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protocolSection identificationModule nctId: NCT06297746, orgStudyIdInfo id: am7mi3VB, briefTitle: Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-10, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: ABSTRACTINTRODUCTIONKnee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.MATERIALS AND METHODSThe study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively., conditionsModule conditions: Total Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Subvastus approach, interventions name: Medial Parapatellar approach, outcomesModule primaryOutcomes measure: Shear wave values, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine, city: Istanbul, state: Fatih, zip: 34098, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06297733, orgStudyIdInfo id: IstanbulBUFC3, briefTitle: Turkish Adaptation, Validity and Reliability of the Approaches and Study Skills Inventory in Physiotherapy Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: The quality and quantity of learning are determined by the learning approach adopted by the student. When learning and studying approaches are mentioned, individual differences between learners' learning intentions during a learning situation or while studying and what types of strategies are used to achieve these intentions come to mind. These learning approaches are thought to determine the quality of learning outcomes. Many measurement tools have been developed to quantitatively measure learning and studying approaches. These developed tools are mostly applied at the higher education level. Among the purposes of using measurement tools; These include identifying low-performing students through screening, evaluating and identifying areas of difficulty that require prediction or improvement plans, evaluating before and after academic improvement programs, and raising awareness and advising students on their academic strengths and weaknesses.When multidimensional measurement tools that evaluate students' study approaches and skills are examined, it is seen that the use of the Approaches and Study Skills Inventory for Students (ASSIST) tool has become widespread in recent years. This vehicle; It has been reported that it measures learning strategies and skills for different students and is sensitive enough to distinguish between learning types.The Portuguese, Norwegian and Danish versions of the survey, which was developed in English and intended to be translated into Turkish as the Study Skills and Approaches Scale, have also been translated, its psychometric properties have been demonstrated and it has been observed that it is becoming widespread in the literature., conditionsModule conditions: Health Education, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Translating the Questionnaire into Turkish and Related Processes, interventions name: Validity, interventions name: Reliability, outcomesModule primaryOutcomes measure: Approaches and Study Skills Inventory for Students, primaryOutcomes measure: Participant Information Form, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Marmara University, status: RECRUITING, city: Istanbul, zip: 34854, country: Turkey, contacts name: Ilksan Demirbuken, Prof, role: CONTACT, phone: 2167775701, phoneExt: +90, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06297720, orgStudyIdInfo id: 2401110013, briefTitle: Early Oral Hydration After Thoracoscopic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.* the degree of improvement in sore throat and dry mouth after oral hydration.* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room., conditionsModule conditions: Anesthesia, conditions: Intubation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Oral hydration, outcomesModule primaryOutcomes measure: sore throat level by VAS (Visual Analogue Scale), primaryOutcomes measure: Mouth dryness, secondaryOutcomes measure: post-operative nausea and vomiting (PONV), secondaryOutcomes measure: timing of post-operative nausea and vomiting (PONV), secondaryOutcomes measure: duration of post-operative nausea and vomiting (PONV), secondaryOutcomes measure: management of post-operative nausea and vomiting (PONV), secondaryOutcomes measure: Heart Rate in PACU (Postanesthesia Care Unit), secondaryOutcomes measure: Blood pressure in PACU (Postanesthesia Care Unit), secondaryOutcomes measure: Patient's satisfaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ChangGung MH, city: Taoyuan, zip: 33380, country: Taiwan, contacts name: JUN-YU CHEN, role: CONTACT, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
protocolSection identificationModule nctId: NCT06297707, orgStudyIdInfo id: P.T.REC/012/005044, briefTitle: Effect of Aquatic High Intensity Resistive Training on Patients With Chronic Heart Failure, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: PURPOSE:to evaluate effect of aquatic high intensity resistive training on cardiac function and exercise capacity in patients with chronic heart failure.BACKGROUND:Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of \>37.7 million individuals globally. HF is a shared chronic phase of cardiac functional impairment secondary to many etiologies, and patients with HF experience numerous symptoms that affect their quality of life, including dyspnea, fatigue, poor exercise tolerance, and fluid retention., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: aquatic high intensity resistive training, interventions name: usual care, outcomesModule primaryOutcomes measure: Cardiac function, secondaryOutcomes measure: exercise capacity, secondaryOutcomes measure: physical symptoms of heart failure, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Cairo, state: Dokki, zip: 11432, country: Egypt, contacts name: marwa M elsayed, phd, role: CONTACT, phone: 01156033818, phoneExt: 02, email: [email protected], contacts name: marwa M elsayed, ph.d, role: CONTACT, phone: 01156033818, phoneExt: 02, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06297694, orgStudyIdInfo id: PamukkaleU., briefTitle: Clinical Interpretation and Cutoff Scores for ABILHAND Questionnaire in Rheumatoid Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: In individuals with rheumatoid arthritis, the most significant symptom is the loss of manual ability and function in the hands. In rheumatoid arthritis, where patient-reported assessment scales are frequently used, hand skills should be evaluated with an ideal questionnaire that best represents hand activities. The ABILHAND-RA questionnaire possesses all these features, being a short and easily fillable survey. The aim is to determine of clinically significant cutoff scores for perceived manual ability evaluated by ABILHAND corresponding to observed and perceived upper extremity assessments in individuals with rheumatoid arthritis., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 156, type: ESTIMATED, outcomesModule primaryOutcomes measure: Disease Activity Score (DAS 28), primaryOutcomes measure: Nine hole peg test, primaryOutcomes measure: Hand grip strength, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06297681, orgStudyIdInfo id: 2023-1-27-2, briefTitle: Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Beijing Chao Yang Hospital, class: OTHER, collaborators name: Beijing Chuiyangliu Hospital, collaborators name: Beijing Boren Hospital, descriptionModule briefSummary: It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min)., conditionsModule conditions: M-protein Related Cardiac Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: 2-year PFS rate, progression free survival (PFS), secondaryOutcomes measure: 2-year OS rate, overall survival (OS), secondaryOutcomes measure: Duration of Relief (DOR), secondaryOutcomes measure: Next treatment time (TTNT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06297668, orgStudyIdInfo id: D5985C00008, briefTitle: A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2024-06-13, completionDateStruct date: 2024-06-13, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Treatment A: BGF MDI HFA, interventions name: Treatment B: BGF MDI HFO, interventions name: Treatment C: BGF MDI HFO, interventions name: AeroChamber Plus Flow-Vu spacer, outcomesModule primaryOutcomes measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI, primaryOutcomes measure: Maximum Observed Concentration (Cmax) of BGF MDI, secondaryOutcomes measure: Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Time to Reach Maximum Observed Concentration (tmax), secondaryOutcomes measure: Terminal Rate Constant (λz), secondaryOutcomes measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz), secondaryOutcomes measure: Mean Residence Time of the Unchanged Drug in the Systemic Circulation from Zero to Infinity (MRTinf), secondaryOutcomes measure: Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Number of Participants with Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, city: Berlin, zip: 14050, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, city: Harrow, zip: HA1 3UJ, country: United Kingdom, geoPoint lat: 51.57142, lon: -0.33371, hasResults: False
protocolSection identificationModule nctId: NCT06297655, orgStudyIdInfo id: TQG202-III-01, briefTitle: A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated., conditionsModule conditions: Hemophilia A, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant human activated coagulation factor VIII for injection, outcomesModule primaryOutcomes measure: The proportion of on-demand treatment improvement for newly occurring bleeding events, primaryOutcomes measure: Activity recovery, secondaryOutcomes measure: The proportion of effective surgical hemostasis, secondaryOutcomes measure: Annualized bleeding rate (ABR), secondaryOutcomes measure: The incidence of Less Han Expected Thermal Effect, secondaryOutcomes measure: The injection times of recombinant human coagulation factor VIII, secondaryOutcomes measure: The dosage of recombinant human coagulation factor VIII, secondaryOutcomes measure: Changes of Haemophilia Joint Health Score before and after on-demand treatment, secondaryOutcomes measure: Changes of Quality of Life Assessment before and after on-demand treatment, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230002, country: China, contacts name: Juan Tong, Doctor, role: CONTACT, phone: 13955114442, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Affiliated Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Shu Chen, Master, role: CONTACT, phone: 13983420188, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, locations facility: The First Hospital of Lanzhou University, city: Lanzhou, state: Gansu, zip: 730013, country: China, contacts name: Yaming Xi, Doctor, role: CONTACT, phone: 13919110815, email: [email protected], geoPoint lat: 36.05701, lon: 103.83987, locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jing Sun, Doctor, role: CONTACT, phone: 13316202696, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Peng Cheng, Master, role: CONTACT, phone: 13977166448, email: [email protected], geoPoint lat: 22.81667, lon: 108.31667, locations facility: Henan Tumor Hospital, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: Hu Zhou, Doctor, role: CONTACT, phone: 13939068863, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Jie Peng, Doctor, role: CONTACT, phone: 13974802938, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Nanjing Drug Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Rongfu Zhou, Doctor, role: CONTACT, phone: 13605142342, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: Jiangxi Provincial People's Hospital, city: Nanchang, state: Jiangxi, zip: 330006, country: China, contacts name: Chenghao Jin, Doctor, role: CONTACT, phone: 13699500207, email: [email protected], geoPoint lat: 28.68396, lon: 115.85306, locations facility: Hematology Hospital of Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lei Zhang, Doctor, role: CONTACT, phone: 13502118379, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Second Affiliated Hospital of Kunming Medical University, city: Kunming, state: Yunnan, zip: 650106, country: China, contacts name: Zeping Zhou, Doctor, role: CONTACT, phone: 18788571605, email: [email protected], geoPoint lat: 25.03889, lon: 102.71833, hasResults: False
protocolSection identificationModule nctId: NCT06297642, orgStudyIdInfo id: TQB2928-AK105-Ib-01, briefTitle: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors., conditionsModule conditions: Advanced Malignant Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: TQB2928 injection, interventions name: Penpulimab, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Adverse event rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of Anti-Drug antibody, secondaryOutcomes measure: Incidence of neutralizing antibodies, secondaryOutcomes measure: Peak time (Tmax), secondaryOutcomes measure: Peak concentration (Cmax), secondaryOutcomes measure: The area under the plasma concentration time curve from zero to after 24h (AUC0-24h), secondaryOutcomes measure: Steady-state apparent volume of distribution (Vz/F), secondaryOutcomes measure: Minimum plasma concentration at steady state (Cmin,ss), secondaryOutcomes measure: Receptor Occupancy (RO%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Science, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Ning Li, Doctor, role: CONTACT, phone: 15601395554, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Gansu Provincial Cancer Hospital, city: Lanzhou, state: Gansu, zip: 730000, country: China, contacts name: Junfeng Jiang, Master, role: CONTACT, phone: 13893332604, email: [email protected], contacts name: Yuhua Liu, Bachelor, role: CONTACT, phone: 15682892029, email: [email protected], geoPoint lat: 36.05701, lon: 103.83987, locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qingqing Cai, Doctor, role: CONTACT, phone: 18376665396, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06297629, orgStudyIdInfo id: 2021-0636, secondaryIdInfos id: NCI-2024-01689, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Astex Pharmaceuticals, Inc., descriptionModule briefSummary: To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant., conditionsModule conditions: Allogeneic Stem Cell Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: ASTX727, interventions name: Donor Lymphocyte Infusion, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Betul Oran, MD, role: CONTACT, phone: 713-745-2820, email: [email protected], contacts name: Betul Oran, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06297616, orgStudyIdInfo id: 18814, secondaryIdInfos id: J3R-JE-YDAB, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of LY3841136 in Japanese Participants With Obesity or Overweight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-12, completionDateStruct date: 2025-10-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits., conditionsModule conditions: Obesity, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: LY3841136, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration, secondaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136, secondaryOutcomes measure: PK: Maximum Observed Concentration (Cmax) of LY3841136, secondaryOutcomes measure: Pharmacodynamics (PD): Change From Baseline in Body Weight, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sumida Hospital, status: RECRUITING, city: Sumida-ku, state: Tokyo, zip: 130-0004, country: Japan, contacts role: CONTACT, phone: 81356087276, contacts name: Takuma Yonemura, role: PRINCIPAL_INVESTIGATOR, locations facility: Hakata Clinic, status: RECRUITING, city: Fukuoka, zip: 812-0025, country: Japan, contacts role: CONTACT, phone: 81922837701, contacts name: Takashi Eto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, hasResults: False
protocolSection identificationModule nctId: NCT06297603, orgStudyIdInfo id: 18806, secondaryIdInfos id: J1I-MC-GZQA, type: OTHER, domain: Eli Lilly and Company, briefTitle: Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-09-11, completionDateStruct date: 2026-10-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Percentage of Participants Achieving HbA1c <7.0%, secondaryOutcomes measure: Percentage of Participants Achieving HbA1c ≤6.5%, secondaryOutcomes measure: Change from Baseline in Fasting Serum Glucose, secondaryOutcomes measure: Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Change from Baseline in Body Weight, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥5%, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥10%, secondaryOutcomes measure: Percentage of Participants Achieving Weight Reduction of ≥15%, secondaryOutcomes measure: Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction, secondaryOutcomes measure: Percent Change from Baseline in Non-HDL Cholesterol, secondaryOutcomes measure: Percent Change from Baseline in Triglycerides, secondaryOutcomes measure: Change from Baseline in Systolic Blood Pressure (SBP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Institute of Arizona (CRI) - Sun City West, status: RECRUITING, city: Sun City West, state: Arizona, zip: 85375, country: United States, contacts name: Jalal Abbas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.66198, lon: -112.34127, locations facility: Diabetes and Endocrine Associates, status: NOT_YET_RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, contacts name: Robert Lipetz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.76783, lon: -117.02308, locations facility: UCLA South Bay Endocrinology, status: RECRUITING, city: Torrance, state: California, zip: 90505, country: United States, contacts name: Dianne Cheung, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.83585, lon: -118.34063, locations facility: Northeast Research Institute (NERI), status: NOT_YET_RECRUITING, city: Fleming Island, state: Florida, zip: 32003, country: United States, contacts name: Senan Sultan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.0933, lon: -81.71898, locations facility: Care Research, status: NOT_YET_RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Hira Siktel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Cotton O'Neil Clinical Research Center, status: RECRUITING, city: Topeka, state: Kansas, zip: 66606, country: United States, contacts name: Alan Wynne, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04833, lon: -95.67804, locations facility: Billings Clinic, status: NOT_YET_RECRUITING, city: Billings, state: Montana, zip: 59101, country: United States, contacts name: Lauren Kleess, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.78329, lon: -108.50069, locations facility: Sierra Nevada Specialty Care, status: NOT_YET_RECRUITING, city: Reno, state: Nevada, zip: 89511, country: United States, contacts name: David Howard, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.52963, lon: -119.8138, locations facility: Albany Medical College, Division of Community Endocrinology, status: NOT_YET_RECRUITING, city: Albany, state: New York, zip: 12203, country: United States, contacts name: Robert Busch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.65258, lon: -73.75623, locations facility: Research Foundation of SUNY - University of Buffalo, status: NOT_YET_RECRUITING, city: Buffalo, state: New York, zip: 14221, country: United States, contacts name: Ajay Chaudhuri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, locations facility: NYC Research INC, status: RECRUITING, city: Long Island City, state: New York, zip: 11106, country: United States, contacts name: Anastasios Manessis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.74482, lon: -73.94875, locations facility: University of North Carolina Medical Center, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Klara Klein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Lucas Research, Inc., status: NOT_YET_RECRUITING, city: Hickory, state: North Carolina, zip: 28601, country: United States, contacts name: Anthony Barber, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.73319, lon: -81.3412, locations facility: Cleveland Clinic, status: NOT_YET_RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Willy Marcos Valencia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Central States Research, status: RECRUITING, city: Tulsa, state: Oklahoma, zip: 74136, country: United States, contacts name: Sarah Land, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.15398, lon: -95.99277, locations facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15243, country: United States, contacts name: Daniel Austin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: AM Diabetes & Endocrinology Center, status: NOT_YET_RECRUITING, city: Bartlett, state: Tennessee, zip: 38133, country: United States, contacts name: Kashif Latif, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.20453, lon: -89.87398, locations facility: Dallas Diabetes Research Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Dan Lender, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Juno Research, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77040, country: United States, contacts name: Damaris Vega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Endocrine Ips, Pllc, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, contacts name: Prashant Koshy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Endocrinology Associates, status: NOT_YET_RECRUITING, city: Mesquite, state: Texas, zip: 75149, country: United States, contacts name: Sumana Gangi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.7668, lon: -96.59916, locations facility: Diabetes & Endocrine Treatment Specialists, status: NOT_YET_RECRUITING, city: Sandy, state: Utah, zip: 84093, country: United States, contacts name: Timothy Graham, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.59161, lon: -111.8841, locations facility: CEDIC, status: NOT_YET_RECRUITING, city: Caba, state: Buenos Aires, zip: C1060ABN, country: Argentina, contacts name: Elizabeth Gelersztein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro de Investigaciones Metabólicas (CINME), status: NOT_YET_RECRUITING, city: Ciudad Autónoma de Buenos Aires, state: Buenos Aires, zip: 1056, country: Argentina, contacts name: Federico Perez Manghi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CIMeL Clinical Research, status: NOT_YET_RECRUITING, city: Lanus, state: Buenos Aires, zip: B1824KAJ, country: Argentina, contacts name: Mariano Chahin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.70252, lon: -58.3955, locations facility: Centro de Investigaciones Médicas Mar del Plata, status: NOT_YET_RECRUITING, city: Mar del Plata, state: Buenos Aires, zip: 7600, country: Argentina, contacts name: Andres Alvarisqueta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -38.00228, lon: -57.55754, locations facility: DIM Clínica Privada, status: NOT_YET_RECRUITING, city: Ramos Mejía, state: Buenos Aires, zip: B1704ETD, country: Argentina, contacts name: Alejandra Camino, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.6551, lon: -58.55318, locations facility: Investigaciones Medicas Imoba Srl, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1056ABH, country: Argentina, contacts name: Silvia Orio, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Viamonte, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1120AAC, country: Argentina, contacts name: Diego Aizenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto de Investigaciones Clinicas Zarate, status: NOT_YET_RECRUITING, city: Rosario, state: Santa Fe, zip: 2000, country: Argentina, contacts name: Marisa Vico, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Instituto de Investigaciones Clinicas Rosario, status: NOT_YET_RECRUITING, city: Rosario, state: Santa Fe, zip: S2000CVD, country: Argentina, contacts name: Maximiliano Sicer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Centro Médico Colón, status: NOT_YET_RECRUITING, city: Córdoba, zip: 5003, country: Argentina, contacts name: Maria Parody, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Centro de Endocrinologia Alcantara Gonzalez, status: NOT_YET_RECRUITING, city: Bayamon, zip: 00959, country: Puerto Rico, contacts name: Altagracia Alcantara -Gonzalez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.39856, lon: -66.15572, locations facility: Private Practice - Dr. Paola Mansilla-Letelier, status: NOT_YET_RECRUITING, city: Guaynabo, zip: 00970, country: Puerto Rico, contacts name: Paola Mansilla-Letelier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.35745, lon: -66.111, locations facility: Endocrinologist Metabolic Clinic & Research Institute, status: NOT_YET_RECRUITING, city: San Juan, zip: 00921, country: Puerto Rico, contacts name: Martha Gomez-Cuellar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.46633, lon: -66.10572, locations facility: Panthera Biopartners - Preston, status: NOT_YET_RECRUITING, city: Preston, state: England, zip: PR2 9QB, country: United Kingdom, contacts name: Reem Handforth, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.76282, lon: -2.70452, locations facility: Lister Hospital, status: NOT_YET_RECRUITING, city: Stevenage, state: Hertfordshire, zip: SG1 4AB, country: United Kingdom, contacts name: Adie Viljoen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.90224, lon: -0.20256, locations facility: Panthera Biopartners - Manchester, status: NOT_YET_RECRUITING, city: Rochdale, state: Manchester, zip: OL11 4AU, country: United Kingdom, contacts name: Krishnakumar Radhakrishnan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.61766, lon: -2.1552, locations facility: Panthera Biopartners - Glasgow, status: NOT_YET_RECRUITING, city: Glasgow, state: Scotland, zip: G51 4LB, country: United Kingdom, contacts name: Raghavendra Madimchetty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False
