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protocolSection identificationModule nctId: NCT06326346, orgStudyIdInfo id: AMC2401, briefTitle: GIST Oral Paclitaxel(Liporaxel), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Asan Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression., conditionsModule conditions: Gastrointestinal Stromal Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Liporaxel, outcomesModule primaryOutcomes measure: 16 week disease control rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Adverse event assessed by NCI-CTCAE Version 5.0, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asan Medical Center, University of Ulsan College of Medicine, city: Seoul, state: Songpagu, zip: 138-736, country: Korea, Republic of, contacts name: Min-Hee Ryu, MD, PhD, role: CONTACT, phone: 82-2-3010-5936, email: miniryu@amc.seoul.kr, contacts name: Hyung-Don Kim, MD, PhD, role: CONTACT, phone: 82-2-3010-0236, email: kimhdmd@amc.seoul.kr, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06326333, orgStudyIdInfo id: E.Kurul-E2-24-6176, briefTitle: Combination of Parasternal and Serratus Anterior Plane Block in Coronary Artery Bypass Graft Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-03-27, completionDateStruct date: 2024-04-18, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. Parasternal block (PSB) and serratus anterior plane block (SAPB) are very superficial and easy to reach. Recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased.With this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying PSB and SAPB applications simultaneously in the postoperative analgesia of CABG patients., conditionsModule conditions: Parasternal Block, conditions: Serratus Anterior Plane Block, conditions: Acute Pain, conditions: Postoperative Analgesia, conditions: Cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Combined parasternal block and serratus anterior plane block, outcomesModule primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, secondaryOutcomes measure: Remifentanyl Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital, city: Çankaya, state: Ankara, zip: 06290, country: Turkey, geoPoint lat: 39.9179, lon: 32.86268, hasResults: False
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protocolSection identificationModule nctId: NCT06326320, orgStudyIdInfo id: E.Kurul-E2-24-6175, briefTitle: Combined SAPB in MICS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-17, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated., conditionsModule conditions: Serratus Anterior Plane Block, conditions: Acute Pain, conditions: Postoperative Analgesia, conditions: Minimal Invasive Cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Combined SAPB, outcomesModule primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, primaryOutcomes measure: Pain Scores, secondaryOutcomes measure: Remifentanyl Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara City Hospital, status: RECRUITING, city: Çankaya, state: Ankara, zip: 06290, country: Turkey, contacts name: Emine N Zengin, MD, role: CONTACT, phone: +905063370548, email: nilbavullu@gmail.com, geoPoint lat: 39.9179, lon: 32.86268, hasResults: False
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protocolSection identificationModule nctId: NCT06326307, orgStudyIdInfo id: 247-05-21, briefTitle: Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: King Abdulaziz University, class: OTHER, descriptionModule briefSummary: The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'* The main question\[s\] it aims to answer are: 1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia. 2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.type of study: clinical trial participant population/health conditions: HealthyIn this randomized crossover clinical trial, study subjects were randomly allocated into two groups:* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P), conditionsModule conditions: Behavioral Guidance in Pediatric Dentistry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: * Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)* Group II: Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Two evaluators, who are blinded to the experimented techniques, watched recorded videos of both groups separately and gave their behavior assessment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 41, type: ACTUAL, armsInterventionsModule interventions name: Tell Show and Do Guidance, interventions name: Puppet Guidance, outcomesModule primaryOutcomes measure: Heart rate, primaryOutcomes measure: Facial Image Scale, primaryOutcomes measure: Vehnam Anxiety Rating Scale, primaryOutcomes measure: Frankl behavior rating scale, primaryOutcomes measure: FLACC Pain scale, primaryOutcomes measure: Venham Scale of Dental behavior, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: King Abulaziz university dental hospital, city: Jeddah, state: Makkah, zip: 21589, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, hasResults: False
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protocolSection identificationModule nctId: NCT06326294, orgStudyIdInfo id: 727/CNBS/23, briefTitle: Assessment of the Effectiveness of TA Versus LEEP for Cervical Cancer Risk Reduction in WLHIV in Mozambique, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Saúde, Mozambique, class: OTHER_GOV, collaborators name: M.D. Anderson Cancer Center, descriptionModule briefSummary: Given that WLWH are more likely to develop persistent HPV infection and CC, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. The vast majority of WLWH live in SSA, where resources are more constrained. Therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in SSA. In this setting, the best method for treatment of screen-positive WLWH has not been determined. The proposed study will compare the effectiveness of TA vs. LEEP, for treating precursor lesions (CIN 2/3) and HPV infection in WLWH, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. Moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence., conditionsModule conditions: HIV Infections, conditions: HPV Infection, conditions: CIN 2/3, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare TA, an ablative cervical treatment modality, and LEEP, an excisional cervical treatment modality, in screen-positive WLWH patients, for eradication of hrHPV and effectiveness of treating biopsy-confirmed CIN 2/3., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4844, type: ESTIMATED, armsInterventionsModule interventions name: Thermal ablation, interventions name: LOOP ELECTROSURGICAL EXCISION PROCEDURE, outcomesModule primaryOutcomes measure: Comparison of treatment success rates for biopsy-confirmed CIN 2/3: Thermoablation (TA) vs. Loop Electrosurgical Excision Procedure (LEEP), eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: INSMozambique, city: Maputo, country: Mozambique, geoPoint lat: -25.96553, lon: 32.58322, hasResults: False
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protocolSection identificationModule nctId: NCT06326281, orgStudyIdInfo id: ACHBILKENT-ANEST-BK-01, briefTitle: Postoperative Pain Management in Laparoscopic Cholecystectomies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-02-22, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction., conditionsModule conditions: Cholecystitis/Cholelithiasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: external oblique intercostal plane block group, interventions name: oblique subcostal TAP block group, interventions name: Local anesthetic infiltration group, interventions name: control group, outcomesModule primaryOutcomes measure: Visual Analogue Scale Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bılkent City Hospital, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06326268, orgStudyIdInfo id: 2023-019, secondaryIdInfos id: 2023-A02133-42, type: OTHER, domain: ID-RCB Number, briefTitle: Interest of Light Therapy in Hematology - The PHOTO-TREAT Study, acronym: PHOTO-TREAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2025-09-17, completionDateStruct date: 2025-09-17, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Institut de cancérologie Strasbourg Europe, class: OTHER, descriptionModule briefSummary: Chemo-induced mucositis is a common complication in patients treated for hematologic malignancies. They can manifest itself as a simple local irritation with erythema and inflammation but can also progress to erosions and ulcerations of the entire oral mucosa and are also responsible for an increased risk of infection in these immunocompromised patients.The only therapies currently offered are local care and intravenous analgesics. Studies in pediatric hematology show the effectiveness of prevention and low-dose laser treatment in chemo-induced mucositis, both in terms of reducing the number of mucositis developed but also in terms of reducing the grade of mucositis. This currently results in a recommendation for the use of photobiomodulation by international bodies such as ESMO (European Society for Medical Oncology)., conditionsModule conditions: Leukemia, Myeloid, Acute, conditions: Lymphoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Phototherapy system CareMin650TM, outcomesModule primaryOutcomes measure: Evaluate the impact of Photobiomodulation (PBM) therapy in the management of chemo-induced mucositis in terms of prevalence of mucositis, secondaryOutcomes measure: Evaluate the impact of PBM in the management of chemo-induced mucositis in terms of reduction in analgesic consumption., secondaryOutcomes measure: Evaluate the impact of PBM in terms of infection by bacterial translocation risk reduction., secondaryOutcomes measure: Evaluate the impact of PBM in terms of reduction of the use of artificial feeding., secondaryOutcomes measure: Evaluate the impact of PBM in terms of reduction of the length of hospital stay., secondaryOutcomes measure: Evaluate the impact of PBM in terms of reduction of the number of transfusions., secondaryOutcomes measure: Evaluate the impact of PBM in terms of pain reduction, secondaryOutcomes measure: Evaluate the impact of PBM on patient's satisfaction regarding pain management during hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut de cancérologie Strasbourg Europe, status: RECRUITING, city: Strasbourg, zip: 67033, country: France, contacts role: CONTACT, phone: (0)3 68 33 95 23, phoneExt: +33, email: promotion-rc@icans.eu, contacts name: Anne ZILLIOX, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
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protocolSection identificationModule nctId: NCT06326255, orgStudyIdInfo id: LYASD, briefTitle: Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:1. Laughter yoga is acceptable to children with ASD and their parents.2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.3. Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group., conditionsModule conditions: Autism Spectrum Disorder, conditions: Parenting Stress, conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: laughter yoga, outcomesModule primaryOutcomes measure: Response rate, primaryOutcomes measure: Attrition rate, primaryOutcomes measure: Attendance rate, primaryOutcomes measure: Perception on laughter yoga, primaryOutcomes measure: Difficulties in laughter yoga, primaryOutcomes measure: Safety issues, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Parenting Stress, secondaryOutcomes measure: Child-parent Relationships, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06326242, orgStudyIdInfo id: IEO 1648, briefTitle: What Unmet Need for the Patients?A Focus on the Social Determinants of Health in Phase 1 Clinical Trials, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: An observational prospective study of patients enrolled and treated with experimental drugs in Phase I studies., conditionsModule conditions: Solid Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Solid Tumor, outcomesModule primaryOutcomes measure: The geographical accessibility of patients attending the Phase 1 facility of the European Institute of Oncology (IEO)., secondaryOutcomes measure: The characterization of enrolled patients involves assessing their participation in clinical trials, secondaryOutcomes measure: The characterization of enrolled patients based on therapeutic compliance., secondaryOutcomes measure: The protocol prescriptions in relation to socioeconomic and geographical determinants., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of oncology, status: RECRUITING, city: Milano, zip: 20141, country: Italy, contacts name: Teresa Profeta, role: CONTACT, phone: +390294372561, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06326229, orgStudyIdInfo id: CEIm 3096, briefTitle: Clinical Validation of Musculoskeletal ICF Core Set in Primary Care Physiotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-09-26, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Valladolid, class: OTHER, collaborators name: Castilla-León Health Service, descriptionModule briefSummary: The aim of this observational study is to validate the content of a tailored ICF core set for the management of musculoskeletal conditions in primary care physiotherapy services.The main question it aims to answer is:- Are the ICF entities included in the ICF Core Set under evaluation useful from a clinical point of view?Participants will evaluate the relevance of each ICF entity included in the ICF core set according to their musculoskeletal condition., conditionsModule conditions: Musculoskeletal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 385, type: ESTIMATED, armsInterventionsModule interventions name: ICF entities assessment, outcomesModule primaryOutcomes measure: ICF core set for post-acute musculoskeletal conditions (adapted version for primary care physiotherapy services), otherOutcomes measure: Sociodemographic data of the sample, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ólvega Primary Care Physiotherapy service, city: Ólvega, state: Soria, zip: 42110, country: Spain, contacts name: Héctor Hernández Lázaro, PhD, role: CONTACT, phone: +34976645480, phoneExt: 38229, email: hhernandezl@saludcastillayleon.es, geoPoint lat: 41.77901, lon: -1.98391, hasResults: False
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protocolSection identificationModule nctId: NCT06326216, orgStudyIdInfo id: 19-011292, secondaryIdInfos id: NCI-2023-05221, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19-011292, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-06-10, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer., conditionsModule conditions: Prostate Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - radical prostatectomy, primaryOutcomes measure: Levels of prostate cancer-derived extracellular vesicles (EVs) - negative controls, primaryOutcomes measure: Correlation between prostate specific antigen (PSA) levels and prostate cancer-derived EVs, primaryOutcomes measure: Prostate cancer-derived EV levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Eugene D. Kwon, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06326203, orgStudyIdInfo id: UPECLIN-MB-8, briefTitle: Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: UPECLIN HC FM Botucatu Unesp, class: OTHER, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, descriptionModule briefSummary: Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation., conditionsModule conditions: Peripheral Arterial Disease, conditions: Leg Ulcer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: CELULAS TRONCO, interventions name: CONVENTIONAL DRESSING, outcomesModule primaryOutcomes measure: Major Amputation, primaryOutcomes measure: Ulcer Healing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326190, orgStudyIdInfo id: EORTC-2334-BTG, briefTitle: 177Lu-DOTATATE for Recurrent Meningioma, acronym: LUMEN-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-06, primaryCompletionDateStruct date: 2027-04-14, completionDateStruct date: 2028-12-22, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: European Organisation for Research and Treatment of Cancer - EORTC, class: NETWORK, collaborators name: Novartis, descriptionModule briefSummary: Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area., conditionsModule conditions: Recurrent Meningioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Local standard of Care, interventions name: 177Lu-DOTATATE, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Radiological response rate, secondaryOutcomes measure: Radiological response rate, secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: Neurological function (NANO scale), secondaryOutcomes measure: Toxicity According to CTCAE Version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326177, orgStudyIdInfo id: Yeditepe U - Poyraz Tuncer, briefTitle: Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Yeditepe University, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters., conditionsModule conditions: Postural Kyphosis, conditions: Postural Lordosis, conditions: Movement, Abnormal, conditions: Spine Injury, conditions: Cervical Lordosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Spine Posture Assessment, interventions name: Spine Movement Assessment, interventions name: Core Muscle Endurance Assessment, interventions name: Scapular Dyskinesia, interventions name: Shoulder Strength, outcomesModule primaryOutcomes measure: Spinal Posture, primaryOutcomes measure: Cervical Movement, primaryOutcomes measure: Thoracic Movement, primaryOutcomes measure: Lumbar Movement, primaryOutcomes measure: Thoracolumbar Movement, secondaryOutcomes measure: Anterior Core Musculature Assessment, secondaryOutcomes measure: Lateral Core Musculature Assessment, secondaryOutcomes measure: Posterior Core Musculature Assessment, secondaryOutcomes measure: Core Musculature Ratio Assessment, secondaryOutcomes measure: Shoulder Strength Assessment, secondaryOutcomes measure: Shoulder Strength Ratio Assessment, secondaryOutcomes measure: Scapular Dyskinesia, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: PT Academy, city: Istanbul, state: Kadıköy, zip: 34744, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06326164, orgStudyIdInfo id: sample, briefTitle: Effect of Kinesio-taping of Lower Limbs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-18, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: kinesio-taping., interventions name: A designed physiotherapy program., outcomesModule primaryOutcomes measure: Change in gait., primaryOutcomes measure: Change in balance., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Asmaa Mohamed Khalil Sedeek, status: RECRUITING, city: Kafr Ash Shaykh, country: Egypt, contacts name: asmaa M khalil, role: CONTACT, phone: 01101011588, email: asmaakhalil011010@gmail.com, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06326151, orgStudyIdInfo id: UMAPS-UDATO, briefTitle: Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Salamanca, class: OTHER, descriptionModule briefSummary: Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person., conditionsModule conditions: Dependent Older People, conditions: Family Caregiver, conditions: Interdisciplinary, conditions: Intervention, conditions: Occupational Therapy, conditions: Psychoeducational, conditions: Psychology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The work of sequencing, randomisation, recruitment and allocation of the trial sample will be carried out by research staff who are not involved in the assessments or interventions of each group, thus avoiding any potential bias in the trial.Participants will also be blinded and will not know which group they have been allocated to and therefore which intervention they will receive. In order to minimise any contamination between groups, the assessment process will be carried out by external research staff who will perform the measurements and who have been previously trained and educated to avoid subjective bias in the process, as they will be unaware of the intervention group to which they have been assigned, thus masking the blinded assessment by third parties in the clinical trial. In addition, the researchers responsible for the statistical analysis of the trial will be blinded in order to increase the rigour of the trial process and thus the scientific quality., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Interdisciplinary Psychoeducational Programme, interventions name: Health Education Programme, outcomesModule primaryOutcomes measure: Mini Mental State Examination (MMSE), primaryOutcomes measure: Barthel Index, primaryOutcomes measure: Caregiver Burden Interview, secondaryOutcomes measure: Centre for Epidemiological Studies Depression Scale, secondaryOutcomes measure: Adaptation of the Psychosocial Support Questionnaire, secondaryOutcomes measure: General Health Questionnaire, secondaryOutcomes measure: World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE), secondaryOutcomes measure: The Bayer-Activities of Daily Living Scale (B-ADL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eduardo Jose Fernandez Rodriguez, city: Salamanca, state: Castilla Y Leon, zip: 37002, country: Spain, contacts name: Eduardo PhD Fernandez, PhD, role: CONTACT, phone: 923294500, email: edujfr@usal.es, geoPoint lat: 40.96882, lon: -5.66388, hasResults: False
