data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06279533, orgStudyIdInfo id: LV232-02, briefTitle: Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Vigonvita Life Sciences, class: INDUSTRY, descriptionModule briefSummary: This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PK characteristics of multiple ascending doses study is parallel design, and FE study is crossover design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: PK characteristics of multiple ascending doses study is double-blinded, placebo-controlled design, and FE study is open-label design, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: LV232/Placebo, interventions name: LV232, outcomesModule primaryOutcomes measure: Tmax, primaryOutcomes measure: Cmax, primaryOutcomes measure: T1/2, primaryOutcomes measure: AUC0-t, primaryOutcomes measure: AUC0-24h, primaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: Number of participants with treatment emergent treatment-related adverse event(s), secondaryOutcomes measure: Laboratory test, secondaryOutcomes measure: Vital signs, secondaryOutcomes measure: Number of participants with ECG findings of potential clinical importance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Xuhui Central Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Chen Yu, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06279520, orgStudyIdInfo id: 2023-08-003, briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result, conditionsModule conditions: Automobile Driving, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VR Driving Simulator, interventions name: Computerized Neurocognitive Function Test, interventions name: Driver Test Station, interventions name: On-road field driving Test, outcomesModule primaryOutcomes measure: Feasibility of VR driving simulator, primaryOutcomes measure: Driving performance in simulator, measured by driving errors, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ja-Ho Leigh, M.D. Msc., role: CONTACT, email: mazican@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06279507, orgStudyIdInfo id: PMK-00007, briefTitle: Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Phramongkutklao College of Medicine and Hospital, class: OTHER, collaborators name: Chulalongkorn University, collaborators name: Khon Kaen University, collaborators name: Police General Hospital, descriptionModule briefSummary: The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritisParticipants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo., conditionsModule conditions: Knee Osteoarthritis, conditions: Pain, Joint, conditions: Stiffness of Knee, Not Elsewhere Classified, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants would be allocated into one treatment group;* Intervention group : Hyaluronic acid injection* Placebo group : Normal saline, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participants will not know what treatment they receive. Co-investigators will not know what the participants are injected. Outcome assessor will not know which treatment participant receive., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: Sodium Hyaluronate, interventions name: Normal Saline, interventions name: Triamcinolone Acetonide 10mg/mL, outcomesModule primaryOutcomes measure: Pain outcome measurement, primaryOutcomes measure: Joint stiffness and function measurement, primaryOutcomes measure: Overall symptom assessment, secondaryOutcomes measure: Knee performance evaluation, secondaryOutcomes measure: Quality of life assessment, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Phramongkutklao Hospital, status: RECRUITING, city: Bangkok, zip: 10400, country: Thailand, contacts name: Suthee Panichkul, role: CONTACT, phone: 6623547600, phoneExt: 93681, email: suthee99@yahoo.com, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
|
protocolSection identificationModule nctId: NCT06279494, orgStudyIdInfo id: Sirolimus for GVHD prophylaxis, briefTitle: Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors., conditionsModule conditions: Acute Leukemia, conditions: Myelodysplastic Syndromes, conditions: Severe Aplastic Anemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus, interventions name: Abatacept, interventions name: MMF, interventions name: ATG, outcomesModule primaryOutcomes measure: Incidence of Grade 2-4 aGVHD within 100 days post transplantation, secondaryOutcomes measure: Incidence of chronic GVHD (cGVHD) within 1 year post transplantation, secondaryOutcomes measure: Incidence of thrombotic microangiopathy within 1 year post transplantation, otherOutcomes measure: Cumulative incidence of relapse, otherOutcomes measure: Transplant-related mortality, otherOutcomes measure: Overall survival, otherOutcomes measure: Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV), eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279481, orgStudyIdInfo id: PUMCH-K2458, briefTitle: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group., conditionsModule conditions: Pain, conditions: Colonoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a single-centered, prospective, randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Nonpharmacological method, outcomesModule primaryOutcomes measure: Comparison of Visual Analogue Scale Mean Scores by Groups, secondaryOutcomes measure: Comparison of State Trait Anxiety Inventory Mean Scores by Groups, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Pulse Rate, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Blood Pressure, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Respiration Rate, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Oxygen Saturation, secondaryOutcomes measure: Comparison of Patient Satisfaction of Colonoscopy between Groups, secondaryOutcomes measure: Comparison of Patient Willingness of Future Colonoscopy between Groups, secondaryOutcomes measure: Comparison of Adverse Effects in both groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100010, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06279468, orgStudyIdInfo id: I-23PJ2232, briefTitle: Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole., conditionsModule conditions: Adolescent Idiopathic Scoliosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: intervertebral disc release, interventions name: Ponte osteotomy, outcomesModule primaryOutcomes measure: The correction rate of axial rotation of the apex vertebrae, secondaryOutcomes measure: Lumbar curve, secondaryOutcomes measure: UIV tilt, secondaryOutcomes measure: C7-CSVL, secondaryOutcomes measure: Lumbar lordosis, secondaryOutcomes measure: SVA, secondaryOutcomes measure: Radiographic parameters measured by CT scan: LIV and LIV+1 translation, secondaryOutcomes measure: LIV tilt, secondaryOutcomes measure: The lowest instrumented vertebra disc angle, secondaryOutcomes measure: Age, secondaryOutcomes measure: Gender, secondaryOutcomes measure: Risser grade of the patients at the time of surgery, secondaryOutcomes measure: number of fused spinal levels, secondaryOutcomes measure: length of operation, secondaryOutcomes measure: Scoliosis Research Society-22,SRS-22 score, secondaryOutcomes measure: the MOS item short from health survey, SF-36 score, secondaryOutcomes measure: EuroQol Five Dimensions Questionnaire, EQ-5D score, secondaryOutcomes measure: Perioperative total blood loss, secondaryOutcomes measure: Visible blood loss, secondaryOutcomes measure: Perioperative transfusion amounts, secondaryOutcomes measure: Perioperative transfusion rates, secondaryOutcomes measure: Rate of postoperative infection, secondaryOutcomes measure: The incidence of nerve damage, secondaryOutcomes measure: The incidence of loss of correction, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100035, country: China, contacts name: Qianyu Zhuang, Professor, role: CONTACT, phone: +86 15200838996, email: baizhuosong@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06279455, orgStudyIdInfo id: E-74555795-050.01.04-392120, briefTitle: Pelvic Floor Muscle Exercise During Pregnancy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-05, primaryCompletionDateStruct date: 2023-03-06, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above., conditionsModule conditions: Lower Urinary Tract Symptoms, conditions: Sexual Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pelvic Floor Muscle Exercise Group, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Pelvic Floor Muscle Exercise, outcomesModule primaryOutcomes measure: Sexual Function, primaryOutcomes measure: Lower Urinary Tract Symptoms, primaryOutcomes measure: Birth Process, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul University-Cerrahpasa, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06279442, orgStudyIdInfo id: LACOG 0723, briefTitle: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Latin American Cooperative Oncology Group, class: OTHER, descriptionModule briefSummary: This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites., conditionsModule conditions: Carcinoma Adrenal, conditions: Carcinoma, Adrenocortical Recurrent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Demographic and Clinical Characterization of Adrenocortical Carcinoma in Brazil, secondaryOutcomes measure: Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival, secondaryOutcomes measure: Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A.C. Camargo Cancer Center, city: São Paulo, zip: 01.509-001, country: Brazil, contacts name: Milena Shizue Tariki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
|
protocolSection identificationModule nctId: NCT06279429, orgStudyIdInfo id: KTGH11137, briefTitle: Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kuang Tien General Hospital, class: OTHER, descriptionModule briefSummary: Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia., conditionsModule conditions: CKD, conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Sideral® Sucrosomial Iron, interventions name: Iron chewable tablet, outcomesModule primaryOutcomes measure: Insomnia Severity Index (ISI), primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Epworth sleepiness Scale (ESS), primaryOutcomes measure: Hemoglobin, primaryOutcomes measure: Ferritin, primaryOutcomes measure: Serum Iron, primaryOutcomes measure: Transferrin Saturation, primaryOutcomes measure: Erythrocyte sedimentation rate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kuang Tien General Hospital, status: RECRUITING, city: Taichung, zip: 433, country: Taiwan, contacts name: Nai-Hwei Wang, MD, role: CONTACT, phone: 886426885599, email: fengcheese@gmail.com, contacts name: Chun-Pai Yang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
|
protocolSection identificationModule nctId: NCT06279416, orgStudyIdInfo id: 2023-31, briefTitle: Expected Difficult Airway Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-30, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Kocaeli City Hospital, class: OTHER_GOV, descriptionModule briefSummary: In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded., conditionsModule conditions: Awake Intubation, conditions: Advanced Airway Techniques, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: fiberoptic intubation, interventions name: laryngeal mask airway-mediated aintree catheter, interventions name: videolaryngoscopy, outcomesModule primaryOutcomes measure: Comparison of advanced airway methods in the awake patient with difficult airway., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli City Hospital, status: RECRUITING, city: Kocaeli, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
|
protocolSection identificationModule nctId: NCT06279403, orgStudyIdInfo id: IIT-2023-0277, briefTitle: Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.Study Design:Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.Sample Size: 20 participants.Patient Grouping: Non-randomized.Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery., conditionsModule conditions: Clear-cell Metastatic Renal Cell Carcinoma, conditions: Immune Checkpoint Inhibitors, conditions: Cytoreductive Nephrectomy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, interventions name: Cytoreductive Nephrectomy, interventions name: Axitinib, outcomesModule primaryOutcomes measure: Pathological Major Response (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06279390, orgStudyIdInfo id: 202305126RINC, briefTitle: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-08, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society., conditionsModule conditions: Intensive Care Unit Delirium, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 381, type: ACTUAL, outcomesModule primaryOutcomes measure: the incidence of delirium, secondaryOutcomes measure: duration of ventilator use, secondaryOutcomes measure: rate of unplanned self-extubation, secondaryOutcomes measure: day of physical restraint, secondaryOutcomes measure: level of mobility, secondaryOutcomes measure: cumulative dose of sedatives, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06279377, orgStudyIdInfo id: Katip Celebi University, briefTitle: Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-05, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Izmir Katip Celebi University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question\[s\] it aims to answer are:* Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?* Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week).Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different., conditionsModule conditions: Cervical Spine Disease, conditions: Surgery, conditions: Rehabilitation, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Stabilization Exercises, interventions name: Standard Exercises, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Dysfunction, primaryOutcomes measure: Joint Range of Motion, primaryOutcomes measure: Proprioception, primaryOutcomes measure: Balance, primaryOutcomes measure: Neck Extensor Muscle Endurance, primaryOutcomes measure: Neck Flexor Muscles Endurance, primaryOutcomes measure: Postural Alignment, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Neck Awareness, secondaryOutcomes measure: Life Quality, secondaryOutcomes measure: Disability, secondaryOutcomes measure: Physical Activity Level, otherOutcomes measure: Sociodemographic İnformation, otherOutcomes measure: Sociodemographic İnformation BMI, otherOutcomes measure: Health-related Habits, otherOutcomes measure: Dominant Side, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Izmir Katip Celebi University Ataturk Education and Research Hospital, status: RECRUITING, city: İzmir, country: Turkey, contacts name: Hasan Kamil SUCU, Prof. Dr., role: CONTACT, contacts name: Hilal UZUNLAR, MSc, RC, role: PRINCIPAL_INVESTIGATOR, contacts name: Sevtap GUNAY UCURUM, Assoc. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Ismail Ertan SEVİN, Prof. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
|