protocolSection identificationModule nctId: NCT06297590, orgStudyIdInfo id: 18795, secondaryIdInfos id: J4T-MC-OLAA, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2024-510604-37-00, type: OTHER, domain: EU Trial Number, secondaryIdInfos id: U1111-1302-6222, type: OTHER, domain: Universal Trial Number, briefTitle: A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for Part B. If conducted, the optional bridging period for Part A participants would last up to approximately 1 year after their completion of Part A.If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 120 weeks., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: LY3954068, interventions name: Placebo, interventions name: Flortaucipir F18, outcomesModule primaryOutcomes measure: Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, primaryOutcomes measure: Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration, secondaryOutcomes measure: Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax), secondaryOutcomes measure: Optional Part B: PK: Cmax, secondaryOutcomes measure: Part A: PK: Area Under the Concentration Versus Time Curve (AUC), secondaryOutcomes measure: Optional Part B: PK: AUC, secondaryOutcomes measure: Part A: PK: Cerebrospinal Fluid (CSF) concentration of LY3954068, secondaryOutcomes measure: Optional Part B: PK: CSF concentration of LY3954068, secondaryOutcomes measure: Part A: Pharmacodynamics (PD): Change from Baseline of CSF tau, secondaryOutcomes measure: Optional Part B: PD: Change from Baseline of CSF tau, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: K2 Medical Research LLC, city: Maitland, state: Florida, zip: 32751, country: United States, contacts role: CONTACT, phone: 407-500-5252, contacts name: Brandon Lenox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Charter Research, LLC, city: The Villages, state: Florida, zip: 32162, country: United States, contacts role: CONTACT, phone: 352-775-1000, contacts name: Jeffrey Norton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.93408, lon: -81.95994, locations facility: Indiana University School of Medicine - Clinical Research Center, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts role: CONTACT, phone: 317-963-7505, contacts name: Jared Brosch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Massachusetts General Hospital (MGH), city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts role: CONTACT, phone: 617-643-5607, contacts name: Steven Arnold, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, locations facility: CenExel AMRI, city: Toms River, state: New Jersey, zip: 08755, country: United States, contacts role: CONTACT, phone: 732-341-9500, contacts name: Sanjiv Sharma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95373, lon: -74.19792, locations facility: Duke University, city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Shruti Raja, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts role: CONTACT, phone: 414-955-0650, contacts name: Malgorzata Franczak, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.0389, lon: -87.90647, locations facility: The University of Tokyo Hospital, city: Bunkyo-ku, state: Tokyo, zip: 113-8655, country: Japan, contacts role: CONTACT, phone: +81-33-815-5411, contacts name: Takeshi Iwatsubo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.37517, lon: 139.92991, locations facility: National Hospital for Neurology and Neurosurgery (UCLH), city: London, zip: WC1N 3BG, country: United Kingdom, contacts role: CONTACT, phone: 0203 448 3011, contacts name: Catherine Mummery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Hallamshire Hospital, city: Sheffield, zip: S10 2JF, country: United Kingdom, contacts name: Daniel Blackburn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, locations facility: University Hospital Southampton, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: Christopher Kipps, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.90395, lon: -1.40428, hasResults: False
protocolSection identificationModule nctId: NCT06297577, orgStudyIdInfo id: MASH2024, briefTitle: Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST., conditionsModule conditions: Intrabony Periodontal Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the type of intervention, only the outcome assessor and the statistician will be blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST), interventions name: Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST), outcomesModule primaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Probing Depth (PD), secondaryOutcomes measure: Radiographic Linear Defect Depth (RLDD), secondaryOutcomes measure: Recession Depth (RD), secondaryOutcomes measure: Post-operative Pain, secondaryOutcomes measure: Radiographic defect fill (RDF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297564, orgStudyIdInfo id: 07/3/9-2023/4, briefTitle: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: New Valley University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments., conditionsModule conditions: Progesterone Primed Endometrial Protocol, conditions: Gonadotropin Releasing Hormone Antagonist Protocol, conditions: Assisted Reproductive Treatments, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Progesterone primed endometrial protocol, interventions name: Gonadotropin-releasing hormone antagonist protocol, outcomesModule primaryOutcomes measure: The number of retrieved oocytes, secondaryOutcomes measure: Pregnancy rate, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: New Valley University, city: New Valley, zip: 72511, country: Egypt, hasResults: False
protocolSection identificationModule nctId: NCT06297551, orgStudyIdInfo id: SBU-AML-LSC, secondaryIdInfos id: IRB2023-00528, type: OTHER, domain: Stony Brook University, briefTitle: Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Suhu Liu, class: OTHER, descriptionModule briefSummary: Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved. Biomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming. The research we are proposing here is to investigate whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. Our retrospective study have found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment. This pilot study will allow us to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Quantification of blood cells positive for CLL1 and CD45RA surface markers by flow cytometry, outcomesModule primaryOutcomes measure: Concordance between the relative fraction of Leukemia Stem Cells (LSC) vs Hematopoietic Stem Cells (HSC) and treatment response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stony Brook Cancer Center, status: RECRUITING, city: Stony Brook, state: New York, zip: 11794, country: United States, contacts name: Caterina Vacchi-Suzzi, PhD, role: CONTACT, phone: 631-728-7425, email: [email protected], contacts name: Suhu Liu, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False
protocolSection identificationModule nctId: NCT06297538, orgStudyIdInfo id: GR-2021-12372323, briefTitle: Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-29, primaryCompletionDateStruct date: 2024-10-29, completionDateStruct date: 2026-04-29, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Neuromed IRCCS, class: OTHER, collaborators name: Fondazione Policlinico Universitario Campus Bio-Medico, collaborators name: I.R.C.C.S. Fondazione Santa Lucia, descriptionModule briefSummary: Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques., conditionsModule conditions: Parkinson Disease, 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: 84, type: ESTIMATED, armsInterventionsModule interventions name: gamma transcranial alternating current stimulation (tACS), interventions name: sham transcranial alternating current stimulation (tACS), outcomesModule primaryOutcomes measure: Changes in bradykinesia features as objectively assessed by kinematic techniques, primaryOutcomes measure: Changes in motor learning performance as objectively assessed by kinematic techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Neuromed, status: RECRUITING, city: Pozzilli, country: Italy, contacts name: Giulia Paparella, role: CONTACT, phone: 3384780752, geoPoint lat: 41.51142, lon: 14.06252, hasResults: False
protocolSection identificationModule nctId: NCT06297525, orgStudyIdInfo id: STP938-201, briefTitle: Study of STP938 in Advanced Solid Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Step Pharma, SAS, class: INDUSTRY, descriptionModule briefSummary: The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: STP938, outcomesModule primaryOutcomes measure: Safety and Tolerability, secondaryOutcomes measure: Area under the curve (AUC) of STP938, secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to reach maximum concentration (TMax), secondaryOutcomes measure: Evaluation of preliminary clinical activity of STP938, secondaryOutcomes measure: Evaluation of best overall response of STP938, secondaryOutcomes measure: Evaluation of Duration of Response, secondaryOutcomes measure: Evaluation of Progression Free Survival, secondaryOutcomes measure: Change in serum CA125 (ovarian cancer only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297512, orgStudyIdInfo id: pGBM-WBRT/DOX2020, briefTitle: Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM)., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-09, primaryCompletionDateStruct date: 2027-11-09, completionDateStruct date: 2028-03-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Iacopo Sardi, class: OTHER, descriptionModule briefSummary: Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB, conditionsModule conditions: Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, Temozolomide, Doxorubicin, outcomesModule primaryOutcomes measure: Evaluation prolonged Dox, primaryOutcomes measure: Percentage of Withdrawal from the study rate, primaryOutcomes measure: Percentage of SAEs, primaryOutcomes measure: Mortality rate, primaryOutcomes measure: Early discontinuation of dox treatment rate, secondaryOutcomes measure: Event-free survival (EFS), disease progression (PFS), and overall survival (OS), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Iacopo Sardi, role: CONTACT, email: [email protected], geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
protocolSection identificationModule nctId: NCT06297499, orgStudyIdInfo id: IRB-22-07-4803, briefTitle: Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, descriptionModule briefSummary: Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration., conditionsModule conditions: Pruritus Caused by Drug, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized double-blinded trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Ondansetron 8mg, outcomesModule primaryOutcomes measure: Pruritus parameters in Post anesthesia Care Unit (PACU), primaryOutcomes measure: Pruritus severity in Post anesthesia Care Unit (PACU), primaryOutcomes measure: Pruritus parameters PACU, primaryOutcomes measure: Pruritus severity PACU, primaryOutcomes measure: Rescue Pruritus Treatment medication, primaryOutcomes measure: Nausea PACU, primaryOutcomes measure: Nausea Post PACU, secondaryOutcomes measure: Post-operative Pain, otherOutcomes measure: Peripheral oxygen saturation- Mother, otherOutcomes measure: Peripheral oxygen saturation- Infant, otherOutcomes measure: Heart rate- Mother, otherOutcomes measure: Heart rate- Infant, otherOutcomes measure: Blood pressure Mother, otherOutcomes measure: Blood pressure- Infant, otherOutcomes measure: Electrocardiogram (ECG ) Mother, otherOutcomes measure: ECG Infant, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Detroit Medical Center- Hutzel Women's Hospital, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: George M McKelvey, PhD, role: CONTACT, phone: 313-598-6036, email: [email protected], contacts name: Justin Hruska, MD, role: CONTACT, phone: 402-432-0985, email: [email protected], geoPoint lat: 42.33143, lon: -83.04575, hasResults: False
protocolSection identificationModule nctId: NCT06297486, orgStudyIdInfo id: SPK-8011-302, secondaryIdInfos id: 2023-504537-46, type: EUDRACT_NUMBER, briefTitle: Study of a Gene Therapy Treatment for Hemophilia A, acronym: KEYSTONE 1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2035-09-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Spark Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy of SPK-8011 in preventing bleed episodes compared with FVIII prophylaxis in participants with hemophilia A without FVIII inhibitors on routine FVIII prophylaxis., conditionsModule conditions: Hemophilia A, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned into one of three cohorts, each receiving the same study treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: SPK-8011, outcomesModule primaryOutcomes measure: Annualized Bleed Rate (ABR) for All Bleeds [Cohort A], secondaryOutcomes measure: Median FVIII: C levels [Cohort A], secondaryOutcomes measure: ABR for treated bleeds [Cohort A], secondaryOutcomes measure: Percentage of Participants with ABR=0 for all bleeds; treated bleeds; treated spontaneous bleeds; and treated joint and target joint bleeds [Cohort A], secondaryOutcomes measure: ABR for treated spontaneous, joint, and target joint bleeds [Cohort A], secondaryOutcomes measure: Annualized FVIII dosage [Cohort A], secondaryOutcomes measure: Proportion of Resolved Target Joints [Cohort A], secondaryOutcomes measure: Mean Change of Total Hemophilia Joint Health Score [Cohort A], secondaryOutcomes measure: FVIII:C levels over time [Cohort A], secondaryOutcomes measure: Mean ABR for all bleeds and treated bleeds [Cohort C], secondaryOutcomes measure: FVIII: C levels over time from Week 26 [Cohort C], secondaryOutcomes measure: Proportion of Participants Who Receive IV Methylprednisolone (IVMP) Prior to Week 8 (Early IVMP) [Cohorts A, B, C], secondaryOutcomes measure: Proportion of Participants Who Receive Secondary Oral Immunomodulation [Cohorts A, B, C], secondaryOutcomes measure: Median Time to First Immunomodulation-related Corticosteroid Dose [Cohorts A, B, C], secondaryOutcomes measure: Median Duration of Secondary Oral Immunomodulation [Cohorts A, B, C], secondaryOutcomes measure: Proportion of Participants with FVIII Inhibitor Development [Cohorts A, B, C], secondaryOutcomes measure: Proportion of participants with Treatment-related AEs of ALT Elevation [Cohorts A, B, C], secondaryOutcomes measure: Proportion of participants with treatment-related AEs of Infusion Reaction [Cohorts A, B, C], secondaryOutcomes measure: Number of participants with abnormal physical exam findings, abnormal vital signs, and abnormal selected clinical laboratory test results [Cohorts A, B, C], secondaryOutcomes measure: Proportion of participants with AEs and SAEs [Cohorts A, B, C], secondaryOutcomes measure: Proportion of participants with AESIs [Cohorts A, B, C], eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90007, country: United States, contacts name: Doris Quon, MD, PhD, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Kaiser Permanente-Oakland Medical Center, status: RECRUITING, city: Oakland, state: California, zip: 94611, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 37.80437, lon: -122.2708, locations facility: Kaiser Permanente-Roseville Medical Center, status: RECRUITING, city: Roseville, state: California, zip: 95661, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 38.75212, lon: -121.28801, locations facility: Kaiser Permanente -Sacramento Medical Center, status: RECRUITING, city: Sacramento, state: California, zip: 95814, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Kaiser Permanente -San Francisco Medical Center, status: RECRUITING, city: San Francisco, state: California, zip: 94115, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of California - San Francisco, status: RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Andrew Leavitt, MD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Kaiser Permanente- Santa Clara Medical Center, status: RECRUITING, city: Santa Clara, state: California, zip: 94115, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 37.35411, lon: -121.95524, locations facility: Kaiser Permanente-Vallejo Medical Center, status: RECRUITING, city: Vallejo, state: California, zip: 94589, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 38.10409, lon: -122.25664, locations facility: Kaiser Permanente -Walnut Creek Medical Center, status: RECRUITING, city: Walnut Creek, state: California, zip: 94596, country: United States, contacts name: Tatjana Kolevska, MD, role: CONTACT, geoPoint lat: 37.90631, lon: -122.06496, hasResults: False
protocolSection identificationModule nctId: NCT06297473, orgStudyIdInfo id: SJ-1050, briefTitle: Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors., acronym: PITCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Zealand University Hospital, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas)., conditionsModule conditions: Non-Functional Pituitary Adenoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized to either intervention or control, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Adverse events (primary outcome) will be established by a blinded adjudication committee.A committé of external endocrinologist/ophthalmologist will blinded to participant ID/allocation assess all the participants admissions to hospital and assess wether it qualifies as an event, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 812, type: ESTIMATED, armsInterventionsModule interventions name: Telephone-/video follow-up, interventions name: In-person follow-up, outcomesModule primaryOutcomes measure: Composite outcome of adverse events, secondaryOutcomes measure: Thyroid replacement therapy, secondaryOutcomes measure: Growth hormone replacement therapy, secondaryOutcomes measure: Desmopressin replacement therapy, secondaryOutcomes measure: Hormonal replacement therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297460, orgStudyIdInfo id: STEPPSPENITENTIARY, briefTitle: Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Universitat Jaume I, class: OTHER, collaborators name: Centre d'Estudis i Formació Especialtzada Generalitat de Catalunya, descriptionModule briefSummary: The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study., conditionsModule conditions: Self Harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Systems Training for Emotional Predictability & Problem Solving (STEPPS), outcomesModule primaryOutcomes measure: Level of emotional and behavioral disregulation of patients, secondaryOutcomes measure: Type and levels of impulsivity of patients, secondaryOutcomes measure: Suicide risk of patients, secondaryOutcomes measure: Self-injury frequency, typology and funcionality of patients, secondaryOutcomes measure: Degree of hopeless of patients, secondaryOutcomes measure: Perceived level of feasibility by professionals, secondaryOutcomes measure: Perceived level of acceptability of the intervention by professionals, secondaryOutcomes measure: Satisfaction of the intervention by patients, secondaryOutcomes measure: Perceived level of adequacy by professionals, secondaryOutcomes measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information, secondaryOutcomes measure: Level of burnout of professionals, otherOutcomes measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rosa, city: Castellón De La Plana, state: Castellón, zip: 12071, country: Spain, geoPoint lat: 39.98567, lon: -0.04935, hasResults: False