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protocolSection identificationModule nctId: NCT06326138, orgStudyIdInfo id: 22121, briefTitle: Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery, acronym: EXPOSE, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-03-11, completionDateStruct date: 2024-03-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, class: OTHER, descriptionModule briefSummary: The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery.Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Edoxaban Pharmacokinetics and Pharmacodynamics, outcomesModule primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326125, orgStudyIdInfo id: SherzadSH, briefTitle: Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, descriptionModule briefSummary: This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture, conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: TICK-B, interventions name: TKTX-Cream, interventions name: TICK-B and TKTX-C, outcomesModule primaryOutcomes measure: severity of Pain, secondaryOutcomes measure: Fear, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sherzad Khudeida Suleman, city: Duhok, state: Erbil, zip: 42012, country: Iraq, geoPoint lat: 36.86709, lon: 42.98845, hasResults: False
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protocolSection identificationModule nctId: NCT06326112, orgStudyIdInfo id: 4588, briefTitle: Role of Active Deresuscitation After Resuscitation:, acronym: RADAR-Canada, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU)., conditionsModule conditions: Fluid Overload, conditions: Critical Illness, conditions: Sepsis, conditions: ARDS, conditions: Trauma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Masking of the health care team will not be feasible as they must administer the intervention, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Furosemide Injection, interventions name: Metolazone Tablets, outcomesModule primaryOutcomes measure: Efficacy: Mean cumulative fluid balance, primaryOutcomes measure: Compliance with deresuscitation protocol, primaryOutcomes measure: Acceptability of protocol, secondaryOutcomes measure: All cause mortality, secondaryOutcomes measure: New onset organ dysfunction, secondaryOutcomes measure: Organ support-free days, otherOutcomes measure: Inflammatory and renal biomarkers - change from baseline values, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unity Health Toronto, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: John C Marshall, MD, role: CONTACT, phone: 4168645225, email: john.marshall@unityhealth.to, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06326099, orgStudyIdInfo id: R34AA030655, type: NIH, link: https://reporter.nih.gov/quickSearch/R34AA030655, briefTitle: Brief Binge Eating and Drinking Online Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling., conditionsModule conditions: Binge Eating, conditions: Binge Drinking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Brief Online Binge Eating and Drinking Intervention, outcomesModule primaryOutcomes measure: Frequency of past 28-day binge drinking, primaryOutcomes measure: Frequency of past 28-day binge eating, primaryOutcomes measure: Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), secondaryOutcomes measure: Mental Health/Substance Use Disorder Treatment History Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326086, orgStudyIdInfo id: REC.65-080-7-1, briefTitle: Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance., conditionsModule conditions: Advanced Lung Cancer, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Chemotherapy drug, interventions name: Targeted Agent, interventions name: Immunotherapy, outcomesModule primaryOutcomes measure: To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment., secondaryOutcomes measure: To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population., otherOutcomes measure: 2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients., otherOutcomes measure: 4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla University, status: RECRUITING, city: Hat Yai, state: Songkla, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, hasResults: False
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protocolSection identificationModule nctId: NCT06326073, orgStudyIdInfo id: OMUKAEK2019/324, briefTitle: Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-01, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2021-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically., conditionsModule conditions: Periodontitis, conditions: Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Non Surgical Periodontal Treatment, outcomesModule primaryOutcomes measure: Evaluation of Periostin levels, primaryOutcomes measure: Evaluation of IL-17A levels, primaryOutcomes measure: Evaluation of IL-17E levels, secondaryOutcomes measure: Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology, city: Samsun, zip: 55270, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-16, uploadDate: 2024-03-16T11:54, filename: Prot_SAP_000.pdf, size: 206405, hasResults: False
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protocolSection identificationModule nctId: NCT06326060, orgStudyIdInfo id: NN9541-5015, secondaryIdInfos id: U1111-1291-9210, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: jRCT2051230198, type: REGISTRY, domain: JRCT, briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-05-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 343, type: ESTIMATED, armsInterventionsModule interventions name: NNC0519-0130, interventions name: Placebo, interventions name: Tirzepatide, outcomesModule primaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Achievement of greater than equal to (≥) 5% weight reduction, secondaryOutcomes measure: Achievement of ≥ 10% weight reduction, secondaryOutcomes measure: Achievement of ≥ 15% weight reduction, secondaryOutcomes measure: Achievement of ≥ 20% weight reduction, secondaryOutcomes measure: Change in body mass index (BMI), secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in glycated hemoglobin (HbA1c), secondaryOutcomes measure: Change in fasting plasma glucose (FPG), secondaryOutcomes measure: Change in systolic blood pressure (SBP), secondaryOutcomes measure: Change in high sensitivity C-Reactive protein (hsCRP), secondaryOutcomes measure: Change in total cholesterol, secondaryOutcomes measure: Change in high-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Change in low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Change in triglycerides, secondaryOutcomes measure: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Psychosocial composite score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Physical Function score, secondaryOutcomes measure: Change in IWQOL-Lite-CT Total score, secondaryOutcomes measure: Number of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centricity Research-Arizona, status: WITHDRAWN, city: Mesa, state: Arizona, zip: 85206, country: United States, geoPoint lat: 33.42227, lon: -111.82264, locations facility: Arkansas Clinical Research, status: WITHDRAWN, city: Little Rock, state: Arkansas, zip: 72205, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Unity Health-Searcy Medical Center, status: RECRUITING, city: Searcy, state: Arkansas, zip: 72143, country: United States, geoPoint lat: 35.25064, lon: -91.73625, locations facility: FDRC, status: RECRUITING, city: Costa Mesa, state: California, zip: 92627, country: United States, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Diablo Clinical Research, Inc., status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Univ of Colorado at Denver, status: WITHDRAWN, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Nature Coast Clinical Research, status: RECRUITING, city: Crystal River, state: Florida, zip: 34429, country: United States, geoPoint lat: 28.90248, lon: -82.5926, locations facility: Northeast Research Institute, status: RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Jacksonville Ctr For Clin Res, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Cedar-Crosse Research Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60607, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Midwest Inst For Clin Res, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Velocity Clin. Res Valparaiso, status: RECRUITING, city: Valparaiso, state: Indiana, zip: 46383, country: United States, geoPoint lat: 41.47309, lon: -87.06114, locations facility: L-MARC Research Center, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40213, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Centennial Medical Group, status: RECRUITING, city: Columbia, state: Maryland, zip: 21045, country: United States, geoPoint lat: 39.24038, lon: -76.83942, locations facility: StudyMetrix Research LLC, status: RECRUITING, city: Saint Peters, state: Missouri, zip: 63303, country: United States, geoPoint lat: 38.80033, lon: -90.62651, locations facility: NYU Bariatric Surgical Ctr, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Medication Mgmnt, LLC_Grnsboro, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27405, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: PharmQuest Life Sciences LLC, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Physicians East Endocrinology, status: RECRUITING, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, locations facility: Piedmont Healthcare, status: RECRUITING, city: Statesville, state: North Carolina, zip: 28625, country: United States, geoPoint lat: 35.78264, lon: -80.8873, locations facility: Accellacare Wilmington, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Remington Davis Inc, status: RECRUITING, city: Columbus, state: Ohio, zip: 43215, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Family Practice Center of Wadsworth Inc., status: RECRUITING, city: Wadsworth, state: Ohio, zip: 44281-9236, country: United States, geoPoint lat: 41.02561, lon: -81.72985, locations facility: Lynn Institute of Norman, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73072, country: United States, geoPoint lat: 35.22257, lon: -97.43948, locations facility: The University of Penn Center, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104-3317, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians_Pittsburgh, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Velocity Clin Res Providence, status: RECRUITING, city: East Greenwich, state: Rhode Island, zip: 02818, country: United States, geoPoint lat: 41.66038, lon: -71.45589, locations facility: Medical University Of South Carolina, status: NOT_YET_RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Spartanburg Medical Research, status: RECRUITING, city: Spartanburg, state: South Carolina, zip: 29303, country: United States, geoPoint lat: 34.94957, lon: -81.93205, locations facility: Holston Medical Group Pc, status: RECRUITING, city: Bristol, state: Tennessee, zip: 37620-7352, country: United States, geoPoint lat: 36.59511, lon: -82.18874, locations facility: Baylr Sctt White Rs Inst, Endo, status: WITHDRAWN, city: Dallas, state: Texas, zip: 75226, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: North Texas Endocrine Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: UT Southwestern Medical Center - Lingvay, status: RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: DCOL Ctr for Clin Res, status: RECRUITING, city: Longview, state: Texas, zip: 75605, country: United States, geoPoint lat: 32.5007, lon: -94.74049, locations facility: Washington Cntr Weight Mgmt, status: RECRUITING, city: Arlington, state: Virginia, zip: 22206, country: United States, geoPoint lat: 38.88101, lon: -77.10428, locations facility: Health Res of Hampton Roads, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: National Clin Res Inc., status: RECRUITING, city: Richmond, state: Virginia, zip: 23294, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Paratus Clinical, status: NOT_YET_RECRUITING, city: Blacktown, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.76667, lon: 150.91667, locations facility: Northern Beaches Clinical Research, status: RECRUITING, city: Brookvale, state: New South Wales, zip: 2100, country: Australia, geoPoint lat: -33.76108, lon: 151.27446, locations facility: Holdsworth House Clinical Research, status: RECRUITING, city: Darlinghurst, state: New South Wales, zip: 2010, country: Australia, geoPoint lat: -33.87939, lon: 151.21925, locations facility: Novatrials, status: RECRUITING, city: Kotara, state: New South Wales, zip: 2289, country: Australia, geoPoint lat: -32.95, lon: 151.68333, locations facility: Paratus Clinical, status: NOT_YET_RECRUITING, city: Herston, state: Queensland, zip: 4006, country: Australia, geoPoint lat: -27.44453, lon: 153.01852, locations facility: University of Sunshine Coast, status: RECRUITING, city: Sippy Downs, state: Queensland, zip: 4556, country: Australia, geoPoint lat: -26.71793, lon: 153.05475, locations facility: CMAX Clinical Research, status: NOT_YET_RECRUITING, city: Norwood, state: South Australia, zip: 5067, country: Australia, geoPoint lat: -34.66667, lon: 149.73333, locations facility: Emeritus Research Melbourne, status: NOT_YET_RECRUITING, city: Camberwell, state: Victoria, zip: 3124, country: Australia, geoPoint lat: -37.84205, lon: 145.0694, locations facility: Austin Health, Metabolic Disorders Centre, status: RECRUITING, city: Heidelberg Heights, state: Victoria, zip: 3081, country: Australia, geoPoint lat: -37.74313, lon: 145.05695, locations facility: Linear Clinical Research, status: WITHDRAWN, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, geoPoint lat: -31.98184, lon: 115.8073, locations facility: OCROM Clinic, status: RECRUITING, city: Suita-shi, state: Osaka, zip: 565-0853, country: Japan, geoPoint lat: 34.76143, lon: 135.51567, locations facility: ToCROM Clinic, status: RECRUITING, city: Tokyo, zip: 160-0008, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False
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protocolSection identificationModule nctId: NCT06326047, orgStudyIdInfo id: NN9541-4945, secondaryIdInfos id: U1111-1291-9196, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: jRCT2031230704, type: REGISTRY, domain: JRCT, briefTitle: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2025-08-26, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: NNC0519-0130, interventions name: Placebo, interventions name: Trizepatide, outcomesModule primaryOutcomes measure: Change in Glycated haemoglobin (HbA1c), secondaryOutcomes measure: Change in Glycated haemoglobin (HbA1c), secondaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Change in fasting plasma glucose (FPG), secondaryOutcomes measure: Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)), secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure (SBP), secondaryOutcomes measure: Change in high sensitivity C-Reactive Protein (hsCRP), secondaryOutcomes measure: Change in total cholesterol, secondaryOutcomes measure: Change in high-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Change in low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Change in triglycerides, secondaryOutcomes measure: Number of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clin Res-Chula Vista, status: RECRUITING, city: Chula Vista, state: California, zip: 91911, country: United States, geoPoint lat: 32.64005, lon: -117.0842, locations facility: Valley Research, status: NOT_YET_RECRUITING, city: Fresno, state: California, zip: 93720, country: United States, geoPoint lat: 36.74773, lon: -119.77237, locations facility: Valley Research, status: WITHDRAWN, city: Fresno, state: California, zip: 93720, country: United States, geoPoint lat: 36.74773, lon: -119.77237, locations facility: Velocity Clin Res San Diego, status: RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, geoPoint lat: 32.76783, lon: -117.02308, locations facility: First Valley Med Grp Lancaster, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: Torrance Clin Res Inst, Inc., status: RECRUITING, city: Lomita, state: California, zip: 90717, country: United States, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Pacific Clinical Studies, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Catalina Research Institute, LLC, status: RECRUITING, city: Montclair, state: California, zip: 91763, country: United States, geoPoint lat: 34.07751, lon: -117.68978, locations facility: Med Partners, Inc., status: RECRUITING, city: Toluca Lake, state: California, zip: 91602, country: United States, geoPoint lat: 34.15262, lon: -118.35731, locations facility: UCLA Health Southbay Endocrine, status: NOT_YET_RECRUITING, city: Torrance, state: California, zip: 90505, country: United States, geoPoint lat: 33.83585, lon: -118.34063, locations facility: University Clin Investigators, status: RECRUITING, city: Tustin, state: California, zip: 92780, country: United States, geoPoint lat: 33.74585, lon: -117.82617, locations facility: University of Colorado Hospital, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Innovative Research of W Florida Inc., status: RECRUITING, city: Clearwater, state: Florida, zip: 33756, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: International Research Associates, LLC_Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33183, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Centricity Research, status: RECRUITING, city: Columbus, state: Georgia, zip: 31904, country: United States, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Elite Clinical Trials, status: RECRUITING, city: Blackfoot, state: Idaho, zip: 83221, country: United States, geoPoint lat: 43.19047, lon: -112.34498, locations facility: Methodist Medical_Center of Illinois, status: RECRUITING, city: Peoria, state: Illinois, zip: 61636, country: United States, geoPoint lat: 40.69365, lon: -89.58899, locations facility: MD Medical Research, status: RECRUITING, city: Oxon Hill, state: Maryland, zip: 20745, country: United States, geoPoint lat: 38.80345, lon: -76.9897, locations facility: Endo And Metab Cons, status: WITHDRAWN, city: Rockville, state: Maryland, zip: 20852, country: United States, geoPoint lat: 39.084, lon: -77.15276, locations facility: Clinvest Research, status: RECRUITING, city: Springfield, state: Missouri, zip: 65807, country: United States, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Mercury Str Med Grp, PLLC, status: RECRUITING, city: Butte, state: Montana, zip: 59701, country: United States, geoPoint lat: 46.00382, lon: -112.53474, locations facility: Palm Research Center Inc-Vegas, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Velocity Clinical Research Binghamton, status: RECRUITING, city: Binghamton, state: New York, zip: 13905, country: United States, geoPoint lat: 42.09869, lon: -75.91797, locations facility: PharmQuest Life Sciences LLC, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27408, country: United States, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Accellacare Wilmington, status: NOT_YET_RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Accellacare Wilmington, status: RECRUITING, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Diab & Endo Assoc of Stark Co, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, geoPoint lat: 40.79895, lon: -81.37845, locations facility: Velocity Clin Res_Cincinnati, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Velocity Clinical Research Springdale, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45246, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Providence Health Partners Ctr, status: RECRUITING, city: Dayton, state: Ohio, zip: 45439, country: United States, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Advanced Med Res Maumee, status: RECRUITING, city: Maumee, state: Ohio, zip: 43537, country: United States, geoPoint lat: 41.56283, lon: -83.65382, locations facility: Tristar Clin Investigations, PC, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19114, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Preferred Primary Care Physicians Inc., status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Preferred Primary Care Physicians, Inc., status: RECRUITING, city: Uniontown, state: Pennsylvania, zip: 15401, country: United States, geoPoint lat: 39.90008, lon: -79.71643, locations facility: Velocity Clinical Research Abilene, status: RECRUITING, city: Abilene, state: Texas, zip: 79606, country: United States, geoPoint lat: 32.44874, lon: -99.73314, locations facility: Velocity Clin Res Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Endocrine Associates Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Biopharma Informatic_Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77043, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Biopharma Informatic_Houston, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77043, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Burke Internal Medicine & Research, status: RECRUITING, city: Burke, state: Virginia, zip: 22015, country: United States, geoPoint lat: 38.79345, lon: -77.27165, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Macquarie University, status: NOT_YET_RECRUITING, city: Macquarie Park, state: New South Wales, zip: 2109, country: Australia, geoPoint lat: -33.7751, lon: 151.11272, locations facility: Royal North Shore Hospital, status: NOT_YET_RECRUITING, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, geoPoint lat: -33.82344, lon: 151.19836, locations facility: Western Endocrine Blacktown, status: NOT_YET_RECRUITING, city: Sydney, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Western Endocrine Blacktown, status: WITHDRAWN, city: Sydney, state: New South Wales, zip: 2148, country: Australia, geoPoint lat: -33.86785, lon: 151.20732, locations facility: Illawarra Diabetes Service Clinical Trials & Research Unit, status: NOT_YET_RECRUITING, city: Wollongong, state: New South Wales, zip: 2500, country: Australia, geoPoint lat: -34.424, lon: 150.89345, locations facility: University of Sunshine Coast, status: NOT_YET_RECRUITING, city: Birtinya, state: Queensland, zip: 4575, country: Australia, geoPoint lat: -26.74322, lon: 153.11913, locations facility: Eastern Clinical Research Unit Box Hill, status: NOT_YET_RECRUITING, city: Box Hill, state: Victoria, zip: 3128, country: Australia, geoPoint lat: -37.81887, lon: 145.12545, locations facility: Austin Health, Metabolic Disorders Centre, status: NOT_YET_RECRUITING, city: Heidelberg Heights, state: Victoria, zip: 3081, country: Australia, geoPoint lat: -37.74313, lon: 145.05695, locations facility: The Royal Melbourne Hospital, status: NOT_YET_RECRUITING, city: Parkville, state: Victoria, zip: 3050, country: Australia, geoPoint lat: -37.78333, lon: 144.95, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), status: RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), status: NOT_YET_RECRUITING, city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Cook Street Medical Clinic, status: RECRUITING, city: Victoria, state: British Columbia, zip: V8V 4A1, country: Canada, geoPoint lat: 48.43294, lon: -123.3693, locations facility: G.A. Research Associates Ltd., status: RECRUITING, city: Moncton, state: New Brunswick, zip: E1G 1A7, country: Canada, geoPoint lat: 46.09454, lon: -64.7965, locations facility: Nova Scotia Hlth Halifax, status: NOT_YET_RECRUITING, city: Halifax, state: Nova Scotia, zip: B3H 1V7, country: Canada, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Wharton Med Clin Trials, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Albion Finch Medical Centre, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M9V 4B4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Albion Finch Medical Centre, status: RECRUITING, city: Toronto, state: Ontario, zip: M9V 4B4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centricity Research Quebec City, status: RECRUITING, city: Levis, state: Quebec, zip: G6W 0M5, country: Canada, geoPoint lat: 46.80326, lon: -71.17793, locations facility: Recherche GCP Research, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H1Y 3H5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centricity Research Ville St. Laurent VSL, status: WITHDRAWN, city: Ville Saint-Laurent, state: Quebec, zip: H4T 1Z9, country: Canada, locations facility: Diex Recherche Quebec Inc., status: NOT_YET_RECRUITING, city: Quebec, zip: G1V 4T3, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Life Care Clinic & Research Centre, status: NOT_YET_RECRUITING, city: Bangalore, state: Karnataka, zip: 560092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Amrita Institute Of Medical Sciences & Research Centre, status: NOT_YET_RECRUITING, city: Kochi, state: Kerala, zip: 682041, country: India, geoPoint lat: 9.93988, lon: 76.26022, locations facility: Seth GS Medical College & KEM Hospital, status: NOT_YET_RECRUITING, city: Mumbai, state: Maharashtra, zip: 400012, country: India, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Chellaram Diabetes Institute, status: NOT_YET_RECRUITING, city: Pune, state: Maharashtra, zip: 411021, country: India, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Christian Medical College Hospital, Vellore, status: NOT_YET_RECRUITING, city: Vellore, state: Tamil Nadu, zip: 632004, country: India, geoPoint lat: 12.9184, lon: 79.13255, locations facility: Kumudini Devi Diabetes Research Center, Ramdevrao Hospital, status: NOT_YET_RECRUITING, city: Hyderabad, state: Telangana, zip: 500072, country: India, geoPoint lat: 17.38405, lon: 78.45636, locations facility: MS Ramaiah, status: NOT_YET_RECRUITING, city: Bengaluru, zip: 560054, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Tokuyama clinic, status: RECRUITING, city: Chiba, zip: 261-0004, country: Japan, geoPoint lat: 35.6, lon: 140.11667, locations facility: Soka Sugiura Internal Medicine Clinic, status: RECRUITING, city: Soka-shi, Saitama, zip: 340-0015, country: Japan, locations facility: Soka Sugiura Internal Medicine Clinic, status: NOT_YET_RECRUITING, city: Soka-shi, Saitama, zip: 340-0015, country: Japan, locations facility: Tokyo-Eki Center-building Clinic, status: RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: NOT_YET_RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Seoul National University Bundang Hospital, status: NOT_YET_RECRUITING, city: Gyeonggi-do, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Nowon Eulji Medical Center, Eulji University, status: NOT_YET_RECRUITING, city: Seoul, zip: 01830, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Korea University Anam Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Kangbuk Samsung Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 03181, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, status: NOT_YET_RECRUITING, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Josha Research, status: WITHDRAWN, city: Bloemfontein, state: Free State, zip: 9301, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Wits Bara Clinical Trial Site, status: WITHDRAWN, city: Johannesburg, state: Gauteng, zip: 2013, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Shop#1 Health Emporium, status: WITHDRAWN, city: Midrand, state: Gauteng, zip: 1685, country: South Africa, geoPoint lat: -25.98953, lon: 28.12843, locations facility: Dr Pillay's Rooms, status: WITHDRAWN, city: Durban, state: KwaZulu-Natal, zip: 4450, country: South Africa, geoPoint lat: -29.8579, lon: 31.0292, locations facility: Dr T Padayachee, status: WITHDRAWN, city: Umkomaas, state: KwaZulu-Natal, zip: 4170, country: South Africa, geoPoint lat: -30.20674, lon: 30.79776, hasResults: False
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protocolSection identificationModule nctId: NCT06326034, orgStudyIdInfo id: AAA234, briefTitle: Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mohammed Mahmood Mohammed, class: OTHER, descriptionModule briefSummary: Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a multifactorial behavioral and pharmacological treatments to prevent or delay complications, morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's physical and psychological status and thus lower the patient's quality of life (QoL) (Verma \& Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic medication should have an impact on weight management to achieve and maintain the optimum glycemic and weight control which are the goals in people without established cardiorenal risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA) (Association, 2020) but has little or even weight neutral effect, as well as gliptins (Hermansen \& Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling glycemia but their use is associated with weight gain and other adverse effects (Derosa \& Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by inducing glycosuria and thus improving glycemic status without affecting insulin level (Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been well tolerated and its safety and efficacy approved in the clinical trials, mostly on cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia (Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019). To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed a significant improvement in the glycemic status after 6 months when used in combination with standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was found to be well-tolerated and effective treatment option for T2DM patients after 6 months (Alguwaihes, 2021)., conditionsModule conditions: Diabetic Nephropathy Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This interventional randomized clinical study was conducted from May to December 2022, at the National Diabetic Centre for treatment and research/ Mustansiriyah University/ Baghdad/ Iraq. Ethical approval from the diabetic center and college of pharmacy/ Mustansiriyah University, was taken prior to the study initiation. All investigations/ procedures carried out in this study involving human participants were in accordance with the 1975 Declaration of Helsinki and its later amendments., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Dapagliflozin, outcomesModule primaryOutcomes measure: Quality of Life Assessment tool, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohammed Mahmood Mahmood, city: Baghdad, zip: 00964, country: Iraq, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
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protocolSection identificationModule nctId: NCT06326021, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-004, briefTitle: Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leukaemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2026-06-15, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-label, non-randomised, single-arm phaseⅠclinical trial to explore the safety and efficacy of FL-33 CAR T therapy for refractory/relapsed acute myeloid leukaemia. The primary endpoints are incidence and type of dose limiting toxicity within 21 days of CAR T infusion; total number, incidence and severity of adverse events (AE) 30 days after CAR T infusion. The secondary endpoints are total number, incidence and severity of AEs 30 days to 2 years after CAR T infusion; objective response rate (ORR), complete response rate (CR) and complete response with incomplete haematological recovery (CRi) by dose group at 15, 30 and 90 Days after CAR T Infusion; duration of response (DOR), progression-free survival (PFS), overall survival (OS); pharmacokinetic characteristics. The trial will use BOIN12 design to explore the optimal biological dose (OBD) of FL-33 CAR T cells for refractory/relapsed acute myeloid leukaemia. FL-33 CAR T is set at two dose levels: 5\*10\^5 (±20%) CAR-T cells/kg for dose 1 (DL-1) and 1\*10\^6 (±20%) CAR-T cells/kg for dose 2 (DL-2), and after the optimal biological dose (OBD) is determined in the dose exploration phase, the dose expansion phase will expand the trial by 6-12 cases at the OBD, enrolling up to 21-27 cases. Enrolment of more than 21 cases can be reported for analysis and the trial will be stopped when enrolment reaches 27 cases., conditionsModule conditions: Refractory/Relapsed Acute Myeloid Leukaemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: autologous FL-33 CAR T therapy, interventions name: prior-HSCT donor-derived FL-33 CAR T therapy, outcomesModule primaryOutcomes measure: Dose-limiting toxicity(DLT), primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Long-term Adverse events (AEs), 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: The persistence of FL-33 CAR T cells, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BeijingGoBroadH, status: RECRUITING, city: Beijing, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06326008, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2023-002, briefTitle: Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r/r B-ALL: a Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r/r B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\~12 cases in dose escalation phase and 36 cases in dose expansion phase., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Long-term Adverse events (AEs), secondaryOutcomes measure: Objective response rate(ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: The persistence of CD19/CD22 CAR T cells., secondaryOutcomes measure: The Maximum concentration (Cmax) of CD19/CD22 CAR T cells., secondaryOutcomes measure: The time to maximum plasma concentration (Tmax) of CD19/CD22 CAR T cells., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325995, orgStudyIdInfo id: Changhai HHHospital, briefTitle: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2030-10-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.Accumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer., conditionsModule conditions: Localized Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Conventional radiation therapy, interventions name: Hypofractionated radiation therapy, outcomesModule primaryOutcomes measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events, secondaryOutcomes measure: 5-year progression-free survival (PFS), secondaryOutcomes measure: quality of life (QoL), secondaryOutcomes measure: medical expenses, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Prostate cancer-specific survival, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Huojun Zhang, M.D., role: CONTACT, phone: +8613311732399, email: chyyzhj@163.com, contacts name: Huojun Zhang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06325982, orgStudyIdInfo id: BYFFL-01, briefTitle: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Fujian Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world., conditionsModule conditions: Radiation Injuries, conditions: Rectal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Triethanolamine cream, outcomesModule primaryOutcomes measure: Occurrence time of acute and chronic radiation rectal injury, primaryOutcomes measure: Evaluation of acute and chronic radiation rectal injury, secondaryOutcomes measure: Clinical symptom assessment, secondaryOutcomes measure: Quality of life assessment assessed by IBDQ, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325969, orgStudyIdInfo id: PCOS Immune, briefTitle: PCOS Patients Immune Status Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-03-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shanghai 10th People's Hospital, class: OTHER, descriptionModule briefSummary: In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients., conditionsModule conditions: Polycystic Ovary Syndrom, conditions: Metformin, conditions: Immune Function, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Detect the immune function of peripheral blood samples, outcomesModule primaryOutcomes measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., primaryOutcomes measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., secondaryOutcomes measure: Homeostasis model assessment of insulin resistance, secondaryOutcomes measure: body mass index, secondaryOutcomes measure: menstrual frequency, secondaryOutcomes measure: fasting glucose, secondaryOutcomes measure: fasting insulin, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: LDL-c, secondaryOutcomes measure: total testosterone, secondaryOutcomes measure: free testosterone, secondaryOutcomes measure: Sex hormone-binding globulin, secondaryOutcomes measure: Androstenedione, secondaryOutcomes measure: Dehydroepiandrosterone, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Shanghai Tenth People's Hospital, status: RECRUITING, city: Shanghai, zip: 200072, country: China, contacts name: Manna Zhang, Doctor, role: CONTACT, phone: +86-021-66301004, email: mannazhang@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06325956, orgStudyIdInfo id: Immune status and metformin, briefTitle: PCOS Immune Function Predicts Metformin Efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shanghai 10th People's Hospital, class: OTHER, descriptionModule briefSummary: In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function., conditionsModule conditions: Polycystic Ovary Syndrome, conditions: Metformin, conditions: Immune Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., primaryOutcomes measure: The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry., secondaryOutcomes measure: Homeostasis model assessment of insulin resistance, secondaryOutcomes measure: body mass index, secondaryOutcomes measure: menstrual frequency, secondaryOutcomes measure: fasting glucose, secondaryOutcomes measure: fasting insulin, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: LDL-c, secondaryOutcomes measure: total testosterone, secondaryOutcomes measure: free testosterone, secondaryOutcomes measure: Sex hormone-binding globulin, secondaryOutcomes measure: Androstenedione, secondaryOutcomes measure: Dehydroepiandrosterone, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Endocrinology, Shanghai Tenth People's Hospital, status: RECRUITING, city: Shanghai, zip: 200072, country: China, contacts name: Manna Zhang, Doctor, role: CONTACT, phone: 86-21-66301004, email: mannazhang@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06325943, orgStudyIdInfo id: CIDPRIT, briefTitle: Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, acronym: CIDPRIT, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-01, primaryCompletionDateStruct date: 2023-05-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, collaborators name: Ospedale Mondino di Pavia, collaborators name: University of Turin, Italy, collaborators name: Istituto Neurologico Carlo Besta di Milano, collaborators name: San Raffaele University Hospital, Italy, collaborators name: Università di Messina, collaborators name: Universita degli Studi di Genova, collaborators name: Istituto Di Ricerche Farmacologiche Mario Negri, collaborators name: Università di Napoli Federico II, descriptionModule briefSummary: Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization., conditionsModule conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a phase 3, multicenter, randomized, placebo-controlled, parallel-group, double-blind study, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Rituximab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability, primaryOutcomes measure: Medical Research Council (MRC), range 0-60 with lower values meaning more severe disability, primaryOutcomes measure: Inflammatory Rasch-built Overall Disability Scale (I-RODS), range 0-48 with lower values meaning more severe disability, secondaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale,, range 0-10 points with higher values meaning more severe disability, secondaryOutcomes measure: Inflammatory Neuropathy Cause and Treatment (INCAT) scale, range 0-10 points with higher values meaning more severe disability, secondaryOutcomes measure: treatment suspension, secondaryOutcomes measure: time to worsening, secondaryOutcomes measure: Short Form Health Survey 36 (SF-36), range from 0 to 100, with a higher score defining a more favorable health state, otherOutcomes measure: motor conduction block in the two most relevant nerves, range 0-100% with lower score defining lesser degree of impairment, otherOutcomes measure: clinical form, otherOutcomes measure: response to rituximab in patients with antinerve antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico Humanitas, city: Rozzano, country: Italy, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
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protocolSection identificationModule nctId: NCT06325930, orgStudyIdInfo id: RIV-HU6-105, briefTitle: A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Rivus Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-HU6, outcomesModule primaryOutcomes measure: To assess the mass balance, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pharmaron Clinical Pharmacology Center (CPC), status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Kristin Satterfield, MD, PhD, role: CONTACT, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06325917, orgStudyIdInfo id: 101271-5, briefTitle: Effect of Diabetes Self-management Education and Support on Glycemic Control Among Patients With Type 2 Diabetic, acronym: DSMES, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Jordan, class: OTHER, descriptionModule briefSummary: Introduction: Diabetes mellitus (DM) is one of the chronic diseases that can have an impact on increasing morbidity, disability, and death. Social media has become a valuable resource for people with diabetes in improving self-management skills Applying diabetes self-management education with ongoing support using social media produces behavioral changes, empowerment, and cost-effectiveness.purpose: the purpose of this study is to examine the effect of self-management education with ongoing support using social media (WhatsApp) on glycemic control among patients with uncontrolled diabetes.Method: 140 patients with diabetes type 2 attending outpatients' diabetes clinic setting in Aqaba will participate in a two-arm randomized controlled trial study. Self-management education will be applied for all participants, ongoing support using social media (what's app) will be applied to the intervention group, and only usual diabetes care by a diabetes specialist nurse will be applied to the control group., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two arms parallel randomized controlled, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: what's app ongoing support, interventions name: usual care, outcomesModule primaryOutcomes measure: glycemic control, secondaryOutcomes measure: diabetes self management behaviors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Jordan, city: Amman, zip: 11942, country: Jordan, geoPoint lat: 31.95522, lon: 35.94503, hasResults: False