protocolSection identificationModule nctId: NCT06279364, orgStudyIdInfo id: SKB264-Ⅲ-11, briefTitle: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting, conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomised in a 1:1 ratio to one of two intervention groups., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 524, type: ESTIMATED, armsInterventionsModule interventions name: SKB264, interventions name: Paclitaxel, interventions name: Nab-paclitaxel, interventions name: Capecitabine, interventions name: Eribulin, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-Free Survival (PFS) assessed by Investigator, secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Adverse events(AEs) and severe adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, country: China, contacts name: Zhimin Shao, role: CONTACT, email: szm@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06279351, orgStudyIdInfo id: Thalicolorectal, briefTitle: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Xinqiao Hospital of Chongqing, class: OTHER, collaborators name: Chongqing Medical University, descriptionModule briefSummary: 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies., conditionsModule conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Thalidomide+cetuximab+FOLFOX/FOLFIRI, outcomesModule primaryOutcomes measure: ETS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279338, orgStudyIdInfo id: [2023] No.0969, briefTitle: A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score, conditionsModule conditions: Myelodysplastic Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Azacitidine Injection, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) at 18 months post-transplant, month, secondaryOutcomes measure: Overall survival (OS) at 18 months post-transplant, month, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279325, orgStudyIdInfo id: C.I. PI23/637, briefTitle: Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universidad de Zaragoza, class: OTHER, descriptionModule briefSummary: Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing., conditionsModule conditions: Mild Cognitive Impairment, conditions: Cognitive Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Computerized cognitive stimulation program, interventions name: Face-to-face training-explanatory session, outcomesModule primaryOutcomes measure: MEC-35 (Spanish version of Folstein's Mini-Mental), primaryOutcomes measure: Cognitive Reserve Questionnaire (CRQ), secondaryOutcomes measure: Set-Test, secondaryOutcomes measure: The SDMT or Symbols and Digits Test, secondaryOutcomes measure: Color Word Stroop Test (CWST), secondaryOutcomes measure: Verbal Learning Test (TAVEC), secondaryOutcomes measure: Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06279312, orgStudyIdInfo id: N202311065, briefTitle: The Effect of Adaptogen Elixir on Sleep Improvement, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: TCI Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions., conditionsModule conditions: Sleep Disorder, conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Placebo drink, interventions name: Adaptogen Elixir drink, outcomesModule primaryOutcomes measure: Sleep monitoring, primaryOutcomes measure: Sleeping qualityy, primaryOutcomes measure: Sleeping disorders, secondaryOutcomes measure: Neuropeptide Y concentration, secondaryOutcomes measure: Cortisol concentration, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Low Frequency/High Frequence (LF/HF) ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Medical University, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Hsin-Chien Lee, Doctor, role: CONTACT, phone: +886-02-22490088, phoneExt: 79213/8158, email: ellalee@tmu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06279299, orgStudyIdInfo id: LLND, briefTitle: Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, China, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection., conditionsModule conditions: Rectal Neuroendocrine Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: lateral pelvic lymph node dissection, outcomesModule primaryOutcomes measure: The rate of lateral pelvic lymph node metastasis, secondaryOutcomes measure: The rate of lymph node metastasis, secondaryOutcomes measure: Disease-free survival rate, secondaryOutcomes measure: Overall survival rate, secondaryOutcomes measure: Locoregional recurrence free survival rate, secondaryOutcomes measure: Radical resection (R0), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Haitao Zhou, M.D., role: CONTACT, phone: +8613381167333, email: zhouhaitao01745@163.com, contacts name: Yueyang Zhang, M.D., role: CONTACT, phone: +8613552910035, email: yyzhang0129@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06279286, orgStudyIdInfo id: HS-10506-201, briefTitle: Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder., conditionsModule conditions: Insomnia Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: HS-10506, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AE), primaryOutcomes measure: Incidence and severity of serious adverse events (SAE), primaryOutcomes measure: Changes in laboratory test before and after drug administration, primaryOutcomes measure: Changes in ECG before and after drug administration, primaryOutcomes measure: Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration, primaryOutcomes measure: Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14, secondaryOutcomes measure: The maximum plasma concentration (C[max]), secondaryOutcomes measure: Time to reach the maximum plasma concentration (T[max]), secondaryOutcomes measure: Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]), secondaryOutcomes measure: Terminal elimination half-life (t1/2), secondaryOutcomes measure: Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring, secondaryOutcomes measure: Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring, secondaryOutcomes measure: Change from baseline in mean LPS measured by PSG, secondaryOutcomes measure: Change from baseline in mean TST measured by PSG, secondaryOutcomes measure: Change from baseline in mean WASO measured by PSG, secondaryOutcomes measure: Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary, secondaryOutcomes measure: Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary, secondaryOutcomes measure: Incidence and severity of adverse events (AE), secondaryOutcomes measure: Incidence and severity of serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xuanwu Hospital Capital Medical University, city: Beijing, country: China, contacts name: yuping Wang, PhD, role: CONTACT, email: wangyuping01@sina.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06279273, orgStudyIdInfo id: NZhong-005, briefTitle: A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Mental Health Center, class: OTHER, collaborators name: Wuhan Mental Health Centre, collaborators name: Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center, descriptionModule briefSummary: The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction., conditionsModule conditions: Methamphetamine Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Frontal lobe activation level, primaryOutcomes measure: cue-induced craving, secondaryOutcomes measure: Cognitive function, otherOutcomes measure: Attention bias towards methamphetamine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06279260, orgStudyIdInfo id: 2023.295RMH21343Protocol_V2.0, briefTitle: National Robotics-Assisted Radical Prostatectomy Database, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Melbourne Health, class: OTHER, collaborators name: Peter MacCallum Cancer Centre, Australia, collaborators name: Epworth Healthcare, collaborators name: St Vincent's Hospital, collaborators name: Austin Health, descriptionModule briefSummary: Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy., conditionsModule conditions: Database, conditions: Prostate Cancer, conditions: Robotic-assisted Radical Prostatectomy, conditions: Surgical Outcomes, conditions: Oncological Outcomes, conditions: Patient Reported Outcome Measures, conditions: Learning Curve, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 10000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa., secondaryOutcomes measure: Patient reported quality of life outcome measures, secondaryOutcomes measure: Surgical, secondaryOutcomes measure: Oncological, eligibilityModule sex: MALE, minimumAge: 16 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Austin Healthcare, city: Melbourne, state: Victoria, zip: 2084, country: Australia, contacts name: Damien Bolton, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, locations facility: E.J Whitten Prostate Cancer Centre, Epworth Healthcare, city: Melbourne, state: Victoria, zip: 3002, country: Australia, geoPoint lat: -37.814, lon: 144.96332, locations facility: St. Vincent's Private Hospital, city: Melbourne, state: Victoria, zip: 3002, country: Australia, contacts name: Lih-Ming Wong, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3050, country: Australia, contacts name: Marlon Perara, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, locations facility: Royal Melbourne Hospital, city: Melbourne, state: Victoria, zip: 3050, country: Australia, contacts name: Nathan Lawrentschuk, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
|
protocolSection identificationModule nctId: NCT06279247, orgStudyIdInfo id: KYLL-202212-011, briefTitle: Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy., conditionsModule conditions: Narcolepsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Wenjing Jiang, role: CONTACT, phone: 18560082210, email: jiangwenjing@qiluhospital.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06279234, orgStudyIdInfo id: C4001002, briefTitle: A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B)., conditionsModule conditions: Type 2 Diabetes Mellitus (T2DM), conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Rosuvastatin, interventions name: Midazolam, interventions name: Omeprazole, interventions name: PF-06954522, outcomesModule primaryOutcomes measure: Number of Participants Reporting Adverse Events, primaryOutcomes measure: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities, primaryOutcomes measure: Number of Participants With Clinically Significan Change From Baseline in Vital Signs, primaryOutcomes measure: Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs, primaryOutcomes measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS), primaryOutcomes measure: Number of Participants With Change From Baseline in Physical Examination, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax), secondaryOutcomes measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau), secondaryOutcomes measure: Time to Reach Maximum Observed Plasma Concentration (Tmax), secondaryOutcomes measure: Plasma Decay Half-Life (t1/2), secondaryOutcomes measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau), secondaryOutcomes measure: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%), secondaryOutcomes measure: Renal Clearance (CLr), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anaheim Clinical Trials, LLC, status: RECRUITING, city: Anaheim, state: California, zip: 92801, country: United States, geoPoint lat: 33.83529, lon: -117.9145, locations facility: Qps-Mra, Llc, status: RECRUITING, city: South Miami, state: Florida, zip: 33143, country: United States, geoPoint lat: 25.7076, lon: -80.29338, hasResults: False
|
protocolSection identificationModule nctId: NCT06279221, orgStudyIdInfo id: B7981055, briefTitle: Litfulo Capsules Special Investigation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2030-06-25, completionDateStruct date: 2030-06-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug., conditionsModule conditions: Alopecia Areata, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: LITFULO, outcomesModule primaryOutcomes measure: Proportion of participants with adverse events (AEs), primaryOutcomes measure: Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less], eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279208, orgStudyIdInfo id: 2023-A00272-43, briefTitle: Phosphoproteomic Profile of Children With Down Syndrome, acronym: PEPS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Perha Pharmaceuticals, class: INDUSTRY, collaborators name: Proteas Bioanalytics, collaborators name: Göteborg University, descriptionModule briefSummary: One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome., conditionsModule conditions: Down Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample, outcomesModule primaryOutcomes measure: Phosphoproteomic profile, secondaryOutcomes measure: Identification of brain proteins, secondaryOutcomes measure: Impact of environnement on phosphoproteomic profile, secondaryOutcomes measure: Impact of DYRK1A on Down Syndrome specific proteomic profile, eligibilityModule sex: MALE, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: CHU Grenoble, status: NOT_YET_RECRUITING, city: Grenoble, country: France, contacts name: Dr Marey, role: CONTACT, phone: 0476767285, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Hospices Civils de Lyon, status: RECRUITING, city: Lyon, country: France, contacts name: Dr Sanlaville, role: CONTACT, phone: 0427855573, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Institut Jérôme Lejeune, status: RECRUITING, city: Paris, country: France, contacts name: Dr Cieuta-Walti, role: CONTACT, phone: 0156586300, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Rennes, status: RECRUITING, city: Rennes, country: France, contacts name: Dr Jean-Marçais, role: CONTACT, phone: 0299266744, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU Saint-Etienne, status: NOT_YET_RECRUITING, city: Saint-Etienne, country: France, contacts name: Dr Touraine, role: CONTACT, phone: 0477828116, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
|
protocolSection identificationModule nctId: NCT06279195, orgStudyIdInfo id: EH23-326, briefTitle: Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-08-02, completionDateStruct date: 2025-08-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: NorthShore University HealthSystem, class: OTHER, collaborators name: Pfizer, descriptionModule briefSummary: The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing., conditionsModule conditions: Pelvic Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants in two groups with different conditions will be give REL-CT., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet, outcomesModule primaryOutcomes measure: Correlation between post-treatment pelvic pain and baseline uterine contraction frequency, primaryOutcomes measure: Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: NorthShore University HealthSystem, city: Evanston, state: Illinois, zip: 60201, country: United States, contacts name: Kevin Hellman, PhD, role: CONTACT, phone: 847-570-2622, email: khellman@northshore.org, geoPoint lat: 42.04114, lon: -87.69006, hasResults: False
|
protocolSection identificationModule nctId: NCT06279182, orgStudyIdInfo id: IRB-FY2024-106, briefTitle: Impact of Barre Stretching Among Dental Hygiene Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Idaho State University, class: OTHER, descriptionModule briefSummary: The healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation.The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students.This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students.Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at P=0.05., conditionsModule conditions: Musculoskeletal Disorders, conditions: Stress Management, conditions: Perceived Stress, conditions: Reported Stress, conditions: Perceived Pain, conditions: Reported Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental group will receive the Barre stretching intervention. The control group will not receive any intervention., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule interventions name: Barre Stretching Intervention, outcomesModule primaryOutcomes measure: Self-Reported Stress (Perceived Stress Scale), primaryOutcomes measure: Self-Reported Pain (Numerical Pain Rating Scale/Visual Analog Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Idaho State University, city: Pocatello, state: Idaho, zip: 83209, country: United States, contacts name: Crystal Kanderis Lane, MS, role: CONTACT, phone: 208-282-4209, email: crystalkanderisla@isu.edu, contacts name: Leciel Bono, PhD(s), role: CONTACT, phone: (208)282-3076, email: lecielbono@isu.edu, geoPoint lat: 42.8713, lon: -112.44553, hasResults: False
|
protocolSection identificationModule nctId: NCT06279169, orgStudyIdInfo id: 2023-BRT-SBF-113355, briefTitle: The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2025-08-29, completionDateStruct date: 2025-08-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Bartın Unıversity, class: OTHER, descriptionModule briefSummary: It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design., conditionsModule conditions: Pain, Acute, conditions: Newborn; Vitality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ESTIMATED, armsInterventionsModule interventions name: Heart Sound, interventions name: White Noise, outcomesModule primaryOutcomes measure: The Newborn Infant Pain Scale (NIPS), secondaryOutcomes measure: oxygen saturation, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: Crying Time, eligibilityModule sex: ALL, minimumAge: 2 Days, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Bartın University, status: RECRUITING, city: Bartın, country: Turkey, contacts name: Fatma Dinç, Asst.Prof., role: CONTACT, phone: +9005383555685, email: fatmadinc@bartin.edu.tr, contacts name: Aylin Kurt, Asst.Prof., role: CONTACT, phone: +9005382087211, email: aylinkurt67@gmail.com, geoPoint lat: 41.63583, lon: 32.3375, hasResults: False
|
protocolSection identificationModule nctId: NCT06279156, orgStudyIdInfo id: MTU-EC-IM-0-014/65, briefTitle: Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-02-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial was to compare the efficiencies of bioelectrical impedance analysis (BIA) measurement frequency in preventing intradialytic hypotension in end-stage renal disease (ESRD) patients undergoing regular hemodialysis. The main question aimed to answer about the optimum frequency of BIA measurements to prevent intradialytic hypotension.Participants underwent BIA measurements to determine their appropriate dry weight, and factors affecting intradialytic hypotension.Researchers compared the efficiencies of BIA measurements between the every-1-month group and the every-2-month group to prevent intradialytic hypotension., conditionsModule conditions: Intradialytic Hypotension, conditions: End Stage Renal Disease on Dialysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ACTUAL, armsInterventionsModule interventions name: Bioelectrical Impedance Analysis (BIA), outcomesModule primaryOutcomes measure: incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA, secondaryOutcomes measure: factors affecting intra-dialytic hypotension, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University Hospital, city: Pathum Thani, zip: 12120, country: Thailand, geoPoint lat: 14.01346, lon: 100.53049, hasResults: False
|
