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protocolSection identificationModule nctId: NCT06306846, orgStudyIdInfo id: 11235794, briefTitle: Neoadjuvant SBRT in Localized Advanced HNSCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Jiang Feng, class: OTHER, descriptionModule briefSummary: The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy,meanwhile,the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body, reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC., conditionsModule conditions: Head and Neck Squamous Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: SBRT+immunochemotherpy, interventions name: Immunochemotherapy, interventions name: cetuximab+immunochemotharpy, outcomesModule primaryOutcomes measure: major pathology response (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Feng Jiang, MD, role: CONTACT, phone: 0086-571-88128202, email: jiangfeng@zjcc.org.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06306833, orgStudyIdInfo id: CLBP-sEMG-14022024, briefTitle: The Surface EMG Biofeedback as an Alternative Therapy to Reduce Chronic Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Amaila Fazal [afazal], class: OTHER, collaborators name: University of Karachi, descriptionModule briefSummary: The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78% leading towards different physiological and psychosocial alterations with the worst cases suffering from disabilities. CLBP is a multifactorial phenomenon in which age, gender, comorbidities, lifestyle conditions, profession, working hours, and different stressors play their roles in its causation. However, different therapeutic techniques have been determined to reduce CLBP. Thus, this study aimed to assess the effectiveness of the biofeedback surface EMG (sEMG) technique in reducing chronic low back pain among sufferers in the long run., 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: 200, type: ESTIMATED, armsInterventionsModule interventions name: Surface Electromyography (sEMG) Biofeedback, outcomesModule primaryOutcomes measure: Pain Intensity and interference, primaryOutcomes measure: Lower back pain related Disability, primaryOutcomes measure: Quality of Life with chronic low back pain, primaryOutcomes measure: Pain and Disability-related Anxiety, secondaryOutcomes measure: Substance P, secondaryOutcomes measure: Cortisol, secondaryOutcomes measure: Beta Endorphins, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Psychophysiology Lab, University of Karachi, status: RECRUITING, city: Karachi, state: Sindh, zip: 75270, country: Pakistan, contacts name: Shamoon Naushad, PhD, role: CONTACT, phone: 03333549258, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
protocolSection identificationModule nctId: NCT06306820, orgStudyIdInfo id: 36264MS257/7/2023, briefTitle: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries., conditionsModule conditions: Ultrasound Guided Recruitment Manauvere, conditions: End Expiratory Pressure, conditions: Pediatric Patients, conditions: Laparoscopic Abdominal Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Fixed PEEP, interventions name: Ultrasound-guided lung recruitment, interventions name: Individualized PEEP, outcomesModule primaryOutcomes measure: Intraoperative oxygenation, secondaryOutcomes measure: Lung ultrasound scores, secondaryOutcomes measure: Mean arterial blood pressure (MAP), secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Postoperative pulmonary complication, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Tanta University, status: RECRUITING, city: Tanta, state: El-Gharbia, zip: 31527, country: Egypt, contacts name: Reham M Rezk, MBBCH, role: CONTACT, phone: 00201013193723, email: rehamrezk95@gmail.com, contacts name: Soher M Soliman, MD, role: SUB_INVESTIGATOR, contacts name: Shaimaa F Abdelkader, MD, role: SUB_INVESTIGATOR, contacts name: Shaimaa E Shaban, MD, role: SUB_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
protocolSection identificationModule nctId: NCT06306807, orgStudyIdInfo id: AtlasUmkaya02, briefTitle: Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Techniques in Text Neck Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-31, primaryCompletionDateStruct date: 2024-03-14, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Atlas University, class: OTHER, descriptionModule briefSummary: Smartphones and tablets are increasingly widespread mobile technological devices used for many purposes such as communication, transportation, entertainment, education and security. Increasing use of mobile technology leads to various symptoms such as insomnia, difficulty concentrating and anxiety, especially musculoskeletal problems. "Text neck" is a musculoskeletal problem seen in individuals who use smartphones and tablets for a long time due to increased head and neck flexion posture. It causes neck, back, shoulder, and head pain, insomnia, tingling and numbness in the hands. Implementation of exercise programs for both preventive and therapeutic purposes is one of the main goals in this picture dominated by posture and pain problems. Proprioceptive neuromuscular facilitation (PNF) treatment technique; In the 1940s by H. Kabat and M. Knott, PNF was expressed as a means of facilitating neuromuscular responses by stimulation of proprioceptors. It is stated that it increases joint stabilization, strength, normal range of motion, endurance and circulation and is effective in improving coordination. Although PNF techniques have been used for different spinal problems, there is no study investigating PNF techniques in text neck syndrome. The study was aimed to compare the effect of a method including muscle relaxation in the anterior elevation direction and repetition techniques in the posterior depression direction from PNF neck patterns on pain intensity, neck normal range of motion, neck muscle endurance, posture and functionality in individuals with text neck syndrome with another method including ergonomic adjustments and simple cervical exercises recommended in the literature to be included in standard treatment., conditionsModule conditions: Neck Muscle Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Exercise program including active cervical range of motion, strengthening, and posture correction exercises and ergonomic modifications, interventions name: PNF exercise program, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Cervical range of motion, primaryOutcomes measure: Neck flexor-extensor muscle endurance test, primaryOutcomes measure: Posture, primaryOutcomes measure: Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Atlas University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06306794, orgStudyIdInfo id: 2011-KAEK-25 2023/12-26, briefTitle: Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Nurgül Tekin, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effect of using amigurumi octopus on the pain and comfort of the newborn in premature infants undergoing endotracheal aspiration.It is a randomized controlled quasi-experimental design. The study will be conducted in the neonatal intensive care unit of Health Sciences University Bursa High Specialization Training and Research Hospital. The population of the study will consist of preterm hospitalized in the neonatal intensive care unit during the period of the conducted study. In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups.PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used as a case report form for the collection of the study data. All the patients included in the study will be intervened by the nurse having a neonatal nursing experience by paying attention to aseptic conditions in accordance with the routine aspiration criteria of the unit. Standardization will be ensured by intervening in all patients with the same application by the same nurse.During the endotracheal aspiration procedure, the octopus will be given to experimental group 10 minutes before the procedure. Babies will be allowed to touch the octopus for 10 minutes during and after the procedure. Physiologic parameters of the infants before, during and after the procedure will be reported and recorded by camera. According to the video recordings, PIPP-R and PICS scale evaluations of the infants will be made by two research nurses other than the main researcher conducting the study. The routine aspiration application steps of the unit will be applied to the control group without any intervention., conditionsModule conditions: Pain, conditions: Premature Baby 26 to 32 Weeks, conditions: Premature Baby 33 to 36 Weeks, conditions: Aspiration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the calculation of the sample size, the power level is 80% and the significance level is 5%. It was determined by the statistical expert that the number of babies that should be included for each group is 26 and the total number of babies required for the whole study is 52 when the effect size is determined as 0.8 for the investigation of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable. Based on aforementioned information, the study sample was determined as 80 preterm infants in which 40 for experimental groups and 40 for control groups. Block randomization method will be applied for the randomization of the groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: crochet octopus, outcomesModule primaryOutcomes measure: pain in the during endotracheal aspiration, secondaryOutcomes measure: comfort in the during endotracheal aspiration, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 5 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306781, orgStudyIdInfo id: HI-IM-002, briefTitle: A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HCL001 Cell Injection (Homologous Allogeneic Hepatocytes) in Patients With Decompensated Cirrhosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: This study protocol is designed to evaluate the clinical efficacy, safety, and tolerability of HCL001 cell injection in the treatment of decompensated cirrhosis. The aim is to provide stronger evidence for the clinical application of HCL001 cell injection in the treatment of decompensated cirrhosis, thereby attempting to improve patients' survival and quality of life to meet the clinical needs for treating decompensated liver cirrhosis., conditionsModule conditions: Decompensated Cirrhosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: HCL001 cell (homologous allogeneic hepatocytes) injection, outcomesModule primaryOutcomes measure: Types and incidence of treatment-related adverse events., primaryOutcomes measure: Dose-Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), secondaryOutcomes measure: Child-Pugh grading., secondaryOutcomes measure: Number of participants with abnormal laboratory tests results, secondaryOutcomes measure: The percentage of participants with improved liver conditions (including changes in portal vein diam, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306768, orgStudyIdInfo id: STU00219979, briefTitle: Remote Therapeutic Monitoring Exercise Tracking, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Shirley Ryan AbilityLab, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform., conditionsModule conditions: Parkinson Disease, conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Activity Monitoring, outcomesModule primaryOutcomes measure: Physical Activity Metric 1, primaryOutcomes measure: Physical Activity Metric 2, secondaryOutcomes measure: Exercise Self Efficacy, secondaryOutcomes measure: Quality of Life from PROMIS 10-b, secondaryOutcomes measure: Quality of Life from PROMIS-29, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shirley Ryan AbilityLab, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Hannah Redd, DPT, role: CONTACT, email: hredd@sralab.org, contacts name: Kristen Hohl, DPT, role: CONTACT, email: khohl@sralab.org, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06306755, orgStudyIdInfo id: 2021YFC2500405, briefTitle: Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer, acronym: ERSS-EGC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2034-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China.A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000.In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment.Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups., conditionsModule conditions: Esophageal Cancer, conditions: Gastric Cancer, conditions: Precision Screening, conditions: Sequential Screening, conditions: Risk Stratification, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 21000, type: ESTIMATED, armsInterventionsModule interventions name: Risk Assessment and Individualized Surveillance, interventions name: Universal screening, outcomesModule primaryOutcomes measure: Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions, secondaryOutcomes measure: Response rate of endoscopic examination, secondaryOutcomes measure: Total screening costs, secondaryOutcomes measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Unit cost per detected early-stage upper gastrointestinal (esophageal/gastric) malignant lesions, secondaryOutcomes measure: Unit cost per detected upper gastrointestinal (esophageal/gastric) premalignant lesions, secondaryOutcomes measure: Satisfaction with the risk-based sequential screening modality, secondaryOutcomes measure: Rate of timely treatment, secondaryOutcomes measure: UGIC-specific mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Quality of life Scale Score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of genetics, Peking University Cancer Hospital & Institute, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Zhonghu He, role: CONTACT, email: zhonghuhe@bjcancer.org, contacts name: Zhonghu He, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06306742, orgStudyIdInfo id: ct9874, briefTitle: Open-label Placebo in Manual Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Studio Osteopatico Busto Arsizio, class: OTHER, descriptionModule briefSummary: to investigate the effects of placebo in patients affected by low-back pain., conditionsModule conditions: Low Back Pain, Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Open-label placebo, interventions name: Osteopathic manipulative treatment, outcomesModule primaryOutcomes measure: Change in Numeric Rating Scale, primaryOutcomes measure: Adverse effects, secondaryOutcomes measure: Change in measures of Von Frey filaments, secondaryOutcomes measure: Changes in algometer measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CTFO, status: RECRUITING, city: Saronno, state: Varese, zip: 21047, country: Italy, contacts name: CFTO, role: CONTACT, phone: +39 02 96701013, email: cfto@aimoedu.it, geoPoint lat: 45.62513, lon: 9.03517, hasResults: False
protocolSection identificationModule nctId: NCT06306729, orgStudyIdInfo id: 316308, briefTitle: Computational Assessment of Bioprosthetic Aortic Valve Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Royal Brompton & Harefield NHS Foundation Trust, class: OTHER, collaborators name: Edwards Lifesciences, collaborators name: Imperial College London, descriptionModule briefSummary: Bioprosthetic valves are usually made of biological tissue that are mounted to a frame and are designed to function similarly to a healthy natural valve. Edwards Magna Ease and Intuity Elite bioprosthetic valves have similar leaflets and mounting designs. However, the valves are implanted in the patient in different ways (one is stitched to the wall of the left ventricular outflow tract, and the other is held in place by the radial force of the valve skirt). The study aims to understand in more detail how the different valves interact with the left ventricular outflow tract and aortic root., conditionsModule conditions: CFD, conditions: Valve Heart Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, Magnetic Resonance Imaging, outcomesModule primaryOutcomes measure: blood flow velocities, primaryOutcomes measure: Time average wall shear stress (TAWSS), secondaryOutcomes measure: Patient's satisfaction, secondaryOutcomes measure: Evidence of major adverse cardiac and cerebrovascular events (MACCE), secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306716, orgStudyIdInfo id: LEO.2021.10, briefTitle: Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Smith & Nephew, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds., conditionsModule conditions: Chronic Wounds, conditions: Acute Wounds, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: RENASYS Film with AIRLOCK Technology, outcomesModule primaryOutcomes measure: Wound Healing Status, secondaryOutcomes measure: Percentage Reduction in Wound Volume from Baseline to Week 3, secondaryOutcomes measure: Percentage Reduction in Wound Area from Baseline to Week 3, secondaryOutcomes measure: Percentage Reduction in Wound depth from Baseline to Week 3, secondaryOutcomes measure: Percentage Area of Wound Bed Covered with Granulation Tissue, secondaryOutcomes measure: Peri-wound Pain Scores at Dressing Removal, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lawson Health Research Institute, city: London, state: Ontario, zip: N6C 2R5, country: Canada, contacts name: Teresa Novic, role: CONTACT, email: teresa.novick@lhsc.on.ca, contacts name: Adam Power, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False