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protocolSection identificationModule nctId: NCT06325904, orgStudyIdInfo id: 9138930, briefTitle: Uniportal VATS Versus Chest Tube for Early Empyema, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-03-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Minia University, class: OTHER, descriptionModule briefSummary: This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost., conditionsModule conditions: Empyema, Pleural, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Uniportal VATS, interventions name: Tube thoracostomy, outcomesModule primaryOutcomes measure: Need for further management, primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Minia University, city: Minya, zip: 61111, country: Egypt, geoPoint lat: 28.10988, lon: 30.7503, hasResults: False
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protocolSection identificationModule nctId: NCT06325891, orgStudyIdInfo id: RP025, briefTitle: Microbiota in Gastric Cancer by Gastric Mucosal Brushing, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, descriptionModule briefSummary: Many studies have shown a significant change of diversity and composition in gut microbiota across the gastric carcinogenesis process, particularly in patients with gastric cancer. However, there has been no analysis of gastric microbiota using the mucosal brushing technique, despites its favoring benefit in microbiota study. Therefore, our study aims to evaluate microbiota profile in patients with gastric cancer, compared to those without gastric cancer by using mucosal brush sampling. This will improve current knowledge of the potential role of the microbiome in patient gastric cancer as a future biomarker marker using brushing sampling., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Gastric mucosal brusing, interventions name: Gastric mucosal biopsy, outcomesModule primaryOutcomes measure: Microbiome analysis using gastric mucosal brushing, secondaryOutcomes measure: Microbiome analysis using gastric mucosal biopsy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Chulalongkorn Memorial Hospital, status: RECRUITING, city: Bangkok, zip: 10330, country: Thailand, contacts name: Rapat Pittayanon, MD, role: CONTACT, phone: +66813132112, email: rapat125@gmail.com, contacts name: Thanrada Vimonsuntirungsri, role: CONTACT, phone: +66853356240, email: aa_choc@docchula.com, geoPoint lat: 13.75398, lon: 100.50144, locations facility: King Chulalongkorn memorial hospital, status: RECRUITING, city: Bangkok, zip: 10330, country: Thailand, contacts name: Thanrada Vimonsuntirungsri, MD, role: CONTACT, phone: +66853356240, email: aa_choc@docchula.com, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06325878, orgStudyIdInfo id: NEU2-OSS-2022-001, briefTitle: Genetic Architecture of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, acronym: GEARCIDP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype \>700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange), conditionsModule conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 3500, type: ESTIMATED, armsInterventionsModule interventions name: Genome-wide association study, outcomesModule primaryOutcomes measure: single nucleotide polymorphisms (SNPs), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, country: Italy, contacts name: Eduardo Nobile Orazio, Prof, role: CONTACT, email: eduardo.nobile@unimi.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
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protocolSection identificationModule nctId: NCT06325865, orgStudyIdInfo id: 23C305, briefTitle: Perception of Unpleasant Sensations During Study Procedures in ALS Patients, acronym: PESALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-19, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures)., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Prevalence of experience of unpleasant sensations or pain, primaryOutcomes measure: Study procedure that causes unpleasant sensations or pain, primaryOutcomes measure: Duration of unpleasant sensations or pain caused by the study procedure, secondaryOutcomes measure: HADS score, secondaryOutcomes measure: ALSFRS score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico italiano IRCSS, San Luca Hospital, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Martina Sodano, role: CONTACT, phone: +39-02619111, phoneExt: 2937, email: m.sodano@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06325852, orgStudyIdInfo id: 22-5772, briefTitle: Directional Bilateral Thalamic Patterned Stimulation (Chronos), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Alfonso Fasano, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor.Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits., conditionsModule conditions: Essential Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: DBS programing, outcomesModule primaryOutcomes measure: Tremor Rating Scale (Part A-B), primaryOutcomes measure: Tremor analysis, primaryOutcomes measure: Tremor Rating Scale (A-C), primaryOutcomes measure: Tremor analysis (meter per second squared), primaryOutcomes measure: Gait speed (meter per second), primaryOutcomes measure: Base of support (meter), primaryOutcomes measure: Step length (meter), primaryOutcomes measure: Stride length (meter), primaryOutcomes measure: Single stance time and double stance time (seconds), primaryOutcomes measure: Tandem gait, primaryOutcomes measure: Posturography (newtons), primaryOutcomes measure: Quality of life in Essential Tremor Questionnaire (QUEST), primaryOutcomes measure: Speech analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Movement Disorders Centre - Toronto Western Hospital, city: Toronto, state: Ontario, zip: M5T 2S8, country: Canada, contacts name: Alfonso Fasano, MD, PhD, role: CONTACT, phone: (416) 603-5800, phoneExt: 5961, email: alfonso.fasano@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06325839, orgStudyIdInfo id: GRU-SBF-ES-01, briefTitle: Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-09-10, completionDateStruct date: 2023-09-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Giresun University, class: OTHER, descriptionModule briefSummary: This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women., conditionsModule conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research is an experimental study with a randomized control group., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Pregnant women included in the study were randomly divided into two groups using the sealed envelope method., whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: HypnoBirthing training and oxytocin massage group, outcomesModule primaryOutcomes measure: Wijma Birth Anticipation/Experience Scale A (W-DEQ-A), secondaryOutcomes measure: Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B), secondaryOutcomes measure: Postpartum Breastfeeding Self-Efficacy Scale - Short Form, secondaryOutcomes measure: Mother-Infant Attachment Scale (MICS), secondaryOutcomes measure: Birth satisfaction scale short form (BSS-SF), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Giresun Gynecology and Children's Diseases Hospital, city: Giresun, state: Center, zip: 28200, country: Turkey, geoPoint lat: 40.91698, lon: 38.38741, hasResults: False
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protocolSection identificationModule nctId: NCT06325826, orgStudyIdInfo id: GES, briefTitle: The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Egyptian Liver Hospital, class: OTHER, descriptionModule briefSummary: This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: General Evaluation Score (GES), outcomesModule primaryOutcomes measure: Hepatocellular Carcinoma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Egyptian Liver Hospital, city: Talkha, state: Dakahlia, zip: 36681, country: Egypt, geoPoint lat: 31.0539, lon: 31.37787, hasResults: False
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protocolSection identificationModule nctId: NCT06325813, orgStudyIdInfo id: CIN001 - ADHD PreSMART, briefTitle: ADHD PreSMA Response Inhibition Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Medical Center, Cincinnati, class: OTHER, descriptionModule briefSummary: ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control., conditionsModule conditions: Attention Deficit Hyperactivity Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Active repetitive TMS, interventions name: Sham repetitive TMS, outcomesModule primaryOutcomes measure: TMS-based Short-Interval Intracortical Inhibition (SICI), primaryOutcomes measure: EEG-based beta activity, primaryOutcomes measure: TMS-based Cortical Silent Period (cSP), primaryOutcomes measure: EEG-based alpha activity, secondaryOutcomes measure: Stop Signal Reaction Time, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325800, orgStudyIdInfo id: 2021401/2023007, secondaryIdInfos id: Grant, type: OTHER_GRANT, domain: Juan Rodés Grant (JR23/00018), briefTitle: Glycoxidation, Arterial Biomechanics, and Target Organ Damage, acronym: GlycOxiTod, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Complejo Hospitalario Universitario de Santiago, class: OTHER, collaborators name: Instituto de Investigación Sanitaria de Santiago de Compostela, collaborators name: Instituto de Salud Carlos III, collaborators name: University of Santiago de Compostela, collaborators name: Hospital de Barbanza, descriptionModule briefSummary: Vascular target organ damage (TOD), defined as structural or functional deleterious changes in large and small arteries, is related to unfavorable arterial biomechanics, atherosclerosis and arteriosclerosis. Endothelial dysfunction due to unfavorable redox and glycation states on the bases of these phenomena. However, little is known about the role of glycoxidation on arterial biomechanics and TOD in apparently healthy individuals. The main hypothesis is that glycation and glycoxidation status are associated with arterial biomechanical abnormalities and TOD in patients with moderate to high cardiovascular risk. This is an observational, ambispective, and multicenter project that will include non-smoking patients over 18 years, without diabetes mellitus or established cardiovascular disease. Demographic, epidemiological, and clinical-anthropometric variables will be collected, including data from ambulatory blood pressure monitoring. The investigators will measure the serum percentage of glycated hemoglobin, glycated albumin, and fructosamine levels; along with quantification of skin advanced glycation and glycoxidation end productos (AGEs). Plasma concentration, activity, and structure of catalase, glutathione peroxidase, and superoxide dismutase in relation to the patient's glycation and glycoxidation status will be also evaluated. Concurrently, several biomechanical parameters will be assessed in the Common, Internal Carotid Artery, and distal limb arteries using ultrasound exploration. Incipient microvasculature damage will be also evaluated by retinal image. Patients will be followed up for the development of arterial biomechanical abnormalities and TOD, along with cardiovascular events., conditionsModule conditions: Oxidative Stress, conditions: Cardiovascular Risk, conditions: Target Organ Damage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of redox status (1), primaryOutcomes measure: Assessment of redox status (2), primaryOutcomes measure: Evaluation of glycation status (1), primaryOutcomes measure: Evaluation of glycation status (2), primaryOutcomes measure: Evaluation of glycation status (3), primaryOutcomes measure: Evaluation of glycation status (4), primaryOutcomes measure: Assessment of Glycoxidation status (1), primaryOutcomes measure: Assessment of Glycoxidation status (2), primaryOutcomes measure: Quantification of arterial targen organ damage (TOD) during the follow-up (1), primaryOutcomes measure: Quantification of arterial targen organ damage (TOD) during the follow-up (2), secondaryOutcomes measure: Evaluation of cardiovascular disease during the follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complejo Hospitalario Universitario de Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Nestor Vazquez Agra, PhD, role: CONTACT, phone: 0034981950000, email: nestor.vazquez.agra@sergas.es, contacts name: Nestor Vazquez-Agra, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ana-Teresa Marques-Afonso, MD, role: SUB_INVESTIGATOR, contacts name: Sofia Barbosa-Gouveia, PhD, role: SUB_INVESTIGATOR, contacts name: Anton Cruces-Sande, PhD, role: SUB_INVESTIGATOR, contacts name: Carla Diaz-Louzao, PhD, role: SUB_INVESTIGATOR, contacts name: Iago Carballo, PhD, role: SUB_INVESTIGATOR, contacts name: Lucia Barrera-Lopez, MD, role: SUB_INVESTIGATOR, contacts name: Adela Lama-López, MD, role: SUB_INVESTIGATOR, contacts name: Lucia Gomez-Suarez, MD, role: SUB_INVESTIGATOR, contacts name: Ivan Fernandez-Castro, MD, role: SUB_INVESTIGATOR, contacts name: Clara Casar-Cocheteux, MD, role: SUB_INVESTIGATOR, contacts name: Alvaro Hermida-Ameijeiras, PhD, role: SUB_INVESTIGATOR, contacts name: Arturo Gonzalez-Quintela, PhD, role: SUB_INVESTIGATOR, contacts name: Antonio Pose-Reino, PhD, role: SUB_INVESTIGATOR, contacts name: Francisco Gude-Sampedro, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False
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protocolSection identificationModule nctId: NCT06325787, orgStudyIdInfo id: S2021-211-02, briefTitle: Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-05-01, primaryCompletionDateStruct date: 2017-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma, conditionsModule conditions: Papillary Thyroid Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1021, type: ACTUAL, armsInterventionsModule interventions name: thyroid lobectomy, interventions name: image-guided thermal ablation, outcomesModule primaryOutcomes measure: disease progression, primaryOutcomes measure: disease-free survival, secondaryOutcomes measure: complications, secondaryOutcomes measure: procedure time, secondaryOutcomes measure: cost, secondaryOutcomes measure: estimated blood loss, secondaryOutcomes measure: hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06325774, orgStudyIdInfo id: Changhai HHospital, briefTitle: Radical Hypofractionated Radiotherapy for Localized Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2031-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Changhai Hospital, class: OTHER, descriptionModule briefSummary: The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way., conditionsModule conditions: Localized Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Hypofractionated radiation therapy, outcomesModule primaryOutcomes measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events, secondaryOutcomes measure: biochemical progression-free survival (bPFS), secondaryOutcomes measure: local progression-free-survival(LPFS), secondaryOutcomes measure: distant metastasis free survival(DMFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Quality of life (QoL), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Huojun Zhang, M.D., role: CONTACT, phone: +8613311732399, email: chyyzhj@163.com, contacts name: Huojun Zhang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06325761, orgStudyIdInfo id: SY-5007-I-02, briefTitle: A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Shouyao Holdings (Beijing) Co. LTD, class: OTHER, descriptionModule briefSummary: This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China., conditionsModule conditions: Health Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: SY-5007, interventions name: SY-5007, outcomesModule primaryOutcomes measure: Cmax for SY-5007, primaryOutcomes measure: Tmax for SY-5007, primaryOutcomes measure: AUC0-t for SY-5007, primaryOutcomes measure: AUC0-∞ for SY-5007, primaryOutcomes measure: t½ for SY-5007, primaryOutcomes measure: CL/F for SY-5007, primaryOutcomes measure: Vz/F for SY-5007, secondaryOutcomes measure: Safety of SY-5007, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Li Zheng, role: CONTACT, phone: 86-28-85423655, email: zhengli@wchscu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06325748, orgStudyIdInfo id: SENTI-202-101, briefTitle: SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2040-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Senti Biosciences, class: INDUSTRY, descriptionModule briefSummary: This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS., conditionsModule conditions: AML/MDS, conditions: CD33 Expressing Hematological Malignancies, conditions: FLT3 Expressing Hematological Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: SENTI-202, outcomesModule primaryOutcomes measure: Safety and tolerability for dose determination of SENTI-202, secondaryOutcomes measure: Anti-cancer activity of SENTI-202, secondaryOutcomes measure: Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202, secondaryOutcomes measure: Host immune response to SENTI-202, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325735, orgStudyIdInfo id: 98, briefTitle: Combined Systemic Inflammatory Indices and Birth Weight, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Campania "Luigi Vanvitelli", class: OTHER, descriptionModule briefSummary: The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight, conditionsModule conditions: Systemic Inflammation Markers, conditions: Birth Weight, conditions: Combined Systemic Inflammatory Indices, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 199, type: ACTUAL, armsInterventionsModule interventions name: None intervention, outcomesModule primaryOutcomes measure: Systemic inflammatory indices and birth weight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -, city: Napoli, state: Italia, zip: 80138, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
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protocolSection identificationModule nctId: NCT06325722, orgStudyIdInfo id: 10001680, secondaryIdInfos id: 001680-DK, briefTitle: Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), class: NIH, descriptionModule briefSummary: Background:In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.Objective:To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.Eligibility:Adults aged 19 to 50 years with a body mass index of 25 or more.Design:Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period...., conditionsModule conditions: Overweight, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Low-carbohydrate Diet, interventions name: Low-fat Diet, outcomesModule primaryOutcomes measure: Change in total fat mass, secondaryOutcomes measure: Rate of body weight change from baseline to week 8, secondaryOutcomes measure: Rate of body weight change during low-carbohydrate diet, secondaryOutcomes measure: Rate of body weight change during low-fat diet, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Kevin Hall, Ph.D., role: CONTACT, phone: 301-402-8248, email: kevinh@niddk.nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06325709, orgStudyIdInfo id: 10001580, secondaryIdInfos id: 001580-I, briefTitle: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2032-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: Background:Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.Objective:To learn if base-edited stem cells will improve white blood cells' ability to fight against infections in people with CGD.Eligibility:Males aged 18 years and older with X-linked CGD.Design:This is a non-randomized study. Participants with the specific mutation under study will be screened during the initial phase.During the development phase, participants will undergo apheresis to collect stem cells for base-editing correction of the mutation.During the treatment phase, participants will receive the base-edited cells after chemotherapy with busulfan. Participants will remain in the hospital until their immunity recovers.Follow-up visits will continue for 15 years., conditionsModule conditions: Chronic Granulomatous Disease (CGD), conditions: X-Linked Chronic Granulomatous Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Base-edited hematopoietic stem and progenitor cells, interventions name: Busulfan, interventions name: Palifermin, interventions name: Filgrastim, interventions name: Plerixafor, outcomesModule primaryOutcomes measure: To evaluate the safety of base-edited autologous CD34+ cells, primaryOutcomes measure: To evaluate the efficacy of base-edited autologous CD34+ cells, secondaryOutcomes measure: Evaluate the efficiency of base-editing., secondaryOutcomes measure: Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells., secondaryOutcomes measure: Evaluate the efficiency in restoring gp91phox expression., secondaryOutcomes measure: Evaluate efficacy in restoring NADPH oxidase function., secondaryOutcomes measure: Evaluate clinical efficacy, secondaryOutcomes measure: Evaluate the stability of gene correction, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06325696, orgStudyIdInfo id: 10001577, secondaryIdInfos id: 001577-E, briefTitle: H01 in Adults With Interstitial Lung Disease (The SOLIS Study), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Environmental Health Sciences (NIEHS), class: NIH, descriptionModule briefSummary: Background:Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.Objective:To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.Eligibility:People aged 18 years and older with interstitial lung disease or lung fibrosis.Design:Participants will have at least 7 clinic visits over 5 months.Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits., conditionsModule conditions: Interstitial Lung Disease, conditions: Idiopathic Pulmonary Fibrosis, conditions: Lung Diseases, Interstitial, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: hymecromone, outcomesModule primaryOutcomes measure: To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD, secondaryOutcomes measure: Evaluate the safety and tolerability of oral H01 in participants with progressive ILD., secondaryOutcomes measure: Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01., secondaryOutcomes measure: Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01., secondaryOutcomes measure: Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NIEHS Clinical Research Unit (CRU), city: Research Triangle Park, state: North Carolina, zip: 27709, country: United States, contacts name: NIEHS Join A Study Recruitment Group, role: CONTACT, phone: 855-696-4347, email: myniehs@nih.gov, geoPoint lat: 35.90567, lon: -78.90497, hasResults: False