protocolSection identificationModule nctId: NCT06279143, orgStudyIdInfo id: dOCT-pBCC, briefTitle: The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes, acronym: dOCT-pBCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Vejle Hospital, class: OTHER, descriptionModule briefSummary: The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.The Hypotheses:* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.* The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.* D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.* The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.* The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.* Delineation of periocular BCC tumour extension is possible using both D-OCT probes, conditionsModule conditions: BCC - Basal Cell Carcinoma, conditions: BCC, conditions: Skin Diseases, conditions: Eyelid Tumor, conditions: Eyelid Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, outcomesModule primaryOutcomes measure: Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region, secondaryOutcomes measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC, secondaryOutcomes measure: Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC, secondaryOutcomes measure: Observer agreement in identifying presence/absence of BCC lesions, using D-OCT, secondaryOutcomes measure: Observer agreement in classifying BCC lesions into subtypes, using D-OCT, secondaryOutcomes measure: Observer agreement in mapping BCC lesions prior to surgery, using D-OCT, secondaryOutcomes measure: Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT, secondaryOutcomes measure: Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT, secondaryOutcomes measure: Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT, secondaryOutcomes measure: Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital, status: RECRUITING, city: Vejle, state: Region Of Southern Danmark, zip: 7100, country: Denmark, contacts name: Sveina B Karlsdóttir, MD, role: CONTACT, phone: 53420448, phoneExt: 0045, email: sveina@outlook.dk, contacts name: Susanne Støvring, role: CONTACT, phone: 79406461, phoneExt: 0045, email: susanne.stoevring@rsyd.dk, geoPoint lat: 55.70927, lon: 9.5357, hasResults: False
|
protocolSection identificationModule nctId: NCT06279130, orgStudyIdInfo id: N23NEO, briefTitle: Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations, acronym: NEOASIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2029-01-29, completionDateStruct date: 2034-01-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed., conditionsModule conditions: Resectable MMR-deficient Solid Tumors, conditions: Resectable MMR-proficient Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Basket, open-label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: botensilimab, interventions name: balstilimab, outcomesModule primaryOutcomes measure: Major pathological response rate, secondaryOutcomes measure: Pathological response rates, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Radiological response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Netherlands Cancer Institute, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1066 CX, country: Netherlands, contacts name: Marieke van de Belt, MsC, role: CONTACT, contacts name: Myriam Chalabi, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
|
protocolSection identificationModule nctId: NCT06279117, orgStudyIdInfo id: 2023/9/8, briefTitle: The Effect of Therapeutic Touch on Exam Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-02-23, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups., conditionsModule conditions: Test Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled clinical trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: therapeutic touch, outcomesModule primaryOutcomes measure: Text Anxiety, primaryOutcomes measure: Text Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gizem Göktuna, status: RECRUITING, city: İzmir, zip: 35000, country: Turkey, contacts name: Gizem Göktuna, role: CONTACT, phone: +905448303393, email: gizemgoktuna@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
|
protocolSection identificationModule nctId: NCT06279104, orgStudyIdInfo id: 2023-TJ-OCCC, briefTitle: A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Wuhan Union Hospital, China, collaborators name: Henan Cancer Hospital, collaborators name: Qilu Hospital of Shandong University, collaborators name: Hubei Cancer Hospital, collaborators name: Anhui Provincial Cancer Hospital, collaborators name: Peking University Cancer Hospital & Institute, collaborators name: Hunan Province Tumor Hospital, collaborators name: First Affiliated Hospital of Suzhou Medical College, collaborators name: Shandong Tumor Hospital, collaborators name: Chongqing University Cancer Hospital, collaborators name: First Affiliated Hospital of Zhongshan Medical University, collaborators name: Peking University Shenzhen Hospital, descriptionModule briefSummary: The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data., conditionsModule conditions: Ovarian Clear Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: physician's choice of chemotherapy, interventions name: immune checkpoint inhibitor based therapy, outcomesModule primaryOutcomes measure: tumor response rate, secondaryOutcomes measure: progression-free survival (PFS), secondaryOutcomes measure: time to response (TTR), secondaryOutcomes measure: duration of response (DOR), secondaryOutcomes measure: disease control rate (DCR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279091, orgStudyIdInfo id: A0104023PP, briefTitle: Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2023-11-05, completionDateStruct date: 2024-05-23, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction., conditionsModule conditions: Dental Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Selected children will be divided randomly into 3 groups:Control group (Group I). Diaphragmatic Breathing group (Group II). Bubble Blower Breathing group (Group III)., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Diaphragmatic Breathing, interventions name: Bubble Blower Breathing, interventions name: Tell Show Do, outcomesModule primaryOutcomes measure: scale of dental anxiety by Corah Dental Anxiety Scale (CDAS), primaryOutcomes measure: scale of dental anxiety by Facial Image Scale (FIS), primaryOutcomes measure: scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS), primaryOutcomes measure: scale of dental anxiety by Pulse Oximeter, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mansura University, city: Mansoura, state: Dakahlia, zip: 35511, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
|
protocolSection identificationModule nctId: NCT06279078, orgStudyIdInfo id: AJOUIRB-DB-2023-446, briefTitle: Long-term Effect of Steroid on Metabolic Diseases in Asthmatics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ajou University School of Medicine, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications., conditionsModule conditions: Asthma, conditions: Osteoporosis, Osteopenia, conditions: Osteoporosis Risk, conditions: Osteoporotic Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Corticosteroid, outcomesModule primaryOutcomes measure: Prevalence of osteoporosis/osteopenia, secondaryOutcomes measure: Bone mineral density (BMD) score, secondaryOutcomes measure: Total alkaline phosphatase, secondaryOutcomes measure: Corrected calcium, secondaryOutcomes measure: Serum phosphate, secondaryOutcomes measure: Serum albumin, secondaryOutcomes measure: prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ajou University Medical Center, status: RECRUITING, city: Suwon, state: Gyeonggi, zip: 16499, country: Korea, Republic of, contacts name: Hyun-Seob Jeon, M.D., role: CONTACT, phone: +82-31-219-4612, email: googlingpenguin@gmail.com, contacts name: Hae-Sim Park, M.D., Ph.D., role: CONTACT, phone: +82-31-219-4779, email: hspark@ajou.ac.kr, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False
|
protocolSection identificationModule nctId: NCT06279065, orgStudyIdInfo id: 373/23-EP, briefTitle: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis, acronym: GCA-Biom, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-18, primaryCompletionDateStruct date: 2026-02-18, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, descriptionModule briefSummary: The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system., conditionsModule conditions: Giant Cell Arteritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Analysis of blood and microbiome samples (stool, oral lavage), outcomesModule primaryOutcomes measure: Significant differences in the composition of the microbiome, secondaryOutcomes measure: Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species, secondaryOutcomes measure: potential association of microbiom composition with application of immune modulating drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn, status: RECRUITING, city: Bonn, state: North Rhine-Westphalia, zip: 53127, country: Germany, contacts name: Valentin S. Schäfer, Dr. med., role: CONTACT, phone: +49 228 287-17000, email: rheumatologie@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, locations facility: University Hospital Bonn, status: RECRUITING, city: Bonn, zip: 53127, country: Germany, contacts name: Valentin Schäfer, MD, role: CONTACT, phone: +28 287 17000, email: rheumatologie@ukbonn.de, contacts name: Maike Adamson, role: CONTACT, phone: +28 287 17000, email: rheumatologie@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False
|
protocolSection identificationModule nctId: NCT06279052, orgStudyIdInfo id: RC31/23/0535, briefTitle: Adolescent Projections During Transition in Prader-Willi Syndrome, acronym: APT-WILL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide., conditionsModule conditions: Prader-Willi Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Phone interview, outcomesModule primaryOutcomes measure: Experience of the disease and aspirations regarding the future, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHU de Toulouse, city: Toulouse, country: France, contacts name: Grégoire BENVEGNU, role: CONTACT, email: benvegnu.g@chu-toulouse.fr, contacts name: Dalil Benkanoun, role: CONTACT, email: dalil.benkanoun@hotmail.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
|
protocolSection identificationModule nctId: NCT06279039, orgStudyIdInfo id: KY20230116-06, briefTitle: Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment., conditionsModule conditions: Exosome, conditions: Skin Regeneration, conditions: Laser, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Exosome liquid dressing, outcomesModule primaryOutcomes measure: Global Aesthetic Improvement Scale score, primaryOutcomes measure: Dermatology Quality of life index, secondaryOutcomes measure: post-inflammatory hyperpigmentation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jie Dai, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: jie dai, role: CONTACT, phone: 02552271117, email: karry_dj@126.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
|
protocolSection identificationModule nctId: NCT06279026, orgStudyIdInfo id: PG-006-5, briefTitle: UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: PersonGen BioTherapeutics (Suzhou) Co., Ltd., class: INDUSTRY, collaborators name: Second Affiliated Hospital of Soochow University, descriptionModule briefSummary: The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw., conditionsModule conditions: Relapsed/Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: UTAA17 injection, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: UTAA17 Injection, outcomesModule primaryOutcomes measure: DLT, primaryOutcomes measure: RP2D, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Huimin Meng, doctor, role: CONTACT, phone: +86-18015580390, email: huimin.meng@persongen.com.cn, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
|
protocolSection identificationModule nctId: NCT06279013, orgStudyIdInfo id: NRG-CC012CD, secondaryIdInfos id: NCI-2023-10831, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: NRG Oncology, secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: DCP, secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: CTEP, secondaryIdInfos id: R01CA279472, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA279472, briefTitle: Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-16, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: NRG Oncology, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes., conditionsModule conditions: Hematopoietic and Lymphoid System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomized, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Interviewers will be blinded to the study arm; IVR is automated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 516, type: ESTIMATED, armsInterventionsModule interventions name: Counseling, interventions name: Health Education, interventions name: Interview, interventions name: Medical Chart Review, interventions name: Monitoring, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Symptom Severity/Toxicity Index, secondaryOutcomes measure: Incidence of Unscheduled Health Services Usage, otherOutcomes measure: Practice personnel time to address weekly interactive voice response (IVR) symptom reports, otherOutcomes measure: Treatment fidelity, otherOutcomes measure: Cost, otherOutcomes measure: Patient financial burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06279000, orgStudyIdInfo id: CTU 22/025, briefTitle: Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery, acronym: COLCAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cantonal Hospital of St. Gallen, class: OTHER, descriptionModule briefSummary: Perioperative myocardial injury/infarction (PMI) and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.However, research in recent years has yielded limited preventive and therapeutic measures for PMI/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of PMI/MACE., conditionsModule conditions: Cardiovascular Diseases, conditions: Cardiovascular Complication, conditions: Perioperative Complication, conditions: Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, triple-blinded, placebo-controlled, multicenter, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Patients, anaesthesia providers and all other health care workers involved in the treatment and the study personal will be blinded to the group allocation by provision of equal looking study drugs (verum and placebo), which are repacked for blinding., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Colchicine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Perioperative Myocardial Injury/Infarction, primaryOutcomes measure: Major Adverse Cardiovascular Events, secondaryOutcomes measure: New onset Atrial fibrillation, secondaryOutcomes measure: postoperative high sensitive cardiac Troponin T concentrations, secondaryOutcomes measure: long term cardiovascular outcome, otherOutcomes measure: Gastrointestinal adverse events, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278987, orgStudyIdInfo id: ANES-2024-32661, briefTitle: Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter., conditionsModule conditions: Hip Fractures, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: PENG block and cryoablation, interventions name: fascia iliaca compartment block, outcomesModule primaryOutcomes measure: Maximum pain score on Post-operative day 30, primaryOutcomes measure: Opioid use, primaryOutcomes measure: functional pain scores, primaryOutcomes measure: number of patients using opioids, primaryOutcomes measure: Length of Hospital Stay, primaryOutcomes measure: Time to first ambulation, primaryOutcomes measure: Number of patients returned home by Post Operative Day 30, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278974, orgStudyIdInfo id: PDSFGOCLMC-2023-001, briefTitle: Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: He Eye Hospital, class: OTHER, descriptionModule briefSummary: The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year., conditionsModule conditions: Myopia, conditions: Cost-effectiveness Analysis, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Improvement in Quality of Life Scores, primaryOutcomes measure: Cost-Effectiveness Analysis, secondaryOutcomes measure: Clinical Effectiveness Analysis, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: HeEyeHospital, status: RECRUITING, city: Shenyang, state: Liaoning, zip: 110000, country: China, contacts name: Lan Hu, Master, role: CONTACT, phone: 15940406919, email: hulan@hsyk.com.cn, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
|
protocolSection identificationModule nctId: NCT06278961, orgStudyIdInfo id: IRB 2021-4329, briefTitle: Families Filming Infants Learning Movement, acronym: FILM, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-28, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ann & Robert H Lurie Children's Hospital of Chicago, class: OTHER, collaborators name: Northwestern University, collaborators name: IRCCS Fondazione Stella Maris, collaborators name: University of Melbourne, collaborators name: University of Sydney, descriptionModule briefSummary: The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants., conditionsModule conditions: Infant Development, conditions: Cerebral Palsy, conditions: Motor Disorders, conditions: Neurological Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Observational, outcomesModule primaryOutcomes measure: Fidgety Movements in healthy, term born infants, primaryOutcomes measure: Fidgety Movements in children with a range of medical complexities, primaryOutcomes measure: Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants, primaryOutcomes measure: Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities, eligibilityModule sex: ALL, minimumAge: 10 Weeks, maximumAge: 20 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Feinberg School of Physical Therapy and Human Movement Sciences, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Ryan Millman, B.S., role: CONTACT, phone: 847-530-2319, email: ryan.millman@northwestern.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
|