protocolSection identificationModule nctId: NCT06297447, orgStudyIdInfo id: N-20230073, briefTitle: Keeping it Simple Study (KISS), acronym: KISS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Bettina Eiger, class: OTHER, collaborators name: University of Southern Denmark, collaborators name: Aalborg University, collaborators name: Central Denmark Region, collaborators name: Vrije Universiteit Brussel, descriptionModule briefSummary: Problem: The number of patients living with chronic musculoskeletal (MSK) pain has steadily increased over the past decade with costs rising equally. Long-standing pain is associated with significant maladaptive beliefs about pain, psychological characteristics and associated behaviors which involve structural and functional neurobiological characteristics which share common pathophysiological mechanisms as chronic pain. The investigators recent priority setting partnership investigated the research priorities from 1000 patients with chronic MSK pain, relatives, and clinicians. Better pain education was rated as one of the three most important research areas.Solution: Pain science education has the potential to target maladaptive psychological and behavioral components that may contribute to the maintenance of chronic pain. The KISS project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this is successful in disrupting maladaptive cycles contributing to chronicity, this may improve outcomes for many thousand citizens., conditionsModule conditions: Musculoskeletal Pain, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter randomized controlled, superiority trial with a 2-group parallel design., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Randomization will be stratified by cite. Block randomization in random concealed block sizes of 4 to 6 (1:1) into two parallel groups is used to avoid imbalance in the randomization between intervention groups. A person not otherwise affiliated with the study will generate the randomization sequence.The randomization will be coded (Group 1 or 2), thus the primary investigator (BE) will not know the code to the groups., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: PNE4Adults - pain science education, interventions name: Usual care, outcomesModule primaryOutcomes measure: Musculoskeletal Health Questionnaire (MSK-HQ), secondaryOutcomes measure: Mean Pain intensity, secondaryOutcomes measure: Pain interference, secondaryOutcomes measure: Concept of pain, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Fear of movement, secondaryOutcomes measure: Patient specific functional limitation, secondaryOutcomes measure: Patient impression of change, secondaryOutcomes measure: Patient satisfaction with current symptom state, secondaryOutcomes measure: Pain Self-efficacy, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Træningsenheden, Holbæk Municipality, status: RECRUITING, city: Holbæk, state: Region Sjælland, zip: 4300, country: Denmark, contacts name: Helle B. Hansen, PT, role: CONTACT, phone: 72363252, email: [email protected], geoPoint lat: 55.71354, lon: 11.7169, locations facility: Træningsenheden, Køge Municipality, status: RECRUITING, city: Køge, state: Region Sjælland, zip: 4600, country: Denmark, contacts name: Annette B. Schlaikjer, PT, role: CONTACT, phone: +45 51 36 33 78, email: [email protected], geoPoint lat: 55.45802, lon: 12.18214, locations facility: Genoptræningscenteret, Solrød Municipality, status: RECRUITING, city: Solrød Strand, state: Region Sjælland, zip: 2680, country: Denmark, contacts name: Linda M. Blæsbjerg, PT, role: CONTACT, phone: +4556182405, email: [email protected], geoPoint lat: 55.53285, lon: 12.22227, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-06, uploadDate: 2024-03-06T10:23, filename: Prot_000.pdf, size: 413728, hasResults: False
protocolSection identificationModule nctId: NCT06297434, orgStudyIdInfo id: JH-221-201, briefTitle: Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: J2H Biotech, class: INDUSTRY, descriptionModule briefSummary: The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH., conditionsModule conditions: Non-alcoholic Steatohepatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: J2H-1702, interventions name: J2H-1702, interventions name: J2H-1702, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes from baseline in results on MRI-PDFF at week12., primaryOutcomes measure: Changes from baseline in results on MRE at week12., eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: J2H Biotech, status: RECRUITING, city: Suwon, state: Gyeonggi-do, zip: 16684, country: Korea, Republic of, contacts name: Eunji Byeon, role: CONTACT, geoPoint lat: 37.29111, lon: 127.00889, hasResults: False
protocolSection identificationModule nctId: NCT06297421, orgStudyIdInfo id: SZYY20240229IBS-D, briefTitle: Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Shenzhen Hospital of Southern Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults., conditionsModule conditions: Irritable Bowel Syndrome With Diarrhea, conditions: Fecal Microbiota Transplantation, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 434, type: ESTIMATED, armsInterventionsModule interventions name: Fecal Microbiota Transplantation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Patients Who Were Composite Weekly Responders, primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0, secondaryOutcomes measure: Percentage of Patients Who Were Composite Weekly Responders, secondaryOutcomes measure: Percentage of Patients Who Were Abdominal Pain Weekly Responder, secondaryOutcomes measure: Percentage of Patients Who Were Stool Consistency Weekly Responder, secondaryOutcomes measure: Percentage of Patients Who Were Abdominal Bloating Weekly Responder, secondaryOutcomes measure: Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale, secondaryOutcomes measure: Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours, secondaryOutcomes measure: Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7, secondaryOutcomes measure: Change from Baseline in the Number of Stools of Type 6 or 7 per Week, secondaryOutcomes measure: Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score, secondaryOutcomes measure: Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores, secondaryOutcomes measure: Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shenzhen Hospital of Southern Medical University, city: Shenzhen, state: Guangdong, zip: 518000, country: China, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False
protocolSection identificationModule nctId: NCT06297408, orgStudyIdInfo id: JWCAR029115, briefTitle: Relma-cel for Moderate to Severe Active Systemic Lupus Erythematosus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Shanghai Ming Ju Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To assess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Relma-cel, outcomesModule primaryOutcomes measure: DLT rate, primaryOutcomes measure: determine RP2D, secondaryOutcomes measure: SELENA-SLEDAI, secondaryOutcomes measure: BILAG -2004, secondaryOutcomes measure: PGA (physician global assessment) score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297395, orgStudyIdInfo id: Cervical Traumatic Inj, briefTitle: Subaxial Cervical Traumatic Injuries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital., conditionsModule conditions: Cervical Injury Spine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Percentage of improvement, secondaryOutcomes measure: Patient Outcomes, secondaryOutcomes measure: Complication, secondaryOutcomes measure: rehabilitation, secondaryOutcomes measure: Complication, secondaryOutcomes measure: rehabilitation, secondaryOutcomes measure: Complication, secondaryOutcomes measure: Complication, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297382, orgStudyIdInfo id: SBU-HEM-PSI-01, briefTitle: Impact of ChatGPT-based Nursing Process Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2025-04-25, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled study is to determine the impact of ChatGPT based nursing process training on nursing students' clinical decision-making competencies and artificial intelligence anxiety.Population and Sample: The population of the research consists of senior students studying at Gülhane Faculty of Nursing, University of Health Sciences. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G\*Power 3.1 program. In a similar study in the relevant literature, the effect size regarding the change in clinical decision-making level was calculated as 0.898. In order to exceed the 99% value in determining the power of the study; At the 5% significance level and 0.898 effect size, 44 people, 22 people in the groups, need to be reached (df=21; t=1.721). In the research, it was aimed to reach a total of 60 people, 30 people in the groups, considering the high power of the test and the losses., conditionsModule conditions: Nurse-Patient Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This research will be conducted as an experimental study with pretest-posttest randomised control group design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Experimental and control groups will be determined using https:// www.randomizer.org., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: ChatGPT Based Nursing Process Training, outcomesModule primaryOutcomes measure: Descriptive Information Form, primaryOutcomes measure: Clinical Decision Making Scale in Nursing, primaryOutcomes measure: rtificial Intelligence Anxiety Scale:, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297369, orgStudyIdInfo id: RHDIRB2020110301 REC #250, briefTitle: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Evaluation of the Effect of N-acetylcysteine in Preventing Cisplatin-Induced Toxicities in Cancer Patients, conditionsModule conditions: Cisplatin Adverse Reaction, conditions: Cisplatin Nephrotoxicity, conditions: Cisplatin Induced Peripheral Neuropathy, conditions: Cancer Patients, conditions: Cisplatin Ototoxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: N acetyl cysteine, outcomesModule primaryOutcomes measure: The occurrence of cisplatin-induced ototoxicity in the form of hearing loss., secondaryOutcomes measure: The occurrence of cisplatin-induced nephrotoxicity., secondaryOutcomes measure: The occurrence of cisplatin-induced peripheral neuropathy., secondaryOutcomes measure: The occurrence of cisplatin-induced peripheral neuropathy., secondaryOutcomes measure: The occurrence of cisplatin-induced peripheral neuropathy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Clinical Oncology and Nuclear Medicine, Ain Shams University Hospitals, Cairo, Egypt., status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06297356, orgStudyIdInfo id: YCEYHAN, briefTitle: The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-02-19, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient.The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels.The main questions it aims to answer are:Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels?For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy.They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment., conditionsModule conditions: Inhalation Therapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Stress ball, outcomesModule primaryOutcomes measure: dyspnea severity, primaryOutcomes measure: anxiety levels, primaryOutcomes measure: treatment duration, secondaryOutcomes measure: Vital signs: Respiratory rate, secondaryOutcomes measure: Vital signs: Pulse, secondaryOutcomes measure: Vital signs: Blood pressure, secondaryOutcomes measure: saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasemin CEYHAN, status: RECRUITING, city: Kırşehir, state: Center, zip: 40100, country: Turkey, contacts name: Yasemin CEYHAN, PhD, role: CONTACT, phone: +9054645898065, email: [email protected], contacts role: CONTACT, phoneExt: CEYHAN, email: [email protected], contacts name: Yasemin CEYHAN, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14583, lon: 34.16389, hasResults: False
protocolSection identificationModule nctId: NCT06297343, orgStudyIdInfo id: 2023-A02491-44, briefTitle: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula, acronym: MODIFVASC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation., conditionsModule conditions: Renal Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 544, type: ESTIMATED, armsInterventionsModule interventions name: Creation of an arteriovenous fistula, outcomesModule primaryOutcomes measure: Occurrence of ischaemia of the hand, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Privé des Peupliers, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06297330, orgStudyIdInfo id: PROMESS - SLEEP, briefTitle: Sleep for Optimal MEdical StudentS (PROMESS), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: Medical students have been shown to have a greater prevalence of poor sleep leading to poorer quality of life than other groups of students. Among medical students, poor sleep quality and insomnia have been associated with higher level of stress, as well as poorer academic performance. Our field surveys carried out in 2022 and 2023 at the Lyon Est medical school make the same alarming observation. They revealed that 53% of students had significant sleep problems.They also showed that students presented high levels of physical and mental fatigue. It is expected that these disorders will significantly degrade their quality of life as well as their health. Indeed, lack of sleep is associated with serious health problems such as illnesses cardiovascular or immune system deficiencies.The PROMESS - SLEEP project aims to offer solutions to students to improve their sleep during their medical studies. It responds to a demand expressed by students: our field study showed that 40% of 4th year students declared being "very interested and/or interested" in following an intervention that aimed at improving sleep. An early knowledge of sleep optimization tools would allow students to quickly acquire the tools necessary to cope with the difficult conditions encountered during their training and lives of future doctors.The objective of this study is to determine the influence of an intervention program based on sleep improvement and fatigue reduction among medical students., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, conditions: Sleep, conditions: Sleep Disorder, conditions: Fatigue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All volunteers will receive an intervention program based on sleep improvement and fatigue reduction., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Sleep, outcomesModule primaryOutcomes measure: Perceived level of sleep troubles. Evolution of the score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI)., secondaryOutcomes measure: Perceived level of sleep troubles. Score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI)., secondaryOutcomes measure: Epworth Sleepiness scale. Score obtained at the Epworth Sleepiness scale., secondaryOutcomes measure: Multidimensional Fatigue. Score obtained at the Multidimensional Fatigue Inventory (MFI)., secondaryOutcomes measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS)., secondaryOutcomes measure: Actimetry records. Time in Bed during the pre-intervention., secondaryOutcomes measure: Actimetry records. Total sleep duration during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sleep efficiency during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sleep Onset Latency during the pre-intervention., secondaryOutcomes measure: Actimetry records. Wake after Sleep Onset during the pre-intervention., secondaryOutcomes measure: Actimetry records. Number of Awakenings during the pre-intervention., secondaryOutcomes measure: Actimetry records. Bedtime during the pre-intervention., secondaryOutcomes measure: Actimetry records. Mid-sleep point during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sleep Onset time during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sleep Inertia during the pre-intervention., secondaryOutcomes measure: Actimetry records. Wake-up time during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sleep regularity index during the pre-intervention., secondaryOutcomes measure: Multidimensional Fatigue. Evolution of the score obtained at the Multidimensional Fatigue Inventory (MFI) during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Time in Bed during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Total sleep duration during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Sleep efficiency during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Sleep Onset Latency during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Wake after Sleep Onset during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Number of Awakenings during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Mid-sleep point during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Bed time during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Sleep Onset Time during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Sleep Inertia during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Wake-up Time during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Sleep regularity index during the intervention., secondaryOutcomes measure: VAS - sleep quantity: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep., secondaryOutcomes measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality., secondaryOutcomes measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue., secondaryOutcomes measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert., secondaryOutcomes measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set., secondaryOutcomes measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention., secondaryOutcomes measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5., secondaryOutcomes measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, status: RECRUITING, city: Lyon, zip: 69008, country: France, contacts name: Sophie Schlatter, Dr., role: CONTACT, phone: 07 68 21 05 51, phoneExt: 33, email: [email protected], contacts name: Angèle Métais, Dr., role: CONTACT, phone: 06 77 39 89 66, phoneExt: 33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
protocolSection identificationModule nctId: NCT06297317, orgStudyIdInfo id: Trailstiff, briefTitle: Longitudinal Changes in Achilles Tendon and Medial Gastrocnemius Muscle Architecture During a 156-km Ultradistance Trail Running Event, acronym: Trailstiff, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-11, primaryCompletionDateStruct date: 2021-11-13, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Hospital, Caen, class: OTHER, descriptionModule briefSummary: This study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. Experienced trail runners (N=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. The resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for Achille tendon cross-sectional area (AT CSA), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. Measurements were performed the day before the race (Baseline), at 52-km (T1), at 104-km (T2), at 156-km (T3) and 12 hours after the race (H12)., conditionsModule conditions: Achilles Tendinopathy, conditions: Calf Injury, conditions: Sport Injury, conditions: Lower Limb Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound measurement of triceps surae muscle-tendon architecture, outcomesModule primaryOutcomes measure: Achille tendon cross sectional area, primaryOutcomes measure: Medial gastrocnemius thickness, primaryOutcomes measure: Medial gastrocnemius pennation angle, primaryOutcomes measure: Medial gastrocnemius fascicle length, primaryOutcomes measure: Medial gastrocnemius muscle length, secondaryOutcomes measure: Finisher status, secondaryOutcomes measure: Average speed, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Caen Normandie, city: Caen, zip: 14000, country: France, geoPoint lat: 49.18585, lon: -0.35912, hasResults: False
protocolSection identificationModule nctId: NCT06297304, orgStudyIdInfo id: PROMESS - PHYSICAL ACTIVITY, briefTitle: Sedentary Behaviors Reduction and Physical Activity Promotion for Optimal Medical StudentS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance.The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, conditions: Physical Inactivity, conditions: Sedentary Behavior, conditions: Sedentary Time, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All volunteers will receive a physical activity and sedentary management intervention., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Sedentary and physical activity behaviors, outcomesModule primaryOutcomes measure: Perceived level of sedentary : Evolution of the score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors., secondaryOutcomes measure: Perceived level of physical activity : Score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity levels., secondaryOutcomes measure: Perceived level of sedentary : Score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors., secondaryOutcomes measure: Actimetry records.Total activity during the pre-intervention., secondaryOutcomes measure: Actimetry records. Moderate-to-vigorous Physical Activity (MVPA) during the pre-intervention., secondaryOutcomes measure: Actimetry records. Light Physical Activity during the pre-intervention., secondaryOutcomes measure: Actimetry records. Steps count during the pre-intervention., secondaryOutcomes measure: Actimetry records. Energy expenditure during the pre-intervention., secondaryOutcomes measure: Actimetry records. Number of sedentary breaks during the pre-intervention., secondaryOutcomes measure: Actimetry records. Sedentary time during the pre-intervention., secondaryOutcomes measure: Actimetry records. Number of prolonged sedentary bouts during the pre-intervention., secondaryOutcomes measure: Actimetry records.Vector of the dynamic body acceleration (VeDBA) during the pre-intervention., secondaryOutcomes measure: Body composition markers. Body Mass Index (BMI) during the pre-intervention., secondaryOutcomes measure: Body composition markers. Skeletal muscle mass measured by bioimpedancemetry during the pre-intervention., secondaryOutcomes measure: Body composition markers. Fat mass measured by bioimpedancemetry during the pre-intervention., secondaryOutcomes measure: Body composition markers. Total body hydration measured by bioimpedancemetry during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers markers - Power. Height of jump during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Power. Time of flight during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Power. Relative Power during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Endurance. Speed through the endurance test during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Endurance. VO2max through the endurance test during the pre-intervention., secondaryOutcomes measure: Physical Fitness markers - Endurance. Heart rate during the endurance test during the pre-intervention., secondaryOutcomes measure: Perceived level of physical activity : Evolution of the score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity level., secondaryOutcomes measure: Actimetry records. Evolution in Total activity during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Moderate-to-vigorous physical activity (MVPA) during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Light physical activity measured in min/day during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Step Count during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Energy expenditure during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in number of sedentary breaks during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in Number of prolonged sedentary bouts during the intervention., secondaryOutcomes measure: Actimetry records. Evolution in the vector of the dynamic body acceleration (VeDBA) during the intervention., secondaryOutcomes measure: Body composition markers. Evolution in BMI during the intervention., secondaryOutcomes measure: Body composition markers. Evolution in fat mass measured by bioimpedancemetry during the intervention., secondaryOutcomes measure: Body composition markers: Impedance metric measures. Evolution in skeletal muscle mass measured by bioimpedancemetry during the intervention., secondaryOutcomes measure: Body composition markers: Impedance metric measures. Evolution in total body hydration measured by bioimpedancemetry during the intervention., secondaryOutcomes measure: VAS - physical fitness: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness., secondaryOutcomes measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical activity., secondaryOutcomes measure: VAS - sedentary behaviours. Evolution of the scores obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviours., secondaryOutcomes measure: Advices given by the expert. Score obtained on a Likert scale ranging from 1 to 5 characterizing the nature of the advices given by the expert., secondaryOutcomes measure: Likert - expert estimation of student's achievements. Score obtained on a Likert scale ranging from 1 to 3 accessing if the expert estimates that the student has achieve the goals previously set., secondaryOutcomes measure: Likert - expert satisfaction. Scores obtained on a Likert scale ranging from 1 to 5 accessing the expert's satisfaction of his/her intervention., secondaryOutcomes measure: Likert - expert level of comfort. Score assessing the expert comfort levels in participant relationships on a likert scale ranging from 1 to 5., secondaryOutcomes measure: Likert - expert estimation of the overall student's achievements. Score obtained on a Likert scale ranging from 1 to 5 accessing the expert's level of satisfaction on the student's progress., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the all intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, status: RECRUITING, city: Lyon, zip: 69008, country: France, contacts name: Sophie Schlatter, Dr., role: CONTACT, phone: 07 68 21 05 51, phoneExt: 33, email: [email protected], contacts name: Angèle Métais, Dr., role: CONTACT, phone: 06 77 39 89 66, phoneExt: 33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