protocolSection identificationModule nctId: NCT06306703, orgStudyIdInfo id: PhD Thesis of Duygu Sultan Oge, briefTitle: Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Duygu Sultan Oge, class: OTHER, descriptionModule briefSummary: The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods., conditionsModule conditions: Pelvic Floor Muscle Weakness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective randomized, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: healthcare provider performing USG evaluation person doing statistical analysis, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: group1, group2, group 3, outcomesModule primaryOutcomes measure: ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG), primaryOutcomes measure: Pelvic Floor Muscle Strength and Endurance:, primaryOutcomes measure: pelvic floor power, minimum and maximum muscle contraction values, secondaryOutcomes measure: DETAILED STORIES OF THE PATIENTS, secondaryOutcomes measure: Pelvic Floor Health Knowledge Test:, secondaryOutcomes measure: Global Pelvic Floor Disorder Questionnaire(GPFDQ), secondaryOutcomes measure: Visual Analog Scale (VAS) assessment for pelvic pain, secondaryOutcomes measure: Determining the severity of incontinence, secondaryOutcomes measure: Sensory Evaluation, secondaryOutcomes measure: Pelvic Floor Reflex Evaluation:, secondaryOutcomes measure: Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction, secondaryOutcomes measure: Pelvic organ prolapse evaluation, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306690, orgStudyIdInfo id: 6401, briefTitle: Biomarkers in Retinitis Pigmentosa, acronym: RPMARKER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence., outcomesModule primaryOutcomes measure: Retinal pigment epithelium changes in Retinitis Pigmentosa., secondaryOutcomes measure: Retinitis Pigmentosa biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maria Cristina Savastano, status: RECRUITING, city: Roma, zip: 00198, country: Italy, contacts name: Maria C Savastano, role: CONTACT, phone: 3200609905, email: mariacristina.savastano@gmail.com, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06306677, orgStudyIdInfo id: SH9H-2023-T369-1, briefTitle: Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, collaborators name: ShanghaiTech University, collaborators name: University of Roma La Sapienza, collaborators name: The University of Hong Kong, descriptionModule briefSummary: Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world., conditionsModule conditions: Periodontitis, conditions: Periodontal Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: AI-clincial-based hybrid system for radiographic image analysis, outcomesModule primaryOutcomes measure: Sensitivity measure, primaryOutcomes measure: Specificity measure, primaryOutcomes measure: The area under the receiver operating characteristic curve (AUC) measure, primaryOutcomes measure: Diagnostic accuracy, secondaryOutcomes measure: Assessment time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Perio-Implant Innovation Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201206, country: China, contacts name: Yuan Li, role: CONTACT, phone: 13916337473, email: ly9919@hotmail.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Prince Philip Dental Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: George Pelekos, role: CONTACT, email: george74@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: La Sapienza Dental School, status: RECRUITING, city: Roma, country: Italy, contacts name: Lorenzo Marini, role: CONTACT, email: lorenzo.marini@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06306664, orgStudyIdInfo id: PT.REC/012/004881, briefTitle: Effect of Two Different Modes of Polarized Polychromatic Non-coherent Light Therapy on Jumper's Knee, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-11-29, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purposes of this study are:1. To examine the combined effects of Yellow CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.2. To examine the combined effects of Green CPPNLT and conventional treatment on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee.3 3- To compare between the effects of Yellow CPPNLT and Green CPPNLT on pain intensity, pain pressure threshold, functional disability, and muscle strength in athletic jumper knee., conditionsModule conditions: Jumper's Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: double, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Bioptron, interventions name: Placebo Comparator, outcomesModule primaryOutcomes measure: Pain (Visual analogue scale)., primaryOutcomes measure: pain intensity (Pressure algometry), primaryOutcomes measure: Disability questionnaire (Victorian institute of sport assessment-patella)., primaryOutcomes measure: Muscle strength (Hand held dynamometer), otherOutcomes measure: Muscle strength and endurance ( Biodex-Isokinetic Dynamometer), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Physical Therapy, city: Giza, state: Dokki, zip: 12612, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06306651, orgStudyIdInfo id: FMASU MD283/2023, briefTitle: High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting., conditionsModule conditions: High Flow Nasal Cannula, conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High flow nasal cannula therapy group, interventions name: Conventional oxygen therapy group, outcomesModule primaryOutcomes measure: Oxygen desaturation index, secondaryOutcomes measure: The length of Intensive care unit stay, secondaryOutcomes measure: The incidence of ventilatory support, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University, status: RECRUITING, city: Cairo, zip: 11591, country: Egypt, contacts name: Omar M Mohamed, Master, role: CONTACT, phone: 00201063190923, email: omarmedhat0100565@med.asu.edu.eg, contacts name: Bahaa A Ali, MD, role: SUB_INVESTIGATOR, contacts name: Adel M Alansary, MD, role: SUB_INVESTIGATOR, contacts name: Nora M Mahmoud, MD, role: SUB_INVESTIGATOR, contacts name: Mohamed M Abdallah, MD, role: SUB_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06306638, orgStudyIdInfo id: I-3901323, secondaryIdInfos id: NCI-2024-01239, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3901323, type: OTHER, domain: Roswell Park Cancer Institute, briefTitle: Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: This phase I/II trial studies the side effects of interstitial photodynamic therapy following palliative radiotherapy and how well it works in treating patients with inoperable malignant central airway obstruction. Patients who have advanced stage cancer tumors in the lung can often have the breathing passages to the lung partially or completely blocked. These tumors could be due to lung cancer or other cancers (e.g., renal, breast, kidney, etc.) that spread to the lung. This blockage puts the patient at a higher risk for respiratory failure, post-obstructive pneumonia, and prolonged hospitalizations. Treatment for these patients may include bronchoscopic intervention (such as mechanical removal, stenting, laser cauterization, or ballooning), radiation therapy with and without chemotherapy. While palliative x-ray radiotherapy may help in shrinking the tumor, high dose curative radiotherapy that can ablate (a localized, nonsurgical destruction) the tumor also has high risk to cause significant toxicity, including bleeding, abnormal connections or passageways between organs or vessels and abnormal scar tissue that can also produce airway obstruction. Photodynamic therapy (PDT) is another possible treatment that can provide local control of the tumor. PDT consists of injecting a light sensitive drug (photosensitizer, PS) into the vein, waiting for the PS to accumulate in the tumor, and then activating it with a red laser light. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving interstitial photodynamic therapy following palliative radiotherapy may improve tumor response and survival without the serious side effects that are associated with the typical high dose curative x-ray radiotherapy alone in patients with malignant central airway obstruction., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Endobronchial Ultrasound Bronchoscopy, interventions name: Interstitial Photodynamic Therapy, interventions name: Palliative Radiation Therapy, interventions name: Physical Performance Testing, interventions name: Questionnaire Administration, interventions name: Verteporfin, outcomesModule primaryOutcomes measure: Incidence of >= grade 3 adverse events (Phase I), primaryOutcomes measure: Overall tumor response (Phase II), secondaryOutcomes measure: Overall tumor response (Phase I), secondaryOutcomes measure: Quality of life (Phase I and II), secondaryOutcomes measure: Functional lung capacity (Phase I and II), secondaryOutcomes measure: Change in the therapeutic laser light transmission (Phase I and II), secondaryOutcomes measure: Association between immune markers and tumor response (Phase I and II), secondaryOutcomes measure: Progression free survival (Phase I and II), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Nathaniel Ivanick, role: CONTACT, phone: 716-845-5873, email: Nathaniel.Ivanick@RoswellPark.org, contacts name: Nathaniel Ivanick, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