protocolSection identificationModule nctId: NCT06278948, orgStudyIdInfo id: LRP23023-depigmenting cream, briefTitle: Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Cosmetique Active International, class: INDUSTRY, descriptionModule briefSummary: This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma., conditionsModule conditions: Melasma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Group TP, interventions name: Group CYS, outcomesModule primaryOutcomes measure: change in mMASI scoring, primaryOutcomes measure: change in Investigator's Global Assessment (IGA), secondaryOutcomes measure: change in Subject Global Assessment of Improvement (SGAI), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: MS Clinical Research Pvt. Ltd, status: RECRUITING, city: Bangalore, country: India, geoPoint lat: 12.97194, lon: 77.59369, hasResults: False
|
protocolSection identificationModule nctId: NCT06278935, orgStudyIdInfo id: APP-24-00887, briefTitle: Lifestyle Tailored Offloading for Diabetic Foot Ulcers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention., conditionsModule conditions: Diabetic Foot Ulcer, conditions: Diabetic Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Lifestyle-based intervention by a occupational therapist, outcomesModule primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Diabetes distress, secondaryOutcomes measure: Factors affecting offloading treatment, secondaryOutcomes measure: DFU-related outcomes, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278922, orgStudyIdInfo id: STUDY00001149, secondaryIdInfos id: R01AA031010, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA031010, briefTitle: Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2028-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome., conditionsModule conditions: PTSD, conditions: Alcohol; Use, Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The PI and all Co-Is will be masked to study condition., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Seeking Safety + Signs of Safety toolkit, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5, primaryOutcomes measure: Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5, secondaryOutcomes measure: Change from Baseline Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for Alcohol Use Disorder to Immediate Post-Treatment as measured by the DSM-5 AUD Assessment Tool, secondaryOutcomes measure: Change from Baseline Percent Days of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Percent Days of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Percent Days of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Number of Instances of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana, secondaryOutcomes measure: Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R), secondaryOutcomes measure: Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R), secondaryOutcomes measure: Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-16, uploadDate: 2024-02-16T10:27, filename: Prot_SAP_000.pdf, size: 2163767, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-08-21, uploadDate: 2024-02-16T10:29, filename: ICF_001.pdf, size: 85664, hasResults: False
|
protocolSection identificationModule nctId: NCT06278909, orgStudyIdInfo id: 6036699, briefTitle: Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Dr. Rafael Freire, class: OTHER, descriptionModule briefSummary: This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).* The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.* The secondary objective will be to monitor changes in GAD symptom severity throughout the study.Results from this study will inform a randomized controlled trial to be conducted in the future., conditionsModule conditions: Generalized Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a traditional feasibility study, which evaluates preliminary safety and effectiveness information. It does not meet the definition of a "device feasibility" study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Trigeminal Nerve Stimulation, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events, primaryOutcomes measure: Incidence of treatment-emergent side effects measured with the NSEC, primaryOutcomes measure: Response to treatment defined by CGI-I score below 3, secondaryOutcomes measure: Remission defined by CGI-S score below 3, secondaryOutcomes measure: Change in anxiety severity measured by CGI-S, secondaryOutcomes measure: Change of anxiety symptoms measured with GAD-7, secondaryOutcomes measure: Change of anxiety symptoms measured with PSWQ, secondaryOutcomes measure: Change of anxiety symptoms measured with BAI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kingston Health Sciences Centre, status: RECRUITING, city: Kingston, state: Ontario, country: Canada, contacts name: Yan Deng, role: CONTACT, phone: +1-613-548-7839, email: yan.deng@queensu.ca, contacts name: Rafael Freire, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Elisa Brietzke, MD PhD, role: SUB_INVESTIGATOR, contacts name: Claudio Soares, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 44.22976, lon: -76.48101, hasResults: False
|
protocolSection identificationModule nctId: NCT06278896, orgStudyIdInfo id: 23-684-END, briefTitle: Early Neutropenic Fever De-escalation of Antibiotics Study, acronym: END, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2028-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Dana-Farber Cancer Institute, descriptionModule briefSummary: This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified., conditionsModule conditions: Hematologic Malignancy, conditions: Febrile Neutropenia, conditions: Antibiotic Stewardship, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Cessation of antibiotics, outcomesModule primaryOutcomes measure: Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia, primaryOutcomes measure: Antibiotic utilization, secondaryOutcomes measure: Mortality post F&N, secondaryOutcomes measure: Drug resistance, secondaryOutcomes measure: Clostridium difficile infection, secondaryOutcomes measure: Candidiasis, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Allergic Reactions, secondaryOutcomes measure: Bacteremia, secondaryOutcomes measure: Neutropenia, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Readmissions, secondaryOutcomes measure: Fever, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278883, orgStudyIdInfo id: Pro00115007, secondaryIdInfos id: R01HG011794, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HG011794, briefTitle: Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase, acronym: GRACE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: National Human Genome Research Institute (NHGRI), descriptionModule briefSummary: The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n\~500).Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing., conditionsModule conditions: Cardiovascular Diseases, conditions: Cancer, conditions: Liver Diseases, conditions: Hyperthermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Everyone who consents is enrolled in the risk assessment pipeline., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Disease Risk Assessment, outcomesModule primaryOutcomes measure: Reach of genomic risk assessment, primaryOutcomes measure: Utility of genomic risk assessment, primaryOutcomes measure: Uptake of genetic counseling risk recommendations by the participant, primaryOutcomes measure: Uptake of genetic testing recommendations by the provider, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UF Health Callahan, city: Callahan, state: Florida, zip: 32011, country: United States, geoPoint lat: 30.56218, lon: -81.83066, locations facility: UF Health Murray Hill, city: Jacksonville, state: Florida, zip: 32205, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Normandy, city: Jacksonville, state: Florida, zip: 32221, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Kernan Square, city: Jacksonville, state: Florida, zip: 32246, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: UF Health Augustine Oaks, city: Jacksonville, state: Florida, zip: 32258, country: United States, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False
|
protocolSection identificationModule nctId: NCT06278870, orgStudyIdInfo id: SYSKY-2023-431-02, briefTitle: Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-06, primaryCompletionDateStruct date: 2031-06-30, completionDateStruct date: 2031-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer., conditionsModule conditions: HER2-positive Metastatic Breast Cancer, conditions: First-line Treatment, 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: 312, type: ESTIMATED, armsInterventionsModule interventions name: disitamab vedotin, interventions name: Pyrotinib, interventions name: trastuzumab, interventions name: Pertuzumab, interventions name: taxane drug, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Clinical Benefit rate (CBR), secondaryOutcomes measure: Adverse Events (Based on CTCAE 5.0 standards), secondaryOutcomes measure: Quality of Life (QoL) by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), secondaryOutcomes measure: Exploration of biomarkers, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Herui Yao, PhD, role: CONTACT, phone: +86 13500018020, email: yaoherui@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06278857, orgStudyIdInfo id: QCGC-001/2023, briefTitle: SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr), acronym: SATELLITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Queensland Centre for Gynaecological Cancer, class: OTHER_GOV, collaborators name: GlaxoSmithKline Research & Development Limited, descriptionModule briefSummary: The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer., conditionsModule conditions: Endometrial Cancer Stage I, conditions: Mmr Deficiency, conditions: Endometrioid Endometrial Adenocarcinoma, conditions: Immune-related Adverse Event, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a non-randomised, prospective, pilot, open-label, single arm study. Participation in this trial involves seven dostarlimab sessions over 12 months, with a treatment protocol of four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI], outcomesModule primaryOutcomes measure: Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab., secondaryOutcomes measure: Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma., secondaryOutcomes measure: TEAEs/irAEIs Leading to Study Drug Discontinuation, secondaryOutcomes measure: TEAEs/irAEIs Leading to Study Withdrawal, secondaryOutcomes measure: Clinically Significant Changes in Haematology, secondaryOutcomes measure: Clinically Significant Changes in Clinical Chemistry, secondaryOutcomes measure: Clinically Significant Changes in Thyroid Function, secondaryOutcomes measure: Abnormal Vital Signs, secondaryOutcomes measure: Abnormal Electrocardiogram (ECG) Parameters, secondaryOutcomes measure: Clinically Significant Abnormal Physical Examination, secondaryOutcomes measure: Concomitant Medications, otherOutcomes measure: Study Feasibility Outcome: Recruitment Rate, otherOutcomes measure: Study Feasibility Outcome: Rationale for Treatment Discontinuation, otherOutcomes measure: Study Feasibility Outcome: Study Withdrawal Rate, otherOutcomes measure: Study Feasibility Outcome: Incidence of Immune-Related Adverse Events (irAEs), otherOutcomes measure: Study Feasibility Outcome: Number of Cycles of dostarlimab Completed, otherOutcomes measure: Qualitative Evaluation by Semi-Structured Interview to gather valuable consumer feedback to inform future clinical research programs., otherOutcomes measure: Participant Burden Assessment, otherOutcomes measure: Participant Burden Assessment - Adverse Events, otherOutcomes measure: Evaluation of Fertility Outcomes/Pregnancy Plans for WOCBP compare to their pre-treatment reproductive plans., otherOutcomes measure: Correlate clinical efficacy (pCR) with irAEs., otherOutcomes measure: Fertility outcome within the fertility preservation population - pregnancy rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - pregnancy loss rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - live birth rates, otherOutcomes measure: Fertility outcome within the fertility preservation population - rates of maternal and fetal complications/abnormalities, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, city: Sydney, state: New South Wales, zip: 2145, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Alison Brand, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Royal Brisbane and Women's Hospital, city: Brisbane, state: Queensland, zip: 4029, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Vanessa Behan, role: CONTACT, phone: 07 3346 5590, email: v.behan@uq.edu.au, contacts name: Jeffrey Goh, Associate Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Linda Mileshkin, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
|
protocolSection identificationModule nctId: NCT06278844, orgStudyIdInfo id: 3020, briefTitle: Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication, acronym: ESCPAND, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed., conditionsModule conditions: Heart Failure With Reduced Ejection Fraction, conditions: Heart Failure With Preserved Ejection Fraction, conditions: Heart Conduction Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Conduction system pacing, interventions name: Right ventricular apical pacing, outcomesModule primaryOutcomes measure: Exercise capacity, secondaryOutcomes measure: Exercise capacity, secondaryOutcomes measure: Echocardiographic parameters (Ejection Fraction), secondaryOutcomes measure: QRS width, secondaryOutcomes measure: Biomarker, N-terminal pro B-type natriuretic peptide levels, secondaryOutcomes measure: Health-related quality of life scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitair Ziekenhuis Antwerpen, status: RECRUITING, city: Edegem, state: Antwerp, zip: 2650, country: Belgium, contacts name: Faro Verelst, role: CONTACT, phone: 038213538, email: faro.verelst@uza.be, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False
|
protocolSection identificationModule nctId: NCT06278831, orgStudyIdInfo id: 2023-02645, briefTitle: Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy, acronym: SOCOFIN-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-08, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University Medical Center Goettingen, class: OTHER, descriptionModule briefSummary: Objectives:* Assess the extent of financial burden of patients undergoing radiotherapy* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity* Design a structured social consultation to reduce financial burden induced by radiotherapyInclusion criteria:1. age ≥ 18 years of age2. indication for radiation treatment of a malignant disease3. Karnofsky Performance score (KPS) ≥ 70%4. Life expectancy ≥ 3 monthsExclusion criteria:1. Inability to provide informed consent2. Inability to attend study visits and fulfill data collection requirements3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapySecondary outcomes:* Socio-Economic factors at baseline* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months* Depression (PHQ-9) at baseline and 3 months* Coping mechanisms to address financial burdenPrimary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.Secondary Endpoints:* Changes in the COST-Score over time* Changes in PHQ-9 over time* Changes in EORTC QLQ-C30 over timeThis is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120, conditionsModule conditions: Financial Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Financial Toxicity, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, secondaryOutcomes measure: Factors that may influence the occurrence or extent of financial burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Göttingen, status: RECRUITING, city: Göttingen, state: Niedersachsen, zip: 37075, country: Germany, contacts name: Rami El Shafie, Prof. Dr., role: CONTACT, phone: +4955164505, email: rami.elshafie@med.uni-goettingen.de, geoPoint lat: 51.53443, lon: 9.93228, hasResults: False
|
protocolSection identificationModule nctId: NCT06278818, orgStudyIdInfo id: MNESYS-PE0000006, briefTitle: Effects of Telerehabilitation on Brain Network Connectivity, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-07, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: University of Parma, collaborators name: University of Bologna, collaborators name: University of Rome Tor Vergata, descriptionModule briefSummary: The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers.This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions.The study aims to:* Identify correlations between improvement in cognitive performance and functional brain data.* Use acquired knowledge to develop neurologically guided TR approaches for broader use.The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up.The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The neurophysiologist and neuroradiologist will be blinded to the type of rehabilitation treatment (experimental group vs. control)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Telerehabilitation, interventions name: Control Condition, outcomesModule primaryOutcomes measure: Changes in resting-state brain networks functional connectivity after NBTC treatment, primaryOutcomes measure: Changes in resting-state EEG coherence after NBTC treatment, primaryOutcomes measure: Changes in resting-state EEG coherence after HomeCore treatment, primaryOutcomes measure: Changes in resting-state brain networks functional connectivity after SMRT treatment, secondaryOutcomes measure: Changes in neuropsychological and caregiver burden measures after TR, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Mondino Foundation, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Cristina Tassorelli, MD, role: CONTACT, phone: 0382380419, phoneExt: 0039, email: cristina.tassorelli@unipv.it, contacts name: Silvia Paola P Caminiti, PhD, role: CONTACT, phone: 0382380419, phoneExt: 0039, email: silviapaola.caminiti@unipv.it, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