protocolSection identificationModule nctId: NCT06297291, orgStudyIdInfo id: CLN0984, briefTitle: Global Paradise System US Post Approval Study, acronym: US GPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2031-07, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: ReCor Medical, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure., conditionsModule conditions: Hypertension, conditions: Cardiovascular Diseases, conditions: Vascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Paradise Ultrasound Renal Denervation Treatment, outcomesModule primaryOutcomes measure: Co-Primary Endpoint #1: Group Mean BP reduction, primaryOutcomes measure: Co-Primary Endpoint #2: Subject Responder, secondaryOutcomes measure: Change in mean home systolic/diastolic BP in mmHg, secondaryOutcomes measure: Change in mean office systolic/diastolic BP in mmHg, secondaryOutcomes measure: Change in home and office pulse pressure, secondaryOutcomes measure: Change in the number and/or dosage and/or type of antihypertensive medications taken, secondaryOutcomes measure: Change in patient reported outcomes, secondaryOutcomes measure: Percentage of patients who are controlled as measured by various cut points of home BP (control to be assessed as both < 130 mmHg systolic and <135 mmHg systolic) office BP (control to also be assessed as <130 mmHg and <140 mmHg systolic), secondaryOutcomes measure: Percentage of patients who demonstrate a reduction in home systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg, secondaryOutcomes measure: Percentage of patients who demonstrate a reduction in office systolic BP of ≥ 5mmHg, ≥ 10 mmHg and ≥ 15 mmHg, secondaryOutcomes measure: Change in home and office heart rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297278, orgStudyIdInfo id: IRB-23-01-5444, secondaryIdInfos id: R01MH132830, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MH132830, briefTitle: Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids, acronym: BRAINS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2028-04-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth., conditionsModule conditions: Adolescence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Moderate Intensity Exercise, outcomesModule primaryOutcomes measure: Skin Conductance Responding (SCR), primaryOutcomes measure: Unconditioned Stimulus (US) Expectancy Ratings, primaryOutcomes measure: Fear extinction neural circuitry: Functional activation and coupling, primaryOutcomes measure: Endocannabinoid (eCB) Concentrations, secondaryOutcomes measure: Fear Ratings, secondaryOutcomes measure: Approach/Avoidance Behavior, secondaryOutcomes measure: Amygdala response during extinction recall, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Tolan Park Medical Building, status: RECRUITING, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: MacKenna Shampine, role: CONTACT, phone: 313-242-7464‬, email: [email protected], geoPoint lat: 42.33143, lon: -83.04575, hasResults: False
protocolSection identificationModule nctId: NCT06297265, orgStudyIdInfo id: 1B-23-2, secondaryIdInfos id: NCI-2023-10828, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 1B-23-2, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer., conditionsModule conditions: Anatomic Stage 0 Breast Cancer AJCC v8, conditions: Anatomic Stage IA Breast Cancer AJCC v8, conditions: Localized Breast Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Lymphedema Management, interventions name: Questionnaire Administration, interventions name: Adjuvant breast radiation therapy, outcomesModule primaryOutcomes measure: Rate of compliance of MLD breast massage sessions, secondaryOutcomes measure: Assess the effect of MLD breast massage breast edema, secondaryOutcomes measure: Assess the effect of MLD breast massage on pain, secondaryOutcomes measure: Assess the effect of MLD breast massage on functional status, secondaryOutcomes measure: Assess the effect of MLD breast massage on quality of life, secondaryOutcomes measure: Assess the effect of MLD breast massage on body image, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Kimberly Arieli, RN, role: CONTACT, phone: 323-865-0451, email: [email protected], contacts name: May L. Tao, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06297252, orgStudyIdInfo id: RECHMPL23_0189, briefTitle: Prevalence of Psychiatric Disorders During Pregnancy at 2nd Trimester Ultrasound: a Feasibility Study in the General Population, acronym: GROUP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, collaborators name: Beziers Hospital, descriptionModule briefSummary: Young women represent a population at risk of psychiatric disorders, the first signs of which often appear between the ages of 15 and 25. Psychiatric disorders are a major source of disability and healthcare costs.The perinatal period is an additional period of psychological vulnerability, during which women are at increased risk of developing or worsening psychiatric disorders. Unfortunately, psychiatric disorders seem to be largely under-diagnosed during this period, and therefore under-treated.The goal of this Prospective multicenter study is to determine the prevalence of the presence of at least one characterized psychiatric disorder, as defined by the use of the Mini International Neuropsychiatric Interview (MINI), in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment.Participants will complete self-questionnaires and have a standardized psychiatric evaluation at T2 ultrasound and at 2 months postpartum., conditionsModule conditions: Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: standardized clinical psychiatric evaluations, interventions name: self-administered psychiatric questionnaire assessments, interventions name: blood sampling, outcomesModule primaryOutcomes measure: To determine the prevalence of the presence of at least one characterized psychiatric disorder, in remission or not, during pregnancy, at the time of the second-trimester ultrasound (T2 ultrasound) based on a standardized clinical assessment., secondaryOutcomes measure: To determine the prevalence of each psychiatric disorder characterized during pregnancy at the time of the second-trimester ultrasound, based on a standardized clinical assessment., secondaryOutcomes measure: Determine comorbidity profiles across all pathologies, describing whether there are patient groups based on these profiles., secondaryOutcomes measure: Compare the prevalence of psychiatric disorders unknown to the obstetrics team with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound., secondaryOutcomes measure: Compare the prevalence of psychiatric disorders unknown to the patient with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound., secondaryOutcomes measure: Compare the prevalence of psychiatric disorders unknown to the general practitioner with the prevalence of known psychiatric disorders in pregnant patients at the time of T2 ultrasound., secondaryOutcomes measure: Assess patients' medication compliance using self-administered questionnaires (MARS)., secondaryOutcomes measure: Assess patients' treatment beliefs using self-administered questionnaires (BMQ)., secondaryOutcomes measure: Determine the sociodemographic, psychological, psychiatric, medical and obstetric factors, as well as those associated with access to care and the care pathway associated with known or unknown diagnoses during pregnancy., secondaryOutcomes measure: Determine the properties (sensitivity) of screening questionnaires (EPDS) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (specificity) of screening questionnaires (EPDS) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (positive predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (negative predictive value) of screening questionnaires (EPDS) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (sensitivity) of screening questionnaires ( MDQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (specificity) of screening questionnaires ( MDQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (positive predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (negative predictive value) of screening questionnaires ( MDQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (sensitivity) of screening questionnaires (PCL-5) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (specificity) of screening questionnaires (PCL-5) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (positive predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (negative predictive value) of screening questionnaires (PCL-5) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (sensitivity) of screening questionnaires (EDEQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (specificity) of screening questionnaires (EDEQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (positive predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population., secondaryOutcomes measure: Determine the properties (negative predictive value) of screening questionnaires (EDEQ) for psychiatric disorders in this population., secondaryOutcomes measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (PAI)., secondaryOutcomes measure: Compare mother-child bonding difficulties between patients with and without a psychiatric diagnosis at the time of the study, using scales (MIBS)., secondaryOutcomes measure: Describe how the study will be carried out, either in person or by teleconsultation, and the reasons for this choice., secondaryOutcomes measure: Determine the prevalence of each psychiatric disorder at two months post-inclusion based on a standardized clinical assessment., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297239, orgStudyIdInfo id: UC001, briefTitle: Argentine Registry of Lp(a), acronym: GAELpa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: School of Medicine. National University of Cuyo, class: OTHER, descriptionModule briefSummary: The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care., conditionsModule conditions: Lp(A), conditions: Hypercholesterolemia, conditions: Cardiovascular Diseases, conditions: Diabete Type 2, conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: prevalence of high level of Lp(a), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad Nacional de Cuyo, status: RECRUITING, city: Mendoza, zip: 5500, country: Argentina, contacts name: Nicolás F Renna, PhD MD FESC, role: CONTACT, phone: +5492615714415, email: [email protected], contacts name: Pablo Corral, MD, role: CONTACT, geoPoint lat: -32.89084, lon: -68.82717, hasResults: False
protocolSection identificationModule nctId: NCT06297226, orgStudyIdInfo id: CA088-1000, briefTitle: Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma, acronym: QUINTESSENTIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-10-02, completionDateStruct date: 2030-06-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: BMS-986393, outcomesModule primaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: BOR of partial response (PR) or better, secondaryOutcomes measure: BOR of complete response (CR) [including stringent complete response sCR], secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Incidence of adverse event of special interest (AESI), secondaryOutcomes measure: Incidence of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Minimal residual disease (MRD) negative status as determined using next generation sequencing (NGS), secondaryOutcomes measure: Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC), secondaryOutcomes measure: Duration of response (DOR) assessed by an IRC, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response rate (ORR) assessed by an Investigator, secondaryOutcomes measure: Complete response rate (CRR) assessed by an Investigator, secondaryOutcomes measure: Time to response (TTR) assessed by an Investigator, secondaryOutcomes measure: Duration of response (DOR) assessed by an Investigator, secondaryOutcomes measure: Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Area under the concentration-time curve (AUC), secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Mean changes from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) selected subscales, secondaryOutcomes measure: Mean changes from baseline in European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) selected subscales, secondaryOutcomes measure: Incidence of healthcare resource utilization (HCRU) events during treatment and during post-treatment follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Local Institution - 0001, status: NOT_YET_RECRUITING, city: Birmingham, state: Alabama, zip: 35294-3300, country: United States, contacts name: Site 0001, role: CONTACT, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Local Institution - 0025, status: NOT_YET_RECRUITING, city: Gilbert, state: Arizona, zip: 85234, country: United States, contacts name: Site 0025, role: CONTACT, geoPoint lat: 33.35283, lon: -111.78903, locations facility: Local Institution - 0037, status: NOT_YET_RECRUITING, city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: Site 0037, role: CONTACT, geoPoint lat: 34.74648, lon: -92.28959, locations facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 214), status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Sarah Larson, Site 0028, role: CONTACT, phone: 310-829-5471, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Local Institution - 0018, status: NOT_YET_RECRUITING, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Site 0018, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Colorado Blood Cancer Institute, status: RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: Tara Gregory, Site 0049, role: CONTACT, phone: 720-754-4800, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Local Institution - 0045, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33176, country: United States, contacts name: Site 0045, role: CONTACT, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Local Institution - 0029, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Site 0029, role: CONTACT, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Local Institution - 0009, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Site 0009, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 0004, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Site 0004, role: CONTACT, geoPoint lat: 33.749, lon: -84.38798, locations facility: Local Institution - 0005, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Site 0005, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0056, status: NOT_YET_RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Site 0056, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Local Institution - 0019, status: NOT_YET_RECRUITING, city: Iowa City, state: Iowa, zip: 52242, country: United States, contacts name: Site 0019, role: CONTACT, geoPoint lat: 41.66113, lon: -91.53017, locations facility: Local Institution - 0016, status: NOT_YET_RECRUITING, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Site 0016, role: CONTACT, geoPoint lat: 39.11417, lon: -94.62746, locations facility: Local Institution - 0026, status: NOT_YET_RECRUITING, city: Saint Matthews, state: Kentucky, zip: 40207, country: United States, contacts name: Site 0026, role: CONTACT, geoPoint lat: 38.25285, lon: -85.65579, locations facility: Local Institution - 0039, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Site 0039, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Local Institution - 0036, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Site 0036, role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Local Institution - 0033, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Site 0033, role: CONTACT, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Local Institution - 0010, status: NOT_YET_RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Site 0010, role: CONTACT, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Local Institution - 0034, status: NOT_YET_RECRUITING, city: New Brunswick, state: New Jersey, zip: 08903, country: United States, contacts name: Site 0034, role: CONTACT, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Local Institution - 0046, status: NOT_YET_RECRUITING, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Site 0046, role: CONTACT, geoPoint lat: 42.88645, lon: -78.87837, locations facility: Local Institution - 0002, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Site 0002, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Local Institution - 0003, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Site 0003, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Local Institution - 0031, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Site 0031, role: CONTACT, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Local Institution - 0054, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45242, country: United States, contacts name: Site 0054, role: CONTACT, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Local Institution - 0032, status: NOT_YET_RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Site 0032, role: CONTACT, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Local Institution - 0038, status: NOT_YET_RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Site 0038, role: CONTACT, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Local Institution - 0043, status: NOT_YET_RECRUITING, city: Nashville, state: Tennessee, zip: 37232, country: United States, contacts name: Site 0043, role: CONTACT, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Local Institution - 0035, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75390-88520, country: United States, contacts name: Site 0035, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Local Institution - 0027, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Site 0027, role: CONTACT, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Local Institution - 0055, status: NOT_YET_RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Site 0055, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Local Institution - 0050, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84143, country: United States, contacts name: Site 0050, role: CONTACT, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Local Institution - 0011, status: NOT_YET_RECRUITING, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Site 0011, role: CONTACT, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Local Institution - 0015, status: NOT_YET_RECRUITING, city: Madison, state: Wisconsin, zip: 53792, country: United States, contacts name: Site 0015, role: CONTACT, geoPoint lat: 43.07305, lon: -89.40123, locations facility: Local Institution - 0020, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 4N2, country: Canada, contacts name: Site 0020, role: CONTACT, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Local Institution - 0021, status: NOT_YET_RECRUITING, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Site 0021, role: CONTACT, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06297213, orgStudyIdInfo id: R-2487-SS-01, briefTitle: R-2487 in Patients With Sjogren's Syndrome (SS), acronym: R-2487-SS-01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-08-30, completionDateStruct date: 2026-08-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Rise Therapeutics LLC, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured., conditionsModule conditions: Sjogren's Syndrome, conditions: Sjögren, conditions: Sjögren Syndrome, Unspecified, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: R-2487, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration, secondaryOutcomes measure: Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI), secondaryOutcomes measure: Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297200, orgStudyIdInfo id: 24-050, briefTitle: Low-Intensity Focused Ultrasound and the Complex Patient, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Virginia Polytechnic Institute and State University, class: OTHER, collaborators name: Salem VA Medical Center, collaborators name: Washington DC VA Medical Center, descriptionModule briefSummary: Studying the effects of Low Intensity Focused Ultrasound (LIFU) on measures of pain, craving, and anxiety in a complex patient population., conditionsModule conditions: Opioid Use Disorder, conditions: Chronic Pain, conditions: Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions., enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Low-Intensity Focused Ultrasound, interventions name: Low-Intensity Focused Ultrasound - sham, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events via a neurological examination, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events via a side effects questionnaire, primaryOutcomes measure: Changes in Heart Rate (HR), primaryOutcomes measure: Changes in Respiration Rate (RR), primaryOutcomes measure: Changes in mood via visual analog mood scale (VAMS), primaryOutcomes measure: Changes in Blood Pressure (BP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fralin Biomedical Research Institute at VTC, city: Roanoke, state: Virginia, zip: 24016, country: United States, contacts name: Jessica Florig, MPH, role: CONTACT, phone: 540-526-2261, email: [email protected], contacts name: Wynn Legon, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False
protocolSection identificationModule nctId: NCT06297187, orgStudyIdInfo id: C-CUSAWH-001, briefTitle: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Integra LifeSciences Corporation, class: INDUSTRY, descriptionModule briefSummary: The study is a single arm, retrospective, single-center, post market registry.The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata., conditionsModule conditions: Vulvar Intraepithelial Neoplasia, conditions: Condylomata Acuminata, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: CUSA (Cavitronic Ultrasonic Surgical Aspirator), outcomesModule primaryOutcomes measure: Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata, secondaryOutcomes measure: Primary Site Recurrence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Center for Cancer and Blood Disorders, city: Dallas, state: Texas, zip: 76014, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