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protocolSection identificationModule nctId: NCT06325683, orgStudyIdInfo id: NCI-2024-01995, secondaryIdInfos id: NCI-2024-01995, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: A072201, type: OTHER, domain: Alliance for Clinical Trials in Oncology, secondaryIdInfos id: A072201, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180821, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180821, briefTitle: Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-21, primaryCompletionDateStruct date: 2028-07-15, completionDateStruct date: 2028-07-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma., conditionsModule conditions: Recurrent Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Lomustine, interventions name: Magnetic Resonance Imaging, interventions name: Nivolumab, interventions name: Relatlimab, interventions name: Surgical Procedure, outcomesModule primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: OS rate, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Radiographic response, secondaryOutcomes measure: Incidence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325670, orgStudyIdInfo id: 23/50374, briefTitle: Type 2 Diabetes and Binge Eating Disorder (BED), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Jascha Fonden, collaborators name: Independent Research Fund Denmark, descriptionModule briefSummary: The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.The main questions it aims to answer are:* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Binge-Eating Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: BED treatment, interventions name: Waitlist, outcomesModule primaryOutcomes measure: Number of binge eating episodes, secondaryOutcomes measure: Binge Eating Disorder Questionnaire, secondaryOutcomes measure: Glucose Sensor Data for Blood Glucose Profile, secondaryOutcomes measure: HbA1c, otherOutcomes measure: Eating Disorder Examination Questionnaire (EDE-Q), otherOutcomes measure: Major Depression Inventory (MDI), otherOutcomes measure: Problem Areas In Diabetes (PAID20), otherOutcomes measure: Lipid profile, otherOutcomes measure: Body Mass Index (BMI), otherOutcomes measure: Blood Pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Region Of Southern Denmark Locations, status: RECRUITING, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, contacts name: Pernille Fiil Nybo, Cand.psych., role: CONTACT, phone: +45 2042 7108, email: Pernille.Fiil.Nybo@rsyd.dk, contacts name: Jakob Linnet, Dr. med., cand.psych., role: CONTACT, phone: +45 2913 8045, email: jakob.linnet@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False
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protocolSection identificationModule nctId: NCT06325657, orgStudyIdInfo id: C3671032, briefTitle: A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants, acronym: MORISOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-06-11, completionDateStruct date: 2025-06-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.The study will look at the safety, tolerability, and immune activity in mothers and their infants.This study is seeking pregnant women who are:* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -* Receiving standard medical care during the pregnancy* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.* agree to be present for all study visits, procedures, and blood draws.Participants will either receive:* RSVpreF vaccine* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.Pregnant participants will be involved in the study from:* consent during their current pregnancy, and* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone., conditionsModule conditions: Respiratory Syncytial Virus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: This is a double-blinded, placebo-controlled study, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: RSVpreF vaccine, interventions name: Placebp, outcomesModule primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions, primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting local reactions, primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs), primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs), primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs), primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes, primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs), primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs), secondaryOutcomes measure: Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B, secondaryOutcomes measure: Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Synergy Biomed Research Institute, status: NOT_YET_RECRUITING, city: East London, state: Eastern CAPE, zip: 5241, country: South Africa, geoPoint lat: -33.01529, lon: 27.91162, locations facility: Josha Research, status: NOT_YET_RECRUITING, city: Bloemfontein, state: FREE State, zip: 9301, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Worthwhile Clinical Trials, status: RECRUITING, city: Benoni, state: Gauteng, zip: 1500, country: South Africa, geoPoint lat: -26.18848, lon: 28.32078, locations facility: REIMED Reiger Park, status: NOT_YET_RECRUITING, city: Boksburg, state: Gauteng, zip: 1459, country: South Africa, geoPoint lat: -26.21197, lon: 28.25958, locations facility: Wits RHI, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2001, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA), status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2013, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Wits VIDA Nkanyezi Research Unit, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2093, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Wits VIDA Nkanyezi, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2093, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Botho Ke Bontle Health Services, status: RECRUITING, city: Pretoria, state: Gauteng, zip: 0184, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Setshaba Research Centre, status: NOT_YET_RECRUITING, city: Tshwane, state: Gauteng, zip: 0152, country: South Africa, locations facility: Qhakaza Mbokodo Research Clinic, status: NOT_YET_RECRUITING, city: Ladysmith, state: Kwazulu-natal, zip: 3370, country: South Africa, geoPoint lat: -28.55874, lon: 29.77896, locations facility: Gole Biomed Research Centre, status: RECRUITING, city: Polokwane, state: Limpopo, zip: 0734, country: South Africa, geoPoint lat: -23.90449, lon: 29.46885, locations facility: MRC Unit on Child And Adolescent Health, status: NOT_YET_RECRUITING, city: Cape Town, state: Western CAPE, zip: 7700, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, hasResults: False
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protocolSection identificationModule nctId: NCT06325644, orgStudyIdInfo id: 2023H0258, secondaryIdInfos id: CDMRP-PR212399-G, type: OTHER_GRANT, domain: Departent of Defense, briefTitle: Well-Formulated Ketogenic Diet Polycystic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet., conditionsModule conditions: Polycystic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ketogenic Diet, interventions name: Ketone/Glucose Monitoring, interventions name: CGM/CKM, interventions name: Blood Draw, interventions name: Body Composition, interventions name: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) ., outcomesModule primaryOutcomes measure: Finger Stick Beta-Hydroxybutyrate, primaryOutcomes measure: Finger Stick Glucose, secondaryOutcomes measure: Blood Pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-01-07, uploadDate: 2024-03-19T14:40, filename: Prot_000.pdf, size: 409140, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-07, uploadDate: 2024-03-19T14:40, filename: ICF_001.pdf, size: 428384, hasResults: False
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protocolSection identificationModule nctId: NCT06325631, orgStudyIdInfo id: Ankara City Hospital Bilkent, briefTitle: Comparative Evaluation of the Results of Facet Joint Injections, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-02, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Oznur Uzun, class: OTHER, descriptionModule briefSummary: Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location., conditionsModule conditions: Low Back Pain, Mechanical, conditions: Facet Syndrome of Lumbar Spine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intra-articular injection to lumbar facet joint, outcomesModule primaryOutcomes measure: Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Bilkent Şehir Hastanesi, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Öznur UZUN, MD, role: CONTACT, phone: +905052912734, email: soznuruzuns@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06325618, orgStudyIdInfo id: 1-10-72-138-23, briefTitle: Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome, acronym: TSCOR_V, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, collaborators name: Aarhus University Hospital, descriptionModule briefSummary: 100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.The aim is to examine and quantify the cardiovascular and lymphatic system in women with TS. The investigators will study a possible causal mechanism between the known pathologic phenotype and alterations in these systems to understand, prevent or treat the life-threatening complications in TS., conditionsModule conditions: Turner Syndrome, conditions: Cardiovascular Diseases, conditions: Lymphedema, conditions: Inflammation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: No intervention other than obtaining biopsies, interventions name: Indocyanine green (ICG), outcomesModule primaryOutcomes measure: Grade dysfunction of clinical and subclinical lymphedema using Indocyanine Green Lymphography and Magnetic Resonance Lymphangiography., primaryOutcomes measure: Detecting low-grade inflammation in Turner Syndrome preforming FDG-PET/CT-scans to locate low grade inflammation., primaryOutcomes measure: Heat maps of the distribution of wall shear stress in the aorta, secondaryOutcomes measure: MRI evaluation and description of vascular abnormalities in Turner Syndrome, secondaryOutcomes measure: Cardiac MRI to evaluate function, secondaryOutcomes measure: Cardiac MRI to evaluate fibrosis of the myocardium, secondaryOutcomes measure: Mapping DNA-methylations patterns in multiple tissues, secondaryOutcomes measure: Immunologic changes in Turner Syndrome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus University Hospital, status: RECRUITING, city: Aarhus N, zip: 8200, country: Denmark, contacts name: Line Balsby, MD, role: CONTACT, phone: +4520461203, email: libals@clin.au.dk, contacts name: Claus Gravholt, MD, Prof., role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06325605, orgStudyIdInfo id: GRYY-LL-KJ2022-064, briefTitle: Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2022-10-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Zhen-Hong Hu, class: OTHER, descriptionModule briefSummary: A total of 100 patients with adolescent depression who were admitted to our hospital between March 2022 and October 2022 were selected. On the basis of double blinding, these patients were randomly divided into the observation group(n=50) and the control group(n=50) using a random number table. 5S management method was used in the whole process of treatment to improve the hospital environment, increase the work efficiency and reduce the occurrence of cross infection through the effective implementation of the five steps of sort(Seiri), set in order(Seiton), shine (Seiso), standardize(Seiketsu) and sustain(Shitsuke)., conditionsModule conditions: Adolescent Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Bifidobacterium, interventions name: High-frequency rTMS, interventions name: Escitalopram Oxalate, outcomesModule primaryOutcomes measure: HAMD-24 scores, primaryOutcomes measure: TNF-α, primaryOutcomes measure: IL-1β, primaryOutcomes measure: IL-6, primaryOutcomes measure: DA, primaryOutcomes measure: 5-HT, primaryOutcomes measure: COR, primaryOutcomes measure: Serum miR-16, primaryOutcomes measure: Serum miR-195, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Tangshan Workers' Hospital, city: Tangshan, state: Hebei, zip: 063003, country: China, geoPoint lat: 39.63333, lon: 118.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06325592, orgStudyIdInfo id: REHSIL2023V1.1, briefTitle: Association Between Surgical Timing and Route of Total Hysterectomy After LEEP and Perioperative Risk in Patients With Cervical HSIL, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sichuan Cancer Hospital and Research Institute, class: OTHER, descriptionModule briefSummary: This study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (HSIL) undergoing total hysterectomy (TH), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details., conditionsModule conditions: High-Grade Squamous Intraepithelial Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 826, type: ACTUAL, armsInterventionsModule interventions name: surgical timing and operation path, outcomesModule primaryOutcomes measure: Postoperative fever, primaryOutcomes measure: Postoperative therapeutic use of antibiotics, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Postoperative hospitalization days, secondaryOutcomes measure: Postoperative hemoglobin, secondaryOutcomes measure: Postoperative white blood cell count, secondaryOutcomes measure: Postoperative erythrocyte count, secondaryOutcomes measure: Postoperative albumin number, secondaryOutcomes measure: Postoperative CRP value, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Cancer Hospital and Research Institute, city: Chengdu, state: Sichuan, zip: 610000, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06325579, orgStudyIdInfo id: AA29411356, briefTitle: Immersive Virtual Reality for Dysphagia, acronym: IVRys, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-24, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-03-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sheffield Hallam University, class: OTHER, descriptionModule briefSummary: People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology., conditionsModule conditions: Virtual Reality, conditions: Dysphagia, conditions: Treatment Compliance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Immersive Virtual Reality for Dysphagia Treatment, outcomesModule primaryOutcomes measure: Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes., primaryOutcomes measure: Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheffield Hallam University, city: Sheffield, state: South Yorkshire, zip: S1 2NU, country: United Kingdom, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False
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protocolSection identificationModule nctId: NCT06325566, orgStudyIdInfo id: MSB-DR004, briefTitle: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain, acronym: HyaluronicAcid, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mesoblast, Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment., conditionsModule conditions: Degenerative Disc Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Rexlemestrocel-L + HA mixture, interventions name: Saline, outcomesModule primaryOutcomes measure: Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score, primaryOutcomes measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Percentage of 30% VAS Pain Responders at 12 Months Post-treatment, secondaryOutcomes measure: Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment, secondaryOutcomes measure: Percentage of Minimal Pain Responders at 12 Months Post-treatment, secondaryOutcomes measure: Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment, secondaryOutcomes measure: Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment, secondaryOutcomes measure: Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325553, orgStudyIdInfo id: 022_2566, briefTitle: Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control, acronym: PTR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, descriptionModule briefSummary: This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs, conditionsModule conditions: Platelet Refractoriness in Adult Acute Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Descriptive statistics, primaryOutcomes measure: Inferential statistics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Siriraj hospital, status: RECRUITING, city: Bangkok, zip: 10700, country: Thailand, contacts name: weerapat Owattanapanich, MD, role: CONTACT, phone: 0891081963, email: weerapato36733@gmail.com, contacts name: Phakaporn Chamweha, DR, role: CONTACT, phone: 06855156615, email: phakaporn.cham@gmail.com, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06325540, orgStudyIdInfo id: pulpcapping, briefTitle: Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the clinical success of theracal pt, therabase, and biodentine indirect pulp capping on primary molars with deep dentin caries. Indirect pulp capping was used on the primary molars of the participants with deep dentin caries. It is aimed to compare the success of biodentine, which is considered the gold standard used in capping treatments, and the currently marketed Teracal PT and Therabase materials after 1, 6 months and 1 year, with biodentine and with each other, and find out which material is more successful., conditionsModule conditions: Dentin, Carious, conditions: Indirect Pulp Capping, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Indirect pulp capping will be applied to primary molar teeth with deep dentin caries in 3 groups with 3 different materials(biodentine, thermal pt, therabase)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: patients and the researcher who evaluates the follow-up results of the patients will not know which material was used for indirect pulp coating., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: indirect pulp capping with theracal pt, interventions name: indirect pulp capping with therabase, interventions name: indirect pulp capping with biodentine, outcomesModule primaryOutcomes measure: successful completion of research, primaryOutcomes measure: unseccessful completion of research, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sağlık Bilimleri Üniversitesi, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06325527, orgStudyIdInfo id: YuGarden-01, briefTitle: Cognitive Impairment Cohort Study of the Elderly Population in YuGarden, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2031-04-01, completionDateStruct date: 2031-06-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.The main questions it aims to answer are:* incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)* to build a predictive model for the progression of cognitive impairment, conditionsModule conditions: Alzheimer Disease, conditions: Neurodegenerative Diseases, conditions: Cognitive Impairment, conditions: Mild Cognitive Impairment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1872, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of cognitive impairment, secondaryOutcomes measure: The change of Mini-Mental State Examination (MMSE), secondaryOutcomes measure: The change of Barthel Index for Activities of Daily Living (ADL), secondaryOutcomes measure: The change of blood biomarkers, secondaryOutcomes measure: The change of urine biomarkers, secondaryOutcomes measure: The change of feces biomarkers, secondaryOutcomes measure: The change of gingival crevicular fluid biomarkers, secondaryOutcomes measure: The change of electroencephalogram (EEG), secondaryOutcomes measure: The change of speech information, secondaryOutcomes measure: The change of structural MRI, secondaryOutcomes measure: The change of functional MRI, secondaryOutcomes measure: The change of magnetic susceptibility, secondaryOutcomes measure: The change of perfusion MR imaging, secondaryOutcomes measure: Positron emission tomography (PET), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, city: Shanghai, state: Shanghai, country: China, contacts name: Jinwen Xiao, role: CONTACT, phone: 13917310784, email: jw_xiao78@163.com, contacts name: Gang Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06325514, orgStudyIdInfo id: NA2024, briefTitle: Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aims to develop an AI program that can classify oral findings into Normal/variation of normal or an oral disease by clinical photos analysis, aiding in lowering the percentages of false positive and false negative diagnosis of oral diseases., conditionsModule conditions: Oral Cancer, conditions: Oral Lichen Planus, conditions: Fordyce Granule, conditions: Leukoplakia, conditions: Erythroplakia, conditions: Leukoedemas, Oral, conditions: Lichenoid Reaction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 241, type: ESTIMATED, armsInterventionsModule interventions name: Artificial intelligence based program, outcomesModule primaryOutcomes measure: risk stratification, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325501, orgStudyIdInfo id: AA-2024-1, briefTitle: Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy., conditionsModule conditions: Myoma;Uterus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Misoprostol 200mcg Tab, interventions name: Oxytocin, outcomesModule primaryOutcomes measure: intra-operative blood loss, secondaryOutcomes measure: blood transfusion, secondaryOutcomes measure: post-operative Hb, secondaryOutcomes measure: total surgery time, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of medicine, Kasr el ainy hospital, Cairo university, status: RECRUITING, city: Cairo, zip: 11562, country: Egypt, contacts name: Mohammad A Taymour, MD, role: CONTACT, phone: 01555761995, email: Mohammadtaymour@gmail.com, contacts name: Waleed M Elkhyat, role: CONTACT, phone: 01005135542, email: Waleed_elkhyat@yahoo.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06325488, orgStudyIdInfo id: H-23035668, briefTitle: Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease, acronym: FORTIFY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Caroline Michaela Kistorp, class: OTHER, collaborators name: Sanofi, descriptionModule briefSummary: The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.The study will achieve this by:1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy., conditionsModule conditions: Fabry Disease, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Renal hypoxia (Fabry patients according to renal impairment), secondaryOutcomes measure: Renal hypoxia (Fabry patient vs controls), secondaryOutcomes measure: Renal cortical perfusion (Fabry vs. controls), secondaryOutcomes measure: Renal medullar perfusion (Fabry vs. controls), secondaryOutcomes measure: Renal inflammation (Fabry vs. controls), secondaryOutcomes measure: Renal fibrosis (Fabry vs. controls), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-07-14, uploadDate: 2023-09-18T03:04, filename: Prot_000.pdf, size: 808560, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-14, uploadDate: 2024-02-21T07:14, filename: SAP_001.pdf, size: 1460496, hasResults: False
