data
stringlengths 358
80.8k
|
|---|
protocolSection identificationModule nctId: NCT06367959, orgStudyIdInfo id: 2021-0324, secondaryIdInfos id: NCI-2024-02939, type: OTHER, domain: NCI-CTRP Clinical Trials Registry, briefTitle: Health Benefits of Writing Therapy Among Asian American Cancer Survivors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-27, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Esays, interventions name: Questionnaires, outcomesModule primaryOutcomes measure: Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Qian Lu, MD, PHD, role: CONTACT, phone: 713-745-8324, email: [email protected], contacts name: Qian Lu, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06367946, orgStudyIdInfo id: XH-24-0093, briefTitle: Mechanism Study of Ventilator-Induced Lung Injury in Elderly People., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: 1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation., conditionsModule conditions: Ventilator-Induced Lung Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: mechanical ventilation, outcomesModule primaryOutcomes measure: KLK8 concentration of lung tissue, primaryOutcomes measure: Endothelial/epithelial damage index concentration in peripheral blood, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Xinhua hospital, status: RECRUITING, city: Shanghai, zip: 200000, country: China, contacts name: Lai Jiang, PhD, role: CONTACT, phone: 13817719616__, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06367933, orgStudyIdInfo id: MISNM, briefTitle: Mini-invasive Spine Surgery for Neuromuscolar Scoliosis, acronym: MISNM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves., conditionsModule conditions: Neuromuscular Scoliosis, conditions: Spine Deformity, conditions: Surgery, conditions: Vertebral Fusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: mini-invasive spine surgery, outcomesModule primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Spine Correction, primaryOutcomes measure: Spine Correction, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, city: Bologna, zip: 40136, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06367920, orgStudyIdInfo id: 2022-02-005, briefTitle: Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Bundang CHA Hospital, class: OTHER, descriptionModule briefSummary: Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders, conditionsModule conditions: Pediatric ALL, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic Resonance Imaging, Behavioral assessments, outcomesModule primaryOutcomes measure: Brain magnetic resonance imaging, secondaryOutcomes measure: Medical records, eligibilityModule sex: ALL, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHA Bundang Medical Center, CHA University, status: RECRUITING, city: Seongnam-si, state: Gyeonggi-do, zip: 463-712, country: Korea, Republic of, contacts name: Minyoung Kim, M.D., Ph.D., role: CONTACT, phone: 82-31-780-1872, email: [email protected], geoPoint lat: 37.43861, lon: 127.13778, hasResults: False |
protocolSection identificationModule nctId: NCT06367907, orgStudyIdInfo id: SM 68/6-1, briefTitle: Biological Effects of Schema Therapy, acronym: BE-ST, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-09, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jena University Hospital, class: OTHER, descriptionModule briefSummary: Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared.Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed.The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations., conditionsModule conditions: Personality Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, parallel-group, single-blinded, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval.Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team).Single-blinded: Researchers are blind as regards group belonging of participants., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: schema therapy, outcomesModule primaryOutcomes measure: Changes in emotion regulation capabilities, secondaryOutcomes measure: Improvement of BPD specific symptomatology, secondaryOutcomes measure: Change of personality traits, secondaryOutcomes measure: Changes of the intensity of early maladaptive schemas., secondaryOutcomes measure: Changes of the intensity of schema modes., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Jena, status: RECRUITING, city: Jena, zip: 07743, country: Germany, contacts name: Stefan Smesny, PhD, role: CONTACT, phone: +4936419390451, email: [email protected], geoPoint lat: 50.92878, lon: 11.5899, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Study Protocol: Study design, date: 2018-06-04, uploadDate: 2024-04-12T04:07, filename: Prot_000.pdf, size: 653719, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Study Protocol: Study design, date: 2018-06-04, uploadDate: 2024-04-12T04:14, filename: Prot_001.pdf, size: 454285, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Information on reliability criteria of assessment tools, date: 2018-06-04, uploadDate: 2024-04-12T04:22, filename: Prot_002.pdf, size: 605787, largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol: Core aspects of therapy conditions, date: 2018-06-04, uploadDate: 2024-04-12T04:23, filename: Prot_003.pdf, size: 440449, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2018-06-04, uploadDate: 2024-04-12T04:10, filename: SAP_004.pdf, size: 692600, hasResults: False |
protocolSection identificationModule nctId: NCT06367894, orgStudyIdInfo id: STONECARE, briefTitle: Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Agnieszka Pozdzik, class: OTHER, descriptionModule briefSummary: Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context).Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire.The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up.The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions)., conditionsModule conditions: Kidney Stone, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 164, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of acute renal colics, primaryOutcomes measure: Number of emergency admissions, primaryOutcomes measure: Number of surgeries, primaryOutcomes measure: Number of hospitalizations, primaryOutcomes measure: Identified genetics abnormalities, primaryOutcomes measure: Wisconsin questionnaire, primaryOutcomes measure: Kidney function outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Brugmann, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Agnieszka POZDZIK, role: CONTACT, phone: 024772641, email: [email protected], contacts name: Sirika Chhem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False |
protocolSection identificationModule nctId: NCT06367881, orgStudyIdInfo id: MD 185/ 2022, briefTitle: Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-18, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide., conditionsModule conditions: Neonatal Respiratory Distress Syndrome, conditions: Inflammatory Response, conditions: Premature Lungs, conditions: Neutrophil Extracellular Trap Formation, conditions: Preterm Birth, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Alveofact, interventions name: Budesonide, outcomesModule primaryOutcomes measure: Assessment of Neutrophil Extracellular Trap (NET), secondaryOutcomes measure: comparison of Alveolar with whole blood NET formation, secondaryOutcomes measure: Clinical out come, secondaryOutcomes measure: Assessment of Reactive Oxygen Species (ROS), secondaryOutcomes measure: oxygen needs, secondaryOutcomes measure: Hospital stay, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 2 Days, stdAges: CHILD, contactsLocationsModule locations facility: Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Ain Shams University, role: CONTACT, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06367868, orgStudyIdInfo id: E-83045809-604.01.02-179951, briefTitle: Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-09, primaryCompletionDateStruct date: 2022-06-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP., conditionsModule conditions: ICP (Intracranial Pressure) Increase, conditions: Optic Nerve Sheath Diameter, conditions: Intracranial Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: After 5 ml CSF Drainage, outcomesModule primaryOutcomes measure: Intracranial Pressure-1 (ICP-1), primaryOutcomes measure: Optic Nerve Sheath Diameter-1 (ONSD-1), secondaryOutcomes measure: Intracranial Pressure-2 (ICP-2), secondaryOutcomes measure: Optic Nerve Sheath Diameter-2 (ONSD-2), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University-Cerrahpasa, city: Istanbul, state: Fatıh, zip: 34098, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06367855, orgStudyIdInfo id: KSKC20222025, briefTitle: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial, acronym: MIS-TLIF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Potsawat Surabotsopon, class: OTHER, descriptionModule briefSummary: Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes., conditionsModule conditions: Spinal Stenosis Lumbar, conditions: Disc Degeneration, conditions: Disc Disease, conditions: Fusion of Spine, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Normal saline, outcomesModule primaryOutcomes measure: effectiveness of dexamethasone, secondaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: Complication, secondaryOutcomes measure: Fusion rate, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367842, orgStudyIdInfo id: MED-02-2023, briefTitle: Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO), acronym: ATTR-ORTHO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Institut Mutualiste Montsouris, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:1. What is the frequency of ATTR deposits in samples retrieved during surgery?2. What is the frequency of cardiac involvement in ATTR positive patients?3. What are the preoperative predictors of ATTR deposits? Participants will * have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples, * undergo a multimodal imaging search for cardiac involvement, if ATTR is identified, * undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis) * ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries, conditionsModule conditions: ATTR Amyloidosis, conditions: Cardiopathy, conditions: Carpal Tunnel Syndrome, conditions: Lumbar Spine Stenosis, conditions: Hip Prosthesis, conditions: Knee Prosthesis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: frequency of ATTR amyloidosis, secondaryOutcomes measure: presence of ATTR cardiopathy, secondaryOutcomes measure: proportion of wild type and hereditary ATTR, secondaryOutcomes measure: Description of preoperative predictors of ATTR, secondaryOutcomes measure: Description of preoperative predictors of ATTR, secondaryOutcomes measure: preoperative predictors of ATTR, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mutualist Montsouris Institute, status: RECRUITING, city: Paris, zip: 75014, country: France, contacts name: Thomas M Bardin, Pr, role: CONTACT, phone: +33 156616263, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06367829, orgStudyIdInfo id: WO.24.025, briefTitle: Lubinus SPII Hip Stem Target Trial Emulation (LARGE), acronym: LARGE, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2025-01-08, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: JointResearch, class: OTHER, collaborators name: OLVG, collaborators name: Uppsala University, collaborators name: Göteborg University, collaborators name: Leiden University Medical Center, descriptionModule briefSummary: The research questions this study aims to answer are as follows:Primary research question:"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"Secondary aims include:* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis., conditionsModule conditions: Treatment Outcome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 110000, type: ESTIMATED, armsInterventionsModule interventions name: Lubinus SPII hip stem 130mm, interventions name: Lubinus SPII hip stem 150mm, outcomesModule primaryOutcomes measure: Mortality rate, primaryOutcomes measure: Revision rate, secondaryOutcomes measure: NRS pain score, secondaryOutcomes measure: Oxford hip score, secondaryOutcomes measure: EQ - 5D, secondaryOutcomes measure: HOOS - PS, secondaryOutcomes measure: Revision rate, secondaryOutcomes measure: Mortality rate, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 105 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLVG, city: Amsterdam, state: Noord Holland, zip: 1090 HM, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06367816, orgStudyIdInfo id: 13509, briefTitle: Brain Recovery With Automated VEntilation, acronym: BRAVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Genova, class: OTHER, descriptionModule briefSummary: Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data., conditionsModule conditions: Brain Injuries, Acute, conditions: Respiration, Artificial, conditions: Automation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: INTELLiVENT, interventions name: Conventional ventilation, outcomesModule primaryOutcomes measure: Proportion of breaths in predefined zones of ventilation, primaryOutcomes measure: Proportion of time in predefined zones of ventilation, secondaryOutcomes measure: Intracerebral changes assessed by multimodal neuromonitoring available, secondaryOutcomes measure: Changes on Electrical Impedence Tomography when available, secondaryOutcomes measure: Effectiveness in primary ABI patients vs non primary ABI patients, secondaryOutcomes measure: Episodes and time of high maximum airway pressure, secondaryOutcomes measure: Episodes and time of high respiratory rate, secondaryOutcomes measure: Incidence of severe hypoxemia, secondaryOutcomes measure: Incidence of severe hypercapnia, secondaryOutcomes measure: Discontinuation of ventilatory mode (yes or no), secondaryOutcomes measure: Percentage of breaths in the predefined 'critical' ventilation zone, secondaryOutcomes measure: Incidence of pneumothorax, secondaryOutcomes measure: Efficacy on glascow coma scale, secondaryOutcomes measure: Duration of ventilation in survivors, secondaryOutcomes measure: Ventilator free days, secondaryOutcomes measure: Intensive care unit length of stay, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: Number of alarms, secondaryOutcomes measure: Number of manual adjustments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, state: GE, zip: 16132, country: Italy, contacts name: Denise Battaglini, MD, PhD, role: CONTACT, phone: +39-0105554970, email: [email protected], contacts name: Lorenzo Ball, MD, PhD, role: CONTACT, phone: +39-0105554970, email: [email protected], geoPoint lat: 44.40478, lon: 8.94438, hasResults: False |
protocolSection identificationModule nctId: NCT06367803, orgStudyIdInfo id: DVS010, briefTitle: Cost Analysis of Vascular Surgical Techniques, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital of Limerick, class: OTHER, descriptionModule briefSummary: Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available., conditionsModule conditions: Critical Limb Ischemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, outcomesModule primaryOutcomes measure: A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Limerick, city: Limerick, state: Munster, country: Ireland, geoPoint lat: 52.66472, lon: -8.62306, hasResults: False |
protocolSection identificationModule nctId: NCT06367790, orgStudyIdInfo id: Bask-Pliomet, briefTitle: Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universidad Católica San Antonio de Murcia, class: OTHER, descriptionModule briefSummary: Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category.Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes.Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®).Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises., conditionsModule conditions: Basketball Players, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group, interventions name: Control group, outcomesModule primaryOutcomes measure: Change from baseline range of motion in loaded dorsal flexion after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline range of motion in unloaded dorsal flexion after treatment and at 4 weeks, secondaryOutcomes measure: Change from baseline vertical jump after treatment and at 4 weeks, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rubén Cuesta-Barriuso, city: Oviedo, state: Asturias, zip: 33006, country: Spain, contacts name: Rubén Cuesta-Barriuso, PhD, role: CONTACT, phone: 607547274, email: [email protected], geoPoint lat: 43.36029, lon: -5.84476, hasResults: False |