protocolSection identificationModule nctId: NCT06306625, orgStudyIdInfo id: 69HCL21_0001, secondaryIdInfos id: 2023-A01315-40, type: OTHER, domain: ID-RCB, briefTitle: REmote COnditioning in Out-of-Hospital Cardiac Arrest, acronym: RECO-OHCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-04, completionDateStruct date: 2026-08-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure., conditionsModule conditions: Out-Of-Hospital Cardiac Arrest, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Remote ischemic conditioning, interventions name: No remote ischemic conditioning, outcomesModule primaryOutcomes measure: All cause of death, primaryOutcomes measure: Multiple organ failure, primaryOutcomes measure: Severe neurological failure, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction, secondaryOutcomes measure: Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction, secondaryOutcomes measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score, secondaryOutcomes measure: Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score, secondaryOutcomes measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA), secondaryOutcomes measure: Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score, secondaryOutcomes measure: Serum level of neuron-specific enolase (NSE), secondaryOutcomes measure: Cerebral Performance Categories (CPC) scale, secondaryOutcomes measure: All-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Louis Pradel, city: Bron, zip: 69500, country: France, contacts name: Thomas BOCHATON, role: CONTACT, phone: 04 72 35 75 41, phoneExt: +33, email: thomas.bochaton@chu-lyon.fr, contacts name: Thomas BOCHATON, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Hôpital Gabriel Montpied, CHU de Clermont Ferrand, city: Clermont-Ferrand, zip: 63000, country: France, contacts name: François THOUY, role: CONTACT, phone: 04 73 75 07 50, phoneExt: +33, email: fthouy@chu-clermontferrand.fr, contacts name: François THOUY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Centre Jean Perrin, Clermont-Ferrand, city: Clermont-Ferrand, zip: 69300, country: France, contacts name: Alexandre LAUTRETTE, role: CONTACT, phone: 04 73 27 80 80, phoneExt: +33, email: alautrette@chu-clermontferrand.fr, contacts name: Alexandre LAUTRETTE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Hôpital F Mitterrand, CHU de Dijon, city: Dijon, zip: 21079, country: France, contacts name: Jean-Pierre QUENOT, role: CONTACT, phone: 03 80 29 37 51, phoneExt: +33, email: jean-pierre.quenot@chu-dijon.fr, contacts name: Jean-Pierre QUENOT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Hôpital Albert Michallon, CHU de Grenoble, city: La Tronche, zip: 38700, country: France, contacts name: Carole SCHWEBEL, role: CONTACT, phone: 04 76 76 87 79, phoneExt: +33, email: cschwebel@chu-grenoble.fr, contacts name: Carole SCHWEBEL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Hôpital Edouard Herriot, city: Lyon, zip: 69003, country: France, contacts name: Marie-Line HARLAY, role: CONTACT, phone: 04 72 11 28 62, phoneExt: +33, email: marie-line.harlay@chu-lyon.fr, contacts name: Laurent ARGAUD, role: CONTACT, phone: 04 72 11 28 62, phoneExt: +33, email: laurent.argaud@chu-lyon.fr, contacts name: Marie-Line HARLAY, role: PRINCIPAL_INVESTIGATOR, contacts name: Laurent ARGAUD, role: SUB_INVESTIGATOR, contacts name: Martin COUR, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Saint-Joseph Saint-Luc, city: Lyon, zip: 69007, country: France, contacts name: Emmanuel VIVIER, role: CONTACT, phone: 04 78 61 82 09, phoneExt: +33, email: evivier@ch-stjosephstluc-lyon.fr, contacts name: Emmanuel VIVIER, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital de la Timone, CHU de Marseille, city: Marseille, zip: 13385, country: France, contacts name: Marc GAINNIER, role: CONTACT, phone: 04 91 38 85 50, phoneExt: +33, email: marc.gainnier@ap-hm.fr, contacts name: Marc GAINNIER, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital lapeyronie, CHU de Montpellier, city: Montpellier, zip: 34295, country: France, contacts name: Kada KLOUCHE, role: CONTACT, phone: 04 67 33 77 36, phoneExt: +33, email: k-klouche@chu-montpellier.fr, contacts name: Kada KLOUCHE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Hôpital Universitaire Carémeau, city: Nîmes, zip: 30029, country: France, contacts name: Claire ROGER, role: CONTACT, phone: 04 66 68 33 31, phoneExt: +33, email: claire.roger@chu-nimes.fr, contacts name: Claire ROGER, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.83333, lon: 4.35, locations facility: Hôpital Lyon-Sud, city: Pierre-Bénite, zip: 69310, country: France, contacts name: Auguste DARGENT, role: CONTACT, phone: 04 78 86 21 18, phoneExt: +33, email: auguste.dargent@chu-lyon.fr, contacts name: Auguste DARGENT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Hôpital Nord, CHU de St Etienne, city: Saint-Priest-en-Jarez, zip: 42270, country: France, contacts name: Guillaume THIERY, role: CONTACT, phone: 04 77 12 78 62, phoneExt: +33, email: guillaume.thiery@chu-st-etienne.fr, contacts name: Guillaume THIERY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.47501, lon: 4.37614, locations facility: Hôpital Nord-Ouest, city: Villefranche-sur-Saône, zip: 69655, country: France, contacts name: Julien ILLINGER, role: CONTACT, phone: 04 74 09 29 31, phoneExt: +33, email: jillinger@hno.fr, contacts name: Julien ILLINGER, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.98333, lon: 4.71667, hasResults: False
protocolSection identificationModule nctId: NCT06306612, orgStudyIdInfo id: IIT-2023-0165, briefTitle: CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer, acronym: CREATIVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are:1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC.2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment.3. To explore the relationship between stage efficacy and clinical prognosis.4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy.Participants will undergo systemic therapy combined with cytoreductive prostatectomy.Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Systemic Chemohormonal Therapy, interventions name: Systemic Hormonal Therapy, interventions name: Cytoreductive Prostatectomy, interventions name: Postoperative Adjuvant Radiotherapy, outcomesModule primaryOutcomes measure: Castration resistant-free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: PSA response, secondaryOutcomes measure: Symptomatic skeletal event, secondaryOutcomes measure: Pain progression, secondaryOutcomes measure: Deterioration of disease-related somatic symptoms, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Liang Dong, Dr., role: CONTACT, phone: +86-13601613536, email: drdongliang@126.com, contacts name: Yinjie Zhu, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Liang Dong, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Ruohua Chen, Dr., role: SUB_INVESTIGATOR, contacts name: Xinxing Du, Dr., role: SUB_INVESTIGATOR, contacts name: Yanhao Dong, Dr., role: SUB_INVESTIGATOR, contacts name: Hanjing Zhu, role: SUB_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06306599, orgStudyIdInfo id: Thyroid AI US operator exp, briefTitle: Ultrasound Operator Influence on Diagnostics With AI for Thyroid Nodules - Clinial Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2023-11-04, completionDateStruct date: 2023-11-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input., conditionsModule conditions: Thyroid Nodule, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 20 participants scan five patients over the course of fours hour and collect their diagnostics analyses on paper forms., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: S-Detect for