protocolSection identificationModule nctId: NCT06297174, orgStudyIdInfo id: BE23-035, briefTitle: Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-26, primaryCompletionDateStruct date: 2024-09-17, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Pharma Nueva, class: INDUSTRY, descriptionModule briefSummary: Objectives:To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditionsStudy Design:An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period, conditionsModule conditions: Healthy Vollunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Racecadotril 100 mg Capsules, interventions name: HIDRASEC®, outcomesModule primaryOutcomes measure: Plasma area Under the Curve (AUC(0-36hr)) for Racecadotril, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Racecadotril, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297161, orgStudyIdInfo id: B1871065, briefTitle: A Study to Learn About the Study Medicine Bosulif in Adult Patients With Chronic Myeloid Leukemia(CML)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to look at how safe and effective is bosulif in routine clinical practice.This study is seeking for participants who are:* Adult Patients who are just confirmed to have Chronic Myeloid Leukemia (CML) defined in Local Product Document (LPD). CML is a type of cancer that starts in the blood-forming cells of the bone marrow and invades the blood. LPD explains what a medicine's benefits and problems are. LPD also explains how to use the medicine correctly in Korea.* willing to take part in the study after being informed about the study. All participants in this study will receive bosulif. All participants who have entered this study should meet the usual prescribing criteria for bosulif as per the LPD. The participants will be treated with bosulif under routine clinical practice in Korea.The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.In this study all treatment and checking of the patients will be done as per the study doctor. The study can be performed in Korean health care centers where bosulif is prescribed to treat CML after the patients have agreed to take part in the study., conditionsModule conditions: Chronic Leukemia Myelogenous, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Bosulif, outcomesModule primaryOutcomes measure: Incidence of AEs, secondaryOutcomes measure: Hematologic response: CHR, not achieved, secondaryOutcomes measure: Cytogenetic response: CCyR, PCyR, mCyR, not achieved, secondaryOutcomes measure: Molecular response: EMR, MMR, MR4.0, MR4.5, not achieved, secondaryOutcomes measure: Relapse after Bosulif response, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297148, orgStudyIdInfo id: 2023/590816, briefTitle: The HIP Self-management Study, acronym: HIPS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: Oslo Metropolitan University, collaborators name: Fysiofondet, collaborators name: University of Oslo, descriptionModule briefSummary: The HIPS-study will be an observer blinded, single-centre, parallel-group randomized controlled trial (RCT).The main purpose of the study is:1. To investigate the clinical effectiveness of a self- management program versus usual care for patients with greater trochanteric pain syndrome (GTPS). * H0: There is no difference between a self-management program and usual care on pain and function in patients with GTPS. * H1: There is a difference between a self-management program and usual care on pain and function in patients with GTPS.2. To investigate if self-management is more cost-effective than usual care in the treatment of patients with GTPS.Participants will be randomly allocated into one of two groups: 1) self-management program or 2) usual care.Follow-up will be at 3-, 6- and 12-months., conditionsModule conditions: GTPS - Greater Trochanteric Pain Syndrome, conditions: Gluteal Tendinopathy, conditions: Trochanteric Bursitis, conditions: Lateral Hip Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Self-management, interventions name: Usual care, outcomesModule primaryOutcomes measure: Victorian Institute of Sport Assessment Gluteal Questionnaire (VISA-G), secondaryOutcomes measure: Numeric rating scale (NRS), secondaryOutcomes measure: Painful sites, secondaryOutcomes measure: The Pain Self-Efficacy Questionnaire (PSEQ), secondaryOutcomes measure: EuroQoL-5 dimensions-5 Level (Eq-5D-5L), secondaryOutcomes measure: Hopkins Symptoms checklist-10 (HSCL-10), secondaryOutcomes measure: iMTA Medical Consumption Questionnaire (iMCQ), secondaryOutcomes measure: iMTA Productivity Cost Questionnaire (iPCQ), secondaryOutcomes measure: Expectations related to VISA-G, secondaryOutcomes measure: Expectations on numeric rating scale (NRS), secondaryOutcomes measure: Global rating of change (GROC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, Ullevål, status: RECRUITING, city: Oslo, zip: 0450, country: Norway, contacts name: Marianne Bakke Johnsen, PhD, role: CONTACT, phone: + 47 92439663, email: [email protected], contacts name: Marianne Bakke Johnsen, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.91273, lon: 10.74609, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-02-22, uploadDate: 2024-03-07T09:23, filename: SAP_001.pdf, size: 1180746, hasResults: False
protocolSection identificationModule nctId: NCT06297135, orgStudyIdInfo id: HSR-2023-020, briefTitle: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Okinawa Institute of Science and Technology Graduate University, class: OTHER, collaborators name: Miyazaki International College, collaborators name: Japan society for the promotion of science, descriptionModule briefSummary: This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Parent Training, outcomesModule primaryOutcomes measure: Number of videos viewed, primaryOutcomes measure: Percentage of completed daily ratings, primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Parent-rated child's difficulties with daily transitions, secondaryOutcomes measure: Parent-rated child's impairment related to transition difficulties, secondaryOutcomes measure: Positive parenting, secondaryOutcomes measure: Negative parenting, secondaryOutcomes measure: Parenting stress, otherOutcomes measure: ADHD symptoms, otherOutcomes measure: ODD symptoms, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Okinawa Institute of Science and Technology Graduate University, status: RECRUITING, city: Onna, state: Okinawa, zip: 904-0495, country: Japan, contacts name: Emi Furukawa, PhD, role: CONTACT, phone: +81989668814, email: [email protected], contacts name: Emi Furukawa, PhD, role: PRINCIPAL_INVESTIGATOR, locations facility: Miyazaki International College, status: RECRUITING, city: Miyazaki, zip: 889-1605, country: Japan, contacts name: Aya Kasai, PhD, role: CONTACT, phone: +81985855931, email: [email protected], contacts name: Aya Kasai, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.91667, lon: 131.41667, hasResults: False
protocolSection identificationModule nctId: NCT06297122, orgStudyIdInfo id: APHP240002, briefTitle: Severe Group A Streptococcus Infections in Paris, France, 2018-2023, acronym: IGASI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Streptococcus pyogenes, commonly referred to as Group A Streptococcus (GAS), has the ability to induce a diverse range of illnesses.In several European countries and the United States, a notable surge in invasive GAS (iGAS) infections has been documented since mid-2022. This sharp increase contrasts with the gradual rise in iGAS incidence observed among children over the past three decades. As demonstrated for several viral infections, the recent upturn in iGAS infections is potentially linked to the relaxation of mitigation measures implemented during the COVID-19 pandemic, such as face mask usage and school closures.Since November 2022, concerns have been raised by French public health authorities regarding the rise in levels of iGAS infections, and an unexpected increase in pediatric severe GAS infections was reported in a French single-center study. However, this study ended in December 2022 and could only explore short-term trends. The Necker - Enfants malades Hospital in Paris, France, represents an excellent opportunity to examine the impact of the COVID-19 pandemic and the associated non-pharmaceutical interventions on the incidence of severe GAS infections, during, and after the pandemic.This study aims to investigate trends of severe GAS infection incidence in children in the Paris area over the course of the COVID-19 pandemic., conditionsModule conditions: Invasive Group A Beta-Haemolytic Streptococcal Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Collection of data from the patient's medical file, outcomesModule primaryOutcomes measure: Monthly incidence of severe Group A Streptococcus (GAS) infections per 1000 pediatric hospital admissions, secondaryOutcomes measure: Age of children age with group A Streptococcus (GAS) infections, secondaryOutcomes measure: Proportion of children needing surgical intervention for the management of GAS infection, secondaryOutcomes measure: Proportion of cases admitted in the PICU for GAS infection, secondaryOutcomes measure: Proportion of deaths from GAS infection, secondaryOutcomes measure: Hospital length of stay for the management of GAS infection, secondaryOutcomes measure: Distribution of infection type of GAS infection, secondaryOutcomes measure: Proportion of healthcare-associated infections during the management of GAS infection, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hôpital Necker-Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Jérémie Cohen, M.D., PhD, role: CONTACT, phone: 1 44 49 48 72, phoneExt: +33, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06297109, orgStudyIdInfo id: S-20230033, briefTitle: Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-12, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Hospital of South West Jutland, class: OTHER, collaborators name: University of Southern Denmark, descriptionModule briefSummary: Orthognathic surgery is a type of jaw surgery where a surgeon cuts the bones of the upper and lower jaw and places them better. There are two ways they can put the bones in the correct place and keep them in place after the surgery. One way, called the "conventional method", is to use a 3D-printed guide called a splint to set the bones in the right place and then screw the bones together using metal plates that the surgeon bends into shape to fit during the surgery. Another way is to use a patient-specific implants (PSI) that has been 3D-printed in titanium beforehand that because of its unique shape both places and keeps all the bones in the correct place after they are screwed in. Both ways of doing it are golden standards, meaning they are already approved.Measuring the accuracy of the surgery is done by comparing the positions of the bones after the surgery with the intended positions of those bones, according to the surgical plan. The closer the achieved position of each bone is to the intended position, the more accurate the result.Measuring the stability of the surgery is done by comparing the positions of the bones after the surgery with the positions of the bones two years later. The less the position is changed, the more stable the result.The goal of this clinical trial is to see how accurate and stable PSIs are in orthognathic surgery when the maxilla is split in 3 pieces, and to compare them with the conventional method in patients with overjet or overbite. The main questions it aims to answer are:* Does using PSIs provide accurate movements of the maxilla pieces?* Does using PSIs provide more accurate movements of the maxilla pieces than the conventional method?* Does using PSIs provide stable movements of the maxilla pieces after 2 years?* Does using PSIs provide more stable movements of the maxilla pieces than the conventional method?Participants will get orthognathic surgery as part of their normal orthodontic treatment.Investigators will compare the PSI and conventional groups to see if the PSIs are more accurate than the conventional method., conditionsModule conditions: Retrognathia, conditions: Malocclusion, Angle Class II, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The care provider and the investigator are blinded up to the selection of the device used for the surgery, as blinding is no longer possible from this state., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Patient-specific implants, interventions name: Conventional mini-plates, outcomesModule primaryOutcomes measure: The accuracy of segmental Le Fort I bone movements, primaryOutcomes measure: The stability of segmental Le Fort I bone movements, primaryOutcomes measure: The stability of the upper airway, secondaryOutcomes measure: The Diagnostic Criteria for Temporomandibular Disorders Symptom questionnaire, secondaryOutcomes measure: The Jaw Functional Limitation Scale, secondaryOutcomes measure: The STOP-BANG - Snorting, Tiredness, Observed apnea, blood Pressure, BMI, Age, Neck circumference, Gender questionnaire, secondaryOutcomes measure: The Epworth Sleepiness Scale questionnaire, secondaryOutcomes measure: The occlusion including horizontal/vertical overlap, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Southern Denmark, status: RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Michael B Holte, ph.d., role: CONTACT, phone: +4520645760, email: [email protected], geoPoint lat: 55.47028, lon: 8.45187, hasResults: False
protocolSection identificationModule nctId: NCT06297096, orgStudyIdInfo id: NIGRIR_004NINTOC-TU, briefTitle: Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease, acronym: NINTOC-TU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-03-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland, class: NETWORK, collaborators name: Medical Research Agency, Poland, descriptionModule briefSummary: The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks., conditionsModule conditions: Systemic Sclerosis, conditions: Interstitial Lung Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Tocilizumab, interventions name: Nintedanib, interventions name: Standard therapy, outcomesModule primaryOutcomes measure: The decrease in forced vital capacity (FVC) of the lungs, secondaryOutcomes measure: Change in percent lung involvement, secondaryOutcomes measure: Assessment of absolute changes in DLCO, secondaryOutcomes measure: Assessment of the absolute changes in predicted FVC%, secondaryOutcomes measure: Change in the Six-minute walk test (6MWT) result, secondaryOutcomes measure: Change in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score, secondaryOutcomes measure: A change in the patient's global assessment of disease activity, secondaryOutcomes measure: A change in the physician's global assessment of disease activity, secondaryOutcomes measure: Assessment of the absolute changes from baseline in total scores in St. George's Respiratory Questionnaire (SGRQ), secondaryOutcomes measure: Assessment of absolute changes compared to baseline values on the modified Rodnan skin Score (mRSS), secondaryOutcomes measure: Percentage of participants with threshold improvement from baseline in modified Rodnan skin Score (mRSS), secondaryOutcomes measure: Percentage of participants with modified Rodnan skin Score (mRSS) improvement greater than or equal to (>/=) 20%, 40%, or 60%, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centrum Wsparcia Badań Klinicznych, city: Warsaw, state: Mazowieckie, zip: 02-637, country: Poland, contacts name: Justyna Kwiatkowska-Golańska, role: CONTACT, phone: 22 6880632, phoneExt: +48, email: [email protected], contacts name: Maria Maślińska, PhD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
protocolSection identificationModule nctId: NCT06297083, orgStudyIdInfo id: 100992, briefTitle: Analysing HIgh Dose Probiotic Peanut Oral Immunotherapy (PPOIT) and High Dose Peanut Oral Immunotherapy (OIT) Versus LOw Dose Peanut OIT for Peanut Allergy, acronym: HILO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: This study will compare the effectiveness of three different treatments to treat peanut allergy, conditionsModule conditions: Peanut Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a three-arm, multi-center, head-to-head randomized study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants, outcome assessors, other research staff, treating clinicians, investigators and trial statistician will be blinded to treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Peanut Oral Powder [PEANUT POWDER], interventions name: Probiotic (LGG®, Lactobacillus Rhamnosus) or placebo probiotic (maltodextrin), outcomesModule primaryOutcomes measure: Difference between the treatment arms in the proportion of participants who achieve remission of peanut allergy at 8 weeks post treatment., secondaryOutcomes measure: Difference between the treatment arms in the proportion of participants who achieve full desensitisation of peanut allergy at end of treatment, secondaryOutcomes measure: Difference between the treatment arms in the exposure-adjusted event rate of adverse events (AE), secondaryOutcomes measure: Difference between treatment arms in changes in Quality of Life Scores using the Food Allergy Quality of Life Questionnaires (FAQLQ)., secondaryOutcomes measure: Difference between treatment arms in changes in the peanut skin prick test (SPT) wheal size., secondaryOutcomes measure: Difference between treatment arms in change from baseline peanut specific immunoglobulin E (sIgE) levels, secondaryOutcomes measure: Difference between treatment arms in adherence to treatment regime as measured by daily treatment doses taken by the participant, secondaryOutcomes measure: Difference between treatment arms in participant experience as assessed from qualitative interviews, secondaryOutcomes measure: Difference between clinical outcome groups in cost using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), secondaryOutcomes measure: Difference between clinical outcome groups in quality adjusted life year (QALY) will be estimated at 32 months using the Food Allergy Quality of Life Form (FAQLQ) mapped to the generic health utility instrument Assessment of Quality of Life-6D (AQoL-6D), secondaryOutcomes measure: Difference between clinical outcome groups in peanut ingestion from end of treatment to 12 months post treatment, secondaryOutcomes measure: Difference between clinical outcome groups in reactions to peanut from end of treatment to 12 months post treatment, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Womans and Childrens Hospital, city: Adelaide, state: South Australia, zip: 5006, country: Australia, contacts name: Michael Gold, role: CONTACT, phone: +61881617000, email: [email protected], geoPoint lat: -34.92866, lon: 138.59863, locations facility: Murdoch Childrens Research Institute, city: Melbourne, state: Victoria, zip: 3052, country: Australia, contacts name: Julie Burns, role: CONTACT, phone: +61399366184, email: [email protected], geoPoint lat: -37.814, lon: 144.96332, hasResults: False
protocolSection identificationModule nctId: NCT06297070, orgStudyIdInfo id: STUDY20231406, briefTitle: Lifestyle Care for Fertility Outcome Evaluation, acronym: PROWESS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Christine Kaiser, LAc, DACM, class: OTHER, descriptionModule briefSummary: An observational outcome evaluation of the Lifestyle Care for Fertility program., conditionsModule conditions: Fertility Issues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Whole Health Lifestyle Care for Reproductive Well-being pilot program, outcomesModule primaryOutcomes measure: Servings of Fruit, primaryOutcomes measure: Servings of Vegetables, primaryOutcomes measure: Glasses of Water, primaryOutcomes measure: Caffeinated Beverages, primaryOutcomes measure: Aerobic Exercise, primaryOutcomes measure: Strengthening Exercise, primaryOutcomes measure: Stretching Exercise, primaryOutcomes measure: Sleep Hygiene, primaryOutcomes measure: Hours of Sleep, primaryOutcomes measure: Self Care - Biofeedback, primaryOutcomes measure: Self Care - Breathing Exercises, primaryOutcomes measure: Self Care - Guided Imagery, primaryOutcomes measure: Self Care - Mindfulness/Meditation, primaryOutcomes measure: Self Care - Progressive Relaxation, primaryOutcomes measure: Self Care - Journaling/Gratitude Journaling, primaryOutcomes measure: Self Care - Tai Chi/Chi Gong, primaryOutcomes measure: Self-Care - Massage Therapy, primaryOutcomes measure: Self Care - Acupuncture/Acupressure, primaryOutcomes measure: Self Care - Nature Walking, secondaryOutcomes measure: PROMIS Sleep Disturbance 8a, secondaryOutcomes measure: Perceived Stress Scale - 4, secondaryOutcomes measure: Infertility Self Efficacy, secondaryOutcomes measure: Chemical pregnancy, secondaryOutcomes measure: Stress Change (level of stress: none [0] to worst possible [10]) - SMA, secondaryOutcomes measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - SMA, secondaryOutcomes measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - SMA, secondaryOutcomes measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - SMA, secondaryOutcomes measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - SMA, secondaryOutcomes measure: Stress Change (level of stress: none [0] to worst possible [10]) - HWC, secondaryOutcomes measure: Anxiety Change (level of anxiety right now: none [0] to worst possible [10]) - HWC, secondaryOutcomes measure: Energy Change (level of energy right now: no energy [0] to most energized [10]) - HWC, secondaryOutcomes measure: Focus Change (level of energy right now: not focused at all [0] to very focused [10]) - HWC, secondaryOutcomes measure: Wellbeing Change (level of energy right now: worst possible [0] to best possible [10]) - HWC, secondaryOutcomes measure: Recruitment Rate, secondaryOutcomes measure: Retention Rate, secondaryOutcomes measure: Pace of Accrual, secondaryOutcomes measure: Data Completeness, secondaryOutcomes measure: Helpfulness of group sessions in addressing needs, secondaryOutcomes measure: Coverage of important issues in the sessions, secondaryOutcomes measure: Helpfulness of tools presented in nutrition session, secondaryOutcomes measure: Helpfulness of tools presented in movement session, secondaryOutcomes measure: Helpfulness of tools presented in relaxation and sleep session, secondaryOutcomes measure: Helpfulness of tools presented in integrate session, secondaryOutcomes measure: Enjoyed group sessions, secondaryOutcomes measure: Enjoyed health and wellness coaching session, secondaryOutcomes measure: Group setting was beneficial, secondaryOutcomes measure: Comfortable in group setting, secondaryOutcomes measure: Helpfulness of individual health coaching sessions, secondaryOutcomes measure: Feedback questionnaire: Location Preference question 1, secondaryOutcomes measure: Feedback questionnaire: Location Preference question 2, secondaryOutcomes measure: Feedback questionnaire: Number of Sessions question., secondaryOutcomes measure: Feedback questionnaire: Length of Sessions question., secondaryOutcomes measure: Rating of level of support during each SMA, secondaryOutcomes measure: Rating of level of support during HWC, secondaryOutcomes measure: Overall level of satisfaction during each SMA, secondaryOutcomes measure: Overall level of satisfaction during each HWC, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Christine Kaiser, DACM LAc, role: CONTACT, phone: 216-285-4070, email: [email protected], contacts name: Jessica Surdam, MPH, role: CONTACT, phone: 216-844-7925, email: [email protected], geoPoint lat: 41.4995, lon: -81.69541, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-20, uploadDate: 2024-01-10T14:17, filename: Prot_SAP_000.pdf, size: 238937, hasResults: False