protocolSection identificationModule nctId: NCT06367777, orgStudyIdInfo id: 2024/14MAR/132, briefTitle: Cervical/Thoracic Neuromodulation and Nociceptive Processing, acronym: MICROVOLT2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS., conditionsModule conditions: Nociceptive Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: cervical a-tsDCS, interventions name: thoracic a-tsDCS, interventions name: sham tsDCS, outcomesModule primaryOutcomes measure: Change in contact-heat evoked potentials amplitude, secondaryOutcomes measure: Change in intensity of perception to contact-heat nociceptive stimuli, secondaryOutcomes measure: Change in skin temperature, secondaryOutcomes measure: Change in cutaneous blood flow, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367764, orgStudyIdInfo id: BPS-2022C3-30535, briefTitle: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations, acronym: LIFESCAPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Patient-Centered Outcomes Research Institute, collaborators name: Stanford University, descriptionModule briefSummary: The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:* Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?* Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?* Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms?* Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?* Do LGBTQIA+ patients complete these treatments?Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment., conditionsModule conditions: PTSD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Processing Therapy, interventions name: STAIR Narrative Therapy, outcomesModule primaryOutcomes measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: Change in Depression Measured by Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales, secondaryOutcomes measure: Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R), secondaryOutcomes measure: Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions, otherOutcomes measure: Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator, otherOutcomes measure: Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCSF Alliance Health Project, city: San Francisco, state: California, zip: 94103, country: United States, contacts name: Annesa Flentje, PhD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False |
protocolSection identificationModule nctId: NCT06367751, orgStudyIdInfo id: 2024-00358; th23Kasenda, briefTitle: Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT), acronym: LIQPLAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: Research Center for Clinical Neuroimmunology and Neuroscience Basel, descriptionModule briefSummary: The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anti-cancer treatment for advanced disease. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent. The study comprises an external comparator arm with 75 (anticipated) cancer patients, and an active comparator arm with 150 (anticipated) cancer patients., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: ctDNA measurement, outcomesModule primaryOutcomes measure: Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment, primaryOutcomes measure: Patients in whom actionable alterations were identified in ctDNA analysis, primaryOutcomes measure: Turn-around time of ctDNA analysis, primaryOutcomes measure: ctDNA kinetics, secondaryOutcomes measure: Number of ctDNA testing results that were successfully made available to the molecular tumor board, secondaryOutcomes measure: Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential, secondaryOutcomes measure: Quality of life and physical function, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Survival rate 6 months, secondaryOutcomes measure: Survival rate 12 months, secondaryOutcomes measure: Time to next treatment line, secondaryOutcomes measure: Unplanned hospital admissions and emergency room visits, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Number of ctDNA analyses with a valid result, otherOutcomes measure: Patients being referred and recruited to a different interventional clinical trial, otherOutcomes measure: Tissue biopsies per patient, otherOutcomes measure: Imaging per patient, otherOutcomes measure: Blood products per patient, otherOutcomes measure: Cumulative doses of cancer drug treatments administered, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367738, orgStudyIdInfo id: 2024-11-14799, briefTitle: Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of California, Berkeley, class: OTHER, descriptionModule briefSummary: We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: MRI measurements of brain structure, secondaryOutcomes measure: Amplitude and pattern of fMRI cortical responses, secondaryOutcomes measure: Peripheral psychophysiology, secondaryOutcomes measure: Perceptual measurements, secondaryOutcomes measure: Cognitive measurements, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06367725, orgStudyIdInfo id: 1-10-72-122-23, briefTitle: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2030-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?Participants will:* Continue to receive the best available therapy for ALL in Western Europe.* Have blood samples taken from their central line to measure dexamethasone levels.* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels., conditionsModule conditions: Acute Lymphoblastic Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Area Under the Plasma Concentration Curve (AUC) of Dexamethasone, secondaryOutcomes measure: Mineral bone density by DXA-scan, secondaryOutcomes measure: Vertebral fracture assessment (VFA) by DXA-scan, secondaryOutcomes measure: Dexamethasone in cerebrospinal fluid, otherOutcomes measure: Physical activity questionnaire, otherOutcomes measure: Biomarkers of bone metabolism, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, status: NOT_YET_RECRUITING, city: Copenhagen, state: København Ø, zip: 2100, country: Denmark, contacts name: Peter EL Pontoppidan, phd, role: CONTACT, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Paediatrics and Adolescent Medicine, Odense University Hospital, status: NOT_YET_RECRUITING, city: Odense, state: Odense C, zip: 5000, country: Denmark, contacts name: Peder S Wehner, phd, role: CONTACT, email: [email protected], geoPoint lat: 55.39594, lon: 10.38831, locations facility: Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital, status: NOT_YET_RECRUITING, city: Aalborg, zip: 9000, country: Denmark, contacts name: Marianne Olsen, phd, role: CONTACT, email: [email protected], geoPoint lat: 57.048, lon: 9.9187, locations facility: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital, status: RECRUITING, city: Aarhus N, zip: 8200, country: Denmark, contacts name: Karen S Jensen, phd, role: CONTACT, email: [email protected], contacts name: Birgitte K Albertsen, Professor, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False |
protocolSection identificationModule nctId: NCT06367712, orgStudyIdInfo id: Ahmed Kassab, briefTitle: Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-10, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-11-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure, conditionsModule conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 132, type: ACTUAL, armsInterventionsModule interventions name: Letrozole tablets, outcomesModule primaryOutcomes measure: Pregnancy test, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ahmed Maher Teaching Hospital, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06367699, orgStudyIdInfo id: H-44821, briefTitle: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV) Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: Boston Medical Center, collaborators name: Northeastern University, descriptionModule briefSummary: The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors., conditionsModule conditions: Human Papilloma Virus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1750, type: ESTIMATED, armsInterventionsModule interventions name: Usual Care, interventions name: ECA-HPV App with Clinic Notification and Adolescent Functions Disabled, interventions name: ECA-HPV App with Clinic Notification Function Enabled, interventions name: ECA-HPV App with Adolescent Function Enabled, interventions name: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled, outcomesModule primaryOutcomes measure: HPV vaccination series completion comparing the control group to the intervention groups, primaryOutcomes measure: HPV vaccination series completion comparing the intervention groups, secondaryOutcomes measure: HPV Knowledge, secondaryOutcomes measure: HPV Attitudes, secondaryOutcomes measure: General Vaccine Attitudes, secondaryOutcomes measure: ECA-HPV App Satisfaction, secondaryOutcomes measure: Clinic Notification Feature Satisfaction, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston Medical Center, city: Boston, state: Massachusetts, zip: 02118, country: United States, contacts name: Lori Henault, MPH, role: CONTACT, phone: 617-414-6935, email: [email protected], contacts name: Rebecca Perkins, MD, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06367686, orgStudyIdInfo id: REK KULMU B 714179, briefTitle: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor, acronym: DISCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Hospital of Vestfold, class: OTHER, collaborators name: Sensocure AS, descriptionModule briefSummary: The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values., conditionsModule conditions: Hypercapnic Respiratory Failure, conditions: Pulmonary Disease, Chronic Obstructive, conditions: Neuromuscular Diseases, conditions: Obesity Hypoventilation Syndrome (OHS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 11, type: ESTIMATED, armsInterventionsModule interventions name: IscAlert sensor, outcomesModule primaryOutcomes measure: Partial pressure (level) of carbon dioxide at the nasal mucosa, secondaryOutcomes measure: Bleeding, secondaryOutcomes measure: Infection, secondaryOutcomes measure: Sinusitis, secondaryOutcomes measure: Ulceration, secondaryOutcomes measure: Pain at sensor insertion site, otherOutcomes measure: Muscular temperature level, otherOutcomes measure: Nasal temperature level, otherOutcomes measure: Temporal temperature level, otherOutcomes measure: IscAlert functionality, otherOutcomes measure: Number of pack-years, otherOutcomes measure: Length of sensor implantation time, otherOutcomes measure: Peripheral oxygen saturation, otherOutcomes measure: Arterial partial pressure (level) of carbon dioxide, otherOutcomes measure: Arterial partial pressure (level) of oxygen, otherOutcomes measure: Intramuscular partial pressure (level) of carbon dioxide, otherOutcomes measure: Transcutaneous partial pressure (level) of carbon dioxide, otherOutcomes measure: Patient-Reported Outcome Measures 1a - discomfort, otherOutcomes measure: Patient-Reported Outcome Measures 1b - discomfort, otherOutcomes measure: Patient-Reported Outcome Measures 2a - runny nose, otherOutcomes measure: Patient-Reported Outcome Measures 2b - runny nose, otherOutcomes measure: Patient-Reported Outcome Measures 3a - sneezing, otherOutcomes measure: Patient-Reported Outcome Measures 3b - sneezing, otherOutcomes measure: Patient-Reported Outcome Measures 3b - Ulceration, otherOutcomes measure: Patient-Reported Outcome Measures 3a - Ulceration, otherOutcomes measure: Patient-Reported Outcome Measures 4a - tenderness, otherOutcomes measure: Patient-Reported Outcome Measures 4b - tenderness, otherOutcomes measure: Patient-Reported Outcome Measures 5b - bleeding, otherOutcomes measure: Patient-Reported Outcome Measures 5a - bleeding, otherOutcomes measure: Patient-Reported Outcome Measures 6a - reduced sense of smell, otherOutcomes measure: Patient-Reported Outcome Measures 6b - reduced sense of smell, otherOutcomes measure: Patient-Reported Outcome Measures 7b - reduced sense of taste, otherOutcomes measure: Patient-Reported Outcome Measures 7a - reduced sense of taste, otherOutcomes measure: Patient-Reported Outcome Measures 8a - difficulty sleeping, otherOutcomes measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping, otherOutcomes measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking, otherOutcomes measure: Patient-Reported Outcome Measures 10 - difficult breathing, otherOutcomes measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses, otherOutcomes measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vestfold Hopsital Trust, city: Tønsberg, zip: 3103, country: Norway, contacts name: Anne-Marie Gabrielsen, MD, PhD, role: CONTACT, phone: 92485580, phoneExt: +47, email: [email protected], contacts name: Morten Waldvogel-Rønning, MD, role: CONTACT, phone: 95203195, phoneExt: +47, email: [email protected], contacts name: Morten Waldvogel-Rønning, MD, role: SUB_INVESTIGATOR, contacts name: Caroline Sahlstrøm, MD, role: SUB_INVESTIGATOR, geoPoint lat: 59.26754, lon: 10.40762, hasResults: False |
protocolSection identificationModule nctId: NCT06367673, orgStudyIdInfo id: QH-ZYDC-01, briefTitle: Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Hangzhou Qihanjiyin Biotech Co.,Ltd., descriptionModule briefSummary: This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML, conditionsModule conditions: AML, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: iPSC-NK cells, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital, School of Medicine, Zhejiang University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 321000, country: China, contacts name: Yongxian Hu, role: CONTACT, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, hasResults: False |
protocolSection identificationModule nctId: NCT06367660, orgStudyIdInfo id: 98-2024, briefTitle: Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Tribhuvan University Teaching Hospital, Institute Of Medicine., class: OTHER, descriptionModule briefSummary: In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale, conditionsModule conditions: Visceral Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Research method: Quantitative Type of study: Randomized, interventional, comparative study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine, outcomesModule primaryOutcomes measure: Primary outcome, secondaryOutcomes measure: Secondary Outcome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367647, orgStudyIdInfo id: zhujiangjy-20240229, briefTitle: Investigation on the Detection Rate of Pathogenic Viruses in Feces of Parenteral Infected Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: This project is a cross-sectional study. Investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the Pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. At the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. Another 200 specimens will be collected from patients with parenteral virus infection. The demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. By virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces., conditionsModule conditions: Virus Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: virus infection checklist, secondaryOutcomes measure: general information of apparently healthy individuals by questionnaire, secondaryOutcomes measure: Self-Rating Anxiety Scale SAS, secondaryOutcomes measure: Self-rating depression scale SDS, secondaryOutcomes measure: Pittsburgh sleep quality index PSQI, secondaryOutcomes measure: demographic characteristics case information of parenteral virus infected patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang hospital of southern medical university, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510280, country: China, contacts name: Yumei Liu, master, role: CONTACT, phone: +8618810795365, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06367634, orgStudyIdInfo id: TEO-TSUL-2301, briefTitle: TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Teoxane SA, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable., conditionsModule conditions: Nasolabial Folds, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinded-Live evaluator, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: injection in NLF, outcomesModule primaryOutcomes measure: WSRS grading, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Second Provincial General Hospital, status: RECRUITING, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06367621, orgStudyIdInfo id: CLS-015C, briefTitle: Retrospective Study of iStatis Syphilis Ab Test (POC), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification., conditionsModule conditions: Syphilis, conditions: Syphilis Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1500, type: ACTUAL, armsInterventionsModule interventions name: iStatis Syphilis Antibody Test, outcomesModule primaryOutcomes measure: Sensitivity and specificity of the iStatis Syphilis Ab Test, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Epicentre Health Research, city: Hillcrest, state: KwaZulu Natal, zip: 3650, country: South Africa, hasResults: False |