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protocolSection identificationModule nctId: NCT06325475, orgStudyIdInfo id: B.30.2.ATA.0.01.00/530, briefTitle: Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-07-26, completionDateStruct date: 2024-08-26, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system., conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: labor with neuraxial labor analgesia, interventions name: labour without noroaxial labor analgesia, outcomesModule primaryOutcomes measure: ObsQoR-10 scores of postpartum patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atatürk University, status: RECRUITING, city: Erzurum, country: Turkey, contacts name: Ayşenur Dostbil, role: CONTACT, phone: +905333677796, email: adostbil@hotmail.com, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06325462, orgStudyIdInfo id: E2232/2023, briefTitle: The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Prince Sultan Military Medical City, class: OTHER, descriptionModule briefSummary: Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios., conditionsModule conditions: Cerebral Oxygenation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843, outcomesModule primaryOutcomes measure: regional cerebral oxygen saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince Sultan Military Medical City, status: RECRUITING, city: Riyadh, zip: 11159, country: Saudi Arabia, contacts name: Muteb AlOtaibi, M.D., role: CONTACT, phone: 00966544793370, email: muteb612@gmail.com, contacts name: Rashid Al-Otaibi, M.D., role: SUB_INVESTIGATOR, contacts name: Osama Shalaan, M.D., role: SUB_INVESTIGATOR, contacts name: Muteb Al-Otaibi, M.D., role: SUB_INVESTIGATOR, contacts name: Majid Al-Sherif, role: SUB_INVESTIGATOR, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False
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protocolSection identificationModule nctId: NCT06325449, orgStudyIdInfo id: 5323, briefTitle: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity, acronym: FLOWERS-PCOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ottawa Hospital Research Institute, class: OTHER, collaborators name: LEAF Weight Loss Clinic, descriptionModule briefSummary: The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?Participants will complete a 24-week weight loss program (STREAM). During this program they will:* weigh themselves* complete regular bloodwork and* fill out a Quality of Life questionnaire at regular intervals, conditionsModule conditions: Polycystic Ovary Syndrome, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: STREAM program, outcomesModule primaryOutcomes measure: Weight loss, primaryOutcomes measure: Change in Endocrine parameters (EP) as measure by blood test, primaryOutcomes measure: Change in insulin sensitivity (IS) as measure by blood test, primaryOutcomes measure: Change in Lipid profile (LP) as measure by blood test, primaryOutcomes measure: Change in liver enzyme profile (LEP) as measure by blood test, primaryOutcomes measure: Change in Menstrual Cyclicity, primaryOutcomes measure: Quality of Life (QoL) Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LEAF Weight Management Clinic, city: Ottawa, state: Ontario, zip: K1J9L3, country: Canada, contacts name: Judy Shiau, MD, role: CONTACT, phone: 613-701-1222, email: dr.shiau@leafwmc.ca, contacts name: Julie Laroche, role: CONTACT, phone: 613-701-1222, email: info@leafwmc.ca, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False
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protocolSection identificationModule nctId: NCT06325436, orgStudyIdInfo id: scores in variceal bleeding, briefTitle: Objective Scores in Variceal Bleeding, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores., conditionsModule conditions: Variceal Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, outcomesModule primaryOutcomes measure: assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325423, orgStudyIdInfo id: response to NAC in MIBC, briefTitle: Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC., conditionsModule conditions: Muscle-Invasive Bladder Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant chemotherapy, outcomesModule primaryOutcomes measure: Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies, primaryOutcomes measure: - Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features, secondaryOutcomes measure: Local recurrence-free survival (RFS), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325410, orgStudyIdInfo id: #11279-20-11-2023, briefTitle: Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01, primaryCompletionDateStruct date: 2022-12, completionDateStruct date: 2022-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.Data was collected from records in a retrospective cohort study, conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: resection of colorectal cancer, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: medical disease, primaryOutcomes measure: previous surgery, primaryOutcomes measure: CEA, primaryOutcomes measure: tumor grade, primaryOutcomes measure: tumor site, primaryOutcomes measure: tumor size, primaryOutcomes measure: surgical margins of resected tumor, primaryOutcomes measure: neoadjuvant therapy, primaryOutcomes measure: adjuvant therapy, primaryOutcomes measure: diet, primaryOutcomes measure: occupation, primaryOutcomes measure: family history, primaryOutcomes measure: type of surgery(laparoscopic or open), primaryOutcomes measure: soiling by during surgery, primaryOutcomes measure: hand sewen or stappled anastmosis, primaryOutcomes measure: post operative complications, primaryOutcomes measure: site of recurrence, primaryOutcomes measure: type of resected tumor, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zagazig University Hospitals, city: Zagazig, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06325397, orgStudyIdInfo id: IIT #88313865, briefTitle: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Matthew Rauen, class: OTHER, descriptionModule briefSummary: To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication, conditionsModule conditions: Nuclear Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: High Intraocular Pressure (IOP), interventions name: Low Intraocular Pressure (IOP), outcomesModule primaryOutcomes measure: Medication Rescue, secondaryOutcomes measure: Physiologic Responses associated with pain/inflammation:, secondaryOutcomes measure: Physiologic Responses associated with pain/inflammation:, secondaryOutcomes measure: Surgeon Experience: Assessment on patient cooperation, secondaryOutcomes measure: Surgeon Experience: Surgeon intraoperative experience, secondaryOutcomes measure: Cost- analysis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wolfe Eye Clinic, status: RECRUITING, city: West Des Moines, state: Iowa, zip: 50266, country: United States, contacts name: Robyn Kohler, RN, role: CONTACT, phone: 515-223-8685, phoneExt: 2305, email: rkohler@wolfeclinic.com, contacts name: Hillery Joiner, role: CONTACT, phone: 5152238685, phoneExt: 2085, email: hjoiner@wolfeclinic.com, contacts name: Matthew Rauen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.57721, lon: -93.71133, hasResults: False
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protocolSection identificationModule nctId: NCT06325384, orgStudyIdInfo id: IRAS ID:1008701, briefTitle: Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care, acronym: VISION-RWE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Xim Limited, class: INDUSTRY, collaborators name: Barts & The London NHS Trust, collaborators name: Mind Over Matter Medtech Ltd, collaborators name: Health Innovation Wessex, descriptionModule briefSummary: A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics, conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Lifelight, interventions name: Blood Pressure Cuff, outcomesModule primaryOutcomes measure: Blood Pressure Measurement Non Inferiority, secondaryOutcomes measure: Adherance to Blood Pressure Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06325371, orgStudyIdInfo id: 0028201, briefTitle: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2, acronym: DEDICATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients., conditionsModule conditions: Aneurysm Abdominal, conditions: Arterial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Visceral aneurysm stenting, outcomesModule primaryOutcomes measure: Efficacy of the stenting in terms of patency and side branches, primaryOutcomes measure: Efficacy of the stenting in terms of aneurysm thrombosis rate, primaryOutcomes measure: Efficacy of the stenting in terms of aneurysm volume assessment, primaryOutcomes measure: Safety in terms of morbidity, primaryOutcomes measure: Safety in terms of mortality, primaryOutcomes measure: Safety in terms of technical issues, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06325358, orgStudyIdInfo id: 0040083/23, briefTitle: the EXPOSITION Study, acronym: EXPOSITION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, collaborators name: National Research Council (Consiglio Nazionale delle Ricerche), collaborators name: IRCCS National Neurological Institute "C. Mondino" Foundation, descriptionModule briefSummary: This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, conditions: Environmental Exposure, conditions: Lifestyle Factors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: microRNAs, primaryOutcomes measure: Air quality, primaryOutcomes measure: Nutritional assessment, primaryOutcomes measure: Neurofilament (NfL), primaryOutcomes measure: Cytokines, primaryOutcomes measure: the Body Mass Index (BMI), primaryOutcomes measure: Physical activity, primaryOutcomes measure: Quality of life related to MS, primaryOutcomes measure: Sleep Quality, primaryOutcomes measure: Smoking habits, primaryOutcomes measure: Dietary supplements use, primaryOutcomes measure: Adherence to Mediterranean diet, primaryOutcomes measure: Effect of diet on inflammation, primaryOutcomes measure: waist and height ratio (WHtR), primaryOutcomes measure: Bioelectrical impedance, secondaryOutcomes measure: Microbiome and biological biomarkers of oxidative stress and inflammation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Foundation C. Mondino, city: Pavia, zip: 27100, country: Italy, contacts name: Eleonora Tavazzi, role: CONTACT, phone: 0382 380403, phoneExt: +39, email: eleonora.tavazzi@mondino.it, contacts name: Roberto Bergamaschi, role: SUB_INVESTIGATOR, contacts name: Eleonora Tavazzi, role: PRINCIPAL_INVESTIGATOR, contacts name: Hellas Cena, role: SUB_INVESTIGATOR, contacts name: Rachele de Giuseppe, role: SUB_INVESTIGATOR, contacts name: Beatrice Maccarini, role: SUB_INVESTIGATOR, contacts name: Aliki Kalmpourtzidou, role: SUB_INVESTIGATOR, contacts name: Elena Colombo, role: SUB_INVESTIGATOR, contacts name: Eleonora Rigoni, role: SUB_INVESTIGATOR, contacts name: Lara Ahmad, role: SUB_INVESTIGATOR, contacts name: Monica Bianchi, role: SUB_INVESTIGATOR, contacts name: Veronica Tosca, role: SUB_INVESTIGATOR, contacts name: Luciana Gracardi, role: SUB_INVESTIGATOR, contacts name: Romina Sarchi, role: SUB_INVESTIGATOR, contacts name: Anna Scarabotto, role: SUB_INVESTIGATOR, contacts name: Matteo Gastaldi, role: SUB_INVESTIGATOR, contacts name: Ghanya Al-Naqeb, role: SUB_INVESTIGATOR, contacts name: Federica Loperfido, role: SUB_INVESTIGATOR, contacts name: Mulubirhan A. Alemayohu, role: SUB_INVESTIGATOR, contacts name: Maria Cristina Monti, role: SUB_INVESTIGATOR, contacts name: Cristina Montomoli, role: SUB_INVESTIGATOR, contacts name: Danilo Porro, role: SUB_INVESTIGATOR, contacts name: Gloria Bertoli, role: SUB_INVESTIGATOR, contacts name: Alessia Lo Dico, role: SUB_INVESTIGATOR, contacts name: Clarissa Consolandi, role: SUB_INVESTIGATOR, contacts name: Marco Severgnini, role: SUB_INVESTIGATOR, contacts name: Francesca Costabile, role: SUB_INVESTIGATOR, contacts name: Stefano Decesari, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06325345, orgStudyIdInfo id: 22-5277, briefTitle: RCT of Gut-directed Hypnotherapy in Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-29, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This randomized, controlled trial (RCT) will evaluate the effectiveness of gut-directed hypnotherapy for management of Irritable Bowel Syndrome (IBS) in individuals diagnosed with Ehlers-Danlos Syndromes or Generalized Hypermobility Spectrum Disorders (G-HSD). Consenting patients recruited from the Toronto General Hospital GoodHope Ehlers-Danlos Syndrome Clinic will be randomly assigned to one of two groups: (1) standard medical therapy or (2) standard medical therapy plus eight sessions of gut-directed hypnotherapy. The main questions this study will answer are:1. Is gut-directed hypnotherapy an efficacious treatment for IBS symptoms among individuals with EDS or G-HSD?2. Does gut-directed hypnotherapy improve other gut symptoms, quality of life, visceral sensitivity, and emotional distress?3. Is the activity of the parasympathetic nervous system (i.e. the body's "rest and digest" system) associated with IBS symptoms or treatment outcomes among individuals with EDS or G-HSD?All participants will be asked to meet with a gastroenterologist three times as part of the standard medical therapy. At each physician visit, they will undergo electrocardiogram recording and complete self-report measures of gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Participants randomized to receive gut-directed hypnotherapy will also eight weekly remotely-delivered sessions of gut-directed hypnotherapy delivered by a trained behavioral therapist in between the first and second physician visit. At each session of gut-directed hypnotherapy, a voluntary, pleasant, and dream-like state of deep relaxation will be induced and suggestions made for greater relaxation, abdominal comfort, and normalization of gut function. The first session will also include 30 minutes of education on the nature of the gut-brain axis and hypnotherapy prior to hypnosis.Researchers will compare study groups to see if participants who engaged in gut-directed hypnotherapy had greater improvement in IBS symptoms, other gastrointestinal symptoms, quality of life, visceral sensitivity, and emotional distress. Exploratory analyses will examine the relationships among heart rate variability, an index of parasympathetic nervous system activity, and study outcomes., conditionsModule conditions: Ehlers-Danlos Syndrome, conditions: Irritable Bowel Syndrome, conditions: Hypermobility Syndrome, conditions: Gastrointestinal Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Gut-directed hypnotherapy, interventions name: Standard Medical Therapy, outcomesModule primaryOutcomes measure: IBS Symptom Severity, secondaryOutcomes measure: Upper Gastrointestinal Symptoms, secondaryOutcomes measure: IBS-related Quality of Life, secondaryOutcomes measure: Visceral Sensitivity, secondaryOutcomes measure: Emotional Distress, otherOutcomes measure: Weekly Ratings of GI Health and Medication Use, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Toronto General Hospital, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06325332, orgStudyIdInfo id: RSV00080, briefTitle: BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study), acronym: BEAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.the secondary objectives are:1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.3. To estimate the impact of nirsevimab on PCR-confirmed RSV.4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.5. To estimate the impact of nirsevimab on antibiotic prescription., conditionsModule conditions: Respiratory Syncytial Virus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 33000, type: ESTIMATED, armsInterventionsModule interventions name: Nirsevimab, outcomesModule primaryOutcomes measure: Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD), primaryOutcomes measure: Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis, secondaryOutcomes measure: Number of respiratory-related medical encounters, secondaryOutcomes measure: Number of respiratory-related medical encounters for LRTD by ICD-10 codes, secondaryOutcomes measure: Incidence of PCR-confirmed RSV (first occurrence of season), secondaryOutcomes measure: Number of medical encounters for otitis media by ICD-10 codes, secondaryOutcomes measure: Number of antibiotic prescriptions by National Drug Code (NDC) codes, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Kaiser Permanente Northern California: Site number 0001, status: RECRUITING, city: Oakland, state: California, zip: 94612, country: United States, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False
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protocolSection identificationModule nctId: NCT06325319, orgStudyIdInfo id: Ref. No. MA.84/261/02/1/115, briefTitle: Effect of Community Engagement Using M-Mama Champions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Dodoma, class: OTHER, collaborators name: Stephen Kibusi, collaborators name: James Tumaini Kengia, descriptionModule briefSummary: This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women.The following is the hypothesis being testedNull Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches.Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches.During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention.The control arm won't receive any intervention., conditionsModule conditions: Obstetric Complication, conditions: Woman's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Community engagement using M-MAMA Champions to improve awareness on obstetric danger signs, bith preparedness and complication readiness among pregnant women, outcomesModule primaryOutcomes measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on awareness of obstetric danger signs among pregnant women., primaryOutcomes measure: Improvement in scores from a semi-structured interviewer-administered questionnaire of awareness of birth preparedness and complication readiness among pregnant women, secondaryOutcomes measure: Improvement in scores from a semi-structured interviewer-administered questionnaire on reported practice of birth preparedness and complication readiness, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Dodoma, city: Dodoma, zip: 259, country: Tanzania, contacts name: Alex P Sanga, MSc. PH, role: CONTACT, phone: 0762144082, email: sanga.alex@gmail.com, contacts name: Stephen Kibusi, PhD, role: CONTACT, phone: 0712600966, email: skibusi@gmail.com, geoPoint lat: -6.17221, lon: 35.73947, hasResults: False
