NCT06331676, orgStudyIdInfo id: 69HCL23_1120, secondaryIdInfos id: 2023-A02339-36, type: OTHER, domain: ID RCB, briefTitle: Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care, acronym: OTEndo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments., conditionsModule conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants enrolled in this study will be given an eutopic and ectopic endometrium biopsies, blood and peritoneal fluid sampling and should answer to a questionnaire on menstrual health and history of hormone treatments for the research purpose.., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Tissue collection, interventions name: Data collection, outcomesModule primaryOutcomes measure: Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering., secondaryOutcomes measure: Change in protein expression, secondaryOutcomes measure: Change in gene expression, secondaryOutcomes measure: Change in inflammation, secondaryOutcomes measure: Change in histological tissue structure, secondaryOutcomes measure: Change in histological tissue structure, secondaryOutcomes measure: Change in tissue elasticity, secondaryOutcomes measure: Change in steroid hormone physiology, secondaryOutcomes measure: Steroid hormones in peritoneal fluid, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Femme Mère Enfant / GHE, city: Bron, zip: 69500, country: France, contacts name: Charles-André PHILIP, MD, PhD, role: CONTACT, phone: 04 27 85 51 70, phoneExt: +33, email: charles-andre.philip01@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital de la Croix-Rousse / GHN, city: Lyon, zip: 69004, country: France, contacts name: Gil DUBERNARD, MD, PhD, role: CONTACT, phone: 04 72 07 16 42, phoneExt: +33, email: gil.dubernard@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06331663, orgStudyIdInfo id: KMUHIRB-F(II)-20240055, briefTitle: SPI and Remifentanil in Skull Pin Fixation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University Chung-Ho Memorial Hospital, class: OTHER, descriptionModule briefSummary: Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed., conditionsModule conditions: Pain, Procedural, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Remifentanil, outcomesModule primaryOutcomes measure: 50% effect concentration of remifentanil, primaryOutcomes measure: 90% effect concentration of remifentanil, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, city: Kaohsiung, country: Taiwan, contacts name: Zhi-Fu Wu, MD, role: CONTACT, phone: 07-3121101, phoneExt: 7035, email: aneswu@gmail.com, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06331650, orgStudyIdInfo id: CROC202314, briefTitle: A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Guangzhou Institute of Respiratory Disease, class: OTHER, descriptionModule briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC)., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cadonilimab, outcomesModule primaryOutcomes measure: Safety assessments and ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangdong, state: Guangzhou, zip: 510000, country: China, contacts name: zhou chegnzhi, doctor, role: CONTACT, phone: 13560351186, email: doctorzcz@163.com, hasResults: False
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protocolSection identificationModule nctId: NCT06331637, orgStudyIdInfo id: 3782, briefTitle: Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis, acronym: TTSS-Pouch, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA), conditionsModule conditions: Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Transanal Transection and Single-Stapled anastomosis (TTSS), interventions name: Double-stapled anastomosis, outcomesModule primaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Anastomotic leak, secondaryOutcomes measure: Patients fit for stoma closure, secondaryOutcomes measure: Healthcare costs, secondaryOutcomes measure: Rectal cuff lenght, secondaryOutcomes measure: Pouch complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, contacts name: Stefano De Zanet, MS, role: CONTACT, phone: 02 8224 4623, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
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protocolSection identificationModule nctId: NCT06331624, orgStudyIdInfo id: GRI-0621-IPF-02, briefTitle: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: GRI Bio Operations, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects complete 6 weeks of treatment (approximately 8 placebo subjects)., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, 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: Tazarotene (GRI-0621), interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety and Tolerability of oral GRI-0621, secondaryOutcomes measure: Change from baseline biomarkers, secondaryOutcomes measure: Plasma concentrations of GRI-0621, secondaryOutcomes measure: Pharmacodynamics of GRI-0621 in blood (Study Population), secondaryOutcomes measure: Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study), otherOutcomes measure: Exploratory - Pulmonary Function, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Newport Native MD, Inc., status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Brandon Vu, role: CONTACT, phone: 949-791-8599, email: Brandon@newportnativemd.com, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Southeastern Research Center, status: RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, contacts name: Karen McCutcheon, role: CONTACT, phone: 336-659-8414, email: kmccutcheon@southeasternresearchcenter.com, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06331611, orgStudyIdInfo id: Motor, briefTitle: MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA, acronym: MOTOR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Istituto Giannina Gaslini, class: OTHER, descriptionModule briefSummary: To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications.The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring.Secondary objectives are:* the time required to extubate different patients,* the incidence of respiratory complications at extubation,* the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent.* Children between 2 months and 6 years* Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent),* Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant. * Children under 2 months of age or over 12 years of age, * Children with an ASA classification \> 3, * Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants, * Confirmed or suspected allergy to sugammadex or rocuroniumt, * Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible, * Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes.One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total.Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA)., conditionsModule conditions: Anesthesia,General, conditions: Neuromuscular Blockade, conditions: Tracheal Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: TOF monitoring, outcomesModule primaryOutcomes measure: Sugammadex administration, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331598, orgStudyIdInfo id: ML43332, secondaryIdInfos id: 2022-003708-33, type: EUDRACT_NUMBER, briefTitle: A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H), acronym: IMperator, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2028-10-20, completionDateStruct date: 2029-09-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Hoffmann-La Roche, class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to evaluate efficacy parameters (disease free survival \[DFS\] and overall survival \[OS\]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence., conditionsModule conditions: Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Atezolizumab, interventions name: Tiragolumab, outcomesModule primaryOutcomes measure: Disease Free Survival (DFS) Rate at 24 Months, secondaryOutcomes measure: DFS Rate at 36, 48 and 60 Months, secondaryOutcomes measure: OS (Overall Survival), secondaryOutcomes measure: Percentage of Participants With Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall dHebron; Oncology, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Virgen; Servicio de Oncologia, status: RECRUITING, city: Sevilla, zip: 41013, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
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protocolSection identificationModule nctId: NCT06331585, orgStudyIdInfo id: KY-2024004, briefTitle: Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2026-03-18, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Hetian District People's Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital., conditionsModule conditions: Low-dose Radiotherapy, conditions: Tumor Microenvironment, conditions: Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: low dose radiotherapy, outcomesModule primaryOutcomes measure: Analysis of the tumor immune microenvironment, secondaryOutcomes measure: Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy, secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hetian District People's Hospital, city: Hetian, state: Xinjiang Uygur Autonomous Region, zip: 848000, country: China, hasResults: False
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protocolSection identificationModule nctId: NCT06331572, orgStudyIdInfo id: 1stChongqingMU-TRD, briefTitle: Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2021-10-25, completionDateStruct date: 2023-12-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Chongqing Medical University, class: OTHER, descriptionModule briefSummary: This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD., conditionsModule conditions: Psychiatric Disorder, conditions: Major Depressive Disorder, conditions: Metabolic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 162, type: ACTUAL, armsInterventionsModule interventions name: 17-HAMD, outcomesModule primaryOutcomes measure: 17 items Hamilton Depression Scale, secondaryOutcomes measure: Hamilton Anxiety Scale, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Province, zip: 400000, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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