|
protocolSection identificationModule nctId: NCT06278805, orgStudyIdInfo id: ayk22, briefTitle: Adaptation and Validation of the LUNS for Use in Turkey., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, collaborators name: Ankara University, collaborators name: Istanbul University, descriptionModule briefSummary: According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.Our hypothesis in this study is:- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population., conditionsModule conditions: Stroke, conditions: Disability Physical, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: The reliability and validity study of the T-LUNS, outcomesModule primaryOutcomes measure: The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS), primaryOutcomes measure: The Stroke Impact Scale 3.0 (SIS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Usak, status: RECRUITING, city: Uşak, zip: 64200, country: Turkey, contacts name: Ali Y Karahan, role: CONTACT, phone: +905386921934, email: ali.karahan@usak.edu.tr, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
|
protocolSection identificationModule nctId: NCT06278792, orgStudyIdInfo id: Z-2021104, briefTitle: Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure, acronym: EASY-HF, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-07, primaryCompletionDateStruct date: 2023-07-12, completionDateStruct date: 2024-01-05, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ziekenhuis Oost-Limburg, class: OTHER, collaborators name: Fund for Scientific Research, Flanders, Belgium, descriptionModule briefSummary: The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:* difference in natriuresis and diuresis* feasibility of the protocol.Participants will be asked to gather two 24 h urine collections.Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours., conditionsModule conditions: Acute Decompensated Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Diuretic protocol, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Urinary sodium excretion after 48 hours, secondaryOutcomes measure: Urinary output after 48 hours, secondaryOutcomes measure: Urinary sodium excretion on daily base, secondaryOutcomes measure: Urinary output on daily base, secondaryOutcomes measure: Achievement of decongestion, otherOutcomes measure: Diuretic dose, otherOutcomes measure: User-friendliness device and protocol, otherOutcomes measure: Weight, otherOutcomes measure: Number of participants with need for heart failure rehospitalization, otherOutcomes measure: Rate of all-cause mortality, otherOutcomes measure: Length of hospital stay, otherOutcomes measure: Number of participants with severe hypotension, otherOutcomes measure: Number of participants with abnormal blood parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuis Oost-Limburg AV, city: Genk, state: Limburg, zip: 3600, country: Belgium, geoPoint lat: 50.965, lon: 5.50082, hasResults: False
|
protocolSection identificationModule nctId: NCT06278779, orgStudyIdInfo id: X23-0311, briefTitle: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression, acronym: TREK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: The George Institute, class: OTHER, collaborators name: The University of New South Wales, descriptionModule briefSummary: The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:* How the two formulations compare in terms of their effectiveness in treating TRD.* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes., conditionsModule conditions: Treatment Resistant Depression, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, prospective, parallel group, comparative effectiveness trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Primary outcome raters will be blinded to treatment allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine group, interventions name: Racemic ketamine, outcomesModule primaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS) score, secondaryOutcomes measure: Response - Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Remission - Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: DASS-21, secondaryOutcomes measure: Clinical Global Impression-Improvement (CGI-I), secondaryOutcomes measure: Clinical Global Impression-Severity (CGI-S), secondaryOutcomes measure: Columbia Suicide Severity Rating Scale (C-SSRS), secondaryOutcomes measure: Speed of response - Clinical Global Impression-Improvement (CGI-I), secondaryOutcomes measure: Psychotomimetic symptoms, secondaryOutcomes measure: Suicide attempts or gestures, secondaryOutcomes measure: Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), secondaryOutcomes measure: Cognitive Failure Questionnaire scores (CFQ), secondaryOutcomes measure: Ketamine liking/craving score, secondaryOutcomes measure: Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET), secondaryOutcomes measure: Acceptability Questionnaire, secondaryOutcomes measure: All-cause dropouts, secondaryOutcomes measure: Recovering Quality of Life Questionnaire (REQOL-10), secondaryOutcomes measure: WHO Disability Assessment Scale (WHODAS-12), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Assessment of Quality of Life Questionnaire (AQoL-8D), secondaryOutcomes measure: Resource Use Questionnaire (RUQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Prince Alfred Hospital, city: Camperdown, state: New South Wales, zip: 2050, country: Australia, contacts name: Hadley Lindsay, role: CONTACT, email: SLHD-RPA-KetamineClinic@health.nsw.gov.au, contacts name: Nicholas Glozier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.88965, lon: 151.17642, locations facility: Black Dog Institute, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: Stella Antoniou, role: CONTACT, email: depressionclinic@blackdog.org.au, contacts name: Adam Bayes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.91439, lon: 151.24895, locations facility: Ramsay Clinic Northside, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: Mayra Ouriques, role: CONTACT, email: neuroinfo.nsc@ramsayhealth.com.au, contacts name: Colleen Loo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, locations facility: Ramsay Clinic Lakeside, city: Warners Bay, state: New South Wales, zip: 2282, country: Australia, contacts name: Sally Sally Wilkinson, role: CONTACT, email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au, contacts name: Natasha Cairns, role: CONTACT, email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au, contacts name: Michael Bull, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.97251, lon: 151.65268, locations facility: Gold Coast University Hospital, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: Catherine Donald, role: CONTACT, email: specialistmooddisorderclinic@health.qld.gov.au, contacts name: Shanthi Sarma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.96724, lon: 153.39796, locations facility: Ramsay Clinic Albert Road, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Melanie Hurley, role: CONTACT, email: research.arc@ramsayhealth.com.au, contacts name: Malcolm Hopwood, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
|
protocolSection identificationModule nctId: NCT06278766, orgStudyIdInfo id: M24-416, briefTitle: A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-04-19, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: ABBV-552, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events (AEs), primaryOutcomes measure: Maximum observed concentration (Cmax) of ABBV-552, primaryOutcomes measure: Time to Cmax (peak time, Tmax) of ABBV-552, primaryOutcomes measure: Terminal phase elimination rate constant (λz) of ABBV-552, primaryOutcomes measure: Terminal phase elimination half-life (t1/2) of ABBV-552, primaryOutcomes measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552, primaryOutcomes measure: Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552, primaryOutcomes measure: Amount of ABBV-552 excreted in the urine over the sampling period (Aeu), primaryOutcomes measure: Percent of ABBV-552 excreted in the urine, primaryOutcomes measure: Renal clearance ABBV-552 (CLr), primaryOutcomes measure: Amount of ABBV-552 excreted in the feces over the sampling period (Aef), primaryOutcomes measure: Percent radioactivity excreted in the feces, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit Inc /ID# 262684, city: Madison, state: Wisconsin, zip: 53704, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
|
protocolSection identificationModule nctId: NCT06278753, orgStudyIdInfo id: 2025/05/02, briefTitle: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Tepecik Training and Research Hospital, class: OTHER, descriptionModule briefSummary: For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared., conditionsModule conditions: Bladder Injury, conditions: Ureter Injury, conditions: Surgical Injury, conditions: Complication of Surgical Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: carbon dioxide cystoscopy, outcomesModule primaryOutcomes measure: It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy., secondaryOutcomes measure: It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tepecik Training and Research Hospital, status: RECRUITING, city: İzmir, state: Eurasia, zip: 35090, country: Turkey, contacts name: Ali Turgut, role: CONTACT, phone: 02324696969, email: iyikliniktepecikeah@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
|
protocolSection identificationModule nctId: NCT06278740, orgStudyIdInfo id: SCIUSG24, briefTitle: Upper Extremity Pathologies in Spinal Cord Injuries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-02-26, completionDateStruct date: 2025-03-26, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Afyonkarahisar Health Sciences University, class: OTHER, descriptionModule briefSummary: This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries., conditionsModule conditions: Spinal Cord Injuries, conditions: Upper Extremity Problem, conditions: Musculoskeletal Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Musculoskeletal Ultrasound, outcomesModule primaryOutcomes measure: Comparison of US findings among participants, secondaryOutcomes measure: Visual Analog Scale (VAS), secondaryOutcomes measure: The Physical Examination of the Shoulder Scale (PESS), secondaryOutcomes measure: The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH), secondaryOutcomes measure: American Spinal Injury Association (ASIA) Impairment Scale, secondaryOutcomes measure: The Spinal Cord Independence Measure (SCIM-III), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Afyonkarahisar Health Sciences University, city: Afyonkarahisar, zip: 03100, country: Turkey, contacts name: Mahmut Sami DOĞANLAR, MD, role: CONTACT, phone: +905512579828, email: mahmutdoganlar96@gmail.com, contacts name: Nuran EYVAZ, MD, role: CONTACT, phone: +905334262442, email: eyvaznuran@gmail.com, geoPoint lat: 38.75667, lon: 30.54333, hasResults: False
|
protocolSection identificationModule nctId: NCT06278727, orgStudyIdInfo id: SYSKY-2023-1173-01, briefTitle: Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached., conditionsModule conditions: Mitral Regurgitation, conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor, interventions name: The development of the prediction model, outcomesModule primaryOutcomes measure: FMR regression rate, secondaryOutcomes measure: FMR regression rate, secondaryOutcomes measure: composite endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun-Yatsen Memorial Hospital, status: RECRUITING, city: Canton, state: Guangdong, country: China, contacts name: Maohuan Lin, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06278714, orgStudyIdInfo id: 0012, briefTitle: Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-03-11, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sierra Varona SL, class: OTHER, collaborators name: Universidad Europea de Madrid, descriptionModule briefSummary: Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.In this study, subjects will be divided into three groups: the experimental group, the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: the outcome assessor will not know in which group is each participant, and the investigator will receive the data without knowing which data is from which group, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory muscle training, outcomesModule primaryOutcomes measure: Respiratory muscle strength, primaryOutcomes measure: Diaphragmatic thickness and thickening fraction, primaryOutcomes measure: Diaphragm movement curve, primaryOutcomes measure: Heart rate variability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278701, orgStudyIdInfo id: 2024-003-01, briefTitle: The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: DU Yao, class: OTHER, descriptionModule briefSummary: Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;* the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :* eat 1h before bedtime;* follow the doctor's instructions during their stay in the hospital;* have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing., conditionsModule conditions: Liver Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study utilizes a grouping method based on patient preference. You will learn about the 2 dietary modalities, the late-evening snacks and the regular diet, and then you will be placed in the different groups according to your preference. Patients who volunteer for the 1h bedtime meal will be in the test group and those who volunteer for the regular diet will be in the control group. Dietary counseling and follow-up visits will be conducted in both groups, the difference being the presence or absence of the 1h bedtime meal pattern., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: late-evening snacks, outcomesModule primaryOutcomes measure: Albumin rising, secondaryOutcomes measure: Prealbumin rising, secondaryOutcomes measure: Decrease in Alanine Aminotransferase, secondaryOutcomes measure: Decrease in Aspartate Aminotransferase, secondaryOutcomes measure: Decrease in Cholinesterase, secondaryOutcomes measure: Decrease in Total bilirubin, secondaryOutcomes measure: Lower total hospitalization costs, secondaryOutcomes measure: Relapse-Free Survival, secondaryOutcomes measure: Improved quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Drum Tower Hospital, Medical School of Nanjing University, city: Nanjing, state: Jiangsu, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-22, uploadDate: 2024-02-02T09:22, filename: Prot_SAP_000.pdf, size: 743937, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-22, uploadDate: 2024-02-04T04:41, filename: ICF_001.pdf, size: 292546, hasResults: False
|
protocolSection identificationModule nctId: NCT06278688, orgStudyIdInfo id: 112R10438Y, briefTitle: Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, collaborators name: National Science and Technology Council, collaborators name: Far Eastern Memorial Hospital, descriptionModule briefSummary: The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI. The main questions it aims to answer are:Aim 1: To investigate the association between gut microbiota, MCI and AD biomarkers. Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data. Also, the relationship between gut microbiota and AD biomarkers, such as amyloid PET and plasma tau, will be explored in MCI and cognitively normal adults.Aim 2: To determine the efficacy of precision probiotic supplementation on cognitive decline (primary outcome) and functional brain changes (secondary outcome) in individuals with MCI due to AD using a randomized, double-blind, placebo-controlled trial. Investigators plan to recruit 120 individuals with MCI due to AD, i.e., MCI with positive amyloid biomarkers. Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo. The primary outcome measure will be the changes in cognitive functions over 6 months (primary endpoint) and 12 months. The secondary outcome measure will be resting-state functional brain changes.Aim 3: To investigate potential mediators underlying the effect of probiotic supplementation. The most apparent mediator will be a shift or changes in gut microbiota. Other potential mediators will be related to decreased lipopolysaccharide, proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6 and IL-10, and increased brain- derived neurotrophic factor, short-chain fatty acid, etc., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Precision probiotics, outcomesModule primaryOutcomes measure: The changes in attention, primaryOutcomes measure: The changes in memory, primaryOutcomes measure: The changes in executive function, secondaryOutcomes measure: The changes in global cognition at the 12th month from baseline., secondaryOutcomes measure: The changes in brain imaging at the 12th month from baseline., eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278675, orgStudyIdInfo id: SEOVA, briefTitle: Multiple Study of Electroaccpuncture in ARDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Nanjing University of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS., conditionsModule conditions: Acute Respiratory Distress Syndrome, conditions: Sepsis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture needles, outcomesModule primaryOutcomes measure: Respiratory mechanics indicators 1, primaryOutcomes measure: Respiratory mechanics indicators 2, primaryOutcomes measure: Respiratory mechanics indicators 3, primaryOutcomes measure: Respiratory mechanics indicators 4, primaryOutcomes measure: Respiratory mechanics indicators 5, primaryOutcomes measure: Respiratory mechanics indicators 6, primaryOutcomes measure: Respiratory mechanics indicators 7, secondaryOutcomes measure: Sedation and analgesia, secondaryOutcomes measure: Sedative drug use, secondaryOutcomes measure: Analgesic drug use, secondaryOutcomes measure: Inflammatory factors, secondaryOutcomes measure: CD4、CD8、CD4/CD8, secondaryOutcomes measure: Vasoactive drugs applications, secondaryOutcomes measure: CRRT applications, secondaryOutcomes measure: ECMO applications, secondaryOutcomes measure: All-cause mortality to day 28, secondaryOutcomes measure: All-cause mortality to day 60, secondaryOutcomes measure: ICU-free days, secondaryOutcomes measure: Hospital-free days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Jun Lu, Doctor, role: CONTACT, phone: +86 13813865758, email: lujun@njucm.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