protocolSection identificationModule nctId: NCT06367608, orgStudyIdInfo id: HP-00104695, briefTitle: MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD), acronym: FUS Dystonia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, collaborators name: Focused Ultrasound Foundation, collaborators name: InSightec, descriptionModule briefSummary: The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping., conditionsModule conditions: Task-Specific Focal Dystonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: ExAblate Transcranial treatment, outcomesModule primaryOutcomes measure: Incidence of Treatment related adverse events, secondaryOutcomes measure: Change in dystonia intensity, secondaryOutcomes measure: Change in patient's perception of quality of life, secondaryOutcomes measure: Change in patient's perception of the effect of the procedure, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Maryland Medical Center, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Kaitlyn Henry, MS, role: CONTACT, phone: 410-328-0939, email: [email protected], contacts name: Rayne Noyes, BS, role: CONTACT, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06367595, orgStudyIdInfo id: Intrathecal MgSO4, briefTitle: Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications., conditionsModule conditions: Abdominal Hysterectomy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Magnesium sulfate, outcomesModule primaryOutcomes measure: effect on postoperative pain after abdominal hysterectomy using visual analog score, secondaryOutcomes measure: sedation by Ramsay sedation scale, secondaryOutcomes measure: time of the first opioid request, secondaryOutcomes measure: Mean arterial blood pressures (MAP), secondaryOutcomes measure: Heart rate (HR), eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367582, orgStudyIdInfo id: CV01-TK-SPINE, briefTitle: SPINE BONE CEMENTS OUTCOMES, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-09-04, primaryCompletionDateStruct date: 2029-09-04, completionDateStruct date: 2039-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Teknimed, class: INDUSTRY, descriptionModule briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.TEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites., conditionsModule conditions: Vertebral Fracture, conditions: Compression Fracture, conditions: Osteoporotic Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Vertebroplasty (VP), interventions name: Kyphoplasty (KP), interventions name: Pedicular Screw Augmentation (PSA), outcomesModule primaryOutcomes measure: Alleviation of Pain, secondaryOutcomes measure: Restoration of quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Stabilization of vertebrae, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Antalgic Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU HautePierre, status: RECRUITING, city: Strasbourg, state: Bas-Rhin, zip: 67200, country: France, contacts name: Vincent LAMAS, MD, role: CONTACT, email: [email protected], contacts name: Vincent LAMAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, locations facility: Pôle Rachis Hôpital Privé d'Eure et Loir, status: RECRUITING, city: Mainvilliers, state: Eure Et Loir, zip: 28300, country: France, contacts name: Jean MEYBLUM, MD, role: CONTACT, email: [email protected], contacts name: Jean MEYBLUM, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.45003, lon: 1.45607, locations facility: Hôpital Toulouse Purpan, status: RECRUITING, city: Toulouse, state: Haute Garonne, zip: 31130, country: France, contacts name: Marie FARUCH, MD, role: CONTACT, email: [email protected], contacts name: Marie FARUCH, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Pôle Sud Santé, status: RECRUITING, city: Le Mans, state: Sarthe, zip: 72100, country: France, contacts name: Alexandru NITULESCU, MD, role: CONTACT, email: [email protected], contacts name: Alexandru NITULESCU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.0, lon: 0.2, locations facility: Centre Hospitalier Métropole Savoie, status: RECRUITING, city: Chambéry, state: Savoie, zip: 73000, country: France, contacts name: Cristian VASILE, MD, role: CONTACT, email: [email protected], contacts name: Cristian VASILE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.56667, lon: 5.93333, locations facility: Hospitale Cruz Vermelha Portuguesa, status: RECRUITING, city: Lisbonne, zip: 1549-008, country: Portugal, contacts name: Miguel CORDEIRO, MD, role: CONTACT, phone: 914655121, email: [email protected], contacts name: Miguel CORDEIRO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.71667, lon: -9.13333, locations facility: Clínica Teknon Instituto de neurociencias, status: RECRUITING, city: Barcelona, zip: 08022, country: Spain, contacts name: Daniel CRUZ MIRANDA, MD, role: CONTACT, email: [email protected], contacts name: David BOSCH GARCIA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Neurotraumatologico, status: RECRUITING, city: Granada, zip: 18013, country: Spain, contacts name: Fernando RUIZ SANTIAGO, MD, role: CONTACT, email: [email protected], contacts name: Fernando RUIZ SANTIAGO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Clínico Universitario Virgen de la Arrixaca, status: RECRUITING, city: Murcia, zip: 30120, country: Spain, contacts name: Gonzalo DE PACO TUDELA, MD, role: CONTACT, email: [email protected], contacts name: Gonzalo DE PACO TUDELA, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98704, lon: -1.13004, locations facility: Fundacio Assistencial Mutua de Terrassa - Edifici Estació, status: RECRUITING, city: Terrassa, zip: 08222, country: Spain, contacts name: David BOSCH GARCIA, MD, role: CONTACT, email: [email protected], contacts name: David BOSCH GARCIA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.56667, lon: 2.01667, locations facility: Hospital de Zafra, status: RECRUITING, city: Zafra, zip: 06300, country: Spain, contacts name: Félix PANTA ANTON, MD, role: CONTACT, email: [email protected], contacts name: Félix PANTA ANTON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.41667, lon: -6.41667, locations facility: Institute of Traumatology and Orthopaedics, status: RECRUITING, city: Kiev, zip: 1601, country: Ukraine, contacts name: Andrii SHEVCHUK, MD, role: CONTACT, email: [email protected], contacts name: Andrii SHEVCHUK, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.45466, lon: 30.5238, hasResults: False |
protocolSection identificationModule nctId: NCT06367569, orgStudyIdInfo id: 2012//375, briefTitle: Evaluation of MRI of the Pineal Gland in Retinoblastoma, acronym: TRbFU, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-10-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (\<15 mm) are potentially curable.Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts.Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma.Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients.Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test., conditionsModule conditions: Retinoblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 607, type: ACTUAL, armsInterventionsModule interventions name: Screening for trilateral retinoblastoma with MRI, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the screening, secondaryOutcomes measure: Survival analysis of trilateral retinoblastoma patients, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: VU University Medical Center, city: Amsterdam, state: Noord-Holland, zip: 1081 HV, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06367556, orgStudyIdInfo id: 4542, briefTitle: Emotion and Symptom-Focused Engagement (EASE) for Caregivers, acronym: EASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-10-01, completionDateStruct date: 2028-10-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: The Hospital for Sick Children, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:- Does EASE reduce traumatic stress symptom severity (primary outcome)?To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience., conditionsModule conditions: Trauma and Stressor Related Disorders, conditions: Pediatric Cancer, conditions: Caregiver Burden, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Quantitative outcome assessors and data analysts will be blinded to participant treatment group. Blinding is not possible for trial participants, intervention providers, or pediatric oncology teams, as assignment cannot be hidden from these individuals., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 306, type: ESTIMATED, armsInterventionsModule interventions name: EASE, outcomesModule primaryOutcomes measure: Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5], secondaryOutcomes measure: SF-36v2 Health Survey, secondaryOutcomes measure: Patient Health Questionnaire [PHQ-9], secondaryOutcomes measure: Caregiving Health Engagement Scale [CHE-s], secondaryOutcomes measure: Family Adaptability and Cohesion Evaluation Scales III [FACES-III], secondaryOutcomes measure: Clinical Evaluation Questionnaire [CEQ], secondaryOutcomes measure: Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10], otherOutcomes measure: Traditional Masculinity-Femininity Scale [TMF], otherOutcomes measure: Caregiver Reaction Assessment Scale [CRA], otherOutcomes measure: ENRICHD Social Support Instrument [ESSI], otherOutcomes measure: Experiences in Close Relationships Scale [ECR-16], otherOutcomes measure: Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367543, orgStudyIdInfo id: AZ 117/22, briefTitle: Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients, acronym: NORMONICU, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-30, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Giessen, class: OTHER, collaborators name: University of Leipzig, collaborators name: University of Wuerzburg, collaborators name: Technical University of Munich, collaborators name: Heidelberg University, collaborators name: University of Cologne, collaborators name: University of Mannheim, collaborators name: University Hospital, Essen, descriptionModule briefSummary: The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit. Specifically, determination of whether the target parameters recommended in the guidelines for temperature, systolic blood pressure, mean arterial blood pressure, blood glucose, arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned., conditionsModule conditions: Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 474, type: ACTUAL, armsInterventionsModule interventions name: Time in therapeutic range of vital parameters, outcomesModule primaryOutcomes measure: Time in Therapy range, secondaryOutcomes measure: Acute measures, secondaryOutcomes measure: Invasive measures performed in the course of the Stay, secondaryOutcomes measure: Duration of ventilation, secondaryOutcomes measure: Deceased on Intensive Care., secondaryOutcomes measure: NIHSS (National Institutes of Health Stroke Scale)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Gießen, city: Gießen, state: Hessen, zip: 35392, country: Germany, geoPoint lat: 50.58727, lon: 8.67554, hasResults: False |
protocolSection identificationModule nctId: NCT06367530, orgStudyIdInfo id: GS-TRIO-2024, briefTitle: Trilateral Retinoblastoma: Incidence and Outcomes, acronym: GS-TRIO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: Patients with heritable retinoblastoma are at risk to develop an intracranial brain tumor, which is often fatal. The investigators intend to look at the incidence and survival of trilateral retinoblastoma (which is a brain tumor that can either be located in the pineal gland or elsewhere in the brain) in retinoblastoma patients globally. All retinoblastoma patients from participating centers will be included. The investigators hypothesize that the apparent incidence of trilateral retinoblastoma (especially the usually later diagnosed pineal trilateral retinoblastoma) in low-income countries will be lower because of low chances of surviving the ocular tumors at about 50% and also because of possible under-diagnosis. Therefore, as retinoblastoma care improves in low-income countries the incidence of (pineal) trilateral retinoblastoma might go up. Knowledge about incidence and survival can help improve health practices in parts of the world where this might be needed. Therefore this global study firstly aims 1) to evaluate survival after trilateral retinoblastoma and factors influencing survival and 2) to evaluate incidence of trilateral retinoblastoma by country income level. The study will run from 2024 through 2027., conditionsModule conditions: Trilateral Retinoblastoma, conditions: Retinoblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4351, type: ESTIMATED, armsInterventionsModule interventions name: Incidence and survival of trilateral retinoblastoma and the differences globally, outcomesModule primaryOutcomes measure: Number of participants (retinoblastoma patients) that will be diagnosed with trilateral retinoblastoma (incidence), primaryOutcomes measure: Overall and event-free survival after being diagnosed with trilateral retinoblastoma, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1082HV, country: Netherlands, contacts name: Pim de Graaf, MD PhD, role: CONTACT, phone: 800-555-5555, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06367517, orgStudyIdInfo id: KB/114/2022, briefTitle: Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease), statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2026-05-20, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Medical University of Warsaw, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease., conditionsModule conditions: Orbitopathy, Graves, conditions: Thyroid Eye Disease, conditions: Ophthalmopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Tocilizumab, outcomesModule primaryOutcomes measure: Disease improvement, primaryOutcomes measure: Improvement of quality of life, secondaryOutcomes measure: Disease inactivation, secondaryOutcomes measure: Proportion of patients achieving response in specific GO signs and symptoms, secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, secondaryOutcomes measure: Decrease in concentration of thyrotropin receptor antibodies, secondaryOutcomes measure: Decrease in levels of proinflammatory cytokines, secondaryOutcomes measure: Number of the rehabilitative surgeries performed after immunosuppressive therapy, secondaryOutcomes measure: The rate of disease relapse, secondaryOutcomes measure: Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Internal Medicine and Endocrinology, Medical University of Warsaw, status: RECRUITING, city: Warsaw, zip: 02-097, country: Poland, contacts name: Tomasz Bednarczuk, MD, PHD, role: CONTACT, email: [email protected], contacts name: Joanna Rymuza, MD, PHD, role: CONTACT, email: [email protected], contacts name: Tomasz Bednarczuk, MD, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Joanna Rymuza, MD, PHD, role: SUB_INVESTIGATOR, contacts name: Aleksander Kuś, MD, PHD, role: SUB_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06367504, orgStudyIdInfo id: DB/230904/DBMF/CDI, briefTitle: A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Vedic Lifesciences Pvt. Ltd., class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI), conditionsModule conditions: Clostridium Difficile Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, parallel group, double-blind, placebo-controlled trial, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: DBMF, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo., secondaryOutcomes measure: To assess the impact of the Investigational product on Number of CDI diarrhea episodes presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD., secondaryOutcomes measure: To assess the impact of the Investigational product on Change in the frequency of watery stools from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo., secondaryOutcomes measure: To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo, secondaryOutcomes measure: To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo., secondaryOutcomes measure: To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AIMS Hospital, city: Dombivali, state: Maharashtra, zip: 421203, country: India, contacts name: Dr Sandeep Kardian, MBBS MD, role: CONTACT, phone: 870364574, email: [email protected], geoPoint lat: 19.21667, lon: 73.08333, locations facility: Stress Test Clinic, city: Mumbai, state: Maharashtra, zip: 400059, country: India, contacts name: Dr Ramesh Dargad, MBBS MS, role: CONTACT, phone: 9820152828, email: [email protected], geoPoint lat: 19.07283, lon: 72.88261, locations facility: Nobel Hospital, city: Pune, state: Maharashtra, zip: 411013, country: India, contacts name: Dr Pramod Katare, MBBS MD, role: CONTACT, phone: 8830793201, email: [email protected], geoPoint lat: 18.51957, lon: 73.85535, locations facility: Gleneagles Hospital, city: Hyderabad, state: Telangana, zip: 500004, country: India, contacts name: Dr G S Sameer Kumar, MBBS MD, role: CONTACT, phone: 8860031692, email: [email protected], geoPoint lat: 17.38405, lon: 78.45636, hasResults: False |