Thyroid, outcomesModule primaryOutcomes measure: Accuracy of S-Detect diagnosis, secondaryOutcomes measure: Accuracy of biopsy recommendation, secondaryOutcomes measure: Nodule classification agreement, secondaryOutcomes measure: Accuracy of EUTIRADS scores, secondaryOutcomes measure: Nodule measurement, secondaryOutcomes measure: OSAUS score, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06306586, orgStudyIdInfo id: 639031, briefTitle: A Digital Treatment for Adolescents With Eating Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, collaborators name: Helse Fonna, descriptionModule briefSummary: The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up., conditionsModule conditions: Eating Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Digital Treatment for Adolescents With Eating Disorders, outcomesModule primaryOutcomes measure: The Credibility and Expectancy Scale (CEQ-1), primaryOutcomes measure: Adherence, primaryOutcomes measure: Module evaluations, primaryOutcomes measure: Client Satisfaction Questionnaire (CSQ-3), primaryOutcomes measure: Recruitment, primaryOutcomes measure: Eating disorder symptoms, primaryOutcomes measure: The Clinical Impairment Assessment Questionnaire (CIA), primaryOutcomes measure: The KIDSCREEN (KIDSCREEN-10), secondaryOutcomes measure: The Patient Health Questionnaire (PHQ-2), secondaryOutcomes measure: Generalized Anxiety Disorder scale (GAD-2), secondaryOutcomes measure: School attendance, secondaryOutcomes measure: Tme with friends, secondaryOutcomes measure: Difficulties with Emotion Regulation Scale (DERS-18), secondaryOutcomes measure: EuroQoL 5D-5L (EQ-5D-5L), otherOutcomes measure: The Rosenberg Self-Esteem Scale (RSES), otherOutcomes measure: The readiness to change questionnaire (RTCQ-6), otherOutcomes measure: Qualitative interviews, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306573, orgStudyIdInfo id: CL1019613, briefTitle: CardioMEMS HF System Real-World Evidence Post-Approval Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Abbott Medical Devices, class: INDUSTRY, descriptionModule briefSummary: The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods., conditionsModule conditions: Heart Failure NYHA Class II, conditions: Heart Failure NYHA Class III, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: CardioMEMS HF System, outcomesModule primaryOutcomes measure: Two-Year Survival in the Primary Cohort (NYHA Class II subjects), secondaryOutcomes measure: Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects), otherOutcomes measure: 3-Year Survival, otherOutcomes measure: HF Hospitalization Rate, otherOutcomes measure: Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor, otherOutcomes measure: Subject Compliance Rates with Weekly Pulmonary Artery (PA) Pressure Uploads, otherOutcomes measure: Number of Subjects with Heart Failure (HF) Prescription Medication Fills, otherOutcomes measure: Proportion of Subjects with Heart Failure (HF) Prescription Medication Fills, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Abbott Medical, city: Atlanta, state: Georgia, zip: 30313, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
protocolSection identificationModule nctId: NCT06306560, orgStudyIdInfo id: MA-SCLC-II-018, briefTitle: A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Harbin Medical University, class: OTHER, descriptionModule briefSummary: This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer., conditionsModule conditions: Extensive-stage Small-cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: adebrelimab, interventions name: famitinib, interventions name: chemotherapy, outcomesModule primaryOutcomes measure: 6-month progression-free survival, secondaryOutcomes measure: 12-month progression-free survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: AEs, secondaryOutcomes measure: QoL, secondaryOutcomes measure: Progression-Free-Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306547, orgStudyIdInfo id: IIM001, briefTitle: Clinical Study Cohort of Idiopathic Inflammatory Myositis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2034-04-01, completionDateStruct date: 2034-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases., conditionsModule conditions: Idiopathic Inflammatory Myopathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: no interventions were involved, outcomesModule primaryOutcomes measure: High Resolution Computed Tomography of Chest, primaryOutcomes measure: Cutaneous Disease Area and Severity Index, primaryOutcomes measure: Forced vital capacity, primaryOutcomes measure: Manual Muscle Testing, primaryOutcomes measure: Forced expiratory volume in one second, secondaryOutcomes measure: Serum creatine kinase, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06306534, orgStudyIdInfo id: AIS-001, secondaryIdInfos id: CIV-22-05-039592, type: OTHER_GRANT, domain: Blackrock Neurotech, briefTitle: Auditory Intranerve Stimulation Study, acronym: AIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-15, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hannover Medical School, class: OTHER, descriptionModule briefSummary: This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve., conditionsModule conditions: Auditory; Nerve, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Auditory Nerve Acute (ANA) Electrode Array, outcomesModule primaryOutcomes measure: Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms, secondaryOutcomes measure: Collection of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hannover Medical School, status: RECRUITING, city: Hannover, zip: 30625, country: Germany, contacts name: Karl-Heinz Dyballa, role: CONTACT, email: dyballa.karl-heinz@mh-hannover.de, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
protocolSection identificationModule nctId: NCT06306521, orgStudyIdInfo id: 20235517, briefTitle: An Adaptive Clinical Trial of BeginNGS Newborn Screening for Hundreds of Genetic Diseases by Genome Sequencing, acronym: BeginNGS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rady Pediatric Genomics & Systems Medicine Institute, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a new method for newborn screening using whole genome sequencing, called BeginNGS. Parents will be approached to provide informed consent to enroll their newborns in prenatal, postnatal, and outpatient settings. The main questions this study aims to answer are:What is the utility of BeginNGS as compared to state newborn screening? What is the acceptability and feasibility of BeginNGS as compared to state newborn screening? What is the cost effectiveness of BeginNGS as compared to state newborn screening?Enrolled newborns will have a blood sample taken and will receive the BeginNGS test. Newborns will have also had the state newborn screening test., conditionsModule conditions: Genetic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: BeginNGS Test, outcomesModule primaryOutcomes measure: Comparison of the clinical utility of BeginNGS and standard of care (state NBS), defined by the proportion of enrollees likely to benefit (likely to have an improved outcome) from an indicated therapeutic intervention, secondaryOutcomes measure: Utility secondary outcome 1, secondaryOutcomes measure: Utility secondary outcome 2, secondaryOutcomes measure: Utility secondary outcome 3, secondaryOutcomes measure: Utility secondary outcome 4, secondaryOutcomes measure: Utility secondary outcome 5, secondaryOutcomes measure: Utility secondary outcome 6, secondaryOutcomes measure: Utility secondary outcome 7, secondaryOutcomes measure: Utility secondary outcome 8, secondaryOutcomes measure: Utility secondary outcome 9, secondaryOutcomes measure: Utility secondary outcome 10, secondaryOutcomes measure: Acceptability outcome 1, secondaryOutcomes measure: Acceptability outcome 2, secondaryOutcomes measure: Acceptability outcome 3, secondaryOutcomes measure: Acceptability outcome 4, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 1, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 2, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 3, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 4, secondaryOutcomes measure: Feasibility (ability of the study to be undertaken as designed) outcome 5, secondaryOutcomes measure: Cost effectiveness outcome 1, secondaryOutcomes measure: Cost effectiveness outcome 2, secondaryOutcomes measure: Cost effectiveness outcome 3, secondaryOutcomes measure: Cost effectiveness outcome 4, secondaryOutcomes measure: Accuracy outcome 1, secondaryOutcomes measure: Accuracy outcome 2, secondaryOutcomes measure: Utility