|
protocolSection identificationModule nctId: NCT06278662, orgStudyIdInfo id: CIRCUS cmRCT, briefTitle: Cohort Multiple Randomized Controlled Trial in Pediatric Asthma, acronym: CIRCUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2034-04-01, completionDateStruct date: 2034-04-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Mattienne van der Kamp, class: OTHER, descriptionModule briefSummary: The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).Primary Objectives within cmRCT cohort:* Provide a framework for multiple randomized (eHealth) interventions for asthmatic children* Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.Secondary Objectives within cmRCT cohort:* Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.* Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.* Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations)., conditionsModule conditions: Pediatric Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The CIRCUS study has a cmRCT design to determine the effects of (eHealth) interventions in asthmatic children. Children are included in the prospective dynamic cohort during outpatient visits. Children and/or their parents are asked to sign consent for three parts of the cmRCT, of which at least consent for part 1 is needed to be eligible for participation:1. Participating in the prospective dynamic cohort and data collection.2. Willingness to participate in interventions.3. Willingness to fill out additional questionnaires and/or do additional measurements if a child is randomly selected for the control group of an intervention, which uses additional outcomes., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: The masking is dependent of the future interventions., enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: video directly observed therapy (vDOT), outcomesModule primaryOutcomes measure: Asthma control, primaryOutcomes measure: Pediatric Asthma Quality of Life, primaryOutcomes measure: Quality of care, primaryOutcomes measure: Self-management capacity, primaryOutcomes measure: Healthcare use, primaryOutcomes measure: Wheather data, primaryOutcomes measure: Air quality, primaryOutcomes measure: Pollen, primaryOutcomes measure: Medication delivery, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278649, orgStudyIdInfo id: 2023-161-Multi-site, briefTitle: Relaxation and Guided Imagery as an Intervention for Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Pace University, class: OTHER, collaborators name: University of Connecticut, collaborators name: Touro University, descriptionModule briefSummary: The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer., conditionsModule conditions: Asthma, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Relaxation and Guided Imagery, outcomesModule primaryOutcomes measure: Asthma, primaryOutcomes measure: Asthma, primaryOutcomes measure: Anxiety, secondaryOutcomes measure: Quality of Life, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06278636, orgStudyIdInfo id: 5745, briefTitle: Laparoscopic Ultrasound Examination: Analysis of Feasibility, acronym: LUXA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon., conditionsModule conditions: Gynecologic Cancer, conditions: Surgical Procedure, Unspecified, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopi ultrasound examination, outcomesModule primaryOutcomes measure: feasibility of the laparoscopic, secondaryOutcomes measure: the learning curve of fellow surgeons, secondaryOutcomes measure: the performance of fellow surgeons, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Floriana Mascilini, Dr, role: CONTACT, contacts name: Antonia Carla Testa, Prof, role: CONTACT, contacts name: Floriana Mascilini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06278623, orgStudyIdInfo id: 4935, briefTitle: Focal Muscle Vibration in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-11, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations., conditionsModule conditions: Parkinson Disease, conditions: Postural; Defect, conditions: Rehabilitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Focal Muscle Vibratory Energy (EVM) Treatment, outcomesModule primaryOutcomes measure: Tinetti scale, secondaryOutcomes measure: NRS numeric rating scale of pain, secondaryOutcomes measure: Stabilometric Test, secondaryOutcomes measure: Mc Gill Pain questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gianpaolo Ronconi, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: gianpaolo ronconi, role: CONTACT, phone: +393477123940, email: gronconi@yahoo.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06278610, orgStudyIdInfo id: 3612, briefTitle: Pelvic Exenteration and Laterally Extended Pelvic Resection, acronym: Pre-PEX, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-11-19, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool., conditionsModule conditions: Gynecologic Cancer, conditions: Surgical Procedure, Unspecified, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: PELVIC EXENTERATION, outcomesModule primaryOutcomes measure: pelvic exenteration resection., secondaryOutcomes measure: accuracy of US with the accuracy of MRI, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: ANTONIA CARLA Pr TESTA, role: CONTACT, email: antoniacarla.testa@policlinicogemelli.it, contacts name: NICOLO' DR BIZZARRI, role: CONTACT, phone: 3471771680, email: nicolo.bizzarri@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2020-05-29, uploadDate: 2023-02-24T13:07, filename: Prot_000.pdf, size: 598158, hasResults: False
|
protocolSection identificationModule nctId: NCT06278597, orgStudyIdInfo id: GLC02-22, briefTitle: Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-05, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2025-01-24, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Fondazione G.B. Bietti, IRCCS, class: OTHER, descriptionModule briefSummary: The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments., conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: NACA Estimator, outcomesModule primaryOutcomes measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp, primaryOutcomes measure: Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy., secondaryOutcomes measure: Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator, secondaryOutcomes measure: Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione GB Bietti, status: RECRUITING, city: Roma, zip: 00184, country: Italy, contacts name: Carmela Carnevale, MD, role: CONTACT, phone: +390677052834, email: carmela.carnevale@fondazionebietti.it, contacts name: Francesco Oddone, PhD, role: CONTACT, phone: +390677052834, email: francesco.oddone@fondazionebietti.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06278584, orgStudyIdInfo id: 2020001-00, briefTitle: iLux Treatment for Meibomian Gland Dysfunction, acronym: MGD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-15, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2022-02-28, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Clínica de Oftalmología de Cali S.A, class: OTHER, descriptionModule briefSummary: Summary:Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE., conditionsModule conditions: Meibomian Gland Dysfunction, conditions: Eyes Dry Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: iLUX Treatment System, outcomesModule primaryOutcomes measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds., primaryOutcomes measure: Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clínica de Oftalmología de Cali S.A, city: Cali, state: Valle Del Cauca, zip: 760036, country: Colombia, geoPoint lat: 3.43722, lon: -76.5225, hasResults: False
|
protocolSection identificationModule nctId: NCT06278571, orgStudyIdInfo id: R-2018-785-100, briefTitle: Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-12-03, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Coordinación de Investigación en Salud, Mexico, class: OTHER_GOV, descriptionModule briefSummary: The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico.The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs.nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10.Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients)., conditionsModule conditions: Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter clinical trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Participants are unaware of other intervention arms, whoMasked: PARTICIPANT, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: Educational intervention with App and web site education, interventions name: Educational interventión with web site education, interventions name: Control group with nutritional therapy, outcomesModule primaryOutcomes measure: Number of participants with glycosylated hemoglobin at control goals, primaryOutcomes measure: Number of participants with iipid profile in control targets, primaryOutcomes measure: Number of participants with body mass index profile in control target, secondaryOutcomes measure: Number of patients with changes to a healthy lifestyle, secondaryOutcomes measure: The proportion of patients with adequate knowledge of diabetes, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Instituto Mexicano Del Seguro Social, status: RECRUITING, city: Ciudad de mexico, zip: 03100, country: Mexico, contacts name: LUBIA Velazquez, PhD, role: CONTACT, phone: 525523259424, email: lubia2002@yahoo.com.mx, contacts name: Gabriela Ortiz, Master, role: CONTACT, phone: 5543379062, email: lubia2002@yahoo.com.mx, contacts name: Abril V Muñoz, PhD, role: SUB_INVESTIGATOR, contacts name: Jorge Escobedo, Phd, role: SUB_INVESTIGATOR, contacts name: Ignacio Pineda, Master, role: SUB_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, hasResults: False
|
protocolSection identificationModule nctId: NCT06278558, orgStudyIdInfo id: 2023-02-01, briefTitle: Psychological Factors Influencing Cancer Post-traumatic Growth, acronym: CEMA-P, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2026-11-10, completionDateStruct date: 2027-11-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Valenciennes, class: NETWORK, collaborators name: Ligue contre le cancer, France, collaborators name: Centre Oscar Lambret, collaborators name: Centre de Cancérologie Les Dentellières, collaborators name: Clinique Teissier, descriptionModule briefSummary: The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 289, type: ESTIMATED, armsInterventionsModule interventions name: Interviews with a psychologist/psychiatrist, outcomesModule primaryOutcomes measure: Post-traumatic growth, primaryOutcomes measure: Post-traumatic growth, primaryOutcomes measure: Post-traumatic growth, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Satisfaction of supportive care needs, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Emotional competence, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Anxiety and depression symptoms, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, secondaryOutcomes measure: Psychological flexibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Valenciennes, status: RECRUITING, city: Valenciennes, zip: 59300, country: France, contacts name: FODIL Hanane, role: CONTACT, phone: 0327140665, email: fodil-h@ch-valenciennes.fr, contacts name: Anne Sophie Baudry, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.35, lon: 3.53333, hasResults: False
|
protocolSection identificationModule nctId: NCT06278545, orgStudyIdInfo id: MANFREDI PHRCK 2022, briefTitle: Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma, acronym: FOLFORINOX SBA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.The primary objective is to assess the percentage of patients alive without prograssion at 8 months., conditionsModule conditions: Locally Advanced or Metastatic Small Bowel Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: modified FOLFORINOX, interventions name: Modified FOLFOX, outcomesModule primaryOutcomes measure: Assess the percentage of patients alive without progression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Dijon Bourgogne, status: RECRUITING, city: Dijon, zip: 21000, country: France, contacts name: Sylvain MANFREDI, role: CONTACT, phone: +33 03 80 29 37 50, email: sylvain.manfredi@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False
|
protocolSection identificationModule nctId: NCT06278532, orgStudyIdInfo id: NEGKOG, briefTitle: Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2026-12-11, completionDateStruct date: 2026-12-11, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Lithuanian University of Health Sciences, class: OTHER, descriptionModule briefSummary: This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test., conditionsModule conditions: Schizophrenia, conditions: Negative Symptoms in Schizophrenia, conditions: Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis), conditions: Cognitive Deficit, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Brief Negative Symptoms Scale, interventions name: The Calgary Depression Scale for Schizophrenia, interventions name: The Schizophrenia Cognition Rating Scale, outcomesModule primaryOutcomes measure: Validated Lithuanian version of the Brief Negative Symptoms Scale., primaryOutcomes measure: Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia., primaryOutcomes measure: Validated Lithuanian version of the Schizophrenia Cognition Rating Scale., secondaryOutcomes measure: Correlation between negative symptoms and cognitive deficits of schizophrenia, secondaryOutcomes measure: Correlation between depressive symptoms and cognitive deficits of schizophrenia, secondaryOutcomes measure: Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics, status: RECRUITING, city: Kaunas, zip: LT-50161, country: Lithuania, contacts name: Jonas Montvidas, role: CONTACT, phone: +37066240919, email: jonas.montvidas@lsmu.lt, contacts name: Eimantas Zauka, role: CONTACT, phone: +37069220076, email: eimantas.zauka@kaunoklinikos.lt, geoPoint lat: 54.90272, lon: 23.90961, locations facility: Jonas Montvidas, status: RECRUITING, city: Kaunas, zip: LT-53137, country: Lithuania, contacts name: Jonas Montvidas, role: CONTACT, phone: +37066240919, email: jonas.montvidas@lsmu.lt, contacts name: Algirdas Musneckis, role: CONTACT, phone: +37061378748, email: algirdas.musneckis@kaunoklinikos.lt, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False
|
protocolSection identificationModule nctId: NCT06278519, orgStudyIdInfo id: CARAMBOLE, briefTitle: CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE), acronym: CARAMBOLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Poitiers University Hospital, class: OTHER, collaborators name: Fédération Française de Cardiologie, descriptionModule briefSummary: ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided.The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI.Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas:* Descriptive epidemiology of STEMI and myocardial reperfusion* Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi)* Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs* Quality of life, personal, familial, social and professional consequences of myocardial infarction* Research of new diagnostic and prognosis biomarkers* Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population)Participants will undergo:* a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up* biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up* questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI., conditionsModule conditions: Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Blood, urinary and feces collection, interventions name: Cardiac MRI, interventions name: Quality of life and cognitive status questionnaire, outcomesModule primaryOutcomes measure: Major Adverse cardiac Events (MACE), secondaryOutcomes measure: Infarct size, secondaryOutcomes measure: Infarct size, secondaryOutcomes measure: No-reflow size, secondaryOutcomes measure: No-reflow size, secondaryOutcomes measure: Cardiac enzymes rate, secondaryOutcomes measure: Cardiac enzymes rate, secondaryOutcomes measure: Cardiac enzymes rate, secondaryOutcomes measure: Cardiac enzymes rate, secondaryOutcomes measure: Inflammatory markers rate, secondaryOutcomes measure: Inflammatory markers rate, secondaryOutcomes measure: Inflammatory markers rate, secondaryOutcomes measure: Inflammatory markers rate, secondaryOutcomes measure: Gut microbiota profiling, secondaryOutcomes measure: Gut microbiota profiling, secondaryOutcomes measure: Genitourinary microbiota profiling, secondaryOutcomes measure: Genitourinary microbiota profiling, secondaryOutcomes measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version), secondaryOutcomes measure: EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version), secondaryOutcomes measure: Codex test, secondaryOutcomes measure: Codex test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: C.H.U. of Poitiers, status: RECRUITING, city: Poitiers, zip: 86000, country: France, contacts name: Claire BOULETI, MD, role: CONTACT, phone: +33 5 49 44 43 25, email: claire.bouleti@chu-poitiers.fr, geoPoint lat: 46.58333, lon: 0.33333, hasResults: False