protocolSection identificationModule nctId: NCT06367491, orgStudyIdInfo id: IRST100.12, briefTitle: National Database of Bone Metastases, acronym: BDMO, statusModule overallStatus: RECRUITING, startDateStruct date: 2013-10-08, primaryCompletionDateStruct date: 2030-01-01, completionDateStruct date: 2030-01-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, class: OTHER, descriptionModule briefSummary: BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection., conditionsModule conditions: Bone Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Registration in a database, outcomesModule primaryOutcomes measure: The establishment of a National Bone Metastasis Database at the IRCCS IRST, secondaryOutcomes measure: Evaluation of clinical factors related to the primary tumor and metastases, secondaryOutcomes measure: Evaluation of clinical factors related to the primary tumor and metastases, secondaryOutcomes measure: Evaluation of clinical factors related to the primary tumor and metastases, secondaryOutcomes measure: Impact of treatment on skeletal events (SRE), secondaryOutcomes measure: Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE), secondaryOutcomes measure: Evaluation of biological factors related to the primary tumour and metastases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A.U.S.L. Imola, status: RECRUITING, city: Imola, state: Bologna, country: Italy, contacts name: Antonio Maestri, MD, role: CONTACT, geoPoint lat: 44.35916, lon: 11.7132, locations facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), status: RECRUITING, city: Meldola, state: FC, zip: 47014, country: Italy, contacts name: Nicoletta Ranallo, MD, role: CONTACT, phone: 0543739100, email: [email protected], contacts name: Nicoletta Ranallo, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.12775, lon: 12.0626, locations facility: Osp. "Sacro Cuore di Gesù", status: NOT_YET_RECRUITING, city: Gallipoli, state: Lecce, country: Italy, contacts name: Rosachiara Forcignanò, MD, role: CONTACT, geoPoint lat: 40.05594, lon: 17.99088, locations facility: Osp. S. Vincenzo - ASP Messina, status: RECRUITING, city: Taormina, state: Messina, country: Italy, contacts name: Francesco Ferrarù, MD, role: CONTACT, geoPoint lat: 37.85358, lon: 15.28851, locations facility: Osp. Ramazzini di Carpi - AUSL Modena, status: RECRUITING, city: Carpi, state: Modena, country: Italy, contacts name: Fabrizio Artioli, MD, role: CONTACT, geoPoint lat: 44.78237, lon: 10.8777, locations facility: P.O. "S. Maria delle Grazie", status: RECRUITING, city: Pozzuoli, state: Napoli, country: Italy, contacts name: Gaetano Facchini, MD, role: CONTACT, geoPoint lat: 40.84394, lon: 14.0952, locations facility: Osp. degli Infermi, status: RECRUITING, city: Faenza, state: Ravenna, country: Italy, contacts name: Enrico Campadelli, MD, role: CONTACT, geoPoint lat: 44.29007, lon: 11.87948, locations facility: Ospedale Umberto I, status: RECRUITING, city: Lugo, state: Ravenna, country: Italy, contacts name: Enrico Campadelli, MD, role: CONTACT, geoPoint lat: 44.42137, lon: 11.91094, locations facility: Istituto Neurotraumatologico Italiano (INI), status: RECRUITING, city: Grottaferrata, state: Roma, country: Italy, contacts name: Gaetano Lanzetta, MD, role: CONTACT, geoPoint lat: 41.78664, lon: 12.67144, locations facility: A.O.U. Ospedali Riuniti, status: RECRUITING, city: Ancona, country: Italy, contacts name: Rosanna Berardi, MD, role: CONTACT, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Centro di Riferimento Oncologico - IRCCS CRO, status: RECRUITING, city: Aviano, country: Italy, contacts name: Alessandro Del Conto, MD, role: CONTACT, geoPoint lat: 46.07056, lon: 12.59472, locations facility: A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII", status: RECRUITING, city: Bari, country: Italy, contacts name: Stefania Succi, MD, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: A.O. "S. Pio", status: RECRUITING, city: Benevento, country: Italy, contacts name: Vincenzo Ricci, MD, role: CONTACT, geoPoint lat: 41.1307, lon: 14.77816, locations facility: IRCCS Ist. Ortopedico Rizzoli, status: RECRUITING, city: Bologna, country: Italy, contacts name: Toni Ibrahim, MD, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: ASST Spedali Civili di Brescia, status: RECRUITING, city: Brescia, country: Italy, contacts name: Rebecca Pedersini, MD, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: A.O. S. Croce e Carle, status: RECRUITING, city: Cuneo, country: Italy, contacts name: Marcella Occelli, MD, role: CONTACT, geoPoint lat: 44.39071, lon: 7.54828, locations facility: A.O.U. "Arcispedale S. Anna" - AUSL Ferrara, status: RECRUITING, city: Ferrara, country: Italy, contacts name: Antonio Frassoldati, MD, role: CONTACT, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Ospedale Civile di Legnano - ASST Ovest Milanese, status: RECRUITING, city: Legnano, country: Italy, contacts name: Elena Farè, MD, role: CONTACT, geoPoint lat: 45.59788, lon: 8.91506, locations facility: Fond. IRCCS Istituto Nazionale dei Tumori - INT, status: RECRUITING, city: Milano, country: Italy, contacts name: Valentina Guadalupi, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: A.O.R.N. "A. Cardarelli", status: RECRUITING, city: Napoli, country: Italy, contacts name: Ferdinando Riccardi, MD, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Istituto Oncologico Veneto, status: RECRUITING, city: Padova, country: Italy, contacts name: Marco Maruzzo, MD, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Fond. IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: Elisa Ferraris, MD, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Osp. Guglielmo da Saliceto, status: RECRUITING, city: Piacenza, country: Italy, contacts name: Luigi Cavanna, MD, role: CONTACT, geoPoint lat: 45.05242, lon: 9.69342, locations facility: Osp. S. Maria delle Croci, status: RECRUITING, city: Ravenna, country: Italy, contacts name: Enrico Campadelli, MD, role: CONTACT, geoPoint lat: 44.41344, lon: 12.20121, locations facility: IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia, status: RECRUITING, city: Reggio Emilia, country: Italy, contacts name: Maria Banzi, MD, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Ospedale degli Infermi, status: RECRUITING, city: Rimini, country: Italy, contacts name: Manuela Fantini, MD, role: CONTACT, geoPoint lat: 44.05755, lon: 12.56528, locations facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica, status: RECRUITING, city: Roma, country: Italy, contacts name: Emilio Bria, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica, status: RECRUITING, city: Roma, country: Italy, contacts name: Alessandra Fabi, MD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest, status: RECRUITING, city: Treviglio, country: Italy, contacts name: Andrea Luciani, MD, role: CONTACT, geoPoint lat: 45.52081, lon: 9.59102, locations facility: A.O.U.I. Verona, status: RECRUITING, city: Verona, country: Italy, contacts name: Jessica Menis, MD, role: CONTACT, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False |
protocolSection identificationModule nctId: NCT06367478, orgStudyIdInfo id: SPEMG, briefTitle: Evaluation of Nerve Conduction Study, acronym: SPEMG, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-08-01, primaryCompletionDateStruct date: 2021-10-22, completionDateStruct date: 2024-10-22, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response, conditionsModule conditions: Nerve Condition, conditions: Health, Subjective, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 125, type: ACTUAL, outcomesModule primaryOutcomes measure: best amplitude of nerve conduction study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan, city: Milan, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06367465, orgStudyIdInfo id: 202308056, briefTitle: Feasibility and Acceptability of HCV Treatment in Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug useParticipant Duration: Approximately 1 year.Aims:Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy., conditionsModule conditions: Hepatitis C, conditions: Pregnancy Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Glecaprevir-pibrentasvir, outcomesModule primaryOutcomes measure: Medication adherence and treatment completion rates., secondaryOutcomes measure: Patient satisfaction Questionnaire, secondaryOutcomes measure: Virologic outcome and clinical success at Day 28 post treatment, secondaryOutcomes measure: Sample size estimation for future study, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barnes Jewish Hospital, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Tracey Bach, role: CONTACT, phone: 314-273-6075, email: [email protected], contacts name: Laura Marks, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Washington Univeristy, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Laura Marks, MD,PhD, role: CONTACT, email: [email protected], contacts name: Tracey Habrock-Bach, MBA, role: CONTACT, phone: 314-273-6075, email: [email protected], geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
protocolSection identificationModule nctId: NCT06367452, orgStudyIdInfo id: CAEP 107.001.23, briefTitle: Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Tecnoquimicas, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women, after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone. The main question it aims to answer is the amount of magnesium and/or aluminum, if any, absorbed into the plasma from this oral administration.Participants will take the medication 30 minutes after a standard breakfast. Both groups of participants will take the standard meal but one group will take the medication and the other one won't.Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption, quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication, when it applies., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Sodium alginate + sodium bicarbonate + magaldrate + simeticone, outcomesModule primaryOutcomes measure: Cmax for Aluminum, primaryOutcomes measure: AUC for Aluminum, primaryOutcomes measure: Cmax for Magnesium, primaryOutcomes measure: AUC for Magnesium, secondaryOutcomes measure: Amount of aluminum ions absorbed after drug administration vs amount provided by food, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: CAEP, city: Campinas, state: Sao Paulo, zip: 13087-567, country: Brazil, geoPoint lat: -22.90556, lon: -47.06083, hasResults: False |
protocolSection identificationModule nctId: NCT06367439, orgStudyIdInfo id: FN-10984, briefTitle: Examining the Effects of Virtual Reality Exercise on Mental Health, acronym: UVIC VR Fit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Victoria, class: OTHER, collaborators name: Meta Platforms, Inc., descriptionModule briefSummary: The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time., conditionsModule conditions: Mental Health, conditions: Mood, conditions: Well-Being, Psychological, conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will utilize a 10-week, two-arm, single-blinded, waitlist control, randomized controlled trial (RCT). Healthy adults (19-64 years) from the Victoria community participating in less than 75 minutes of vigorous physical activity per week will be randomized to either the Supernatural (SN) condition or the wait-list control (WLC) condition for a 10-week period., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Single - Primary Investigator, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Supernatural Condition, interventions name: Supernatural Condition, outcomesModule primaryOutcomes measure: Depression and anxiety mood symptoms, primaryOutcomes measure: Well-being: subjective vitality, primaryOutcomes measure: Perceived cognitive function, secondaryOutcomes measure: Short-term Mood, secondaryOutcomes measure: Core Affect Measure - Feeling Scale, secondaryOutcomes measure: Core Affect Measure - Felt Arousal Scale, otherOutcomes measure: Perceived exertion, otherOutcomes measure: Supernatural Target Accuracy, otherOutcomes measure: Attitude towards physical activity, otherOutcomes measure: Attitude towards Supernatural physical activity, otherOutcomes measure: Perceived opportunity for physical activity, otherOutcomes measure: Perceived opportunity for Supernatural physical activity, otherOutcomes measure: Perceived capability for physical activity, otherOutcomes measure: Perceived capability for Supernatural physical activity, otherOutcomes measure: Intentions for physical activity behaviour, otherOutcomes measure: Intention for regular Supernatural physical activity behaviour, otherOutcomes measure: Behavioural regulation of physical activity behaviour, otherOutcomes measure: Behavioural regulation of Supernatural physical activity, otherOutcomes measure: Physical activity habit, otherOutcomes measure: Supernatural physical activity habit, otherOutcomes measure: Physical activity identity, otherOutcomes measure: Supernatural physical activity identity, otherOutcomes measure: Physical activity behaviour, otherOutcomes measure: Supernatural physical activity behaviour, otherOutcomes measure: Weekly Supernatural Physical Activity Behaviour, otherOutcomes measure: Direct assessment of Supernatural physical activity behaviour, otherOutcomes measure: Direct assessment of physical activity behaviour, otherOutcomes measure: Feasibility and Acceptability of Supernatural and the Meta Quest 3 headset, otherOutcomes measure: Supernatural usability, otherOutcomes measure: Meta Quest 3 headset usability, otherOutcomes measure: Personality, otherOutcomes measure: Physical Activity Environment, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Behavioural Medicine Lab, status: RECRUITING, city: Victoria, state: British Columbia, zip: V8W3N4, country: Canada, contacts name: Colin Wierts, PhD, role: CONTACT, contacts name: Ryan Rhodes, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.43294, lon: -123.3693, hasResults: False |
protocolSection identificationModule nctId: NCT06367426, orgStudyIdInfo id: Pharmacobio, briefTitle: A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Pharmacobio, class: INDUSTRY, descriptionModule briefSummary: The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects, conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: To maintain double-blindness, DDN-A-0101 tablets and placebo with the same formulation and properties that cannot be distinguished in appearance will be used, and sub-packaging will also be the same., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: DDN-A-0101 (SAD), interventions name: DDN-A-0101 (MAD), interventions name: Placebo (SAD), interventions name: Placebo (MAD), outcomesModule primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in plasma, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, primaryOutcomes measure: Assessment of pharmacokinetics of Quercitrin in urine, secondaryOutcomes measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test, secondaryOutcomes measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University College of Medicine and Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, contacts name: In-Jin Jang, Doctor, role: CONTACT, phone: 82-2-740-8290, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06367413, orgStudyIdInfo id: UTH-PRoNAC Study, briefTitle: Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery, acronym: PRoNAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between., conditionsModule conditions: Aseptic Muscle Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized, double-blind, placebo-controlled, parallel group model., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants, outcomes assessor and the principal investigator will be blinded until the intervention and the outcomes' assessment is done., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: NAC, interventions name: NAC + Whey Protein, outcomesModule primaryOutcomes measure: Change in maximal voluntary isometric muscle contraction., primaryOutcomes measure: Change in countermovement jump height., primaryOutcomes measure: Change in delayed onset of muscle soreness (DOMS), primaryOutcomes measure: Change in reduced glutathione content., primaryOutcomes measure: Change in oxidized glutathione content., primaryOutcomes measure: Change in catalase activity., primaryOutcomes measure: Change in protein carbonyl concentration, primaryOutcomes measure: Change in myoglobin concentration in blood., secondaryOutcomes measure: Participants' lean body mass, secondaryOutcomes measure: Participants' daily physical activity-related energy expenditure., secondaryOutcomes measure: Participants daily dietary intake., secondaryOutcomes measure: Participants' resting metabolic rate., secondaryOutcomes measure: Participants' cardiorespiratory fitness status., secondaryOutcomes measure: Participants' fat free mass., secondaryOutcomes measure: Participants' fat mass., secondaryOutcomes measure: Participants' body fat percent., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 27 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Physical Education and Sport Science, University of Thessaly, status: RECRUITING, city: Tríkala, state: Karies, zip: 42100, country: Greece, contacts name: Dimitrios Draganidis, PhD, role: CONTACT, phone: +30 2431047078, email: [email protected], contacts name: Ioannis G Fatouros, PhD, role: CONTACT, phone: +302431047047, email: [email protected], geoPoint lat: 39.55493, lon: 21.76837, hasResults: False |
protocolSection identificationModule nctId: NCT06367400, orgStudyIdInfo id: SwePSQ, briefTitle: Validation of Pediatric Sleep Questionnaire on a Swedish Cohort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Örebro University, Sweden, collaborators name: Umeå University, collaborators name: Göteborg University, descriptionModule briefSummary: This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing., conditionsModule conditions: Obstructive Sleep Apnea, conditions: Sleep Disorder, conditions: Sleep Disorders in Children, conditions: Obstructive Sleep Apnea of Child, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Pediatric Sleep Questionnaire, outcomesModule primaryOutcomes measure: Level of baseline PSQ, primaryOutcomes measure: Changes of baseline PSQ after treatment, secondaryOutcomes measure: PSQ vs OSA-18, secondaryOutcomes measure: PSQ vs. PSG, secondaryOutcomes measure: PSQ levels of healthy controls vs children with OSDB, otherOutcomes measure: 5 and 10 years follow-up, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Akademiska hospital, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Isabella Sjölander, role: CONTACT, phone: 018-6110000, email: [email protected], geoPoint lat: 59.85882, lon: 17.63889, hasResults: False |