protocolSection identificationModule nctId: NCT06297057, orgStudyIdInfo id: 2021.07, briefTitle: Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings, acronym: MEEGOPTI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: IRCCS San Camillo, Venezia, Italy, class: OTHER, collaborators name: University Ghent, collaborators name: University of Padova, descriptionModule briefSummary: The study aims to optimize and validate protocols for acquiring neurophysiological data, specifically resting state functional connectivity, using advanced research techniques (hdEEG and MEG) and a user-friendly device (MUSE). Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI, yet few have focused on hdEEG and MEG data. Additionally, the impact of subjects' eye conditions (open or closed) during resting state recordings on network identification remains debated.The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations.The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements.Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE.The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings.Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Neurophysiological Recordings, outcomesModule primaryOutcomes measure: Neurophysiological data acquisition protocol - resting state, primaryOutcomes measure: Neurophysiological data acquisition protocol - resting state, primaryOutcomes measure: Neurophysiological data acquisition protocol - auditory stimulation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: San Camillo IRCCS s.r.l., city: Venice-Lido, state: Venice, zip: 30126, country: Italy, geoPoint lat: 45.4131, lon: 12.3742, hasResults: False
protocolSection identificationModule nctId: NCT06297044, orgStudyIdInfo id: 2017.20, briefTitle: Neural and Cognitive Correlates of Pragmatic Abilities, acronym: APACS_Neuro, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-03-29, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: IRCCS San Camillo, Venezia, Italy, class: OTHER, descriptionModule briefSummary: Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans., conditionsModule conditions: Right Hemispheric Stroke, conditions: Left Hemispheric Stroke, conditions: Traumatic Brain Injury, conditions: Right Hemispheric Brain Tumor, conditions: Left Hemispheric Brain Tumor, conditions: Mild Cognitive Impairment, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological assessment, outcomesModule primaryOutcomes measure: Pragmatic Profile, secondaryOutcomes measure: Theory of Mind, secondaryOutcomes measure: Functional Communication Abilities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Camillo IRCCS s.r.l., city: Venice-Lido, state: Venice, zip: 30126, country: Italy, geoPoint lat: 45.4131, lon: 12.3742, hasResults: False
protocolSection identificationModule nctId: NCT06297031, orgStudyIdInfo id: 2020/20, briefTitle: Heat Application to the Sacral Region and Pain Level During the First Stage of Labor, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2021-05-01, completionDateStruct date: 2021-05-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istanbul Demiroglu Bilim University, class: OTHER, descriptionModule briefSummary: The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process., conditionsModule conditions: Heat Exposure, conditions: Labor Pain, conditions: Apgar Score, conditions: Duration of Labor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ACTUAL, armsInterventionsModule interventions name: heat application, outcomesModule primaryOutcomes measure: Change From Baseline labor Pain at three times, secondaryOutcomes measure: Duration of the first stage of labor, secondaryOutcomes measure: Change From Baseline APGAR score after delivery, secondaryOutcomes measure: Change From Baseline Fetal Heart Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Demiroglu Bilim University, city: Istanbul, zip: 34384, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06297018, orgStudyIdInfo id: February 18, 2024, briefTitle: Bioenergy, Depression, Anxiety and Stress After Liver Transplantation, statusModule overallStatus: TERMINATED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-02-09, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istanbul Aydın University, class: OTHER, descriptionModule briefSummary: In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Interventional Crossover Assignment, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: Experimental, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: Bioenergy application, outcomesModule primaryOutcomes measure: Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Semra Bulbuloglu, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06297005, orgStudyIdInfo id: 21/FFP-P/10154, briefTitle: The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study, acronym: ECHO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University College Dublin, class: OTHER, collaborators name: Royal College of Surgeons, Ireland, descriptionModule briefSummary: Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age., conditionsModule conditions: Vaping, conditions: Pregnancy Related, conditions: Pediatric Respiratory Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Incidence of preterm birth, primaryOutcomes measure: Incidence of low birth weight, primaryOutcomes measure: Incidence of wheeze during the first two years of life, secondaryOutcomes measure: Incidence of smoking and vaping, secondaryOutcomes measure: Estimated foetal weight, secondaryOutcomes measure: Trends in carbon monoxide levels, secondaryOutcomes measure: Blood pressure measurements (both diastolic and systolic), secondaryOutcomes measure: Urine cotinine measurements, secondaryOutcomes measure: Incidence of maternal cough, wheeze and/or asthma, secondaryOutcomes measure: Maternal history of abnormal cervical screening cytology, secondaryOutcomes measure: Incidence of pre-eclampsia and/or hypertension during pregnancy, secondaryOutcomes measure: Incidence of birth complications, secondaryOutcomes measure: Edinburgh postnatal depression score, secondaryOutcomes measure: APGAR scores at 1, 5 and 10 minutes after birth, secondaryOutcomes measure: Admission to neonatal intensive care, secondaryOutcomes measure: Incidence of neonatal complications, secondaryOutcomes measure: Neonatal and paediatric anthropometric measurements over first two years of life, secondaryOutcomes measure: Neonatal body composition measurements, secondaryOutcomes measure: Incidence of respiratory illnesses, secondaryOutcomes measure: Number of attendances/admissions to hospital, secondaryOutcomes measure: Frequency of prescribed respiratory medications use, secondaryOutcomes measure: Barkely Functional Impairment score (BFIS), secondaryOutcomes measure: Early Executive Functions Questionnaire (EEFQ), secondaryOutcomes measure: Infant Behaviour Questionnaire (IBQ), secondaryOutcomes measure: Child Behaviour Checklist (CBCL), secondaryOutcomes measure: Early Childhood Behaviour Questionnaire (ECBQ), secondaryOutcomes measure: Bayley Scales of Infant and Toddler Development (BSID), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 46 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rotunda Hospital, status: RECRUITING, city: Dublin, zip: D01 P5W9, country: Ireland, contacts name: Adele Reddin, BSc/MSc, role: CONTACT, email: [email protected], geoPoint lat: 53.33306, lon: -6.24889, locations facility: National Maternity Hospital, Holles Street, status: RECRUITING, city: Dublin, zip: D02 YH21, country: Ireland, contacts name: Emma Doyle, BSc/MSc, role: CONTACT, email: [email protected], geoPoint lat: 53.33306, lon: -6.24889, locations facility: Coombe Womens Hospital, status: RECRUITING, city: Dublin, zip: D08 XW7X, country: Ireland, contacts name: Eibhlin Cary Healy, MRCPI, role: CONTACT, email: [email protected], contacts name: Mariapia Dado, BSc/MSc, role: CONTACT, phone: +35314085571, phoneExt: 4541, email: [email protected], geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
protocolSection identificationModule nctId: NCT06296992, orgStudyIdInfo id: B2023:035, briefTitle: Type 1 Diabetes, Exercise and Mentoring Trial, acronym: TEAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D., conditionsModule conditions: Type 1 Diabetes, conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 12-week TEAM peer mentor program, outcomesModule primaryOutcomes measure: Enrollment rates, primaryOutcomes measure: Adherence to the intervention arms, primaryOutcomes measure: Retention for follow-up measurements, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Quality of Life (DQOL), secondaryOutcomes measure: Quality of Life (PedsQL 4.0), otherOutcomes measure: Diabetes Distress, otherOutcomes measure: Mastery, otherOutcomes measure: Autonomy, otherOutcomes measure: Motivation for physical activity (LCE), otherOutcomes measure: Readiness for change, otherOutcomes measure: Motivation to engage in exercise, otherOutcomes measure: Motivation for Physical Activity (EMI-2), eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296979, orgStudyIdInfo id: 0881-N-23, briefTitle: Effectiveness of Noninvasive Phrenic Nerve Neuromodulation in Shoulder Pain and Hepatobiliary Visceral Comorbidity., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Pain, particularly shoulder pain, is a social and economic problem worldwide. Although visceral pathology is not yet taken into account in the diagnosis of these pains, it is likely that on numerous occasions the hepatobiliary visceral condition causes referred pain in the metameric area belonging to the shoulder due to the involvement of the phrenic nerve. Therefore, the aim of this project is to study the response of treatment by neuromodulation of the phrenic nerve for shoulder pain in patients with associated hepatobiliary pathologies, assessing the possible visceral involvement in the symptomatology., conditionsModule conditions: Shoulder Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Phrenic nerve neuromodulation, interventions name: common Physical therapy, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale, secondaryOutcomes measure: Algometry, secondaryOutcomes measure: Goniometry passive, secondaryOutcomes measure: Quick Dash questionnaire, secondaryOutcomes measure: Goniometriy active, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centro de Salud Ronda Histórica, status: RECRUITING, city: Sevilla, zip: 41008, country: Spain, contacts name: Deseada López Carballo, Dra, role: CONTACT, email: [email protected], geoPoint lat: 37.38283, lon: -5.97317, locations facility: Centro de Salud las Letanías, status: RECRUITING, city: Sevilla, zip: 41013, country: Spain, contacts name: Alicia Valero Sáinz, role: CONTACT, phone: 649532242, phoneExt: +34, email: [email protected], geoPoint lat: 37.38283, lon: -5.97317, locations facility: Centro de Salud Bellavista, status: RECRUITING, city: Sevilla, zip: 41014, country: Spain, contacts name: María Isabel Morilla Párraga, role: CONTACT, phone: 609582376, phoneExt: +34, email: [email protected], geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
protocolSection identificationModule nctId: NCT06296966, orgStudyIdInfo id: VP-VSJ-110-2201, briefTitle: A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Vanda Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye., conditionsModule conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: VSJ-110, interventions name: Placebo, outcomesModule primaryOutcomes measure: Schirmer's Tear Test, secondaryOutcomes measure: Ocular Staining, secondaryOutcomes measure: Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanda Investigational Site, status: RECRUITING, city: Andover, state: Massachusetts, zip: 01810, country: United States, contacts name: Vanda Pharmaceuticals Inc., role: CONTACT, phone: 202-734-3400, email: [email protected], geoPoint lat: 42.65843, lon: -71.137, hasResults: False
protocolSection identificationModule nctId: NCT06296953, orgStudyIdInfo id: PeriSaFe01, secondaryIdInfos id: CIV-23-11-044875, type: OTHER, domain: Swedish Medical Product Agency, briefTitle: Safety & Feasibility of PERIsign System in Demonstrating Involuntary Muscle Defense as a Sign of Peritonitis in Subjects With Appendicitis, acronym: PeriSaFe01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: STB INN AB, class: INDUSTRY, collaborators name: Scandinavian CRO, collaborators name: Region Halland, descriptionModule briefSummary: This will be an explorative, proof-of-principle, open, multi-center investigation.The investigation aims to investigate the safety of the PERIsign system and the ability of physicians to differentiate between healthy individuals and subjects with involuntary muscle defense as a sign of peritonitis by utilizing PERIsign data. The investigation will include a total of 20 subjects admitted to hospital for suspected appendicitis and planned for emergency surgery and 20 healthy volunteers. Both male and female subjects aged 18-70 years will be enrolled.All subjects will undergo PERIsign examinations. Subjects with suspected appendicitis will undergo 1-2 PERIsign examinations before their planned appendectomy surgery. For the healthy volunteers, there is only 1 PERIsign examination. During each examination, 4 PERIsign curves will be obtained, one from each quadrant of the abdomen. The attending physician will interpret the appearance of the PERIsign curves of all subjects, including those from the healthy volunteers. The duration of the PERIsign examination will be documented, and usability data will be gathered, including the need for sensor adjustments, subject perception of the examination, and any discomfort experienced. In addition, blinded physicians will evaluate all subjects' PERIsign curves and determine whether each subject has involuntary muscle defense as a sign of peritonitis. These blinded physicians will have access to all 4 PERIsign curves obtained during each examination, while other data will not be disclosed to them.Safety will be evaluated through analysis of reported adverse events and device deficiencies, conditionsModule conditions: Appendicitis Acute, conditions: Appendicitis, conditions: Abdominal Pain, conditions: Peritonitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PERIsign examination, outcomesModule primaryOutcomes measure: Proportion of subjects experiencing any adverse events during the examination, primaryOutcomes measure: Proportion of device deficiencies during the evaluation, secondaryOutcomes measure: To estimate the sensitivity and specificity of diagnosing pathological muscle defense when using the PERIsign system, secondaryOutcomes measure: Proportion of examinations of the PERIsign system that its performed without usability issues., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hallands Sjukhus Halmstad, status: RECRUITING, city: Halmstad, country: Sweden, contacts name: Cleas Hjalmarsson, Ass. Prof., role: CONTACT, contacts name: Åsa Anveden, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 56.67446, lon: 12.85676, locations facility: Hallands Sjukhus Varberg, status: RECRUITING, city: Varberg, country: Sweden, contacts name: Claes Hjalmarsson, ass. Prof, role: CONTACT, contacts name: Stefan Lindskog, ass. prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.10557, lon: 12.25078, hasResults: False
protocolSection identificationModule nctId: NCT06296940, orgStudyIdInfo id: WEST 2.0, briefTitle: Written Exposure in Substance Treatment, acronym: WEST, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Potomac Health Foundations, class: OTHER, collaborators name: University of Maryland, Baltimore County, descriptionModule briefSummary: The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?, conditionsModule conditions: Posttraumatic Stress Disorder, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Written Exposure Therapy, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Efficacy of WET, secondaryOutcomes measure: Feasibility of WET delivered in residential SUD treatment context, secondaryOutcomes measure: Acceptability of WET delivered in residential SUD treatment context, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maryland Treatment Centers, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21229, country: United States, contacts name: Kevin Wenzel, PhD, role: CONTACT, phone: 410-233-1400, email: [email protected], contacts name: Marc Fishman, MD, role: CONTACT, phone: 410.233.1400, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06296927, orgStudyIdInfo id: SumeyyeKose-E.138186, briefTitle: The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening., conditionsModule conditions: Mammography Screening, conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a randomized controlled two-group study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Freedom Technique, outcomesModule primaryOutcomes measure: Anxiety, primaryOutcomes measure: Pain Level, secondaryOutcomes measure: Satisfaction Level, secondaryOutcomes measure: Cortisol Level, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center, city: Istanbul, country: Turkey, contacts name: SUMEYYE KOSE, role: CONTACT, phone: 2163961630, phoneExt: 6173, email: [email protected], contacts name: Sümeyye Köse, Phd Student, role: PRINCIPAL_INVESTIGATOR, contacts name: Handan Özcan, Assoc.Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Türkinaz Aşti, Prof.Dr., role: SUB_INVESTIGATOR, contacts name: Fatih Hacımustafaoğlu, Lecturer Dr., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06296914, orgStudyIdInfo id: 89776, briefTitle: A mHealth System for Patients With POTS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jami Warren, class: OTHER, descriptionModule briefSummary: Postural Orthostatic Tachycardia Syndrome (POTS) affects approximately 500,000 - 3 million Americans. This number will only increase due to the large number of patients experiencing POTS due to "long COVID." POTS patients experience several symptoms, including tachycardia, palpitations, dizziness, and pre-syncope or syncope, among others. POTS can be very debilitating and not only affect patients physically but also emotionally and financially. It takes an average of four years and seven doctors for POTS patients to achieve a diagnosis and it is often a frustrating and negative experience fraught with misdiagnoses, stigma, and depression and anxiety. Recent research demonstrates that mHealth technology may be one way that POTS patients can improve their experience in the healthcare system by providing objective data to their healthcare providers. Patients may also better take care of themselves through symptom monitoring and instant patient education via mHealth technology. The two study aims are: 1) Developing a mHealth app to improve the delay to diagnosis and the quality of life of POTS patients; and 2) Evaluate the usability and feasibility of the mHealth app and study design. To achieve these aims, researchers in this study will work with a programmer and leaders from the mHealth Application Modernization and Mobilization Alliance (MAMMA) and stakeholders (patients, caregivers, and providers) to co-design a mHealth app for POTS patients, including key educational components guided by the IDEA model, an instructional risk communication approach. A group of diagnosis-seeking POTS (n=20) patients will pilot test the app and provide feedback for improvement as well as evaluate its usability. Results from this study will allow researchers to acquire necessary data to apply for external funding to conduct a larger clinical trial to evaluate its influence on health outcomes, such as patient experience during visits with physicians, perceived stigma, and time to diagnosis., conditionsModule conditions: POTS - Postural Orthostatic Tachycardia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: POTSapp, interventions name: Waitlist Control, outcomesModule primaryOutcomes measure: Change in POTSapp Usability as measured by uMARS, primaryOutcomes measure: Change in POTSapp Usage, primaryOutcomes measure: Change in POTSapp Usability as measured by Health-ITUES, primaryOutcomes measure: Change in POTSapp Effectiveness as measured by Message Effectiveness scale, secondaryOutcomes measure: Change in Participant Quality of Life, secondaryOutcomes measure: Change in Doctor Patient Communication (DPC), secondaryOutcomes measure: Adapted IBS Perceived Stigma Scale, secondaryOutcomes measure: Cognitive Learning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40506, country: United States, contacts name: Jami Warren, PhD, role: CONTACT, phone: 859-323-1100, email: [email protected], geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
protocolSection identificationModule nctId: NCT06296901, orgStudyIdInfo id: 202310353, briefTitle: To Wipe or Not To Wipe?: That Is The Question, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Joanna A. Orzel, class: OTHER, descriptionModule briefSummary: The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI., conditionsModule conditions: Urinary Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Perineal Wipe, outcomesModule primaryOutcomes measure: Rate of Contamination, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06296888, orgStudyIdInfo id: P-2022-673, secondaryIdInfos id: 2203718, type: OTHER, domain: De Videnskabsetiske Medicinske Komiteer, briefTitle: Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome, acronym: RABAAF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-08-09, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jim Hansen, class: OTHER, collaborators name: University Hospital, Gentofte, Copenhagen, collaborators name: Biosense Webster, Inc., descriptionModule briefSummary: Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Radiofrequency balloon catheter ablation, outcomesModule primaryOutcomes measure: Proportion of durably isolated PVs observed at repeat EP study, secondaryOutcomes measure: Proportion of patients with durable isolation of all PVs observed at repeat EP study, secondaryOutcomes measure: Proportion of patients remaining free from recurrence of ATA after the initial PVI, secondaryOutcomes measure: Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI, secondaryOutcomes measure: Complications, otherOutcomes measure: Proportion of patients remaining free from recurrence of ATA after the repeat EP study, otherOutcomes measure: Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gentofte Hospital, city: Hellerup, zip: 2820, country: Denmark, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False