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protocolSection identificationModule nctId: NCT06325306, orgStudyIdInfo id: 2023/392, secondaryIdInfos id: B7072023000102, type: OTHER, domain: Comité d'Ethique Hospitalo-Facultaire Universitaire de Liège, briefTitle: Physical Literacy-Based Intervention for Chronic Disease Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Liege, class: OTHER, collaborators name: Centre Hospitalier Universitaire de Liege, descriptionModule briefSummary: The goal of this quasi-experimental study is to evaluate the effectiveness of a physical literacy-based intervention for chronic disease management in adults with chronic diseases participating in adapted physical activity group sessions in Belgium. The main questions it aims to answer are:* How does incorporating physical literacy elements in adapted physical activity sessions affect participants overall physical literacy levels?* Can a physical literacy-oriented adapted physical activity program enhance long-term engagement in physical activities and improve health outcomes for chronic disease patients?Participants will:* Undergo assessments for physical literacy levels and health outcomes at the beginning, after three months, and at the end of the six-month period.* Engage, in intervention groups, in adapted physical activity sessions, which may include physical fitness exercises and educational components on physical literacy.Researchers will compare 3 groups: a control group, a traditional Adapted Physical Activity (APA) group, and a Physical Literacy Oriented APA (APA+PL) group to see if integrating physical literacy components results in improved physical literacy levels, better sustained engagement in physical activities, and enhanced health outcomes., conditionsModule conditions: Chronic Disease, conditions: Chronic Disease Management, conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: Traditional APA, interventions name: APA+PL, outcomesModule primaryOutcomes measure: Global Physical Literacy Score, primaryOutcomes measure: Physical Activity Behavior and Engagement, primaryOutcomes measure: Motivation and Confidence in Physical Activity, primaryOutcomes measure: Physical Competence, primaryOutcomes measure: Knowledge and Understanding of Physical Activity, primaryOutcomes measure: Environment interactions, primaryOutcomes measure: Meaningful and Purposeful Activities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Sportif du Sart-Tilman, status: RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Jean-Pierre Weerts, M.A., role: CONTACT, phone: +32 4366 3818, email: jpweerts@uliege.be, contacts name: Cédric Lehance, M.A., role: CONTACT, phone: +32 477490055, email: clehance@chuliege.be, contacts name: Jean-Pierre Weerts, M.A., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-02, uploadDate: 2024-03-08T06:13, filename: ICF_000.pdf, size: 334181, hasResults: False
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protocolSection identificationModule nctId: NCT06325293, orgStudyIdInfo id: 2023-01295, secondaryIdInfos id: 207286, type: OTHER_GRANT, domain: Swiss National Science Foundation, briefTitle: A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study, acronym: MYTHIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Christoph Berger, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.Researchers will then compare the length of symptoms between the placebo and the antibiotic group., conditionsModule conditions: Community Acquired Pneumonia in Children, conditions: Mycoplasma Pneumoniae, conditions: Mycoplasma Pneumoniae Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 376, type: ESTIMATED, armsInterventionsModule interventions name: Azithromycin Pfizer®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Co-primary outcome: days to normalization of all vital signs, primaryOutcomes measure: Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status, secondaryOutcomes measure: Overall clinical outcome, secondaryOutcomes measure: Time (days) to normalization of CAP-related symptoms, secondaryOutcomes measure: Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being, secondaryOutcomes measure: Time (days) to return to daily routine, secondaryOutcomes measure: Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report, otherOutcomes measure: Length of hospital stay (LOS), otherOutcomes measure: Number of unscheduled medical visits, otherOutcomes measure: Proportion of patients (re-)treated with antibiotics for any reason, otherOutcomes measure: Side effects/AEs/serious AE (SAE)s of investigational medicinal product (IMP), otherOutcomes measure: Microbiological indicators, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Aarau, Switzerland, city: Aarau, state: Aargau, zip: 5001, country: Switzerland, contacts name: Henrik Köhler, Prof. Dr. med., role: CONTACT, phone: 0041 62 838 41 41, email: Henrik.Koehler@ksa.ch, contacts name: Henrik Köhler, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.39254, lon: 8.04422, locations facility: University of Basel Children's Hospital, Switzerland, city: Basel, state: Basel-Stadt, zip: 4056, country: Switzerland, contacts name: Julia A Bielicki, PD Dr. Dr. med., role: CONTACT, phone: 0041 61 704 12 12, email: julia.bielicki@ukbb.ch, contacts name: Julia A Bielicki, PD Dr. Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Ulrich Heiniger, Prof. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, locations facility: Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland, city: Chur, state: Graubünden, zip: 7000, country: Switzerland, contacts name: Beate Deubzer, Dr. med., role: CONTACT, phone: 0041 81 256 61 11, email: beate.deubzer@ksgr.ch, contacts name: Beate Deubzer, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.84986, lon: 9.53287, locations facility: Children's Hospital of Eastern Switzerland St. Gallen, city: St. Gallen, state: Saint Gallen, zip: 9006, country: Switzerland, contacts name: Anita Niederer-Loher, Dr. med., role: CONTACT, phone: 0041 71 243 71 11, email: anita.niederer@kispisg.ch, contacts name: Anita Niederer-Loher, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42391, lon: 9.37477, locations facility: Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland, city: Bellinzona, state: Ticino, zip: 6500, country: Switzerland, contacts name: Lisa Kottanattu, Dr. med., role: CONTACT, phone: 0041 91 811 91 11, email: Lisa.Kottanattu@eoc.ch, contacts name: Lisa Kottanattu, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.19278, lon: 9.01703, locations facility: Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland, city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Ludivine Coulon, Dr. med., role: CONTACT, phone: 0041 21 314 11 11, email: Ludivine.Coulon@chuv.ch, contacts name: Ludivine Coulon, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, locations facility: Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland, city: Winterthur, state: Zurich, zip: 8401, country: Switzerland, contacts name: Andreas Jung, Dr. med., role: CONTACT, phone: 0041 52 266 41 44, email: andreas.jung@ksw.ch, contacts name: Andreas Jung, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.50564, lon: 8.72413, locations facility: University Children's Hospital Bern, Switzerland, city: Bern, zip: 3010, country: Switzerland, contacts name: Philipp Agyeman, PD Dr. med., role: CONTACT, phone: 0041 31 632 21 11, email: Philipp.Agyeman@insel.ch, contacts name: Philipp Agyeman, PD Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Kristina Keitel, PD Dr. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Department of Pediatrics, Fribourg Hospital, Switzerland, city: Fribourg, zip: 1708, country: Switzerland, contacts name: Petra Zimmermann, PD Dr. Dr. med., role: CONTACT, phone: 0041 26 306 00 00, email: petra.zimmermann@unifr.ch, contacts name: Petra Zimmermann, PD Dr. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.80237, lon: 7.15128, locations facility: Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland, city: Geneva, zip: 1205, country: Switzerland, contacts name: Noémie Wagner, Dr. med., role: CONTACT, phone: 0041 22 372 40 00, email: Noemie.Wagner@hcuge.ch, contacts name: Noémie Wagner, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, locations facility: Children's Hospital of Central Switzerland, Switzerland, city: Luzern, zip: 6000, country: Switzerland, contacts name: Alex Donas, Dr. med., role: CONTACT, phone: 0041 41 205 31 66, email: alex.donas@luks.ch, contacts name: Alex Donas, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.05048, lon: 8.30635, locations facility: University Children's Hospital Zurich, Switzerland, city: Zurich, zip: 8032, country: Switzerland, contacts name: Michelle Seiler, PD Dr. med, role: CONTACT, phone: 0041 44 266 71 11, email: Michelle.Seiler@kispi.uzh.ch, contacts name: Michelle Seiler, PD Dr. med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Department of Pediatrics, Triemli Hospital Zurich, Switzerland, city: Zurich, zip: 8063, country: Switzerland, contacts name: Maren Tomaske, Prof. Dr. med., role: CONTACT, phone: 0041 44 416 11 11, email: Maren.Tomaske@stadtspital.ch, contacts name: Maren Tomaske, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06325280, orgStudyIdInfo id: Pro00132542, briefTitle: Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function., conditionsModule conditions: Pediatric ALL, conditions: Congenital Heart Disease, conditions: Heart Transplantation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Exercise cardiac MRI Assessment, interventions name: Cardiopulmonary Exercise Test, outcomesModule primaryOutcomes measure: MRI assessment of cardiac structure at rest, primaryOutcomes measure: MRI assessment of cardiac function at rest, primaryOutcomes measure: Maximal exercise MRI assessment of cardiac structure, primaryOutcomes measure: Cardioplumonary Exercise Test, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Alberta, city: Edmonton, state: Alberta, zip: T6G 2B7, country: Canada, contacts name: Rae Foshaug, role: CONTACT, phone: 780-407-7499, email: rae.foshaug@albertahealthservices.ca, contacts name: Michael Khoury, MD, role: CONTACT, phone: 780-492-0103, email: khoury1@ualberta.ca, contacts name: Michael Khoury, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False
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protocolSection identificationModule nctId: NCT06325267, orgStudyIdInfo id: PLC, briefTitle: Clinical Characteristics of Primary Liver Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: Primary liver cancer (PLC) is the sixth most common malignancy in the world and the third most common cause of malignancy death. In 2020, there were about 905,677 new cases of PLC worldwide, and 830,180 deaths. Despite the availability of a variety of treatments for PLC, the 5-year net survival rate is still only 5% to 30%. How to effectively reduce the disease burden of PLC is a major public health problem that needs to be solved worldwide. The clinical characteristics and prognosis of PLC caused by different pathogenic factors are different. Therefore, it is of great significance to fully identify the risk factors of PLC, be familiar with the clinical characteristics and prognosis of disease development, and understand the relevant monitoring and follow-up strategies for the prevention and treatment of PLC., conditionsModule conditions: Primary Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Epidemiological characteristics of overall cohort by liver disease etiology, primaryOutcomes measure: Clinical characteristics of overall cohort by liver disease etiology, secondaryOutcomes measure: Survival rates of overall cohort and different etiologies, secondaryOutcomes measure: Risk factors of prognosis in overall cohort and different etiologies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Jie Li, M.D., Ph.D, role: CONTACT, phone: 15863787910, email: lijier@nju.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06325254, orgStudyIdInfo id: MAFLD, briefTitle: Clinical Characteristics of Metabolic Associated Fatty Liver Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: Metabolic associated fatty liver disease (MAFLD), which can lead to liver fibrosis, cirrhosis, liver failure and even hepatocellular carcinoma, poses a significant burden on society. With the improvement of living standards and changes in dietary habits, MAFLD patients show a younger and increasing trend, but there is still no specific drug. The clinical features and prognosis of MAFLD may be different with different metabolic disorder phenotypes and treatment measures. Therefore, further systematic study of the clinical characteristics and prognosis of MAFLD patients will be of great significance for the formulation of corresponding clinical prevention and treatment strategies., conditionsModule conditions: Metabolic Associated Fatty Liver Disease, conditions: Clinical Features, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Clinical characteristics and follow-up outcomes of MAFLD patients, secondaryOutcomes measure: Clinical characteristics and follow-up outcomes of MAFLD patients under different subgroups, secondaryOutcomes measure: Baseline clinical characteristics MAFLD patients, secondaryOutcomes measure: Risk factors for progression to cirrhosis and hepatocellular carcinoma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Jie Li, M.D.,Ph.D, role: CONTACT, phone: 15863787910, email: lijier@nju.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06325241, orgStudyIdInfo id: 20200048-01H, briefTitle: Validating the Use of Frailty Measurements to Predict Care & Quality of Life, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-12, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Ottawa Hospital Research Institute, class: OTHER, descriptionModule briefSummary: The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 123, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Respiratory Health Related Quality of Life, secondaryOutcomes measure: Burden of symptoms - COPD Assessment, secondaryOutcomes measure: Burden of symptoms - Dyspnea, secondaryOutcomes measure: Psycho-social well being - Anxiety, secondaryOutcomes measure: Psycho-social well being - Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ottawa Hospital, General Campus, city: Ottawa, state: Ontario, zip: K1J 0J2, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-09-22, uploadDate: 2022-11-29T13:05, filename: Prot_SAP_000.pdf, size: 617838, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: Verbal consent, date: 2022-11-09, uploadDate: 2022-11-29T13:08, filename: ICF_001.pdf, size: 317754, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form: English Information Sheet, date: 2022-11-09, uploadDate: 2022-11-29T13:11, filename: ICF_002.pdf, size: 161773, hasResults: False
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protocolSection identificationModule nctId: NCT06325228, orgStudyIdInfo id: NKBBN/241/2023, secondaryIdInfos id: SONP/SP/549693/2022, type: OTHER_GRANT, domain: Minister of Education and Science, briefTitle: Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Medical University of Gdansk, class: OTHER, collaborators name: Ministry of Science and Higher Education, Poland, descriptionModule briefSummary: The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up.The main questions it aims to answer are:* Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation?* Do athletes with high sports specialization will sustain injury in one-year follow-up?* Does sports specialization have a relationship with sports performance tests, and quality of life?* Does sport specialisation, training volume, geographical factor relate to injury history?* Does sports specialisation, injury history differ between sports (individual and team sports)?* Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?, conditionsModule conditions: Sport Injury, conditions: Healthy, conditions: Injury;Sports, conditions: Quality of Life, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 373, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of Participants with sports injury after one-year follow-up, primaryOutcomes measure: Type, location, duration, and return to sports in participants with injury at one-year follow up, secondaryOutcomes measure: Sports Specialization, secondaryOutcomes measure: History of sports-related injuries, secondaryOutcomes measure: Health-related quality of life: EQ-5D-Y, secondaryOutcomes measure: Y-Balance Test - dynamic balance test, secondaryOutcomes measure: Functional Movement Screen (FMS), secondaryOutcomes measure: Hand-Held Dynamometer (HHD) measurement - Isometric Strength of the lower extremities muscle, otherOutcomes measure: Sport workload (hours per trainings or competition), otherOutcomes measure: Peak Height Velocity, otherOutcomes measure: Sports discipline and position, otherOutcomes measure: Participants characteristics - Body Mass Index, otherOutcomes measure: Sports experience, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Immunobiology and Environment Microbiology, Medical University of Gdańsk, city: Gdańsk, zip: 80-211, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-01-15, uploadDate: 2024-04-22T03:58, filename: ICF_000.pdf, size: 183809, hasResults: False
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protocolSection identificationModule nctId: NCT06325215, orgStudyIdInfo id: SCaglar, briefTitle: The Effect of Hydrocolloid to Prevent Nasal Injuries in Preterm Infants, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-05, primaryCompletionDateStruct date: 2022-10-29, completionDateStruct date: 2022-11-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effect of using hydrocolloid tapes in preventing pressure injuries on the nose and columella regions caused by non-invasive mechanical ventilation (NIMV) in preterm infants., conditionsModule conditions: Pressure Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Experimantal, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: After providing information about the study to the parents of preterm newborns who met the inclusion criteria, informed consent forms were obtained without disclosing which group their babies would be assigned to. The research outcome measurements were recorded by two nurses working at NICU. Prior to the study, necessary training and information about the form and process were provided to the nurses. The data analysis was conducted by an independent statistician., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 56, type: ACTUAL, armsInterventionsModule interventions name: Hidrocolloid Bant, outcomesModule primaryOutcomes measure: Neonatal Skin Condition Score, primaryOutcomes measure: Pressure İnjury Staging Scale, secondaryOutcomes measure: Neonatal Skin Risk Assessment Scale, eligibilityModule sex: ALL, minimumAge: 24 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Abide-i Hurriyet Cad. Istanbul University-Cerrahpaşa, Florence Nightingale Faculty of Nursing, city: Istanbul, zip: 34381, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06325202, orgStudyIdInfo id: STUDY00020946, secondaryIdInfos id: 1U01DK135126, type: NIH, link: https://reporter.nih.gov/quickSearch/1U01DK135126, briefTitle: Closed Loop and Education for Hypoglycemia Awareness Restoration, acronym: CLEAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), collaborators name: University of Minnesota, collaborators name: University of Kentucky, collaborators name: University of Pennsylvania, collaborators name: University of California, San Diego, collaborators name: AdventHealth, collaborators name: University of Leicester, collaborators name: University of Sheffield, collaborators name: University of Melbourne, collaborators name: Jaeb Center for Health Research, descriptionModule briefSummary: The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential Multiple Assignment Randomized Trial (SMART) design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Omnipod 5 or Medtronic 780G, interventions name: My HypoCOMPaSS Education, interventions name: HARPdoc Education, outcomesModule primaryOutcomes measure: epinephrine (pg/ml), primaryOutcomes measure: Towler questionnaire, secondaryOutcomes measure: geometric mean of plasma glucagon, secondaryOutcomes measure: geometric mean of plasma pancreatic polypeptide, secondaryOutcomes measure: geometric mean of plasma free fatty acids, secondaryOutcomes measure: glucose infusion rate, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: % of time with sensor hypoglycemia <70 mg/dL, secondaryOutcomes measure: % of time with sensor hypoglycemia <54 mg/dL, secondaryOutcomes measure: number of hypoglycemia events, secondaryOutcomes measure: % time with sensor glucose in range, secondaryOutcomes measure: sensor glucose coefficient of variation, secondaryOutcomes measure: sensor use as the average numbers of days per week, secondaryOutcomes measure: glycemia risk index, secondaryOutcomes measure: Trail Making Test - Part B, secondaryOutcomes measure: Four Choice Reaction Time, secondaryOutcomes measure: sleep duration, secondaryOutcomes measure: sleep quality, secondaryOutcomes measure: 24-hour step count, secondaryOutcomes measure: exercise bouts, secondaryOutcomes measure: resting heart rate, secondaryOutcomes measure: heart rate during exercise, secondaryOutcomes measure: heart rate variability, secondaryOutcomes measure: Hypo-METRICS questionnaire, secondaryOutcomes measure: Hypoglycemic Confidence Scale, secondaryOutcomes measure: Hypoglycemia Fear Survey-II, secondaryOutcomes measure: Attitudes to Awareness of Hypoglycaemia, secondaryOutcomes measure: Type 1 Diabetes Distress Scale, secondaryOutcomes measure: Diabetes Self-Management Questionnaire, secondaryOutcomes measure: Diabetes Management Experiences Questionnaire, secondaryOutcomes measure: PROMIS Sleep Disturbance - Short Form 8a, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: 12-Item Hypoglycemia Impact Profile, secondaryOutcomes measure: EQ-5D-5L, secondaryOutcomes measure: device-related adverse events, secondaryOutcomes measure: severe hypoglycemic events, self-reported on a CLEAR data collection form, secondaryOutcomes measure: diabetic ketoacidosis (DKA) events, secondaryOutcomes measure: number of participants with hospitalizations, secondaryOutcomes measure: number of participants with emergency room (ER) visits, secondaryOutcomes measure: major adverse cardiovascular events (MACE), secondaryOutcomes measure: all-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Diego, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Jeremy H Pettus, MD, role: CONTACT, phone: 858-246-2160, email: jpettus@ucsd.edu, contacts name: Jeremy H Pettus, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: AdventHealth, city: Orlando, state: Florida, zip: 32804, country: United States, contacts name: Keri Whitaker, role: CONTACT, phone: 407-303-2519, email: keri.whitaker@adventhealth.com, contacts name: Richard E Pratley, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Casu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40508, country: United States, contacts name: Simon Fisher, MD, PhD, role: CONTACT, phone: 859-562-0473, email: simon.fisher@uky.edu, contacts name: Simon Fisher, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Cornelia (Ginger) Dalton-Bakes, role: CONTACT, phone: 215-746-2085, email: corneliv@pennmedicine.upenn.edu, contacts name: Michael R Rickels, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Melbourne, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Katrin Brown, role: CONTACT, phone: 61 3 9231 2574, email: katie.brown@unimelb.edu.au, contacts name: Catriona Sims, role: CONTACT, phone: 61 3 9231 2574, email: catriona.sims@unimelb.edu.au, contacts name: David O'Neal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.79839, lon: 144.97833, locations facility: University of Leicester, city: Leicester, zip: LE5 4PW, country: United Kingdom, contacts name: Andrew Kingsnorth, role: CONTACT, phone: 44 116-258-4874, email: a.kingsnorth@leicester.ac.uk, contacts name: Pratik Choudhary, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.6386, lon: -1.13169, locations facility: University of Sheffield, city: Sheffield, zip: S10 2RX, country: United Kingdom, contacts name: Simon Heller, MD, role: CONTACT, phone: 44 114-215-9009, email: s.heller@sheffield.ac.uk, contacts name: Simon Heller, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False