protocolSection identificationModule nctId: NCT06367387, orgStudyIdInfo id: STUDY23080191, secondaryIdInfos id: RM1DA055311, type: NIH, link: https://reporter.nih.gov/quickSearch/RM1DA055311, briefTitle: Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment, acronym: TREETOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jessica Merlin, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).The research study is testing two different interventions along with usual clinical care:1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention., conditionsModule conditions: Opioid Use Disorder, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: Patient-Oriented Dosing (POD), interventions name: Pain Self-Management (PSM), interventions name: Usual Care, interventions name: Standard Buprenorphine Dosing Condition, outcomesModule primaryOutcomes measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline, primaryOutcomes measure: Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline, secondaryOutcomes measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline, secondaryOutcomes measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline, secondaryOutcomes measure: Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline, secondaryOutcomes measure: Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline, secondaryOutcomes measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline, secondaryOutcomes measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Outpatient Addiction Treatment Services (OATS), city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center, city: Baltimore, state: Maryland, zip: 21223, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Sophia Purekal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Wells House, city: Hagerstown, state: Maryland, zip: 21740, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Eric Weintraub, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.64176, lon: -77.71999, locations facility: Central City Concern (CCC), city: Portland, state: Oregon, zip: 97209, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Recovery Works Northwest (RWNW), city: Portland, state: Oregon, zip: 97233, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: OHSU Harm Reduction Bridges to Care (HRBR), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: OHSU Internal Medicine Clinic (IMC), city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Research Team, role: CONTACT, email: [email protected], contacts name: Jonathan Robbins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: UPMC Latterman Family Health Center, city: McKeesport, state: Pennsylvania, zip: 15132, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: [email protected], contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.34785, lon: -79.86422, locations facility: UPMC St. Margaret Family Health Center, city: New Kensington, state: Pennsylvania, zip: 15068, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: [email protected], contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.56979, lon: -79.76477, locations facility: UPMC Internal Medicine Recovery Engagement Program (IM-REP), city: Pittsburgh, state: Pennsylvania, zip: 15219, country: United States, contacts name: Research Team, role: CONTACT, phone: 412-852-8499, email: [email protected], contacts name: Jessica Merlin, MD, PhD, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: WVU Crisis Support & Recovery Center, city: Martinsburg, state: West Virginia, zip: 25401, country: United States, contacts name: Research Team, role: CONTACT, phone: 304-290-9159, email: [email protected], contacts name: Dorothy Van Oppen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.45621, lon: -77.96389, locations facility: WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT), city: Morgantown, state: West Virginia, zip: 26505, country: United States, contacts name: Research Team, role: CONTACT, phone: 304-290-9159, email: [email protected], contacts name: Dorothy Van Oppen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62953, lon: -79.9559, hasResults: False |
protocolSection identificationModule nctId: NCT06367374, orgStudyIdInfo id: BGB-11417-2002-IIT；BDH-CLL-004, briefTitle: MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2030-02-28, completionDateStruct date: 2030-07-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Sonrotoclax, interventions name: Zanubrutinib, outcomesModule primaryOutcomes measure: 4-Year Progressive Free Survival (PFS) Rate, secondaryOutcomes measure: Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD), secondaryOutcomes measure: Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Next Therapy (TTNT), secondaryOutcomes measure: Overall survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367361, orgStudyIdInfo id: SIDISI 201221, secondaryIdInfos id: U01AI155323, type: NIH, link: https://reporter.nih.gov/quickSearch/U01AI155323, briefTitle: One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universidad Peruana Cayetano Heredia, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Children and adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population PK modeling studies will be performed in the first 24 hours after the first dose of oxfendazole., conditionsModule conditions: Fascioliasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study arm 1: Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.Study arm 2: Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: Oxfendazole, interventions name: Triclabendazole, outcomesModule primaryOutcomes measure: Parasitological cure rate of chronic fascioliasis, primaryOutcomes measure: Egg reduction rate day 7, primaryOutcomes measure: Egg reduction rate day 30, secondaryOutcomes measure: Safety information on day 0, secondaryOutcomes measure: Safety information on day 3, secondaryOutcomes measure: Safety information on day 7, secondaryOutcomes measure: Safety information on day 30, secondaryOutcomes measure: Laboratory safety information day 7, secondaryOutcomes measure: Laboratory safety information day 30, secondaryOutcomes measure: Population pharmacokinetics model constructs for oxfendazole, secondaryOutcomes measure: Population pharmacokinetics model constructs for oxfendazole sulfone, secondaryOutcomes measure: Population pharmacokinetics model constructs fenbendazole, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367348, orgStudyIdInfo id: R01AA031445, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031445, secondaryIdInfos id: R01AA031445, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031445, briefTitle: An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi., conditionsModule conditions: HIV/AIDS, conditions: Alcohol Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Couples will be randomized 1:1 to intervention or control arm, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Mlambe, outcomesModule primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, primaryOutcomes measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test, secondaryOutcomes measure: Viral Suppression measured using whole blood viral load tests, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Antiretroviral medication adherence measured using a Visual Analog Scale, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Medical appointment adherence assessment, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: Number of drinking days measured using the "Timeline follow-back" method, secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test., secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, secondaryOutcomes measure: PEth level measured using a Phosphatidylethanol biomarker test, otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale., otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), otherOutcomes measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Invest in Knowledge Initiative (IKI), city: Zomba, country: Malawi, geoPoint lat: -15.38596, lon: 35.3188, hasResults: False |
protocolSection identificationModule nctId: NCT06367335, orgStudyIdInfo id: ETIC, briefTitle: Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer, acronym: ETIC, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Milano Bicocca, class: OTHER, descriptionModule briefSummary: The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making., conditionsModule conditions: DILI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 128, type: ACTUAL, armsInterventionsModule interventions name: Ribociclib, palbociclib, abemaciclib, outcomesModule primaryOutcomes measure: Incidence of DILI, secondaryOutcomes measure: withdrawal of therapy, secondaryOutcomes measure: delayed reprise of antineoplastic therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Milano-Bicocca,, city: Monza, zip: 20900, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, hasResults: False |
protocolSection identificationModule nctId: NCT06367322, orgStudyIdInfo id: EMP-PARA-20170-01, briefTitle: Statins and Post-ERCP Acute Pancreatitis (Stark Project), acronym: Stark, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-10, primaryCompletionDateStruct date: 2018-07-31, completionDateStruct date: 2018-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hospital General Universitario de Alicante, class: OTHER, collaborators name: European Pancreatic Club (EPC), Pancreas 2000 Educational Program, descriptionModule briefSummary: Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP., conditionsModule conditions: Post-ERCP Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1016, type: ACTUAL, armsInterventionsModule interventions name: Statin, outcomesModule primaryOutcomes measure: To assess the incidence and relative risk of PEAP according to statin use., secondaryOutcomes measure: To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP., secondaryOutcomes measure: To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alicante, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Hospital General Universitario de Alicante, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, hasResults: False |
protocolSection identificationModule nctId: NCT06367309, orgStudyIdInfo id: 2023 - 02357, briefTitle: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair, acronym: ALPINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: St. Clara Hospital, Basel, Switzerland, collaborators name: Innklinikum Altötting, Germany, descriptionModule briefSummary: This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.The main questions it aims to answer are:* pain after the operation* rate of complications* rate of recurrence and reoperations* quality of life.Participants will:Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes., conditionsModule conditions: Ventral Hernia, conditions: Abdominal Wall Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Extended totally extraperitoneal repair, interventions name: Intraperitoneal onlay mesh, outcomesModule primaryOutcomes measure: primary outcome: pain numeric rating scale (NRS), primaryOutcomes measure: pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a, secondaryOutcomes measure: pain mid-term, secondaryOutcomes measure: recurrence and reoperation, secondaryOutcomes measure: LOS, secondaryOutcomes measure: Functional recovery, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Quality of life (SF 12), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Clara Hospital, city: Basel, state: Basel-Stadt, zip: 4058, country: Switzerland, contacts name: Fiorenzo Angehrn, MD, role: CONTACT, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, hasResults: False |
protocolSection identificationModule nctId: NCT06367296, orgStudyIdInfo id: RETOPO2024, briefTitle: Resistance Exercise Training in the Older Population With Obesity, acronym: RETOPO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-01-28, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universidad de La Frontera, class: OTHER, descriptionModule briefSummary: Background:Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.Hypothesis:A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.Goals:The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.Methodology:The present clinical trial will consider 2 groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat \<25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % \>32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated., conditionsModule conditions: Aging, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged resistance exercise training, outcomesModule primaryOutcomes measure: Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training, secondaryOutcomes measure: Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training., secondaryOutcomes measure: Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise training., eligibilityModule sex: FEMALE, minimumAge: 60 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad de La Frontera, city: Temuco, state: IX Región De La Araucanía, zip: 4780000, country: Chile, contacts name: Nicolás Vidal-Seguel, MSc, role: CONTACT, phone: 998595445, email: [email protected], contacts name: GABRIEL MARZUCA, MSc, PhD, role: CONTACT, phone: 996343630, email: [email protected], geoPoint lat: -38.73965, lon: -72.59842, hasResults: False |
protocolSection identificationModule nctId: NCT06367283, orgStudyIdInfo id: 2023-509181-38-00, briefTitle: Metformin Treatment of Patients With Hand Osteoarthritis, acronym: METRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Marius Henriksen, class: OTHER, descriptionModule briefSummary: To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms., conditionsModule conditions: Hand Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Finger pain, secondaryOutcomes measure: Function, secondaryOutcomes measure: Thumb base pain, secondaryOutcomes measure: Hand pain, secondaryOutcomes measure: Physician tender joint count, secondaryOutcomes measure: Patient global assessment, secondaryOutcomes measure: Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale, secondaryOutcomes measure: Hand strength, secondaryOutcomes measure: Number of treatment responders, otherOutcomes measure: Stiffness of both hands, otherOutcomes measure: Composite of pain, function and stiffness, otherOutcomes measure: Physical function, otherOutcomes measure: Physician global assessment, otherOutcomes measure: Swollen joint count, otherOutcomes measure: Fatigue, otherOutcomes measure: Sleep quality, otherOutcomes measure: Absence or presence of inflammation of target hand, otherOutcomes measure: Change in use of analgesics, otherOutcomes measure: Inflammatory biomarker, otherOutcomes measure: Metabolic outcomes, otherOutcomes measure: Metabolic outcomes, otherOutcomes measure: Vitamin K, otherOutcomes measure: Proteomics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Parker Institute, Bispebjerg and Frederiksberg hospital, city: Copenhagen, state: Frederiksberg, zip: 2000, country: Denmark, contacts name: Kasper Staberg Madsen, MD, role: CONTACT, phone: +4538164162, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06367270, orgStudyIdInfo id: UW 23-361, briefTitle: The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies, acronym: PIPAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity., conditionsModule conditions: Peritoneal Metastases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pressured Intraperitoneal Aerosol Chemotherapy, outcomesModule primaryOutcomes measure: Clinical benefit rate (CBR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Mary Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Ian WONG, Dr., role: CONTACT, phone: +852 2255 4774, email: [email protected], contacts name: Ian WONG, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06367257, orgStudyIdInfo id: Emento App, briefTitle: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Erlangen-Nürnberg Medical School, class: OTHER, descriptionModule briefSummary: Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition., conditionsModule conditions: Squamous Cell Carcinoma of Head and Neck, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: App Usage, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Change in rates of weight loss with additional app-based Patient Care, secondaryOutcomes measure: Frequency of deteriorations in health status subjectively reported by patients and recorded via the app., secondaryOutcomes measure: Frequency of additional app-triggered contacts of the clinic with the patients, secondaryOutcomes measure: Frequency of critical health conditions (physician-verified) detected earlier by the app., secondaryOutcomes measure: Change in quality of life measured per questionnaires, secondaryOutcomes measure: Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy., secondaryOutcomes measure: Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy., secondaryOutcomes measure: Rate of therapy interruptions/discontinuations, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease-free/progression-free survival, secondaryOutcomes measure: Change of Loco-regional tumor control, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Erlangen, Strahlenklinik, city: Erlangen, state: Bavaria, zip: 91054, country: Germany, contacts name: Marlen Haderlein, PD, role: CONTACT, phone: +49913185, phoneExt: 33968, email: [email protected], contacts name: Studiensekretariat, role: CONTACT, phone: +49913185, phoneExt: 33968, email: [email protected], contacts name: Allison Lamrani, role: PRINCIPAL_INVESTIGATOR, contacts name: Charlotte Schmitter, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.59099, lon: 11.00783, hasResults: False |
protocolSection identificationModule nctId: NCT06367244, orgStudyIdInfo id: TWP2023, briefTitle: Transplant Wellness Program, acronym: TWP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2033-11, completionDateStruct date: 2033-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization., conditionsModule conditions: Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The TWP is a parallel study design with two arms. Participants are assigned to either the kidney or liver arm depending on the organ transplant they are listed or in evaluation for. Each arm will have a pre- or post- transplant group. Participants will be assigned to group depending on length of time between study enrollment and transplant surgery. Those with more than 12-weeks until surgery will complete the TWP pre-transplant and those with less than 12-weeks will complete the TWP post-transplant., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Transplant Wellness Program - Kidney and Liver, outcomesModule primaryOutcomes measure: Self-reported exercise, primaryOutcomes measure: Generic self-reported quality of life, primaryOutcomes measure: Kidney disease quality of life., primaryOutcomes measure: Liver disease quality of life, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Lower extremity flexibility, secondaryOutcomes measure: Aerobic Endurance, secondaryOutcomes measure: Lower extremity muscular strength, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Nutrition, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Mental Health, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Program implementation and evaluation, secondaryOutcomes measure: Health economic evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Calgary, status: RECRUITING, city: Calgary, state: Alberta, zip: T2N 1N4, country: Canada, contacts name: Maneka Perinpanayagam, PhD, role: CONTACT, phone: 403-944-3699, email: [email protected], contacts name: S. Nicole Culos-Reed, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kelly Burak, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Debra Isaac, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False |