protocolSection identificationModule nctId: NCT06296875, orgStudyIdInfo id: KAMM, briefTitle: The Krill Ageing Muscle Mechanisms (KAMM) Study, acronym: KAMM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Glasgow, class: OTHER, descriptionModule briefSummary: This study aims to determine the mechanisms via which krill oil supplementation increases muscle strength and whether this translates to improvements in gait and functional characteristics in older adults. The studies we will carry out will establish, in healthy older adults, the effects of 6 months of supplementation with krill oilObjective 1) Muscle structure and function Hypothesis: Krill oil supplementation will increase muscle size and strength alongside positive changes in muscle architecture (pennation angle and fascicle length).Objective 2) Neuromuscular control and central nervous system (CNS) function Hypothesis: Krill oil supplementation will improve Neuromuscular Junction (NMJ) transmission stability and increase central drive and intramuscular coherence, as a measure of muscle synergy.Objective 3) Gait and functional characteristics Hypothesis: Krill oil supplementation will improve gait and functional characteristics., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1:1 parallel group design, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: All supplements will be matched for taste and look, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Vegetable oil, interventions name: Krill oil, outcomesModule primaryOutcomes measure: Grip strength, primaryOutcomes measure: Neuromuscular junction transmission instability, primaryOutcomes measure: Gait speed, secondaryOutcomes measure: Knee extensor maximal torque, secondaryOutcomes measure: Vastus lateralis muscle cross sectional area, secondaryOutcomes measure: Vastus lateralis pennation angle, secondaryOutcomes measure: Vastus lateralis fascicle length, secondaryOutcomes measure: Erythrocyte fatty acid composition, secondaryOutcomes measure: Knee extensor force steadiness, secondaryOutcomes measure: Vastus lateralis motor unit conduction velocity, secondaryOutcomes measure: Vastus lateralis and vastus medialis intramuscular coherence, secondaryOutcomes measure: Hand flexor muscles intermuscular coherence, secondaryOutcomes measure: Cortico-muscular coherence between sensory motor cortex and hand extensor muscles, secondaryOutcomes measure: Femoral Nerve Stimulation, secondaryOutcomes measure: Transcranial Magnetic Stimulation (TMS), secondaryOutcomes measure: TMS Inhibition, secondaryOutcomes measure: TMS Excitation, secondaryOutcomes measure: Gait characteristics during 4m walk test and the timed up and go test, secondaryOutcomes measure: Gait cycle with leg support parameters, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 90 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Glasgow, city: Glasgow, country: United Kingdom, geoPoint lat: 55.86515, lon: -4.25763, hasResults: False
protocolSection identificationModule nctId: NCT06296862, orgStudyIdInfo id: STUDY00005563, briefTitle: Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: Emory University, descriptionModule briefSummary: The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Approaches to Stop Hypertension Diet, outcomesModule primaryOutcomes measure: B-natriuretic peptide (BNP), secondaryOutcomes measure: N-terminal-proBNP (NT-proBNP), secondaryOutcomes measure: Systolic and Diastolic Pulmonary Artery Pressures, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 110 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Clinical Cardiovascular Research Center (ECCRI), city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Arshed A Quyyumi, MD, PhD, role: CONTACT, phone: 404-727-6635, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, hasResults: False
protocolSection identificationModule nctId: NCT06296849, orgStudyIdInfo id: 00007344, briefTitle: Dyadic Financial Incentive Treatments for Dual Smoker Couples, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: McMaster University, collaborators name: University of Kentucky, descriptionModule briefSummary: Smokers partnered with other smokers (i.e., dual-smoker couples) represent \~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population., conditionsModule conditions: Smoking, Cigarette, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Financial Incentive Treatment (FIT), outcomesModule primaryOutcomes measure: Point-Prevalence Abstinence at End of Treatment, secondaryOutcomes measure: Point-Prevalence Abstinence After Treatment, secondaryOutcomes measure: Point-Prevalence Abstinence at First Follow-up, secondaryOutcomes measure: Point-Prevalence Abstinence at Second Follow-up, secondaryOutcomes measure: Partner Point-Prevalence Abstinence, secondaryOutcomes measure: Smoking Heaviness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Georgia, status: RECRUITING, city: Athens, state: Georgia, zip: 30602, country: United States, contacts name: Michelle R vanDellen, PhD, role: CONTACT, email: [email protected], geoPoint lat: 33.96095, lon: -83.37794, hasResults: False
protocolSection identificationModule nctId: NCT06296836, orgStudyIdInfo id: 2024-001, briefTitle: Effect of Continuing Versus Holding Metformin During Hospitalizations., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: Emily Hanners, collaborators name: Dulal Bhaumik, collaborators name: Avisek Datta, collaborators name: Peggy Choye, collaborators name: Hailey Soni, collaborators name: Annesti Elmasri, collaborators name: Julie Jun, collaborators name: Colin Goodman, descriptionModule briefSummary: A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, parallel, prospective trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: Mean glucose levels, secondaryOutcomes measure: Incidence of hyperglycemia greater than 300 mg/dl., secondaryOutcomes measure: Incidence of hypoglycemia (Glu = 54 - 70)., secondaryOutcomes measure: Incidence of moderate hypoglycemia (Glu < 54), secondaryOutcomes measure: Incidence of severe hypoglycemia (Glu < 54 with symptoms), secondaryOutcomes measure: Mean lactic acid levels., secondaryOutcomes measure: Incidence of lactic acid levels greater than 2.0., secondaryOutcomes measure: Mean anion gap., secondaryOutcomes measure: Incidence of anion gap > 11, secondaryOutcomes measure: Incidence of elevated lactic acid level or anion gap., secondaryOutcomes measure: Incidence of inadvertently not continuing metformin on discharge, secondaryOutcomes measure: GI adverse effects, secondaryOutcomes measure: Mortality, otherOutcomes measure: Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, city: Chicago, state: Illinois, zip: 60612, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06296823, orgStudyIdInfo id: 22-0466, briefTitle: Biomarkers for Peripheral Circadian Clocks in Humans, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Boulder, class: OTHER, collaborators name: University of Colorado, Denver, descriptionModule briefSummary: The purpose of this project is to improve our understanding of peripheral circadian rhythms in humans. Circadian clocks are present in most tissues of the body with importance for optimal physiological function, health, and behavior. This project will utilize simulated jetlag protocols to systematically test novel hypotheses about the regulation of peripheral circadian rhythms in humans. Specifically, we will examine how changes in the time of when we are exposed to light and the timing of when we eat impacts proteins in the blood and saliva that represent rhythms from clocks in the brain (e.g., rhythms of the hormones melatonin and cortisol coordinated by the brain) and rhythms from clocks in body tissues (e.g., proteins made by immune and bone cells, and cells in the stomach and liver). We also aim to discover new blood-based biomarkers of peripheral rhythms in humans. We anticipate our findings will be the first step in developing novel circadian based treatments for aligning peripheral clocks under conditions such as jetlag, and for developing novel circadian biomarkers that will advance our scientific understanding of circadian rhythms., conditionsModule conditions: Circadian Rhythms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Simulated jetlag protocol, outcomesModule primaryOutcomes measure: PYY, primaryOutcomes measure: Ghrelin, primaryOutcomes measure: Leptin, primaryOutcomes measure: CRP, primaryOutcomes measure: OMD, primaryOutcomes measure: PAI-1, primaryOutcomes measure: IgE, primaryOutcomes measure: CCL18, primaryOutcomes measure: PTH, secondaryOutcomes measure: Glucose, secondaryOutcomes measure: Insulin, secondaryOutcomes measure: Proteomics, otherOutcomes measure: Melatonin, otherOutcomes measure: Cortisol, otherOutcomes measure: Core body temperature, otherOutcomes measure: Skin temperature, otherOutcomes measure: Cognition, otherOutcomes measure: Blood pressure, otherOutcomes measure: Metabolomics (grant application planned to analyze not currently funded), otherOutcomes measure: Oral microbiome (grant application planned to analyze not currently funded), otherOutcomes measure: Skin microbiome (grant application planned to analyze not currently funded), eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sleep and Chronobiology Laboratory, status: RECRUITING, city: Boulder, state: Colorado, zip: 80303, country: United States, contacts name: Kenneth Wright, role: CONTACT, phone: 303-735-1923, email: [email protected], geoPoint lat: 40.01499, lon: -105.27055, hasResults: False
protocolSection identificationModule nctId: NCT06296810, orgStudyIdInfo id: 23-0847, briefTitle: Adaptive DBS to Offset STN Dysregulation During Exercise in PD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: aDBS, outcomesModule primaryOutcomes measure: identification of L-beta frequency peak power, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296797, orgStudyIdInfo id: 5R18HS029432-02, type: AHRQ, link: https://reporter.nih.gov/quickSearch/5R18HS029432-02, secondaryIdInfos id: R18HS029432, type: AHRQ, link: https://reporter.nih.gov/quickSearch/R18HS029432, briefTitle: Patient-centered Information on Permanent Contraception, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Essential Access Health, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.Participants will:* Complete a baseline survey* Receive access to web-based educational resources* Complete a brief follow up survey immediately after exploring these web-based resources* Complete a follow-up survey 3 months after enrollingThe investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization., conditionsModule conditions: Contraception, conditions: Reproductive Behavior, conditions: Contraception Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Control arm: Existing educational website, interventions name: Advancing Access Website, outcomesModule primaryOutcomes measure: Perceived Access to Long Acting Contraceptives, secondaryOutcomes measure: Person-Centered Contraceptive Counseling Measure, secondaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems, secondaryOutcomes measure: Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI), secondaryOutcomes measure: Knowledge of Long-Acting Contraceptives, secondaryOutcomes measure: Use of preferred method of contraception, secondaryOutcomes measure: Would recommend website to a friend, otherOutcomes measure: Suggestions for how to improve web-based resources for people considering permanent contraception., eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Eleanor Schwarz, MD, MS, role: CONTACT, email: [email protected], contacts name: Hannah Begna, MS, role: CONTACT, email: [email protected], geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
protocolSection identificationModule nctId: NCT06296784, orgStudyIdInfo id: PG/2021/8551, briefTitle: An E-health Psychoeducation for People With Bipolar Disorders, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-26, primaryCompletionDateStruct date: 2021-11-15, completionDateStruct date: 2021-11-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Cagliari, class: OTHER, collaborators name: Alessandra Perra, descriptionModule briefSummary: This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic, conditionsModule conditions: Bipolar Disorder, conditions: Psychoeducation, conditions: COVID-19 Pandemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Open-label cross-over randomized controlled trial (two arms), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: e-health psychoeducation, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), primaryOutcomes measure: Hamilton Depression Rating Scale (HDRS21), primaryOutcomes measure: Short Form Health Survey (SF-12), primaryOutcomes measure: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Giovanni di Dio Hospital, city: Cagliari, state: CA, zip: 09100, country: Italy, geoPoint lat: 39.23054, lon: 9.11917, hasResults: False
protocolSection identificationModule nctId: NCT06296771, orgStudyIdInfo id: 12345678280233, secondaryIdInfos id: UBath, type: REGISTRY, domain: Chatwalai, briefTitle: The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial, acronym: CARE training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-22, primaryCompletionDateStruct date: 2025-02-22, completionDateStruct date: 2025-05-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, descriptionModule briefSummary: The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are:1. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI2. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes., conditionsModule conditions: Spinal Cord Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Dietary energy restriction group (D), interventions name: Dietary energy restriction and exercise group (D+E), outcomesModule primaryOutcomes measure: Lipid profile, primaryOutcomes measure: Fasting insulin concentration, primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Resting matabolic rate, secondaryOutcomes measure: Body mass, secondaryOutcomes measure: Waist and hip circumference, secondaryOutcomes measure: Height, secondaryOutcomes measure: Total body fat percentage, secondaryOutcomes measure: Total Fat-Free Mass, secondaryOutcomes measure: Visceral Adipose Tissue, secondaryOutcomes measure: Total Fat Mass, secondaryOutcomes measure: Muscle, adipose and bone cross-sectional areas around the tibia and femur, secondaryOutcomes measure: Bone geometry and tissue densities around the tibia and femur, secondaryOutcomes measure: adipose tissue, secondaryOutcomes measure: Upper extremity muscle strength, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Shoulder Pain, secondaryOutcomes measure: Energy intake and dietary macronutrient composition, secondaryOutcomes measure: Energy expended in different physical activity intensities (MET categories) (kJ or kcal), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bath, city: Bath, state: England, zip: BA2 7AY, country: United Kingdom, contacts name: James Bilzon, PhD, role: CONTACT, email: [email protected], contacts name: Jennifer Maher, PhD, role: CONTACT, email: [email protected], contacts name: Chatwalai Sonthikul, Master degree, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.3751, lon: -2.36172, hasResults: False
protocolSection identificationModule nctId: NCT06296758, orgStudyIdInfo id: SiFi_HIP FRACTURE, briefTitle: SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study., conditionsModule conditions: Hip Fractures, conditions: Surgery, conditions: Anesthesia, Local, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A concealed-allocation parallel-group blinded randomized controlled clinical, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Regional anesthesia, outcomesModule primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Postoperative analgesics administered, secondaryOutcomes measure: Mobilization, secondaryOutcomes measure: Time to readiness for discharge, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alberta Hospital, city: Edmonton, state: Alberta, zip: t6g2b7, country: Canada, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False
protocolSection identificationModule nctId: NCT06296745, orgStudyIdInfo id: 2024-KY-008-01, briefTitle: Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-01-20, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib., conditionsModule conditions: Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Pemetrexed, outcomesModule primaryOutcomes measure: Clinical response rate, primaryOutcomes measure: Neurological progression-free survival (NPFS), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296732, orgStudyIdInfo id: NCPHOI-2024-01, briefTitle: Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification, acronym: ANLAP-R, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2026-10-26, completionDateStruct date: 2031-11-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Federal Research Institute of Pediatric Hematology, Oncology and Immunology, class: OTHER, collaborators name: Corporate Fund University Medical Centre, descriptionModule briefSummary: Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma., conditionsModule conditions: Neuroblastoma, conditions: Ganglioneuroma, conditions: Ganglioneuroblastoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Duration of surgery intervention, outcomesModule primaryOutcomes measure: Duration of surgery intervention, secondaryOutcomes measure: The influence of surgical risk factors, secondaryOutcomes measure: Cases of conversion from laparoscopic to cavity access, secondaryOutcomes measure: Comparison of surgeon's visual assessment of the tumor resection, secondaryOutcomes measure: 1-, 3-, 5-years local recurrence-free survival, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Research Institute of Pediatric Hematology, Oncology and Immunology, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Dmitry m Akhaladze, MD, Doc, role: CONTACT, phone: +7 (905) 587-89-92,, email: [email protected], geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
protocolSection identificationModule nctId: NCT06296719, orgStudyIdInfo id: ACP Community 2024, briefTitle: The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity., conditionsModule conditions: Old Age, conditions: Family Members, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chit-Chat, outcomesModule primaryOutcomes measure: ACP engagement, secondaryOutcomes measure: Knowledge of ACP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296706, orgStudyIdInfo id: HB1801-010, briefTitle: A Clinical Study of Docetaxel for Injection (Albumin-bound) in Patients With Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 630, type: ESTIMATED, armsInterventionsModule interventions name: Docetaxel for injection (Albumin-bound), interventions name: Taxotere (docetaxel), outcomesModule primaryOutcomes measure: OS, secondaryOutcomes measure: ORR by IRC, secondaryOutcomes measure: ORR by investigator, secondaryOutcomes measure: PFS, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DoR, secondaryOutcomes measure: AE and SAE, secondaryOutcomes measure: Plasma concentration of docetaxel (free and total), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296693, orgStudyIdInfo id: 2023.062(051-DEFI/053-CE), briefTitle: Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children, acronym: POCUS-L, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centro Hospitalar Universitário de Santo António, class: OTHER, descriptionModule briefSummary: 1. Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.2. Who can participate: The investigators will include, consecutively, all children aged \>12 months and \<18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation.3. What does the study involve: The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary.4. What are the possible benefits and risks of participating: Children will have a more frequent and serial assessment of CAP, which does not involve risks.5. Where is the study run from: The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre.6. When is the study starting and how long is it expected to run for:The recruitment period is expected to start in January/2024 and end in January 2025., conditionsModule conditions: Pneumonia, conditions: Pneumonia, Viral, conditions: Pneumonia, Bacterial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized, outcomesModule primaryOutcomes measure: POCUS vs. CXR for the etiological diagnosis of CAP, secondaryOutcomes measure: CXR image vs. ultrasound, secondaryOutcomes measure: Clinical progression and ultrasound images, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 12 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296680, orgStudyIdInfo id: EGE_UNI_SEVCAN_OZ_KAHVECI_0001, briefTitle: Reiki for Cancer: Pain, Anxiety, and Stress, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-02, primaryCompletionDateStruct date: 2022-11-30, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effects of Reiki, Sham Reiki, and Progressive Relaxation Exercise on the levels of pain, anxiety, and stress in cancer patients.The main questions it aims to answer are:* Question 1: The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group.* Question 2: The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group.* Question 3: The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group.* Question 4: The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group.* Participants have answered the questions in the Individual Identification Form, Visual Comparison Scale, State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest.* Afterwards, the patients in the intervention group received Reiki for four consecutive days, the patients in the placebo group received Sham Reiki, and the patients in the control group received Progressive Relaxation Exercise.* The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days, with an average of three minutes.* The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days, with an average of three minutes.* Progressive Relaxation Exercise (PRE) group patients received PRE for four days.* On the 4th day, pain and anxiety levels (0-10 Likert-type scale) of the patients were evaluated after the last applications.* On the 21st day, the day of the next chemotherapy cycle, pain and anxiety levels were evaluated, state anxiety scale and perceived stress scale were administered, and serum cortisol level was evaluated in the morning before the start of chemotherapy.* At the 3rd month follow-up, pain and anxiety levels (0-10 Likert-type scale), state anxiety scale and perceived stress scale were evaluated., conditionsModule conditions: Therapeutic Touch, conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: In order to prevent assessment bias, blinding was implemented throughout the collection of data from patients, evaluation of the effectiveness and reliability of the applied dependent variables, data processing, reporting, and statistical analysis. The researcher was provided with a randomization list by a statistical expert. The researcher was included in the study without knowing which group the patients would be assigned to, and the patients were also enrolled without knowledge of their group assignment. Therefore, this study was conducted as a three-arm, double-blind, randomized follow-up study in the experimental research model, with intervention, placebo, and control groups., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: Reiki, interventions name: Sham Reiki, interventions name: Progressive Relaxation Exercise, outcomesModule primaryOutcomes measure: Stress levels, secondaryOutcomes measure: Anxiety levels, secondaryOutcomes measure: Pain levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ege University, city: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