|
protocolSection identificationModule nctId: NCT06278506, orgStudyIdInfo id: 4612, briefTitle: Resection or Ablation of Small Kidney Tumors, acronym: RESTART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2037-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Karolinska University Hospital, class: OTHER, descriptionModule briefSummary: Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer., conditionsModule conditions: Kidney Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Ablation, interventions name: Surgery, outcomesModule primaryOutcomes measure: Number of participants with surgical complications according to Clavien-Dindo grade 2-5, primaryOutcomes measure: Radiological signs of a residual tumor at the 6-month follow-up, primaryOutcomes measure: Number of postoperative hospitalization days (LOS), secondaryOutcomes measure: Cancer-specific survival (CSS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Change in eGFR one year after treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, zip: 14186, country: Sweden, contacts name: Anders Kjellman, MD, PhD, role: CONTACT, phone: +46736995258, email: anders.kjellman@regionstockholm.se, contacts name: Per-Olof Lundgren, MD, PhD, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
|
protocolSection identificationModule nctId: NCT06278493, orgStudyIdInfo id: AL2846-I-0002, briefTitle: A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-23, primaryCompletionDateStruct date: 2021-10-25, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: AL2846 capsules, interventions name: Gemzar, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Maximum tolerated dose (MTD), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Hospital, city: Tianjin, state: Tianjin, zip: 300181, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06278480, orgStudyIdInfo id: LNC-MECA-003, briefTitle: Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: L&C Bio, class: INDUSTRY, descriptionModule briefSummary: The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery., conditionsModule conditions: Osteoarthritis, Knee, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: MegaCarti®, interventions name: microfracture, outcomesModule primaryOutcomes measure: Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment, primaryOutcomes measure: Comparison of macroscopic status of regenerated cartilage, secondaryOutcomes measure: Comparison of IKDC score, secondaryOutcomes measure: Comparison of VAS score, secondaryOutcomes measure: Comparison of KOOS score, secondaryOutcomes measure: Comparison of WOMAC score, secondaryOutcomes measure: Comparison of Kellgren-Lawrence grade, secondaryOutcomes measure: Comparison of HKA angle, Posterior Tibial slope, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health System, Gangnam Severance Hospital, city: Seoul, zip: 06273, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06278467, orgStudyIdInfo id: KonyaBeyhekimTRH2023, briefTitle: Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2024-02-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Konya Beyhekim Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60., conditionsModule conditions: Cognitive Dysfunction, conditions: Low Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 107, type: ACTUAL, armsInterventionsModule interventions name: visual pain scale (VASpain/fatigue), Beck depression index (BDI),, interventions name: Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire, interventions name: Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36),, interventions name: Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT), outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment Scale (MOCA), primaryOutcomes measure: Standard Mini mental test (SMMT), primaryOutcomes measure: Short Form-36 ( SF-36), primaryOutcomes measure: Beck depression scale (BDI), primaryOutcomes measure: Roland Morris Disability Questionnaire, primaryOutcomes measure: A single Likert type question in the Pittsburgh questionnaire (Sleep quality), primaryOutcomes measure: VAS pain and VAS fatigue, primaryOutcomes measure: Pain catastrophizing scale, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Konya Beyhekim Training and Research Hospital, city: Konya, state: Selçuklu, zip: 42060, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, locations facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation, city: Konya, zip: 42060, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
|
protocolSection identificationModule nctId: NCT06278454, orgStudyIdInfo id: NrtPac-1, secondaryIdInfos id: CTR20240312, type: OTHER, domain: Center for Drug Evaluation, NMPA, briefTitle: Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Chengdu New Radiomedicine Technology Co. LTD., class: INDUSTRY, descriptionModule briefSummary: This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study., conditionsModule conditions: Unresectable Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: NRT6008 Injection + Systematic chemotherapy, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D), primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Adverse events (AE) and severe adverse events (SAE), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Resection rate (R0 and R1), otherOutcomes measure: Concentration of tumor biomarkers, otherOutcomes measure: Numeric rating scale (NRS) of pain, otherOutcomes measure: Distribution of NRT6008 injection in human body and radioactivity of biological samples, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Suxia Luo, role: CONTACT, contacts name: Suxia Luo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Second Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, country: China, contacts name: Duanmin Hu, role: CONTACT, contacts name: Duanmin Hu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Shanghai Changhai Hospital, city: Shanghai, state: Shanghai, zip: +8602131162338, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Chongqing University Cancer Hospital, city: Chongqing, country: China, contacts name: Weiqing Chen, role: CONTACT, contacts name: Weiqing Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Tianjin Medical University General Hospital, city: Tianjin, country: China, contacts name: Bangmao Wang, role: CONTACT, contacts name: Bangmao Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06278441, orgStudyIdInfo id: Zila Özlem KIRBAŞ, briefTitle: The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Karadeniz Technical University, class: OTHER, descriptionModule briefSummary: Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of \>2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p\<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p\<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p\<0.001).Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing., conditionsModule conditions: Healthy Newborns, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is parallel-group, randomized controlled., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Due to the nature of the intervention, blinding could not be done for the participants, and the two researchers who collected the data, but the statistician and two other researchers who analyzed the results were unaware of group allocation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Kangaroo care and White noise, outcomesModule primaryOutcomes measure: Ninety newborns were randomized into three groups (30 in each group)., eligibilityModule sex: ALL, minimumAge: 32 Hours, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Bayburt University, city: Bayburt, zip: 69100, country: Turkey, geoPoint lat: 40.25631, lon: 40.22289, hasResults: False
|
protocolSection identificationModule nctId: NCT06278428, orgStudyIdInfo id: DEE UMC, briefTitle: Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2028-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Number 2 Children's Hospital, Ho Chi Minh City, class: OTHER, descriptionModule briefSummary: According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age?, conditionsModule conditions: Epilepsy; Seizure, conditions: Child Development, conditions: Gene Abnormality, conditions: Early Onset Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Genotye of early-onset developmental epileptic encephalopathy, otherOutcomes measure: Phenotye of early-onset developmental epileptic encephalopathy, otherOutcomes measure: Progression of epileptic encephalopathy and early onset developmental epileptic encephalopathy, eligibilityModule sex: ALL, maximumAge: 23 Months, stdAges: CHILD, contactsLocationsModule locations facility: Children hospital number 2, status: RECRUITING, city: Ho Chi Minh, zip: 700000, country: Vietnam, contacts name: Thuy-Minh-Thu LT NGUYEN, MD, role: CONTACT, phone: +84983966371, email: dr.thu.nguyen.neurology@gmail.com, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False
|
protocolSection identificationModule nctId: NCT06278415, orgStudyIdInfo id: P2021/Neonat/PhyCord 1, briefTitle: Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery, acronym: PhyCord1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-21, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Queen Fabiola Children's University Hospital, class: OTHER, collaborators name: The Belgian Kids Fund, collaborators name: Fonds IRIS-Recherche, collaborators name: Ars Statistica, descriptionModule briefSummary: Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother., conditionsModule conditions: Transient Tachypnea of the Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Physiological based cord clamping, interventions name: Differed cord clamping, outcomesModule primaryOutcomes measure: Rate of neonatal mortality, primaryOutcomes measure: Rate of neonatal resuscitation, primaryOutcomes measure: Rate of neonatal respiratory morbidity, primaryOutcomes measure: Number of admission to the NICU or special care baby unit, secondaryOutcomes measure: Success of PBCC, secondaryOutcomes measure: Time to first breath/cry, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Changes in physiological variables during neonatal transition, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Early neonatal parameters, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Bilirubin level, secondaryOutcomes measure: Number of neonatal adverse events, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Maternal perioperative parameters, secondaryOutcomes measure: Number of maternal adverse events, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Rate of maternal-infant bonding, secondaryOutcomes measure: Child developmental assessment, secondaryOutcomes measure: Parental satisfaction survey, eligibilityModule sex: ALL, minimumAge: 37 Weeks, maximumAge: 42 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: CHU Brugmann, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Andrew CARLIN, role: CONTACT, phone: +3224773295, email: andrew.carlin@chu-brugmann.be, contacts name: Andrew CARLIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Hôpital Universitair Des Enfants Reine Fabiola, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Anna AMORUSO, role: CONTACT, phone: +3224773250, email: anna.amoruso@hubruxelles.be, contacts name: Anna AMORUSO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
|
protocolSection identificationModule nctId: NCT06278402, orgStudyIdInfo id: JinnahH, briefTitle: Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-01-06, completionDateStruct date: 2024-01-16, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Jinnah Hospital, class: OTHER, descriptionModule briefSummary: To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2., conditionsModule conditions: Alopecia Areata, conditions: Alopecia Totalis, conditions: Alopecia Universalis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study includes patients with moderate to severe Alopecia Areata, totalis and universalis. The efficacy of JAK 1/3 inhibitor, Tofacitinib will be assessed by using SALT score (Severity of Alopecia Tool) at Baseline, 06 weeks, 12 weeks and 24 weeks. Oral Tofacitinib given at a dose of 5 mg twice daily after relevant investigations. The data will be analyzed in SPSS version 23., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Tofacitinib, outcomesModule primaryOutcomes measure: Alopecia, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Misbah Zari Qadir, city: Karachi, state: Sindh, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
|
protocolSection identificationModule nctId: NCT06278389, orgStudyIdInfo id: ADYY-ACC017-101, secondaryIdInfos id: CTR20240167, type: REGISTRY, domain: chinadrugtrials.org.cn, briefTitle: Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2024-04-23, completionDateStruct date: 2024-04-23, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Jiangsu Aidea Pharmaceutical Co., Ltd, class: INDUSTRY, collaborators name: Chengdu Aidea Pharmaceutical Technology Co., Ltd, descriptionModule briefSummary: The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions:* Recommended dosage for ACC017 tablets used in phase Ib/IIa trial;* The pharmacokinetic (PK) characteristics of single dose ACC017 tablets;* The effect of food (FE) on the PK of ACC017 tablets;* Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II)., conditionsModule conditions: Healthy Adult Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: ACC017 tablets, interventions name: Emtricitabine and Tenofovir Alafenamide Fumarate Tablets, outcomesModule primaryOutcomes measure: Frequency, causality, severity, and expectedness of adverse events (AEs), primaryOutcomes measure: ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition), primaryOutcomes measure: ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition), secondaryOutcomes measure: Vital signs: temperature, secondaryOutcomes measure: Vital sign: pulse, secondaryOutcomes measure: Vital signs: blood pressure, secondaryOutcomes measure: Vital signs: respiration, secondaryOutcomes measure: Electrocardiogram (ECG): heart rate, secondaryOutcomes measure: Electrocardiogram (ECG): PR interval, secondaryOutcomes measure: Electrocardiogram (ECG): QRS duration, secondaryOutcomes measure: Electrocardiogram (ECG): QTc interval, secondaryOutcomes measure: ACC017 PK parameter: Cmax, secondaryOutcomes measure: ACC017 PK parameter: C24h, secondaryOutcomes measure: ACC017 PK parameter: AUC0-t, secondaryOutcomes measure: ACC017 PK parameter: AUC0-∞, secondaryOutcomes measure: ACC017 PK parameter: Tmax, secondaryOutcomes measure: ACC017 PK parameter: t1/2, secondaryOutcomes measure: ACC017 PK parameter: Vz/F, secondaryOutcomes measure: ACC017 PK parameter: CL/F, secondaryOutcomes measure: ACC017 PK parameter: λz, secondaryOutcomes measure: ACC017 PK parameter: AUC_%Extrap, secondaryOutcomes measure: ACC017 PK parameter: MRT0-t, secondaryOutcomes measure: ACC017 PK parameter: MRT0-∞, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Ditan Hospital Capital Medical University, status: RECRUITING, city: Beijing, zip: 100015, country: China, contacts name: Fujie Zhang, role: CONTACT, email: treatment@chinaaids.cn, contacts name: Chaoying Hu, role: CONTACT, email: hucarol@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06278376, orgStudyIdInfo id: f/2023/045, briefTitle: Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Jessa Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans., conditionsModule conditions: Magnetic Resonance Imaging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 410, type: ACTUAL, outcomesModule primaryOutcomes measure: Incidence, secondaryOutcomes measure: Therapeutical implications: diagnosis, secondaryOutcomes measure: Therapeutical implications: treatment, secondaryOutcomes measure: Clinical indications, secondaryOutcomes measure: Evaluation of body part, secondaryOutcomes measure: Evaluation of symptoms, secondaryOutcomes measure: Clinical outcome: adverse event, secondaryOutcomes measure: Clinical outcome: surgery, secondaryOutcomes measure: Clinical outcome: admission to hospital, secondaryOutcomes measure: Clinical outcome: mortality, secondaryOutcomes measure: Evaluation of age, secondaryOutcomes measure: Influence of COVID-19 pandemic, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Jessa hospital, city: Hasselt, zip: 3500, country: Belgium, geoPoint lat: 50.93106, lon: 5.33781, hasResults: False
|