protocolSection identificationModule nctId: NCT06367231, orgStudyIdInfo id: Pro00134554, briefTitle: SCGs as a Proxy for Determining the Cognitive Status of Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: Detecting memory problems early is crucial for treating conditions like Mild Cognitive Impairment (MCI), which often leads to dementia. Currently, doctors use tests in clinics to check for these issues. However, there's a growing need for better methods to monitor our cognitive skills over time. Computer games emerge as a cost-effective solution for assessing the brain functions of older adults.In our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. We developed the VibrantMinds platform, featuring five games: Whack-a-Mole, Bejeweled, Mahjong Solitaire, Word Search, and Memory Game. We have evaluated these games for ease of use, enjoyment, and their impact on brain functions. Now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults.We are collecting demographic data, game-playing data, and cognitive test results. Our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. Additionally, we will assess both the perceived and observed engagement of older adults as they play the games., conditionsModule conditions: Mild Cognitive Impairment, conditions: Dementia, conditions: Alzheimer Disease, conditions: Healthy Aging, conditions: Cognitive Decline, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: VibrantMinds, outcomesModule primaryOutcomes measure: Cognition - Global, secondaryOutcomes measure: Cognition - Global, secondaryOutcomes measure: Cognition - Executive Function, secondaryOutcomes measure: Game Performance, secondaryOutcomes measure: Game Engagement, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367218, orgStudyIdInfo id: S058, briefTitle: Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience., conditionsModule conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: opioid based strategy, interventions name: opioid-free strategy, interventions name: Laryngeal mask airway; Preserved spontaneous breathing, interventions name: Double lumen tracheal tube; Mechanical ventilation, outcomesModule primaryOutcomes measure: Lung function 30 days after surgery, secondaryOutcomes measure: Intraoperative respiratory parameters, secondaryOutcomes measure: Intraoperative respiratory parameters, secondaryOutcomes measure: Intraoperative respiratory parameters, secondaryOutcomes measure: Intraoperative respiratory parameters, secondaryOutcomes measure: Intraoperative respiratory parameters, secondaryOutcomes measure: Perioperative stage indicators, secondaryOutcomes measure: Perioperative stage indicators, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative Lung function, secondaryOutcomes measure: Postoperative Lung function, secondaryOutcomes measure: Postoperative pulmonary complications, secondaryOutcomes measure: Postoperative gastrointestinal function, secondaryOutcomes measure: Postoperative depression/anxiety, secondaryOutcomes measure: Postoperative cognitive function, secondaryOutcomes measure: Time of first exercise after surgery, secondaryOutcomes measure: The 6-minute walking experiment, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Quality of life measurement, secondaryOutcomes measure: Intraoperative circulation parameters, secondaryOutcomes measure: Intraoperative circulation parameters, secondaryOutcomes measure: Intraoperative circulation parameters, secondaryOutcomes measure: Intraoperative circulation parameters, secondaryOutcomes measure: Intraoperative circulation parameters, secondaryOutcomes measure: Intraoperative circulation parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367205, orgStudyIdInfo id: LY2023-135-A, briefTitle: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies., conditionsModule conditions: Delayed Graft Function, conditions: End Stage Renal Disease, conditions: Kidney Transplantation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: Goal-Directed Fluid Therapy (GDFT), interventions name: Regular Fluid Therapy, outcomesModule primaryOutcomes measure: The incidence of delayed graft function (DGF), secondaryOutcomes measure: The area under the curve of serum creatinine levels from postoperative day 1 to 7, secondaryOutcomes measure: Duration of DGF, secondaryOutcomes measure: Number of dialysis sessions during postoperative hospitalization, secondaryOutcomes measure: Total urine output on the second postoperative day, secondaryOutcomes measure: Duration of intensive care unit (ICU) stay, secondaryOutcomes measure: Length of hospitalization, secondaryOutcomes measure: Incidence of readmission within 30 days post-discharge, otherOutcomes measure: The incidence of acute rejection during hospitalization, otherOutcomes measure: The survival rates of transplanted kidneys at the one-year postoperative mark, otherOutcomes measure: The survival rates of transplanted patients at the one-year postoperative mark, otherOutcomes measure: The occurrence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, contacts name: Jianjun Yang, Dr., role: CONTACT, geoPoint lat: 34.75778, lon: 113.64861, locations facility: General Hospital of Northern Theatre Command, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110016, country: China, contacts name: Yugang Diao, Dr., role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Renji Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Muyan Shi, B.S., role: CONTACT, phone: +862168383702, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06367192, orgStudyIdInfo id: SKITS2, secondaryIdInfos id: K23HL166697, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL166697, briefTitle: School Readiness Intervention for Preschool Children With Sickle Cell Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: St. Jude Children's Research Hospital, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 4-6 years old).Primary ObjectiveAssess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) diagnosed with sickle cell disease.Secondary ObjectivesObjective 1:Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (4-6) diagnosed with sickle cell disease.Objective 2:Examine implementation factors (i.e., barriers and facilitators) during post-intervention., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: The adapted Kids in Transition to School Intervention, interventions name: Standard school resources, outcomesModule primaryOutcomes measure: Feasibility of Intervention Measure, primaryOutcomes measure: Acceptability of Intervention Measure, secondaryOutcomes measure: Bracken School Readiness Assessment - 3rd Edition, secondaryOutcomes measure: Woodcock Johnson Tests of Achievement - Fourth Edition, secondaryOutcomes measure: NIH Toolbox Flanker Test, secondaryOutcomes measure: Head-Toes-Knees-Shoulders Revised, secondaryOutcomes measure: Behavior Rating Inventory of Executive Functioning Preschool or Child, secondaryOutcomes measure: The Parenting Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: St. Jude Children's Research Hospital, city: Memphis, state: Tennessee, zip: 38105, country: United States, contacts name: ANDREW HEITZER, PhD, role: CONTACT, contacts name: ANDREW HEITZER, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False |
protocolSection identificationModule nctId: NCT06367179, orgStudyIdInfo id: 202401039RINC, briefTitle: Virtual Reality and AI Wound-detecting System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-02-04, completionDateStruct date: 2025-02-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: This study is an experimental study. The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects. During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group. The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days. Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy., conditionsModule conditions: Pressure Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality and AI use, interventions name: Health education leaflet, outcomesModule primaryOutcomes measure: Accurate dressing change rate of pressure injury, secondaryOutcomes measure: Pressure injury dressing change of self-efficacy, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100225, country: Taiwan, contacts name: Cian Huei Wang, role: CONTACT, phone: (02)23123456, phoneExt: 263502, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06367166, orgStudyIdInfo id: RyazanSMU, briefTitle: Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ryazan State Medical University, class: OTHER, descriptionModule briefSummary: The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin)., conditionsModule conditions: Varicose Veins of Lower Limb, conditions: Varix, conditions: Vascular Diseases, conditions: Leg Edema, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: "Venarus®" (diosmin and hesperidin), interventions name: Endovenous laser ablation (EVLA) with miniphlebectomy, interventions name: Elastic compression, interventions name: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores, outcomesModule primaryOutcomes measure: changes in biomarkers of venous wall remodeling, primaryOutcomes measure: Changes in biomarkers expression in venous wall, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RyazanSMU, city: Ryazan, country: Russian Federation, geoPoint lat: 54.6269, lon: 39.6916, hasResults: False |
protocolSection identificationModule nctId: NCT06367153, orgStudyIdInfo id: 1447-0007, secondaryIdInfos id: 2023-510461-10-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1303-9187, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), briefTitle: A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2024-08-24, completionDateStruct date: 2024-08-24, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates)., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: CROSSOVER, interventionModelDescription: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: BI 1569912, interventions name: repaglinide, interventions name: midazolam, interventions name: bupropion, outcomesModule primaryOutcomes measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), secondaryOutcomes measure: Maximum measured concentration of the analyte in plasma (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367140, orgStudyIdInfo id: SYU 2021-06-001-002, briefTitle: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sahmyook University, class: OTHER, collaborators name: Seoul National University Hospital, collaborators name: Kyungdong University, descriptionModule briefSummary: The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The evaluators were blinded to the intervention details of the participants., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: EMG-triggered CIMCT device, interventions name: general cycling training, outcomesModule primaryOutcomes measure: Muscle Strength, primaryOutcomes measure: Static Balance, primaryOutcomes measure: Timed Up and Go (TUG), primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Functional Reach Test (FRT), primaryOutcomes measure: Modified Barthel Index (MBI), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Physicla Therapy, Sahmyook University, city: Seoul, zip: 01795, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06367127, orgStudyIdInfo id: Pingfanghu, briefTitle: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Shanghai Changzheng Hospital, class: OTHER, descriptionModule briefSummary: Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE., conditionsModule conditions: Hepatic Encephalopathy, conditions: Covert Hepatic Encephalopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of Beans Clamping in 1 minute, secondaryOutcomes measure: Participants' feedback on CBT1 test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Changzheng hospital, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06367114, orgStudyIdInfo id: ssCART-19-II-1, briefTitle: Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, class: INDUSTRY, collaborators name: The First Affiliated Hospital of Soochow University, collaborators name: Peking University People's Hospital, descriptionModule briefSummary: This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration., conditionsModule conditions: Relapsed or Refractory Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ssCART-19, interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL)., secondaryOutcomes measure: Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia., secondaryOutcomes measure: Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion., secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Recurrence free survival (RFS), secondaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of adverse events following ssCART-19 infusion, secondaryOutcomes measure: Pharmacodynamic of ssCART-19 cells, secondaryOutcomes measure: Pharmacodynamic of ssCART-19 cells, secondaryOutcomes measure: Pharmacodynamic of ssCART-19 cells, otherOutcomes measure: Anti-drug antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd., city: Shanghai, state: Shanghai, zip: 201210, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Affiliated Hospital of Soochow University, city: Suzhou, country: China, contacts name: Depei Wu, Dr., role: CONTACT, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06367101, orgStudyIdInfo id: 202002525B0, briefTitle: AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-18, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chang Gung University, class: OTHER, descriptionModule briefSummary: A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms., conditionsModule conditions: Parkinson Disease(PD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: AR training with gait and HRV feedback, outcomesModule primaryOutcomes measure: Walking Speed, primaryOutcomes measure: Step Length, primaryOutcomes measure: Step Time, primaryOutcomes measure: Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR), primaryOutcomes measure: Time-Domain Index of HRV：pNN50, primaryOutcomes measure: Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD), primaryOutcomes measure: Frequency-Domain Index of HRV: Low Frequency (LF), primaryOutcomes measure: Frequency-Domain Index of HRV: High Frequency (HF), primaryOutcomes measure: Frequency-Domain Index of HRV: Ratio of LF to HF Power, primaryOutcomes measure: Total Time to Complete the Time Up and Go test (TUG test), secondaryOutcomes measure: Double Support Time, secondaryOutcomes measure: Single Support Time, secondaryOutcomes measure: Swing Time, secondaryOutcomes measure: Stance Time, secondaryOutcomes measure: Cadence, secondaryOutcomes measure: Total UPDRS-III Score, secondaryOutcomes measure: Total NFOG-Q Score, secondaryOutcomes measure: Overall PDQ-39 Score, secondaryOutcomes measure: Total HADS Score, secondaryOutcomes measure: Overall PSQI Score, secondaryOutcomes measure: Non-linear Index of HRV: SD1, secondaryOutcomes measure: Non-linear Index of HRV: SD2, secondaryOutcomes measure: Non-linear Index of HRV: Ratio of SD1-to-SD2, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University, status: RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Ya-Ju Chang, PhD, role: CONTACT, phone: 88632118800, phoneExt: 5515, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False |
protocolSection identificationModule nctId: NCT06367088, orgStudyIdInfo id: Sophia, briefTitle: Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients., conditionsModule conditions: Triple-negative Breast Cancer, conditions: Cadonilimab, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, outcomesModule primaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: AE, otherOutcomes measure: Progression-free survival, otherOutcomes measure: Overall survival, otherOutcomes measure: Disease control rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Jie Xiong, role: CONTACT, phone: +8615927611872, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06367075, orgStudyIdInfo id: AK104-sarcoma-202401, briefTitle: A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, collaborators name: Sun Yat-sen University, collaborators name: Xiangya Hospital of Central South University, collaborators name: Yunnan Cancer Hospital, collaborators name: The Affiliated Hospital Of Guizhou Medical University, collaborators name: First Affiliated Hospital of Guangxi Medical University, descriptionModule briefSummary: This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin., conditionsModule conditions: Advanced Soft-tissue Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: cadonilimab (AK104) with adriamycin, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Adriamycin, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Adverse event (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367062, orgStudyIdInfo id: SH9H-2023-T296, briefTitle: General Anesthesia/Surgical Exposure on White Matter Development in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development., conditionsModule conditions: Neurodevelopmental Delay, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: MRI-based assessment of brain development, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06367049, orgStudyIdInfo id: 2023-FXY-230-NPC, briefTitle: Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, collaborators name: Guangdong Women and Children Hospital, collaborators name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University, descriptionModule briefSummary: Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer., conditionsModule conditions: Nasopharyngeal Carcinoma, conditions: Early Diagnosis of Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 470, type: ACTUAL, armsInterventionsModule interventions name: Methylation-specific PCR, outcomesModule primaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06367036, orgStudyIdInfo id: 2021-52, briefTitle: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-02, primaryCompletionDateStruct date: 2022-12-29, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Uskudar University, class: OTHER, descriptionModule briefSummary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test., conditionsModule conditions: Pain, conditions: Ecchymosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Two researchers do not know which site was injected., whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Topical hypericum perforatum oil intervention, outcomesModule primaryOutcomes measure: Pain point, primaryOutcomes measure: Ecchymosis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatice Demirdağ, city: Üsküdar, state: İstanbul, zip: 34672, country: Turkey, geoPoint lat: 41.02252, lon: 29.02369, hasResults: False |