secondary outcome 11, secondaryOutcomes measure: Feasibility outcome 6, secondaryOutcomes measure: Feasibility outcome 7, secondaryOutcomes measure: Utility secondary outcome 12, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Rady Children's Hospital San Diego, status: RECRUITING, city: San Diego, state: California, zip: 92123, country: United States, contacts name: Lauren Olsen, MSN, role: CONTACT, phone: 858-576-1700, phoneExt: 228456, email: lolsen1@rchsd.org, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06306508, orgStudyIdInfo id: HUvbayraktaroglu, briefTitle: Effect of Parental Attitude on Functional and Physical Level of Children With Cystic Fibrosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-02-16, completionDateStruct date: 2025-02-16, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: Some parents may be more protective of children with CF due to concerns about worsening of the disease due to infection, which can affect their functional level. The goal of this observational study is to learn about the family's protective approach to the functioning and disease course of children with cystic fibrosis (CF) to determine whether there are possible negative effects. There will be an alternative viewpoint offered to clinicians regarding the management of CF with outputs of this study., conditionsModule conditions: Cystic Fibrosis, conditions: Cystic Fibrosis in Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Modified shuttle walk test (MST), secondaryOutcomes measure: Forced expiratory volume at one second (FEV1), secondaryOutcomes measure: Forced vital capacity (FVC), secondaryOutcomes measure: Forced expiratory volume at one second / Forced vital capacity rate (FEV1/FVC), secondaryOutcomes measure: Peak expiratory flow (PEF), secondaryOutcomes measure: Maximum inspiratory pressure (MIP), secondaryOutcomes measure: Maximum expiratory pressure (MEP), secondaryOutcomes measure: Physical Activity Questionnaire for Children (PAQ-C), secondaryOutcomes measure: Munich physical fitness test (MFT), secondaryOutcomes measure: Quadriceps strength, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Cystic Fibrosis Questionnaire Revised (CFQ-R), secondaryOutcomes measure: Parental Attitude Scale (PAS), secondaryOutcomes measure: Parent Attitude Scale, secondaryOutcomes measure: Perceived Social Support Scale (PSS), secondaryOutcomes measure: Breathlessness Beliefs Questionnaire (BBQ), eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Haliç University, status: RECRUITING, city: Istanbul, state: Eyup, zip: 34060, country: Turkey, contacts name: Vildan Bayraktaroglu, PT, MSc, role: CONTACT, phone: (0212) 924 24 44, email: vildanbayraktaroglu@halic.edu.tr, contacts name: Seda Saka, PT, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06306495, orgStudyIdInfo id: 26.01.2022/17, briefTitle: Insomnia, Physical Activity Level and Stress Level, acronym: PA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-27, primaryCompletionDateStruct date: 2023-08-12, completionDateStruct date: 2024-01-29, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, descriptionModule briefSummary: Insomnia is a common, acute, intermittent, or chronic complaint of unwanted sleep difficulties characterized by sleep disturbance. Important risk factors leading to insomnia: advanced age, poor health, work stress, shift work, loss of a loved one, divorce, domestic violence, excessive anxiety, repressed personality, perfectionism, neuroticism, alcohol and substance abuse, excessive caffeine intake, excessive smoking, low socio-economic status and low physical activity level. Research shows that college students face more sleep problems than the general public. Factors that disrupt the sleep hygiene of university students; Students' excessive use of computers during lecture and exam periods, exposure to lights and screens for long periods of time, and environmental changes. The aim of this study is to determine the prevalence of insomnia in healthy individuals after the start of face-to-face education in university students after the pandemic period and to determine the physical activity associated with insomnia in this population group. Examining levels and other behavioral factors. The research was conducted on students studying at Istanbul Rumeli University, Haliç University and Yalova University between March 2022 and August 2022. It will be held online via Google Forms with students between the ages of 18-25. Study data will be collected with the International Physical Activity Survey, Demographic Data Form, Sleep Hygiene Index, Distress Tolerance Scale, and Pittsburgh Sleep Quality Index. An application will be made to obtain approval from the Haliç University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from people participating in the research. Statistical analysis of the data will be done with IBM SPSS 23.0 software., conditionsModule conditions: Sleep Initiation and Maintenance Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 473, type: ACTUAL, armsInterventionsModule interventions name: International Physical Activity Survey, outcomesModule primaryOutcomes measure: Prevalence of insomnia in university students, secondaryOutcomes measure: The effect of insomnia on physical activity level, secondaryOutcomes measure: The effect of insomnia on stress levels in university students, secondaryOutcomes measure: Effects of sleep hygiene on insomnia in university students, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Halic University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06306482, orgStudyIdInfo id: SBA 23/390, briefTitle: Determination of Posture in Patients With Restrictive and Obstructive Lung Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-03-07, completionDateStruct date: 2026-03-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease., conditionsModule conditions: Lung Diseases, Obstructive, conditions: Lung Diseases, conditions: Postural; Defect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of horizontal alignment of the head anterior view, primaryOutcomes measure: Evaluation of horizontal alignment of the trunk anterior view, primaryOutcomes measure: Evaluation of horizontal alignment of the head lateral view, primaryOutcomes measure: Evaluation of vertical alignment of the head lateral view, primaryOutcomes measure: Evaluation of horizontal alignment of the trunk lateral view, primaryOutcomes measure: Evaluation of vertical alignment of the trunk lateral view, primaryOutcomes measure: Evaluation of horizontal asymmetry trunk in posterior view, primaryOutcomes measure: Evaluation of scapulae, primaryOutcomes measure: Posture, secondaryOutcomes measure: Functional exercise capacity, secondaryOutcomes measure: Respiratory Muscle Strength, secondaryOutcomes measure: Lung function, secondaryOutcomes measure: Dyspnea, secondaryOutcomes measure: Peripheral muscle strength, secondaryOutcomes measure: Lower extremity capacity, secondaryOutcomes measure: Energy expenditure, secondaryOutcomes measure: Balance and Fall risk, secondaryOutcomes measure: Tightness of muscle, secondaryOutcomes measure: Severity of disease for patients with COPD, secondaryOutcomes measure: Severity of disease for patients with bronchiectasis, secondaryOutcomes measure: Diffusion capacity for patients with diffuse parenchymal lung diseases, secondaryOutcomes measure: Symptoms for patients with COPD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aynur Demirel, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Hacettepe University, city: Ankara, zip: 06100, country: Turkey, contacts name: Aynur Demirel, role: CONTACT, phone: +905545295057, phoneExt: 178, email: aynur.demirel@hacettepe.edu.tr, contacts name: hidaye yamikan, role: CONTACT, phone: +905349898724, email: hidaye.yamikan@hacettepe.edu.tr, contacts name: hidaye yamikan, role: SUB_INVESTIGATOR, contacts name: irem seleoglu, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06306469, orgStudyIdInfo id: PHRI-2022-1001, briefTitle: Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-02, primaryCompletionDateStruct date: 2022-07-09, completionDateStruct date: 2024-01-11, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Pranic Healing Research Institute, class: OTHER, descriptionModule briefSummary: The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Meditation practice, outcomesModule primaryOutcomes measure: Assessing the changes in gut and oral microbiome profile of the participants during retreat, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pranic Healing Research Institute, city: Lyndhurst, state: New Jersey, zip: 07071, country: United States, geoPoint lat: 40.81204, lon: -74.12431, hasResults: False