protocolSection identificationModule nctId: NCT06296667, orgStudyIdInfo id: P.T.REC/012/003644, briefTitle: Effect of Core Muscles Training On Patients With Chronic Mechanical Low Back Pain According To SALIBA'S Postural Classification System, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study is designed as a pre and post experimental study. The purposes of this study are to evaluate the effect of core muscles training in patients with chronic mechanical low back pain according to SALIBA'S postural classification system (SPCS) in terms of pain intensity, function, and core muscles endurance., conditionsModule conditions: Chronic Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: core muscles training exercises, outcomesModule primaryOutcomes measure: pain intensity., primaryOutcomes measure: function disability, primaryOutcomes measure: core muscles endurance, otherOutcomes measure: participants gender will be male and females, their age in years,their height in meters,weight in kilograms., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University,Faculty of Physical Therapy, city: Giza, zip: 11432, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06296654, orgStudyIdInfo id: 25/2021-22 dt. Dec. 12,2021, briefTitle: Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-20, primaryCompletionDateStruct date: 2022-10-21, completionDateStruct date: 2022-10-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Bahrain, class: OTHER, descriptionModule briefSummary: This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD).The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not., conditionsModule conditions: Self-Efficacy, conditions: Self-Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Empowerment-Based Interventions, interventions name: Standard Health Education, outcomesModule primaryOutcomes measure: Sickle Cell Self-Efficacy, secondaryOutcomes measure: Self-Care Capacity, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: College of Health and Sport Sciences, University of Bahrain, city: Manama, zip: 11511, country: Bahrain, geoPoint lat: 26.22787, lon: 50.58565, hasResults: False
protocolSection identificationModule nctId: NCT06296641, orgStudyIdInfo id: AAAU9477, briefTitle: Needs Navigation for Caregivers of AYAs, acronym: Cope-CAYAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Columbia University, class: OTHER, descriptionModule briefSummary: The overall aim of the study is to address unmet health-related social needs and reduce outcome disparities among AYA cancer survivors. Aim 1 aimed to refine a needs navigation model in partnership with expert consultants. Aim 2 and 3 will involve the deployment and pilot testing of the adapted needs navigation intervention among caregivers of younger AYAs with cancer., conditionsModule conditions: Cancer in Adolescence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants who screen positive all move forward to receive the intervention, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Needs navigation intervention, outcomesModule primaryOutcomes measure: Number of (OR percentage of) participants who completed the intervention, primaryOutcomes measure: Percentage of eligible participants who consented to be in study, secondaryOutcomes measure: Personal Financial Wellness Scale (PFWS) / Comprehensive Score of Financial Toxicity (COST measure), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 26 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Columbia University Irving Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Melissa Beauchemin, PhD, MSN,CPNP-PC, CPO, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06296628, orgStudyIdInfo id: 2000037049, secondaryIdInfos id: 000, type: OTHER, domain: CTGTY, briefTitle: Rehabilitation Device for Hand Mirror Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: Management Center Innsbruck (MCI), Austria, collaborators name: Yale School of Engineering Center for Engineering 26 Innovation and Design, descriptionModule briefSummary: This study is a randomized and open comparative study that uses two parallel groups: a control group training with conventional therapy and another group that trains with the device "Miraπ". The participants are patients with stroke with motor weakness in one hand. Two measurement visits are required. During those visits, different hand function assessments will be carried out to analyze the motor function of the subjects hand. The measurements will be done during their inpatient rehabilitation stay, one at time of admission and the second at discharge, each taking 20 minutes. In the time between the measurement visits, the hand therapy takes place fivemtimes a week., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are patients admitted to the acute inpatient rehabilitation unit for rehabilitation of the hand and fingers who have one paralyzed hand without pronounced spasticity., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Miraπ, interventions name: Mirror Therapy, outcomesModule primaryOutcomes measure: Change in Jebsen-Taylor Hand Function Test score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yale New Haven Health Inpatient Rehabilitation Unit, Bridgeport Hospital, city: Bridgeport, state: Connecticut, zip: 06610, country: United States, geoPoint lat: 41.16704, lon: -73.20483, hasResults: False
protocolSection identificationModule nctId: NCT06296615, orgStudyIdInfo id: 2020-022, briefTitle: Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2022-10-30, completionDateStruct date: 2022-10-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: ShangHai Ji Ai Genetics & IVF Institute, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about vaginal microbial characteristics in the patients under in vitro fertilization treatment. The study aims to address the following questions: (1) Is there any difference in microbial composition between the pregnancy and non-pregnancy groups? (2) Is there any differences in specific bacterial species between the two groups? (3) What are the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy? Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. The study will compare vaginal microbiota between pregnant and non-pregnant patients to assess its potential influence on clinical outcomes., conditionsModule conditions: Infertility, Female, conditions: Microbial Colonization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 161, type: ACTUAL, outcomesModule primaryOutcomes measure: Rate of clinical pregnancy, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Ji Ai Genetics & IVF Institute, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06296602, orgStudyIdInfo id: 2023/777, briefTitle: Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV), acronym: ANAPreP'HPV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-11-04, completionDateStruct date: 2024-11-04, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation., conditionsModule conditions: Pre-Exposure Prophylaxis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.A questionnaire will be completed by the doctor to record the data of interest., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: A prelevement for HPV genotyping and anal cytology will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections., outcomesModule primaryOutcomes measure: prevalence HPV, primaryOutcomes measure: typing HPV, secondaryOutcomes measure: High risk HPV risk factors, secondaryOutcomes measure: Cytologist abnormalies, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Besançon, status: RECRUITING, city: Besancon, zip: 25000, country: France, contacts name: Cédric LEBRETON, Dr, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, hasResults: False
protocolSection identificationModule nctId: NCT06296589, orgStudyIdInfo id: HT94252310861, briefTitle: Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure, acronym: PORT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Veterans Medical Research Foundation, class: OTHER, collaborators name: University of Minnesota, collaborators name: Center for Veterans Research and Education, descriptionModule briefSummary: The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are:Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?, conditionsModule conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Trauma Informed Guilt Reduction Therapy, interventions name: Prolonged Exposure Therapy, outcomesModule primaryOutcomes measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Brief Psychosocial Functioning Inventory (B-IPF), secondaryOutcomes measure: Trauma Related Guilt Inventory Cognitions Scale (TRGI), secondaryOutcomes measure: Trauma Related Shame Inventory (TRSI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Little Rock Veterans Health Care System (LRVHCS), city: Little Rock, state: Arkansas, zip: 72205, country: United States, contacts name: Brandon Griffin, role: CONTACT, phone: 501-257-1000, email: [email protected], geoPoint lat: 34.74648, lon: -92.28959, locations facility: Southeast Louisiana Veterans Health Care System (SLVHCS), city: New Orleans, state: Louisiana, zip: 70119, country: United States, contacts name: Laurel Franklin, PhD, role: CONTACT, phone: 800-935-8387, email: [email protected], geoPoint lat: 29.95465, lon: -90.07507, locations facility: William S. Middleton Memorial Hospital, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Michael Messina, PhD, role: CONTACT, phone: 608-284-6302, email: [email protected], geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06296576, orgStudyIdInfo id: CHM-2023/S49/06, briefTitle: Acceleration Time Assessment for Prediction of Critical Limb Ischemia, acronym: ATACLI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier le Mans, class: OTHER, descriptionModule briefSummary: Critical Limb Ischaemia (CLI), the final stage of arterial disease, is a therapeutic emergency whose prognosis depends largely on the time taken to diagnose it. The growing prevalence of this condition and the associated healthcare costs make it an important public health objective. Diagnostic criteria for Critical Limb Ischaemia differ between learned societies and countries.Its diagnosis is most frequently based on the combination of a clinical criterion (ischaemic decubitus pain and/or necrotic wounds, with a time to onset \> 2 weeks) and a haemodynamic criterion (ankle systolic pressure (ASP) \< 50mmHg or toe systolic pressure (TSP) \< 30 mmHg or transcutaneous oxygen pressure (TCPO2) \< 30 mmHg).Recent studies have highlighted the importance of pulsed Doppler flow analysis in quantifying arteriopathy of the lower limbs, both by systematically analysing flow modulation and by measuring the systolic rise time of distal arteries (dorsal artery of the foot and lateral plantar artery).The main aim of our study is therefore to validate a reliable and accessible diagnostic tool for screening patients suffering from CLI so that they can be referred to a reference centre as early as possible., conditionsModule conditions: Critical Limb Ischemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 431, type: ESTIMATED, armsInterventionsModule interventions name: arterial ultrasound scan, outcomesModule primaryOutcomes measure: Evaluate the intrinsic diagnostic performance of the maximum systolic rise time (TASmax) in the distal arteries of the foot, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de CHOLET, city: Cholet, zip: 49300, country: France, contacts name: Marie GAUME, role: CONTACT, email: [email protected], contacts name: Jean-Eudes TRIHAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.06667, lon: -0.88333, locations facility: Centre Hospitalier du Mans, city: Le Mans, zip: 72000, country: France, contacts name: Christelle JADEAU, role: CONTACT, phone: 02 44 71 07 81, email: [email protected], contacts name: Claire NEVEUX-BRECHETEAU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.0, lon: 0.2, hasResults: False
protocolSection identificationModule nctId: NCT06296563, orgStudyIdInfo id: SHR1316-ICC-SD-001, briefTitle: Perioperative Treatment of Resectable Intrahepatic Cholangiocarcinoma With the Combination of Adebrelimab and Apatinib and HAIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Lei ZHAO, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: HAIC, interventions name: Adebrelimab, interventions name: Apatinib, outcomesModule primaryOutcomes measure: Pathologic complete response (pCR), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Event free survival (EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Cancer Hospital and Institute, status: RECRUITING, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Lei Zhao, MD, role: CONTACT, phone: +86 053167626368, email: [email protected], contacts name: Peifei Sun, MD, role: CONTACT, phone: +86 053167626242, contacts name: Lei Zhao, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06296550, orgStudyIdInfo id: Dulce Digital CGM, briefTitle: Enhancing Digitally Delivered Diabetes Education With Real-Time CGM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Scripps Whittier Diabetes Institute, class: OTHER, descriptionModule briefSummary: The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients., conditionsModule conditions: Diabetes Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Dulce Digital Text Messaging Intervention, interventions name: CGM Device, outcomesModule primaryOutcomes measure: HbA1c, secondaryOutcomes measure: CGM Metric Time in Range, secondaryOutcomes measure: CGM Metric Time above Range, secondaryOutcomes measure: CGM Metric Time Below Range, secondaryOutcomes measure: Summary of Diabetes Self Care Activitiers (SDSCA) Survey, secondaryOutcomes measure: Diabetes Distress Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scripps Whittier Diabetes Institute, city: San Diego, state: California, zip: 92121-1520, country: United States, contacts name: Athena Philis-Tsimikas, MD, role: CONTACT, phone: 858-729-4830, email: [email protected], contacts name: Kallie Brown, MA, role: CONTACT, phone: 858-678-6294, email: [email protected], geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06296537, orgStudyIdInfo id: E-10840098-202.3.02-1434, briefTitle: Effectiveness of Balance Training And Dynamic Neuromuscular Stabilization Training in Amateur Athletes With Chronic Ankle Instability, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are:* Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?* Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?Participants will apply:* a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby.* balance training which consist of an effective postural stability program.* conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises.Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance., conditionsModule conditions: Ankle Inversion Sprain, conditions: Chronic Instability of Joint, conditions: Chronic Pain, conditions: Athlete Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is designed as a prospective, randomized, controlled study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic Neuromuscular Stabilization Training (DNS), interventions name: Balance Training, interventions name: Conventional Training, outcomesModule primaryOutcomes measure: Star Excursion Balance Test, primaryOutcomes measure: Balance Error Scoring System (BESS), secondaryOutcomes measure: Foot and Ankle Ability Measurement (FAAM), secondaryOutcomes measure: Cumberland Ankle Instability Questionnaire, secondaryOutcomes measure: International Physical Activity Questionnaire - Short Form, secondaryOutcomes measure: Manual Muscle Strength Test with Hand Dynamometer, secondaryOutcomes measure: Single Heel Lift Test, secondaryOutcomes measure: Joint Position Sense Test, secondaryOutcomes measure: Foot Lift Test, secondaryOutcomes measure: Blazepod Reaction Time, secondaryOutcomes measure: Side Hop Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sevval Yeşilkır, status: RECRUITING, city: Istanbul, state: Beşiktaş, zip: 34347, country: Turkey, contacts name: Sevval Yeşilkır, role: CONTACT, phone: +90 530 869 64 76, email: [email protected], contacts name: Gizem Ergezen, role: CONTACT, phone: +90 216 681 24 70, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06296524, orgStudyIdInfo id: SPC-2022-09, briefTitle: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Maharishi Markendeswar University (Deemed to be University), class: OTHER, descriptionModule briefSummary: Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot., conditionsModule conditions: Flatfoot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Footcore exercises and conventional therapy, interventions name: conventional therapy, outcomesModule primaryOutcomes measure: Navicular Drop Test, primaryOutcomes measure: Harris Mat for Plantar Pressure Distribution, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: MMIPR, status: RECRUITING, city: Ambala, state: Haryana, zip: 133207, country: India, contacts name: Mousumi Saha, MPT, role: CONTACT, phone: +919366787310, email: [email protected], contacts name: subhasish chatterjee, Phd(NEURO), role: CONTACT, phone: +918950037407, email: [email protected], contacts name: subhasish chatterjee, Phd, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.36099, lon: 76.79782, hasResults: False
protocolSection identificationModule nctId: NCT06296511, orgStudyIdInfo id: Loughborough University, briefTitle: The Influence of Acute Moderate-intensity Continuous Exercise on Appetite Regulation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-23, primaryCompletionDateStruct date: 2023-11-07, completionDateStruct date: 2023-11-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Loughborough University, class: OTHER, descriptionModule briefSummary: A key area of obesity research has focused on the link between appetite, energy balance and weight control. Within this area, several appetite-related hormones and cellular cytokines have been identified as key signals influencing appetite and food intake. This includes the appetite-suppressing hormone oxyntomodulin (OXM) and a cellular stress-induced cytokine growth differentiation factor 15 (GDF-15).The aims of this study are: (1) to investigate the effect of acute moderate-intensity continuous exercise on oxyntomodulin and GDF-15 concentrations; (2) to investigate whether exercise-induced changes in circulating OXM and GDF-15 concentrations are correlated with subjective appetite perceptions and subsequent energy intake., conditionsModule conditions: Obesity, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Exercise, outcomesModule primaryOutcomes measure: Oxyntomodulin, primaryOutcomes measure: Growth Differentiation Factor 15, secondaryOutcomes measure: Visual analogue score (VAS) for subjective appetite, secondaryOutcomes measure: Energy intake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Loughborough University, city: Loughborough, zip: LE11 3TU, country: United Kingdom, geoPoint lat: 52.76667, lon: -1.2, hasResults: False
protocolSection identificationModule nctId: NCT06296498, orgStudyIdInfo id: 20230505HU, briefTitle: Application of L-PRF in Periodontal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-19, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center at San Antonio, class: OTHER, descriptionModule briefSummary: The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception., conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The proposed study is a split-mouth design, randomized, prospective clinical trial in which we will use either OFD alone or OFD + L-PRF for periodontal surgery. Both procedures are standard of care, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be blinded to the intervention which they are randomized to., whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Leukocyte Platelet-rich fibrin, interventions name: Standard of care OFD, outcomesModule primaryOutcomes measure: Probing depth, primaryOutcomes measure: Postoperative Pain (PROM), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Charles Powell, DDS, MS, role: CONTACT, phone: 210-567-3593, email: [email protected], geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06296485, orgStudyIdInfo id: IRB-1996616, secondaryIdInfos id: R01DK134446, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK134446, briefTitle: Safer Aging With Diabetes Monitoring, acronym: SAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2027-03-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Hypoglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3-arm pragmatic randomized clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Participant randomization status will be masked during data collection (baseline and follow-up surveys) by research assistants, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: SAGE Group Sessions, interventions name: SAGE Group Sessions + Diabetes Pharmacist, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Hypoglycemia aggregate outcome, secondaryOutcomes measure: Self-reported hypoglycemia, secondaryOutcomes measure: Hypoglycemia-related utilization, secondaryOutcomes measure: Diabetes Distress, secondaryOutcomes measure: Hypoglycemia Confidence, secondaryOutcomes measure: Hypoglycemia Distress, otherOutcomes measure: Technology Proficiency, otherOutcomes measure: Confidence in Adjusting Insulin, otherOutcomes measure: Insulin Adjustment, otherOutcomes measure: Caregiver Action, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296472, orgStudyIdInfo id: MDQ23, briefTitle: De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,* the experimental group will subsequently carry out a program of eccentric exercises., conditionsModule conditions: De Quervain Disease, conditions: Hand Tenosynovitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation, interventions name: Standard, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: Numeric Pain Rating Scale, secondaryOutcomes measure: Disabilities of Arm, Shoulder and Hand, secondaryOutcomes measure: Disabilities of Arm, Shoulder and Hand, secondaryOutcomes measure: Disabilities of Arm, Shoulder and Hand, secondaryOutcomes measure: Disabilities of Arm, Shoulder and Hand, secondaryOutcomes measure: Patient-Rated Wrist Evaluation, secondaryOutcomes measure: Patient-Rated Wrist Evaluation, secondaryOutcomes measure: Patient-Rated Wrist Evaluation, secondaryOutcomes measure: Patient-Rated Wrist Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, zip: 40136, country: Italy, contacts name: Fabio Vita, MD, role: CONTACT, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
protocolSection identificationModule nctId: NCT06296459, orgStudyIdInfo id: 20220556HU, briefTitle: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-21, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center at San Antonio, class: OTHER, descriptionModule briefSummary: A closed sinus augmentation is performed for dental implant placement., conditionsModule conditions: Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A 2 arm study using two methods of imaging in a participant, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: 3D R100 scanner, interventions name: Conventional Radiograph, outcomesModule primaryOutcomes measure: Dimensional Change in augmentation at 8mm, primaryOutcomes measure: Dimensional Change in augmentation at 10mm, primaryOutcomes measure: Dimensional Change in augmentation at 12mm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Charles Powell, DDS, MS, role: CONTACT, phone: 210-567-3593, email: [email protected], geoPoint lat: 29.42412, lon: -98.49363, hasResults: False