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protocolSection identificationModule nctId: NCT06325189, orgStudyIdInfo id: Rec-42336, briefTitle: Effects of Aerobic Interval Training on Fatigue Level and Functional Performance in Post Angioplasty Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-20, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to determine the effects of aerobic interval training on levels of tiredness and functional performance in post-angioplasty patients. The main question it aims to answer is:Does aerobic interval training reduce fatigue and improve functional performance compared to medication alone in post-angioplasty patients?Participants will:Be randomly assigned to either the control group (medication) or the experimental group (medication + aerobic interval training) Perform aerobic interval training for 30 minutes, three times a week, for six weeks (experimental group only) Complete pre and post-intervention assessments using the fatigue severity scale, the 6-minute walk test, and the one minute sit to stand test Researchers will compare the two groups to see if aerobic interval training leads to significant improvements in fatigue levels and functional performance., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this parallel-group randomized controlled trial (RCT), post-angioplasty patients will be assigned to either the control group (receiving standard medication) or the experimental group (receiving medication along with aerobic interval training). The study aims to evaluate the impact of aerobic interval training on fatigue levels and functional performance in these patients., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study was single-blinded, as assessors of the study were kept blind to the intervention group to which the participant was allocated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Aerobic Interval Training, outcomesModule primaryOutcomes measure: Fatigue Severity Scale, primaryOutcomes measure: Six Minute Walk Test, primaryOutcomes measure: 1 minute sit to stand:, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gulab Devi Chest Hospital, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06325176, orgStudyIdInfo id: REC/RCR & AHS/23/0569, briefTitle: Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness, and Healing of Episiotomy Wound, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days., conditionsModule conditions: Episiotomy Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Cryotherapy, interventions name: Infrared light therapy, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: The standardized REEDA scale:, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bahawalpur Victoria Hospital(BVH), status: RECRUITING, city: Bahāwalpur, state: Punjab, zip: 63100, country: Pakistan, contacts name: Ghulam Fatima, PhD*, role: CONTACT, phone: 03034073057, email: ghulam.fatima@riphah.edu.pk, geoPoint lat: 29.4, lon: 71.68333, hasResults: False
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protocolSection identificationModule nctId: NCT06325163, orgStudyIdInfo id: MIU-IRB-2223-219, briefTitle: Accuracy of Artificial Intelligence Technology in Detecting Number of Root Canals in Human Mandibular First Molars Obturated and Indicated for Retreatment: Diagnostic Accuracy Experimental Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-25, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2023-10-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Misr International University, class: OTHER, descriptionModule briefSummary: evaluate the accuracy of new AI technology for detecting root canals in mandibular first molars retreatment cases in comparison to dentist clinical access cavity and CBCT imaging., conditionsModule conditions: Missed Canals, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: CBCT, interventions name: clinical examination under dental operating microscope, interventions name: canal detection AI software (diagnocat), outcomesModule primaryOutcomes measure: Number of canals, secondaryOutcomes measure: linear morphological variations in failed cases, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Misr International University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06325150, orgStudyIdInfo id: STUDY00008572, briefTitle: The Impact of Light Exposure on Cognitive Function in Classrooms, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Michigan State University, class: OTHER, descriptionModule briefSummary: Humans are constantly exposed to a variety of light types, created naturally or through artificial means. Light exposure captured by the eyes impacts many physiological functions in humans, including but not limited to cognitive output, fatigue levels, and mood regulation. The level of impact on cognitive learning from different types of light on undergraduate adult students remains unclear., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study will test the effect of light emitting glasses, vs placebo, vs no-glasses to attention in college students. This is a crossover study, where participants will be randomly assigned to one of three groups, and tested in random order. The students will be tested on 2 or 3 different conditions (no glasses, placebo or light emitting glasses). The assignment to each of the groups, and the order of the intervention (+/- glasses) will be randomized.Note-light emitting glasses are not FDA regulated. Because light emitting glasses can change physiology, this is considered a phase 1 clinical trial., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Light emitting glasses, outcomesModule primaryOutcomes measure: Assessment of attention, secondaryOutcomes measure: Determine how time of day impacts attention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Michigan State University, city: East Lansing, state: Michigan, zip: 48824, country: United States, contacts name: Hanne M Hoffmann, PhD, role: CONTACT, phone: 517-353-1415, email: hanne@msu.edu, geoPoint lat: 42.73698, lon: -84.48387, hasResults: False
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protocolSection identificationModule nctId: NCT06325137, orgStudyIdInfo id: RC 24/2022, briefTitle: Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-16, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity., conditionsModule conditions: Nephrotic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Transcriptome analyses, outcomesModule primaryOutcomes measure: Between groups differences in molecular signature by whole transcriptome analysis, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Marco Pennesi, MD, role: CONTACT, phone: +39.040-3785263, email: marco.pennesi@burlo.trieste.it, contacts name: Barbara Bonifacio, role: CONTACT, phone: +39.040.3785.422, email: barbara.bonifacio@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06325124, orgStudyIdInfo id: REC/01805 MARIA NAWAZ, briefTitle: Muscle Energy Technique of Lower Limb Muscles in Forward Head Posture, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled trial is to find the effect of muscle energy technique of muscles involved in lower limb superficial backline (hamstring and Gastro-soleus) on improving craniovertebral angle and cervical proprioception and minimizing pain among patients with forward head posture, conditionsModule conditions: Forward Head Posture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Muscle energy technique, interventions name: Conventional PT, outcomesModule primaryOutcomes measure: Neck disability index (NDI), primaryOutcomes measure: Numeric Pain Rating Scale NPRS, secondaryOutcomes measure: Bubble inclinometer, secondaryOutcomes measure: FHP Mobile Application (To measure Craniovertebral angle), secondaryOutcomes measure: Cervical Joint Position Error, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: We Care Physical Therapy Clinic street 13 phase 4A, Ghouri town Islamabad, status: RECRUITING, city: Islamabad, state: Punjab, country: Pakistan, contacts name: KINZA ANWAR, MS-OMPT, role: CONTACT, phone: +92-3239735427, email: kinza.anwar@riphah.edu.pk, contacts name: MARIA NAWAZ, MS-OMPT*, role: CONTACT, phone: +92-3435625466, contacts name: MARIA NAWAZ, role: SUB_INVESTIGATOR, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False
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protocolSection identificationModule nctId: NCT06325111, orgStudyIdInfo id: RC 06/2023, briefTitle: Determinants of Glycaemic Control in Children With Type 1 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-29, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Type 1 diabetes (T1D) is a common chronic disease of childhood associated with a significantly increased risk of micro- and macro-vascular complications, including neuropathy, nephropathy and cardiovascular diseases. The risk of development T1D comorbidities is associated with glycaemic control, a complex mechanism involving biological, physiological environmental factors.While more than 60 genetic variants were already associated with Glycated hemoglobin (HbA1c) in healthy subjects, very few genes have been identified in T1D individuals. Also, hyperglycaemia could be the cause of epigenetic changes at specific target genes, such as DNA methylation, histone modifications and microRNAs, correlated to accelerated development of diabetes-related complications. Most recently, increasing evidence also suggested that human microbiome may play a crucial role in the onset and progression of T1D and dysbiosis of the gut and oral microbiota was reported as a typical feature of hyperglycaemia.However, potential differences among poorly and good managed T1D subjects have not been still studied. Also, the exact mechanism by long-term hyperglycaemia's acts in T1D remains poorly understood. Therefore, this project will explore an emerging area of research by the study of possible genetic, epigenetic and environmental biomarkers among T1D subjects with different glycaemic control., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Determinants of T1D glycaemic control, outcomesModule primaryOutcomes measure: Identification of genes involved in T1D glycaemic control, primaryOutcomes measure: Identification of DNA methylation patterns involved in T1D glycaemic control, primaryOutcomes measure: Identification of microRNAs involved in T1D glycaemic control, primaryOutcomes measure: Identification of oral microbiome characteristics associated to T1D glycaemic control, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Eulalia Catamo, BSc, role: CONTACT, phone: +39 040.3785470, email: eulalia.catamo@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06325098, orgStudyIdInfo id: PER-NEPH, briefTitle: Implementation of a Diagnostic Workflow for Personalized Diagnosis of Nephrotic Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-26, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Nephrotic syndrome (NS) is a clinical picture common to several diseases resulting from damage to podocytes and glomerular filtration barrier. Currently, there is limited consensus regarding the diagnostic pathway and management of the specific etiology. Some patients show complete response to first-line steroid therapy (steroid-sensitive nephrotic syndrome, SSNS), especially in children and young adults. The prognosis of this group is generally favorable. In contrast, patients unresponsive to steroids (steroid-resistant NS, SRNS) frequently undergo immunosuppressive therapies, which are burdened with numerous side effects. Resistance to treatment is associated with a high likelihood of progression to chronic renal disease (CKD) and kidney failure (ESKD). Recent evidence suggests that immunological mechanisms (including permeabilizing factors) are involved in the pathogenesis of post-transplant NS recurrence and SSNS.Providing patients with NS with a correct diagnosis is the cornerstone of personalized medicine, reducing morbidity and side effects of therapies, ensuring their appropriate prescription, and slowing or preventing progression to ESKD., conditionsModule conditions: Nephrotic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with nephrotic syndrome (SSNS, SRNS), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Anti-nephrin antibodies, interventions name: u-RPC cultures, outcomesModule primaryOutcomes measure: Role of anti-nephrin antibodies in the pathogenesis of NS, secondaryOutcomes measure: Functional role of VUS in the pathogenesis of SRNS, secondaryOutcomes measure: Identification of potential predictive biomarkers of renal outcome., secondaryOutcomes measure: Cost-effectiveness analysis, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Paola Romagnani, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
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protocolSection identificationModule nctId: NCT06325085, orgStudyIdInfo id: Ayesha Saddiqa, briefTitle: Compensatory and Restorative Rehabilitation Techniques in Stroke, acronym: The, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-04-20, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled trial is to find the combined effects of restorative and compensatory cognitive rehabilitation techniques in mild cognitive impairment after stroke., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: compensatory and restorative rehabilitation techniques, interventions name: Traditional cognitive rehabilitation training, outcomesModule primaryOutcomes measure: Montreal cognitive assessment test (Urdu version), primaryOutcomes measure: Cognitive assessment scale for stroke patients (CASP), secondaryOutcomes measure: Stroke specific quality of life questionnaire (Urdu version), secondaryOutcomes measure: Modified Rankin Scale (MRS), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shafi Hospital Dina, status: RECRUITING, city: Dina, state: Punjab, country: Pakistan, contacts name: Dr. Aroosa Tariq, MS:NMPT, role: CONTACT, phone: 03161578156, email: aroosa.tariq@riphah.edu.pk, contacts name: Ayesha Saddiqa, MS:NMPT*, role: CONTACT, phone: 0315-5568417, email: aisha.sadeeqa23@gmail.com, contacts name: Dr. Aroosa Tariq, MS:NMPT, role: PRINCIPAL_INVESTIGATOR, contacts name: Ayesha Saddiqa, MS:NMPT*, role: SUB_INVESTIGATOR, hasResults: False
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protocolSection identificationModule nctId: NCT06325072, orgStudyIdInfo id: NIKE, briefTitle: Set-up of a Platform for Personalized Diagnosis of Rare Kidney Diseases (NIKE), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-07-09, primaryCompletionDateStruct date: 2023-06-27, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Chronic kidney disease (CKD) is a major health problem, with steadily increasing incidence and prevalence and the threat of a true "epidemic". Converging evidence suggests a high prevalence of genetic etiology in rare kidney diseases and the list of new disease-causing genes is constantly updated. Recent advances in next-generation sequencing (NGS) technologies have prompted a significant improvement in the diagnosis of rare kidney diseases. Notwithstanding this, NGS generates high numbers of information that need to be properly analysed by the joint efforts of geneticists, nephrologists and bioinformatics in order to integrate clinical and genetic information in a personalized manner. In addition, in selected cases, the contribution of researchers proves essential for the development of experimental models of the disease to study and understand the pathogenic features and propose a personalized therapeutic approach. Such an innovative, integrated diagnostic paradigm is currently available in few centers all over the world and cannot be easily translated in daily clinical practice.The aim of the study is to set-up an integrated diagnostic algorithm to extend the newest personalized diagnostic and treatment strategies for rare kidney diseases to all patients in the Tuscany region, under 40 years of age with kidney disease. This algorithm will be based on a constant cross-talk between participating centers and a dedicated multidisciplinary team. Diagnostic and therapeutic performances will be validated at European level., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients selected based on the inclusion criteria will be evaluated by a multidisciplinary team of experts. All the selected patients will undergo genetic testing by clinical exome sequencing and in silico filtering for a panel of genes described as causing or in association with CKD. Identified variants will be classified according to the American College of Medical Genetics and Genomics (ACMG) guidelines. Reverse phenotyping will be performed according to the results of genetic testing. The results of the diagnostic work-up will be evaluated by a multi-disciplinary team of experts in order to establish conclusive diagnosis., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Conclusive genetic testing, interventions name: Genotype-phenotype correlation for personalized diagnosis, interventions name: Personalized study of variants of uncertain clinical significance (VUS) through functional studies on 3D organ-on-a-chip, outcomesModule primaryOutcomes measure: Validation of genetic diagnosis, secondaryOutcomes measure: Identification of molecular pathways, secondaryOutcomes measure: Explore the applicability of gene editing in rare kidney diseases, eligibilityModule sex: ALL, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Careggi, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Meyer Children's Hospital IRCCS, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: USL Toscana Centro, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliero Universitaria Pisana, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06325059, orgStudyIdInfo id: BIO-KIDNEY, briefTitle: The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-22, primaryCompletionDateStruct date: 2047-03-22, completionDateStruct date: 2047-11-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression., conditionsModule conditions: Nephropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients affected by nephropathy, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Study of renal progenitors, outcomesModule primaryOutcomes measure: Evaluation of the role of renal progenitors in the progression of glomerular diseases, secondaryOutcomes measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI), secondaryOutcomes measure: Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Firenze, country: Italy, contacts name: Paola Romagnani, role: CONTACT, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
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