protocolSection identificationModule nctId: NCT06367023, orgStudyIdInfo id: 32-2024, briefTitle: Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Manipur International University, class: OTHER, collaborators name: Brahmakumaris, descriptionModule briefSummary: Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention., conditionsModule conditions: Prevalence, conditions: Depression, conditions: Happiness, conditions: Quality of Life, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Rajyoga Meditation Practice, outcomesModule primaryOutcomes measure: Anxiety score, primaryOutcomes measure: Depression score, primaryOutcomes measure: quality of life score, secondaryOutcomes measure: Rate of Relapse, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rehabilitation center, city: Biratnagar, state: Koshi, zip: 56613, country: Nepal, contacts name: Rajiv Ranjan Karn, MPH, role: CONTACT, phone: +9779842068053, email: [email protected], contacts name: Ajaya Bhattarai, PhD, role: CONTACT, phone: +9779842077434, email: [email protected], geoPoint lat: 26.45505, lon: 87.27007, hasResults: False |
protocolSection identificationModule nctId: NCT06367010, orgStudyIdInfo id: MR-36-24-010942, briefTitle: Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy., conditionsModule conditions: Thyroid Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Iodine-125 brachytherapy combine with Anlotinib, outcomesModule primaryOutcomes measure: The CT images were used to measure the change in the maximum diameter of the lesion in millimeters., primaryOutcomes measure: Serological assessment, primaryOutcomes measure: Use the Numerical Rating Scale (NRS) to record patients' pain scores., primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiangxi Cancer Hospital, city: Nanchang, state: Jiangxi, zip: 330029, country: China, geoPoint lat: 28.68396, lon: 115.85306, hasResults: False |
protocolSection identificationModule nctId: NCT06366997, orgStudyIdInfo id: CQGOG0207, briefTitle: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-09, primaryCompletionDateStruct date: 2023-04-18, completionDateStruct date: 2023-05-05, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chongqing University Cancer Hospital, class: OTHER, collaborators name: Zhejiang Cancer Hospital, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: 3D Medicines Corporation, descriptionModule briefSummary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study., conditionsModule conditions: Epithelial Ovarian Cancer, conditions: Adnexal Mass, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1352, type: ACTUAL, outcomesModule primaryOutcomes measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: No.181, Hanyulu Road, Shapingba District, city: Chongqing, state: Chongqing, zip: 400030, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06366984, orgStudyIdInfo id: Adeel4, briefTitle: Outcome of Plastibell Circumcision Versus Open Method Circumcision, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-11, primaryCompletionDateStruct date: 2022-07-11, completionDateStruct date: 2022-08-11, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Children Hospital and Institute of Child Health, Lahore, class: OTHER, descriptionModule briefSummary: To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition)., conditionsModule conditions: Bleeding, conditions: Site Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controll trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: outcome assessor is unaware of group allocated, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 174, type: ACTUAL, armsInterventionsModule interventions name: plastibell, interventions name: open method, outcomesModule primaryOutcomes measure: infection, eligibilityModule sex: MALE, minimumAge: 1 Day, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: The Children Hospital, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06366971, orgStudyIdInfo id: auhucgun01, briefTitle: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD., conditionsModule conditions: Sacroiliac Joint Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: The Patient Education, interventions name: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training, outcomesModule primaryOutcomes measure: The Level of Low Back Pain, primaryOutcomes measure: Mobility, primaryOutcomes measure: Flexibility, primaryOutcomes measure: Lumbar Range of Motion, primaryOutcomes measure: Posture, primaryOutcomes measure: Trunk Muscle Endurance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Atlas University, city: Istanbul, state: Kagıthane, zip: 34408, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06366958, orgStudyIdInfo id: Dorsal wrist ganglion, briefTitle: Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-02-02, completionDateStruct date: 2025-04-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion, conditionsModule conditions: Hand Ganglion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: excision of dorsal wrist ganglion, outcomesModule primaryOutcomes measure: comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion, secondaryOutcomes measure: compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366945, orgStudyIdInfo id: SYSKY-2024-157-02, briefTitle: Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2029-05-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis, conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, conditions: Head and Neck Cancer, conditions: HNSCC, conditions: Head Cancer Neck, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin, interventions name: Tislelizumab, interventions name: Polymeric Micellar Paclitaxel, interventions name: Surgical Resection of Primary +/- Neck Dissection, interventions name: Post-operative radiation therapy, outcomesModule primaryOutcomes measure: Major pathological response (MPR) rate of metastatic lymph nodes, secondaryOutcomes measure: Major pathological response (MPR) rate of primary tumor, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Incidence of treatment-related adverse events, secondaryOutcomes measure: EORTC QLQ-C30, secondaryOutcomes measure: pathological downstaging rate, secondaryOutcomes measure: Distant metastasis-free survival(DMFS) rate, secondaryOutcomes measure: logical regional-free survival(LRFS) rate, otherOutcomes measure: Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366932, orgStudyIdInfo id: DermAtOmics-II, briefTitle: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Instituto de Investigación Hospital Universitario La Paz, class: OTHER, descriptionModule briefSummary: This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Second-line systemic treatment, interventions name: Folllow-up of second-line systemic treatment already started, outcomesModule primaryOutcomes measure: Percentage of patients with primary non-response to second-line treatment., secondaryOutcomes measure: Percentage of patients achieving EASI-75, secondaryOutcomes measure: Time to treatment failure after week 16, secondaryOutcomes measure: Mean percentage of change in Eczema Area and Severity Index (EASI) score, secondaryOutcomes measure: Percentage of change in SCORAD (SCORing Atopic Dermatitis), secondaryOutcomes measure: Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis), secondaryOutcomes measure: Change of IGA (Investigator Global Assessment), secondaryOutcomes measure: Time to IGA score of 0/1 (Investigator Global Assessment), secondaryOutcomes measure: Change of BSA (Body surface area), secondaryOutcomes measure: Change in NRS, secondaryOutcomes measure: Change in RECAP, secondaryOutcomes measure: Percentage of patients having a variation of 4 points in their improvement in DLQI, secondaryOutcomes measure: Change in POEM (Patient-Oriented Eczema Measure), secondaryOutcomes measure: Rate of adverse events associated to second-line systemic treatment, secondaryOutcomes measure: Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital La Paz, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, contacts name: Irene García, MD, role: CONTACT, phone: +34-912071466, email: [email protected], geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06366919, orgStudyIdInfo id: DPT/Batch-Fall19/559, briefTitle: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients, conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Alexander Technique (AT), interventions name: Feldenkrais Technique (FT), outcomesModule primaryOutcomes measure: Northwick Park Neck Pain Questionnaire, primaryOutcomes measure: REEDCO Posture Assessment and Sleep Quality Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University, city: Lahore, state: Punjab, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False |
protocolSection identificationModule nctId: NCT06366906, orgStudyIdInfo id: SYSKY-2023-426-01, briefTitle: 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-10, primaryCompletionDateStruct date: 2024-02-10, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis., conditionsModule conditions: HNSCC, conditions: AI, conditions: Radiomic, conditions: MRI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 319, type: ACTUAL, armsInterventionsModule interventions name: The Resnet50 deep learning (DL) model, outcomesModule primaryOutcomes measure: AUC(the area under the curve) values of the model, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun yat-sen memorial hospital, city: Guangzhou, state: Guangdong, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun yat-sun memorial hospital, city: Guangzhou, state: Guangdong, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06366893, orgStudyIdInfo id: PR(AG)297/2019, briefTitle: Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03-04, completionDateStruct date: 2025-03-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency.The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency.The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona., conditionsModule conditions: Infant, Premature, Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: DHA/AA emulsion supplement for preterm infant, outcomesModule primaryOutcomes measure: Percentage comparison of erythrocyte membrane levels of DHA and AA, secondaryOutcomes measure: Tolerance of DHA emulsion administration, secondaryOutcomes measure: Compare the presence of pathologies in preterm infants between the supplemented group and the control group, eligibilityModule sex: ALL, maximumAge: 7 Days, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Materno Infantil Vall d'Hebron, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Félix Castillo Salinas, Dr., role: CONTACT, phone: +34 934893899, email: [email protected], contacts name: Félix Castillo Salinas, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06366880, orgStudyIdInfo id: 2022.HPS.DI.434, briefTitle: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hospital Pediátrico de Sinaloa, class: OTHER_GOV, descriptionModule briefSummary: Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants., conditionsModule conditions: Cholestasis in Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Parenteral nutrition cycling, outcomesModule primaryOutcomes measure: Incidence of cholestasis on Day 28 of admission., secondaryOutcomes measure: are total plasma bilirrubine profiles, secondaryOutcomes measure: the incidence of hypoglycaemia, eligibilityModule sex: ALL, minimumAge: 1 Hour, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Pediatrico de Sinaloa, status: RECRUITING, city: Culiacán, state: Sinaloa, zip: 80200, country: Mexico, contacts name: Ana Karen Camargo Angulo, Dr., role: CONTACT, phone: 6681890586, phoneExt: +52, email: [email protected], geoPoint lat: 24.79032, lon: -107.38782, hasResults: False |
protocolSection identificationModule nctId: NCT06366867, orgStudyIdInfo id: Pro00097579, briefTitle: An Open Platform of Serious Games for Cognitive Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-03, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, collaborators name: Alberta Health services, collaborators name: CapitalCare, descriptionModule briefSummary: Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning., conditionsModule conditions: Mild Cognitive Impairment, conditions: Dementia, conditions: Alzheimer Disease, conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: DOUBLE, maskingDescription: Random allocation, 1:1 ratio by a computer-based randomizer, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: VibrantMinds, outcomesModule primaryOutcomes measure: Cognition - Global, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Agitation, secondaryOutcomes measure: Occupational Performance, secondaryOutcomes measure: Engagement, secondaryOutcomes measure: Affect, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CapitalCare Group Inc Facilities, status: RECRUITING, city: Edmonton, zip: T5J 3M9, country: Canada, contacts name: Adriana Rios Rincon, PhD, R.OT, role: CONTACT, phone: 7804921728, email: [email protected], geoPoint lat: 53.55014, lon: -113.46871, hasResults: False |
protocolSection identificationModule nctId: NCT06366854, orgStudyIdInfo id: IRAS: 332418, briefTitle: UK ANDROMEDA-Shock-2 RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, collaborators name: Pontificia Universidad Catolica de Chile, collaborators name: University of Rotterdam, The Netherlands, descriptionModule briefSummary: The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care., conditionsModule conditions: Septic Shock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Personalised fluid and haemodynamic resuscitation, outcomesModule primaryOutcomes measure: hospital mortality, primaryOutcomes measure: organ support, primaryOutcomes measure: length of stay, secondaryOutcomes measure: mortality, secondaryOutcomes measure: vital organ support, secondaryOutcomes measure: length of stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366841, orgStudyIdInfo id: 6439, briefTitle: Stigma and Psychological profilE in REctal-anal caNcer pAtients, acronym: SERENA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time., conditionsModule conditions: Rectal Cancer, conditions: Anal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: Psychological tests administration, outcomesModule primaryOutcomes measure: Evaluation of rectal and anal cancer stigma, secondaryOutcomes measure: Evaluation of psychological characteristics in rectal and anal cancer, secondaryOutcomes measure: Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version, secondaryOutcomes measure: Toronto Alexithymia Scale, secondaryOutcomes measure: EORTC QLQ - CR29 and EORTC QLQ-ANL27, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06366828, orgStudyIdInfo id: 11446, briefTitle: Prediction Models for Complications After CRT in Esophageal Cancer, acronym: MODELS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2030-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Dutch Cancer Society, collaborators name: Comprehensive Cancer Centre The Netherlands, collaborators name: Dutch Institute for Clinical Auditing (DICA), collaborators name: ZorgTTP, descriptionModule briefSummary: The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer, conditionsModule conditions: The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: retrospective, outcomesModule primaryOutcomes measure: Multivariable NTCP models will be developed for the prediction of the following, primaryOutcomes measure: Cardiac events grade II or higher (CTCAE v 5.0), including:, primaryOutcomes measure: Mortality, primaryOutcomes measure: Complication Sum Score, that will be determined in Delphi consensus, secondaryOutcomes measure: Patient-rated dysphagia, secondaryOutcomes measure: Patient-rated nausea, secondaryOutcomes measure: Patient-rated fatigue / daily functioning, secondaryOutcomes measure: Hospitalization after esophagectomy (days), secondaryOutcomes measure: Intensive care unit stay after esophagectomy (days), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radboud UMC, status: RECRUITING, city: Nijmegen, state: Gelderland, zip: 6525GA, country: Netherlands, contacts name: H. Rutten, MD, role: CONTACT, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Maastro clinic, status: RECRUITING, city: Maastricht, state: Limburg, zip: 6229ET, country: Netherlands, contacts name: M. Berbee, MD, PHD, role: CONTACT, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: P. van Rossum, MD, PHD, role: CONTACT, contacts name: H.W.M. van Laarhoven, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015GE, country: Netherlands, contacts name: J. Nuyttens, MD, PHD, role: CONTACT, contacts name: B. Wijnhoven, MD, PHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Holland PTC, status: NOT_YET_RECRUITING, city: Delft, country: Netherlands, contacts name: Yvonne Klaver, MD, PHD, role: CONTACT, geoPoint lat: 52.00667, lon: 4.35556, locations facility: UMCG, status: RECRUITING, city: Groningen, zip: 9715GZ, country: Netherlands, contacts name: Christina Muijs, MD, PHD, role: CONTACT, phone: 0503616161, email: [email protected], contacts name: C. T. Muijs, MD, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: J. A. Langendijk, Prof., MD, PHD, role: SUB_INVESTIGATOR, contacts name: B. van Etten, MD, PHD, role: SUB_INVESTIGATOR, contacts name: J. J. de Haan, MD, PHD, role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Zuyderland hospital, status: RECRUITING, city: Heerlen, country: Netherlands, contacts name: Meindert Sosef, MD, role: CONTACT, geoPoint lat: 50.88365, lon: 5.98154, locations facility: UMCU, status: RECRUITING, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: G Meijer, PHD, role: CONTACT, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False |