protocolSection identificationModule nctId: NCT06278363, orgStudyIdInfo id: StrokeSex_23, briefTitle: Sexual Nursing Care in Stroke Patients, acronym: StrokeSex_23, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Centro Neurolesi "Bonino-Pulejo", class: OTHER, descriptionModule briefSummary: The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We aim to assess the effectiveness of an intervention in stroke subjects to increase awareness of sexual health, effectively manage sexual dysfunctions, reduce their frequency, and enhance psychophysical well-being., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Participant Masking: Participants are unaware of the treatment they are receiving. This helps prevent biases in reporting outcomes based on knowledge of the treatment.Care Provider Masking: The individuals providing care, such as therapists or nurses, are also unaware of the treatment assigned to each participant. This prevents them from inadvertently influencing outcomes based on their knowledge of the treatment.Investigator Masking: The individuals responsible for collecting and analyzing the data are blinded to the treatment allocation. This helps ensure impartiality and prevents biases in data interpretation.Outcomes Assessor Masking: Individuals responsible for assessing the outcomes of the study, such as evaluating patient progress or interpreting test results, are blinded to the treatment group to which participants belong. This prevents biases in outcome assessment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 113, type: ESTIMATED, armsInterventionsModule interventions name: Sexual Nursing care, interventions name: Standard Nursing Care, outcomesModule primaryOutcomes measure: Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness, secondaryOutcomes measure: psychosocial well-being and relational dynamics of stroke patients and their partners, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Centro Neurolesi Bonino Pulejo, status: RECRUITING, city: Messina, state: Italy/Messina, zip: 98124, country: Italy, contacts name: Maria Grazia Maggio, PsyD, PhD, role: CONTACT, phone: +39-09060128840, email: mariagrazia.maggio@irccsme.it, contacts name: Maria Grazia Maggio, PsyD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False
|
protocolSection identificationModule nctId: NCT06278350, orgStudyIdInfo id: D2570-201, briefTitle: Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: InventisBio Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis ., conditionsModule conditions: Plaque Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: D-2570, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of subjects with at least 75% improvement in PASI, secondaryOutcomes measure: Percentage of subjects with at least 75% improvement in PASI, secondaryOutcomes measure: Percentage of subjects with at least 90% improvement in PASI, secondaryOutcomes measure: Percentage of subjects with 100% improvement in PASI, secondaryOutcomes measure: Percentage improvement in PASI, secondaryOutcomes measure: Percentage of subjects with a PGA, secondaryOutcomes measure: The main PK parameters ：Time to maximum measured plasma concentration（Tmax）, secondaryOutcomes measure: The main PK parameters ：Peak Plasma Concentration（Cmax), secondaryOutcomes measure: The main PK parameters：Area under the plasma concentration versus time curve（AUC）, secondaryOutcomes measure: The main PK parameters：Vz/F (apparent volume of distribution), secondaryOutcomes measure: The main PK parameters： Half-life（t1/2）, secondaryOutcomes measure: The main PK parameters： Mean Residence Time (MRT), secondaryOutcomes measure: The main PK parameters：CL/F (apparent clearance), secondaryOutcomes measure: Weight and height will be combined to report BMI in kg/m^2, secondaryOutcomes measure: Incidence and severity of AEs based on NCI CTCAE V5.0, secondaryOutcomes measure: Incidence and severity of TEAEs based on NCI CTCAE V5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Jianzhong Zhang, role: CONTACT, phone: 13911815813, email: rmzjz@126.com, contacts name: Cheng Zhou, role: CONTACT, phone: 010-88325470, email: zhoucheng@live.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06278337, orgStudyIdInfo id: C19-35, briefTitle: X-linked Moesin Associated Immunodeficiency, acronym: X-MAIDReg, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-08-12, primaryCompletionDateStruct date: 2026-08-12, completionDateStruct date: 2027-01-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Institut National de la Santé Et de la Recherche Médicale, France, class: OTHER_GOV, descriptionModule briefSummary: Moesin deficiency was initially described in 7 male participants aged 4 to 69 years and is characterized by lymphopenia of the 3 lineages and moderate neutropenia. Genetically, 6 out of 7 participants had the same missense mutation in the moesin gene located on the X chromosome. The 7th patient has a mutation leading to the premature introduction of a STOP codon into the protein.Clinically the 7 participants with X-linked moesin-associated immunodeficiency all presented with recurrent bacterial infections of the respiratory, gastrointestinal or urinary tracts, and some had severe varicella.Therapeutically, in the absence of a molecular diagnosis and due to his SCID-like phenotype, one patient was treated with geno-identical hematopoietic stem cell transplantation . The remaining are untreated or treated with immunoglobulin substitution and/or prophylactic antibiotics.Since this study, the moesin gene has been integrated into DNA chips used for the molecular diagnosis of immune deficiencies in several countries. Physicians in Canada, the United States, Japan, South Africa and Europe have contacted us with a total of 16 known participants to date. Because of their very low severe, uncontrolled CMV infection and the absence of treatment recommendations, two 2 American participants were treated with allogeneic transplantation with severe post-transplant complications (1), and one of the participants died as a result of the transplant. Management of XMAID participants therefore varies widely from country to country, depending on age at diagnosis and clinical picture. It ranges from no treatment treatment (associated with recurrent infections and skin manifestations), IgIv substitution and/or antibiotic prophylaxis antibiotic prophylaxis, with low toxicity and apparent efficacy, and allogeneic transplantation, with all the risks risks involved (graft-related toxicity, graft versus host, disease, rejection, risk of infection). The Investigators therefore feel it is important to review the diagnosis, clinical presentation and management of X-MAID participants. The study the investigator propose will enable to understand the presentation of X-MAID participants, establish guidelines and provide the best treatment for each patient according to his or her clinical picture, conditionsModule conditions: Immune Deficiency, conditions: Autoimmune Diseases, conditions: Infections, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: genetic restrospective study, outcomesModule primaryOutcomes measure: The main objective, secondaryOutcomes measure: Secondary objectives1, otherOutcomes measure: secondary objectives 2, otherOutcomes measure: secondary objective 3, otherOutcomes measure: secondary objectives 4, otherOutcomes measure: secondary objective 5, eligibilityModule sex: MALE, minimumAge: 4 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health, status: NOT_YET_RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Luigi Notarangelo, Doctor, role: CONTACT, geoPoint lat: 38.98067, lon: -77.10026, locations facility: Perelman School of medecine, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19050, country: United States, contacts name: Jennifer Heimall, Pr, role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Brown University, status: NOT_YET_RECRUITING, city: Providence, state: Rhode Island, zip: 02912, country: United States, contacts name: Anthony Hayward, role: CONTACT, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Genomic Research Centre, School of Biomedical Sciences Institute of Health and Biomedical Innovation, status: NOT_YET_RECRUITING, city: Brisbane, zip: 4001, country: Australia, contacts name: Lyn Griffith, Pr, role: CONTACT, geoPoint lat: -27.46794, lon: 153.02809, locations facility: Hôpital Universitaire de la Reine Fabiola, status: NOT_YET_RECRUITING, city: Bruxelles, zip: 1020, country: Belgium, contacts name: Catherine Heijmans, Doctor, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Hôpital Necker, status: RECRUITING, city: Paris, zip: 75015, country: France, contacts name: Benedicte NEVEN, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Rennes, CNRS UMR 629, status: RECRUITING, city: Rennes, zip: 35000, country: France, contacts name: Virginie Gandemer, Doctor, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU St Etienne Hôpital Nord, status: NOT_YET_RECRUITING, city: Saint-Étienne, zip: 42270, country: France, contacts name: Jean-Louis STEPHAN, Doctor, role: CONTACT, geoPoint lat: 45.43389, lon: 4.39, locations facility: Tokyo Medical and Dental University (TMDU), status: NOT_YET_RECRUITING, city: Bunkyō-Ku, zip: 1138510, country: Japan, contacts name: Kohsuke Imai, Pr, role: CONTACT, geoPoint lat: 35.37517, lon: 139.92991, locations facility: Departments of Internal Medicine and Immunology, status: NOT_YET_RECRUITING, city: Rotterdam, country: Netherlands, contacts name: Virgil Dalm, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
|
protocolSection identificationModule nctId: NCT06278324, orgStudyIdInfo id: C1736, secondaryIdInfos id: 2023-A02286-39, type: REGISTRY, domain: ANSM, briefTitle: Effectiveness of a Nasal Spray on Viral Respiratory Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: CEN Biotech, class: INDUSTRY, collaborators name: Urgo Research, Innovation & Development, descriptionModule briefSummary: There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment., conditionsModule conditions: Acute Respiratory Tract Infection, conditions: Flu, Human, conditions: COVID-19, conditions: Common Cold, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, parallel arms (1:1 allocation ratio), single center, with a blind assessment for primary outcome, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinded assessment of viral load analyses, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nasal Spray HSV Treatment, outcomesModule primaryOutcomes measure: Performance of nasal spray in eliminating viruses, secondaryOutcomes measure: Changes from baseline in viral load, secondaryOutcomes measure: Rate of patients cleared from viral infection, secondaryOutcomes measure: Rate of patients with improved viral infection, secondaryOutcomes measure: Rate of patients with worsening viral infection, secondaryOutcomes measure: Rate of patients with new viral infection, secondaryOutcomes measure: Changes in symptom severity, secondaryOutcomes measure: Duration of illness, secondaryOutcomes measure: Time to clinical improvement of the symptoms, secondaryOutcomes measure: Adverse event occurence, otherOutcomes measure: Patient opinion of nasal spray, otherOutcomes measure: Nasal spray safety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 84 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cen Experimental, status: RECRUITING, city: Dijon, state: Burgundy, zip: 21000, country: France, contacts name: Amandine FRY, role: CONTACT, phone: 0033380680513, email: amandine.fry@groupecen.com, contacts name: Carole PERRIN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.31667, lon: 5.01667, hasResults: False
|
protocolSection identificationModule nctId: NCT06278311, orgStudyIdInfo id: 20235761, briefTitle: Correlation of Toxins With Gastrointestinal (GI) and Overall Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Vibrant America Clinical Lab, class: INDUSTRY, collaborators name: Los Angeles Integrative Gastroenterology and Nutrition, Inc, descriptionModule briefSummary: The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health., conditionsModule conditions: Gastrointestinal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Determination of the Total Toxicity score, primaryOutcomes measure: Determination of the Symptom score, primaryOutcomes measure: Determination of the Diagnosis score, secondaryOutcomes measure: Determination of individual scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Angeles Integrative Gastroenterology and Nutrition, Inc, city: Los Angeles, state: California, zip: 90067, country: United States, contacts name: Dr. Farshid S Rahbar, MD, role: CONTACT, phone: 310-289-8000, email: Research@laintegrativegi.com, contacts name: Dr. Farshid S Rahbar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Vibrant America Clinical Lab, city: Santa Clara, state: California, zip: 95054, country: United States, contacts name: Hari K Krishnamurthy, MS, role: CONTACT, phone: 866-364-0963, email: hari@vibrantsci.com, contacts name: Hari K Krishnamurthy, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.35411, lon: -121.95524, hasResults: False
|
protocolSection identificationModule nctId: NCT06278298, orgStudyIdInfo id: REC/012/003318, briefTitle: Different Level of ECSWT in Post Mastectomy Lymphedema, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol), conditionsModule conditions: Lymphedema of Upper Limb, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Shockwave, interventions name: CDT, outcomesModule primaryOutcomes measure: lymphedema volume, primaryOutcomes measure: skin thickness of the arm, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, state: Dokki, zip: 12612, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
|
protocolSection identificationModule nctId: NCT06278285, orgStudyIdInfo id: 21-AOIP-01, briefTitle: Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery, acronym: Maigrir_OT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Blood GLP1, interventions name: Blood No treated GLP1, outcomesModule primaryOutcomes measure: Rate of oxytocin, secondaryOutcomes measure: Fibrosis rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nice - Hôpital de l'Archet, status: RECRUITING, city: Nice, state: Alpes-maritimes, zip: 06200, country: France, contacts name: Roux Christian, PhD, role: CONTACT, phone: +33492039220, email: roux.c@chu-nice.fr, contacts name: Iannelli Antonio, PhD, role: CONTACT, phone: +33492035900, email: iannelli.a@chu-nice.fr, contacts name: Iannelli Antonio, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
|
protocolSection identificationModule nctId: NCT06278272, orgStudyIdInfo id: AIPEI, briefTitle: AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: Early assessment of pancreatic exocrine insufficiency (PEI) is crucial for determining appropriate chronic pancreatitis (CP) treatment plans, thereby avoiding unnecessary suffering and further complications in patients. A total of 504 patients with CP who underwent fecal elastase-1 test and contrast-enhanced CT at Changhai Hospital between January 2018 and April 2023 were enrolled in this study. The investigators aim to establish a fully automated workflow to establish a PEI classification model based on radiomic features, semantic features and deep learning features on enhanced CT images for evaluating the severity of PEI., conditionsModule conditions: Chronic Pancreatitis, conditions: Exocrine Pancreatic Insufficiency, conditions: Machine Learning, conditions: Deep Learning, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 504, type: ACTUAL, outcomesModule primaryOutcomes measure: Classification of pancreatic exocrine insufficiency, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai Hospital, city: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06278259, orgStudyIdInfo id: P.T.REC/012/005023, briefTitle: Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video with the Baduanjin exercise program ,the control group will receive the same aerobic exercises only, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Telerehabilitation program bases aerobic and Baduanjin exercises, interventions name: Telerehabilitation program bases aerobic exercises, outcomesModule primaryOutcomes measure: physical function, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: sleep quality, secondaryOutcomes measure: participants' satisfaction with the program, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Cairo, state: Dokki, zip: 11432, country: Egypt, contacts name: marwa M elsayed, phd, role: CONTACT, phone: 01156033818, phoneExt: 02, email: marwadd999@gmail.com, contacts name: marwa M elsayed, ph.d, role: CONTACT, phone: 01156033818, phoneExt: 02, email: marwadd999@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06278246, orgStudyIdInfo id: 050/2021, briefTitle: Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms., conditionsModule conditions: Schizophrenia, conditions: Schizophreniform Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: PET Scan, outcomesModule primaryOutcomes measure: M4 receptor expression, primaryOutcomes measure: Clinical Data Statistical Analysis, secondaryOutcomes measure: Statistical Analysis of Cognitive Data, secondaryOutcomes measure: Statistical Analysis of Psychopathological Personality Traits in Health Control Group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for Addiction and Mental Health, city: Toronto, state: Ontario, zip: M5T1R8, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.