protocolSection identificationModule nctId: NCT06306456, orgStudyIdInfo id: GH21C201, briefTitle: A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, descriptionModule briefSummary: This study, including phase Ib, phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations., conditionsModule conditions: Non-Small Cell Lung Cancer With EGFR Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: GH21+Osimertinib, outcomesModule primaryOutcomes measure: Number of participants with dose limiting toxicities, primaryOutcomes measure: Number of participants with adverse events, primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of response (DCR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Time to achieve Cmax (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Caicun Zhou, Doctorate, role: CONTACT, phone: 021-65115006, email: caicunzhoudr@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06306443, orgStudyIdInfo id: 20235453, briefTitle: Buprenorphine for Individuals in Jail, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Friends Research Institute, Inc., class: OTHER, descriptionModule briefSummary: This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: open label randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: extended-release buprenorphine (XR-B), outcomesModule primaryOutcomes measure: urine toxicology, primaryOutcomes measure: days of opioid use, primaryOutcomes measure: time to opioid relapse, secondaryOutcomes measure: retention in buprenorphine treatment, secondaryOutcomes measure: urine toxicology for other illicit substance use, secondaryOutcomes measure: days of illicit substance use, secondaryOutcomes measure: overdose events, secondaryOutcomes measure: PROMIS Patient-Reported Outcomes Measurement Information System - physical health, secondaryOutcomes measure: PROMIS Patient-Reported Outcomes Measurement Information System - mental health, secondaryOutcomes measure: HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score, secondaryOutcomes measure: HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score, secondaryOutcomes measure: criminal activity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Friends Research Institute, city: Baltimore, state: Maryland, zip: 21201, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Baltimore Central Booking & Intake Center, city: Baltimore, state: Maryland, zip: 21202, country: United States, contacts name: Michael Gordon, DPA, role: CONTACT, phone: 410-837-3977, phoneExt: 251, email: mgordon@friendsresearch.org, contacts name: Thomas R Blue, PhD, role: CONTACT, phone: 4108373977, email: tblue@friendsresearch.org, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06306430, orgStudyIdInfo id: uLAM TB FIA, briefTitle: Detection of Lipoarabinomannan in Urine Evaluation of the STANDARDTMF TBLAMFIA and Its Impact on the Initial TB Diagnosis, acronym: uLAMTBFIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Evaluation of the performance of an in vitro test, the STANDARDTM F TB LAM Ag FIA (SD BIOSENSOR, INC.) for the early diagnosis of tuberculosis (TB) infection. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of tuberculosis infection. The test will be used according to the instructions for use (IFU)., conditionsModule conditions: Tuberculosis, conditions: Diagnoses Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: STANDARDTM F TB LAM FIA, outcomesModule primaryOutcomes measure: Evaluate the diagnostic performance of a new test based on the detection of lipoarabinomannan (LAM) antigen in human urine using immunoassay, secondaryOutcomes measure: Exploratory Objectives Evaluate if the test can be used as marker of treatment response (only for PTB subjects), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emerging Bacterial Pathogens Unit, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306417, orgStudyIdInfo id: PKUTH TCM, briefTitle: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-28, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients., conditionsModule conditions: Polycystic Ovary Syndrome (PCOS), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: lifestyle intervention, interventions name: acupuncture, interventions name: Sham acupuncture, outcomesModule primaryOutcomes measure: HOMA-IR, secondaryOutcomes measure: Hirsutism(FG score >4), acne and early alopecia, secondaryOutcomes measure: AUC insulin, secondaryOutcomes measure: Follicle stimulating hormone (FSH), secondaryOutcomes measure: luteinizing hormone (LH), secondaryOutcomes measure: Progestin (P), secondaryOutcomes measure: Estrogen (E2), secondaryOutcomes measure: Prolactin (PRL), secondaryOutcomes measure: Androgen(T), secondaryOutcomes measure: Anti-mullerian hormone (AMH), secondaryOutcomes measure: Sex hormone-binding globulin (SHBG), secondaryOutcomes measure: Free testosterone index (FAI), secondaryOutcomes measure: total cholesterol, secondaryOutcomes measure: triglycerides, secondaryOutcomes measure: high density lipoprotein (HDL), secondaryOutcomes measure: low density lipoprotein (LDL), secondaryOutcomes measure: Bile acidomics, secondaryOutcomes measure: Metagenomics and 16S rDNA sequencing analysis, secondaryOutcomes measure: short form-36 (SF36), secondaryOutcomes measure: Self-Rating Anxiety Scale (SAS), secondaryOutcomes measure: Self-Rating Depress Scale (SDS), secondaryOutcomes measure: polycystic ovary syndrome questionnaire, PCOSQ, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Fat%, secondaryOutcomes measure: waist to hip ratio(WHR), secondaryOutcomes measure: glycosylated hemoglobin level, secondaryOutcomes measure: ovarian size, secondaryOutcomes measure: number of follicles, secondaryOutcomes measure: uterine size, secondaryOutcomes measure: endometrial thickness, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University third hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Haolin Zhang, PHD, role: CONTACT, phone: +8615611963539, email: zoe@bjmu.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06306404, orgStudyIdInfo id: NL86165.100.24, briefTitle: Improving Sleep and Mood in the Peri-menopause, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: VU University of Amsterdam, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, collaborators name: Netherlands Brain Foundation, collaborators name: Purplexus, descriptionModule briefSummary: The perimenopause is known as a vulnerable period for some women, with noticeable somatic and psychological issues. Aside from climacteric symptoms, insomnia and depression are common. About half of women during the peri-menopausal period experience sleep problems like problems falling asleep, awakening during the night and being unable to return to sleep. This is often attributed to vasomotor symptoms, but this is not the only reason of poor sleep (Joffe et al., 2010). Also, the peri-menopausal period is a critical time for the occurrence of new onset and recurrent depressions (Cohen et al., 2006). It has been suggested that fluctuations in estradiol may increase the risk for depression by altering neuronal functions in the brain. But there are also indications that the risk for depression increases by indirect effects, such as the increase in insomnia. Poor sleep has increasingly been recognized as the key modifiable factor affecting mental issues like depression (Van Someren, 2021). While antidepressants and psychotherapies continue to be the treatments of choice for depression, and Cognitive Behavioral Therapy for sleep (CBTi) for insomnia, preclinical and clinical data support the benefits of estrogen-based therapies to improve mood, sleep and other menopause-related symptoms (Gordon et al. 2018). Transdermal estradiol patches, which provide a stable release of estradiol and lead to more stable blood levels, have been suggested to have a positive effect on sleep (Joffe et al., 2020) and depressive symptoms (Gordon et al., 2018) in randomized controlled trials. However, it is currently unclear if the relation between improvement in mood and estradiol patches is mediated by improvement in sleep problems, and if the effect of estradiol patches on sleep problems is more effective during peri-menopause than the current evidence-based sleep interventions of CBTi, preferably in combination with Circadian Rhythm Support (CRS). The aim of the study is to pinpoint the determinants of complaints about sleep and mood and how they respond to Menopausal Hormone Treatment (MHT) with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS.Measurements