protocolSection identificationModule nctId: NCT06366815, orgStudyIdInfo id: 4619, briefTitle: phenotypeS in Non Ambulant Duchenne Muscular Dystrophy, acronym: GUP21003, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function, conditionsModule conditions: Duchenne Muscular Dystrophy, conditions: Natural History, conditions: Motor Function; Retardation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Different Phenotypes of non ambulant patients with Duchenne Muscular Dystrophy, outcomesModule primaryOutcomes measure: motor function, primaryOutcomes measure: respiratory function, primaryOutcomes measure: cardiac function, secondaryOutcomes measure: identify patterns of severity and of progression related to differnt genotypes, eligibilityModule sex: MALE, minimumAge: 8 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS catholic univeristy, status: RECRUITING, city: Roma, country: Italy, contacts name: Marika Pane, prof, role: CONTACT, phone: 0038063015, phoneExt: 6742, email: [email protected], contacts name: Daniela Leone, role: CONTACT, phone: 00390630158821, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06366802, orgStudyIdInfo id: Prognosis model-MM09, briefTitle: Cohort Construction and Prognostic Model Construction for Multiple Myeloma, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-05-03, primaryCompletionDateStruct date: 2027-05-02, completionDateStruct date: 2027-05-02, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression free survival(PFS), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215006, country: China, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False |
protocolSection identificationModule nctId: NCT06366789, orgStudyIdInfo id: ZE46-0134-0002, secondaryIdInfos id: CT-2024-CTN-00161-1, type: OTHER, domain: Therapeutic Goods Administration, briefTitle: Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Eilean Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 mutated Relapsed or Refractory Acute Myeloid Leukemia, conditionsModule conditions: AML With Gene Mutations, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: dose escalation and dose optimization study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ZE46-0134, outcomesModule primaryOutcomes measure: The incidence of DLTs, secondaryOutcomes measure: Incidence of AE/SAE, secondaryOutcomes measure: Incidence of clinically significant abnormal laboratory results, secondaryOutcomes measure: Incidence of abnormal clinically significant ECG results, secondaryOutcomes measure: Number of patients with AEs of Grade ≥ 3, secondaryOutcomes measure: Number of treatment-related deaths, secondaryOutcomes measure: Plasma Cmax, secondaryOutcomes measure: Plasma Css, secondaryOutcomes measure: Plasma Cmin, secondaryOutcomes measure: Plasma AUC, secondaryOutcomes measure: Number of patients attaining any type of Complete Remission (CR, CRh, CRi) by Cycle 6, secondaryOutcomes measure: Number of patients attaining CR by Cycle 6, secondaryOutcomes measure: Number of patients attaining response (CR, CRh, CRi, MLFS) by Cycle 6, otherOutcomes measure: Proportion of patients who became FLT3 ITD and TKD undetectable, otherOutcomes measure: Number of patients with Genomic or proteomic abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Linear Clinical Research Ltd, city: Perth, state: Nedlands, WA, zip: 6009, country: Australia, contacts name: Carolyn Grove, Prof, role: CONTACT, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False |
protocolSection identificationModule nctId: NCT06366776, orgStudyIdInfo id: 23-278, briefTitle: Emulated Study of Vitamin D Correction vs Non-Correction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: The Cooper Health System, class: OTHER, collaborators name: Won Sook Chung Foundation, descriptionModule briefSummary: * This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database.* The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels., conditionsModule conditions: Vitamin D Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 9000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A., primaryOutcomes measure: Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A., secondaryOutcomes measure: Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B)., secondaryOutcomes measure: Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366763, orgStudyIdInfo id: ChengduUTCMvs5, briefTitle: Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chengdu University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction., conditionsModule conditions: Vascular Diseases, Peripheral, conditions: Venous Insufficiency of Leg, conditions: Varicose Veins of Lower Limb, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, outcomesModule primaryOutcomes measure: Pain after radiofrequency ablation, primaryOutcomes measure: Bleeding after radiofrequency ablation, primaryOutcomes measure: Tension blisters after radiofrequency ablation, secondaryOutcomes measure: The rate of occlusion of treated vein post-procedure, secondaryOutcomes measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14), secondaryOutcomes measure: Clinical Change using Venous Clinical Severity Score (VCSS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of Chengdu University of Traditional Chinese Medicine, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Chunshui He, Doctor, role: CONTACT, phone: 86-18981885601, email: [email protected], contacts name: Qiqi Wangqiqi, Master, role: CONTACT, phone: 86-15184495605, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06366750, orgStudyIdInfo id: CDX0159-10, secondaryIdInfos id: 2023-510279-80-00, type: OTHER, domain: EU CT, briefTitle: A Study of Barzolvolimab in Patients With Prurigo Nodularis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Celldex Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis., conditionsModule conditions: Prurigo Nodularis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: barzolvolimab, interventions name: Matching Placebo, outcomesModule primaryOutcomes measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24., secondaryOutcomes measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24)., secondaryOutcomes measure: Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24., secondaryOutcomes measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24., secondaryOutcomes measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24., secondaryOutcomes measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD., secondaryOutcomes measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24., secondaryOutcomes measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Revival Research Institute, LLC, status: RECRUITING, city: Troy, state: Michigan, zip: 48084, country: United States, contacts name: Sikar Grewal, role: CONTACT, email: [email protected], geoPoint lat: 42.60559, lon: -83.14993, locations facility: Center for Clinical Studies, status: RECRUITING, city: Webster, state: Texas, zip: 77598, country: United States, contacts name: Perla Rivas, role: CONTACT, email: [email protected], geoPoint lat: 29.53773, lon: -95.11826, hasResults: False |
protocolSection identificationModule nctId: NCT06366737, orgStudyIdInfo id: CEBD-CU-2024-03-02, briefTitle: En-mass Retraction by Lingual Retractor Versus Clear Aligner Appliances, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: en-mass retraction by lingual retractor versus clear alighner therapy, conditionsModule conditions: Maxillary Prognathism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Lingual Retractor Appliance, interventions name: clear aligner, outcomesModule primaryOutcomes measure: patient satisfaction ( time, cost, quality), secondaryOutcomes measure: inclination of upper anterior teeth, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Cairo, country: Egypt, contacts name: zainab abdulrhman, role: CONTACT, phone: 00201092445775, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06366724, orgStudyIdInfo id: 2024P000087, briefTitle: LIFT: Life Improvement Trial, acronym: LIFT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Open Medicine Foundation, descriptionModule briefSummary: The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance.This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition., conditionsModule conditions: ME/CFS, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Randomized factorial group double-blinded placebo-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The Mass General Brigham Investigational Drug Services (IDS) will be responsible for randomizing the four arms. The rest of the study staff and collaborators will be blinded as well as the participant., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Pyridostigmine, interventions name: Low-Dose Naltrexone, interventions name: Placebo, outcomesModule primaryOutcomes measure: Functional Capacity, primaryOutcomes measure: Physiologic Response - Oxygen Uptake Efficiency Slope (OUES), primaryOutcomes measure: Physiologic Response - Oxygen Utilization (VO2), primaryOutcomes measure: Physiologic Response - Heart Rate Recovery (HRR), secondaryOutcomes measure: Post-Exertional Malaise, secondaryOutcomes measure: PROMIS-29-Pain, secondaryOutcomes measure: Daily Activity, secondaryOutcomes measure: Heart Rate Variability, secondaryOutcomes measure: Blood Oxygen, secondaryOutcomes measure: Resting Heart Rate, secondaryOutcomes measure: DANA Brain Vital-Simple Reaction Time (SRT), secondaryOutcomes measure: DANA Brain Vital-Procedural Reaction Time (PRT), secondaryOutcomes measure: DANA Brain Vital-Memory Search (MS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366711, orgStudyIdInfo id: 23/BW/MAT/NO/754, briefTitle: Remote Telemedicine Fetal Monitoring Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Birmingham Women's NHS Foundation Trust, class: OTHER_GOV, collaborators name: GE Healthcare, collaborators name: Nestmedic S.A., descriptionModule briefSummary: During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited.Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received.Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research., conditionsModule conditions: Pregnancy, High Risk, conditions: Telemonitoring, conditions: Telemedicine, conditions: Ultrasound, conditions: Cardiotocography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives., primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Pregnabit Pro device and PregnaOne platform, interventions name: Pulsenmore device, outcomesModule primaryOutcomes measure: The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring., primaryOutcomes measure: The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring., secondaryOutcomes measure: The number of participants completing the full schedule of home maternal-fetal monitoring episodes., secondaryOutcomes measure: To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home?, secondaryOutcomes measure: The number of women approached who agreed to participate within the study., secondaryOutcomes measure: What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring., secondaryOutcomes measure: What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring., secondaryOutcomes measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring., secondaryOutcomes measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring., secondaryOutcomes measure: The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06366698, orgStudyIdInfo id: 23-55, briefTitle: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia, acronym: IDA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Arrowhead Regional Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded., conditionsModule conditions: Iron Deficiency Anemia of Pregnancy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Venofer 200 MG Per 10 ML Injection, interventions name: Ferrous sulfate, outcomesModule primaryOutcomes measure: Hemoglobin difference, primaryOutcomes measure: Ferritin difference, primaryOutcomes measure: Delivery Hemoglobin, primaryOutcomes measure: Rates of blood transfusion, primaryOutcomes measure: Symptoms, secondaryOutcomes measure: Preterm delivery, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Birthweight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arrowhead Regional Medical Center, status: RECRUITING, city: Colton, state: California, zip: 92324, country: United States, contacts name: Guillermo Valenzuela, MD, role: CONTACT, phone: 909-580-4145, email: [email protected], contacts name: Tina M Bui, DO, role: PRINCIPAL_INVESTIGATOR, contacts name: Kristina Roloff, DO, role: SUB_INVESTIGATOR, contacts name: Guillermo Valenzuela, MD, role: SUB_INVESTIGATOR, contacts name: Lily Zhu, DO, role: SUB_INVESTIGATOR, contacts name: Phoebe Jen, DO, role: SUB_INVESTIGATOR, contacts name: Mary Tsaturian, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.0739, lon: -117.31365, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-21, uploadDate: 2024-04-10T14:44, filename: ICF_000.pdf, size: 165063, hasResults: False |
protocolSection identificationModule nctId: NCT06366685, orgStudyIdInfo id: YJS20230170, briefTitle: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy, acronym: Recovery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Mengmeng Yuan, class: OTHER, collaborators name: Anhui Medical University, descriptionModule briefSummary: Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist.This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management., conditionsModule conditions: Esophageal Cancer, conditions: Exercise Training, conditions: Psychotherapy, conditions: Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Exercise and Psychological Intervention, outcomesModule primaryOutcomes measure: the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC), secondaryOutcomes measure: 6-Minute Walk Test, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Postoperative Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Medical University, city: Hefei, state: Anhui, zip: 234000, country: China, contacts name: Mengmeng Yuan, Graduate, role: CONTACT, phone: 18205575607, email: [email protected], contacts name: Shaoxue Li, Graduate, role: CONTACT, phone: 18712335223, email: [email protected], contacts name: Shuwen Li, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False |
protocolSection identificationModule nctId: NCT06366672, orgStudyIdInfo id: 202312043, briefTitle: Evaluating the Human Immune Response to the JYNNEOS Vaccine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow., conditionsModule conditions: Vaccinia, conditions: Virus Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will be vaccinated with MVA-BN according to the FDA-approved labeling and immune responses in the blood, lung mucosa, skin, and bone marrow will be monitored prior to and following vaccination using phlebotomy, research bronchoscopy, skin punch biopsy, and bone marrow aspiration procedures., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection, interventions name: Phlebotomy, interventions name: Research bronchoscopy, interventions name: Skin punch biopsy, interventions name: Bone marrow aspiration, outcomesModule primaryOutcomes measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the blood, primaryOutcomes measure: Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma, secondaryOutcomes measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways, secondaryOutcomes measure: Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid, otherOutcomes measure: Evaluate the magnitude and surface phenotype of T cells in the blood, airspace, and skin over time, otherOutcomes measure: Evaluate the magnitude and surface phenotype of B cells in the blood and bone marrow over time., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Washington University in Saint Louis School of Medicine Emergency Care and Research Core, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Jamie Mills, role: CONTACT, phone: 314-305-1054, email: [email protected], geoPoint lat: 38.62727, lon: -90.19789, hasResults: False |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.