will be conducted at baseline (T0), 2 months (T1) and 4 months (T3), with questionnaires, sleep measurements (EEG sleepband and actigraph) and skin conductance (to measure hot flushes). Participants will be recruited via www.slaapregister.nl and via OLVG outpatient clinic population of peri-menopausal women seeking help for climacteric complaints (like hot flushes, feeling bloated, increase in weight), including sleep problems. The participants are adults between 40-55 years old, with an Insomnia Severity Index score ≥10 and Climacteric Green Scale score ≥ 13.They have the self-considered capability to complete online questionnaires and diaries in Dutch.The intervention will be MHT (estradiol transdermal patches 50 mcg (Systen), in combination with 200 mg progesterone (Utrogestan tablets for 2 weeks, adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines), with and without the addition of a guided eHealth sleep intervention that combines CBTi + CRS., conditionsModule conditions: Menopause, conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 222, type: ESTIMATED, armsInterventionsModule interventions name: Estrogens and Progestogens, interventions name: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy, outcomesModule primaryOutcomes measure: The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline)., eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306391, orgStudyIdInfo id: IMIMFCTL/NLX_1, briefTitle: Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Parc de Salut Mar, class: OTHER, collaborators name: Food and Drug Administration (FDA), descriptionModule briefSummary: This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Intravenous naloxone, interventions name: Intranasal naloxone, outcomesModule primaryOutcomes measure: Effects of naloxone on heart rate (HR)., primaryOutcomes measure: Effects of naloxone on systolic and diastolic blood pressure (BP)., secondaryOutcomes measure: Effects of naloxone on plasma cortisol at visit 1 and visit 4., otherOutcomes measure: Adverse effects., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: IMIM (Hospital del Mar Medical Research Institute), status: RECRUITING, city: Barcelona, zip: 08003, country: Spain, contacts name: Rafael De la Torre Fornell, PharmD, PhD, role: CONTACT, phone: 00343160780, phoneExt: 1780, email: rtorre@imim.es, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06306378, orgStudyIdInfo id: XJTU1AF2023LSK-481, briefTitle: The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, collaborators name: Xi'an TCM Hospital of Encephalopathy, descriptionModule briefSummary: Research background and project basisAutism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.Research purposeExploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: social memory levels and spindle levels, outcomesModule primaryOutcomes measure: Recognition accuracy, primaryOutcomes measure: Response delay time, primaryOutcomes measure: Sleep spindle density, primaryOutcomes measure: Sleep spindle average duration, primaryOutcomes measure: Sleep spindle amplitude, primaryOutcomes measure: Sleep spindle frequency, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Afflicated Hospital Xian Jiaotong University, status: RECRUITING, city: Xi'an, state: Shaanxi, zip: 710061, country: China, contacts name: Yan Li, MD., PhD., role: CONTACT, phone: 13720418610, email: liyanxjtu@xjtu.edu.cn, contacts name: Dongqi Cui, PhD., role: CONTACT, phone: 18501059233, email: 18501059233@163.com, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
protocolSection identificationModule nctId: NCT06306365, orgStudyIdInfo id: PI-DOC003-WBOA, briefTitle: Effects of Modern Board Games on Well Being in Older Adults, acronym: JUMEMO3e+, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: European University Miguel de Cervantes, class: OTHER, collaborators name: Centro Doctor Villacián, Valladolid, Spain, descriptionModule briefSummary: The aim of the study is to assess the effects of an intervention using modern board game-based learning in a sample of older individuals. The evaluation will focus on determining if there is a change in executive functions, social participation, and participants' perception of well-being., conditionsModule conditions: Executive Functions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A quasi-experimental methodology will be employed, involving both a control group and an experimental group. Randomized control trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: No masking., enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Modern board game-based learning, outcomesModule primaryOutcomes measure: Examination for Mental Disorders of the Elderly, primaryOutcomes measure: Trail Making Test to evaluate Executive Functions, primaryOutcomes measure: Assessment of quality of life in older adults and people with disabilities, primaryOutcomes measure: Psychometric development and practical use, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 120 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European University Miguel of Cervante, status: RECRUITING, city: Valladolid, zip: 47012, country: Spain, contacts name: Azael J. Herrero, PhD, role: CONTACT, phone: +34983001000, email: jaherrero@uemc.es, contacts name: Raquel Martínez-Sinovas, PhD, role: CONTACT, phone: +34983001000, email: rmsinovas@uemc.es, geoPoint lat: 41.65518, lon: -4.72372, hasResults: False
protocolSection identificationModule nctId: NCT06306352, orgStudyIdInfo id: 1070, secondaryIdInfos id: NL82999.091.22, type: OTHER, domain: CCMO, briefTitle: Vibrotactile Feedback in Exoskeletons, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-06, primaryCompletionDateStruct date: 2023-06-21, completionDateStruct date: 2023-06-21, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Sint Maartenskliniek, class: OTHER, collaborators name: ABLE Human Motion S.L., collaborators name: Netherlands Organisation for Scientific Research, descriptionModule briefSummary: This study aims to investigate the impact of providing discrete vibrotactile feedback related to weight shift and step initiation on exoskeleton use in individuals with motor-complete SCI., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 7, type: ACTUAL, armsInterventionsModule interventions name: Vibrotactile feedback, outcomesModule primaryOutcomes measure: Walking distance covered, secondaryOutcomes measure: Reach path ratio, secondaryOutcomes measure: Reach time, secondaryOutcomes measure: User experience questionnaire, secondaryOutcomes measure: Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) - only including the eight items related to user satisfaction with the assistive device, otherOutcomes measure: Dutch System Usability Scale (D-SUS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sint Maartenskliniek, city: Nijmegen, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, hasResults: False
protocolSection identificationModule nctId: NCT06306339, orgStudyIdInfo id: hzVSF_v13-0015, briefTitle: A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: ImmuneMed, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab (hzVSF-v13) when added to Disease-Modifying Antirheumatic Drug (DMARD) treatment as Standard of Care (SOC) in participants with moderate to severe Rheumatoid Arthritis (RA)., conditionsModule conditions: Moderate to Severe Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Burfiralimab, interventions name: SOC (Standard of care), interventions name: Placebo, outcomesModule primaryOutcomes measure: Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12, secondaryOutcomes measure: Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined, secondaryOutcomes measure: Clinical response at Week 12, assessed as remission defined, secondaryOutcomes measure: Improvement of physical function at Week 12, secondaryOutcomes measure: Pain relief at Week 12 assessed by the (mean) change from Baseline, secondaryOutcomes measure: Health-related quality of life at Week 12, assessed as the change from Baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Urtrecht, city: Utrecht, state: GA, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
protocolSection identificationModule nctId: NCT06306326, orgStudyIdInfo id: pkussfatgrafting, briefTitle: 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-12-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis., conditionsModule conditions: Adipocytes, conditions: Autografts, conditions: Imaging, Three-Dimensional / Methods, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: 3dMD technology, outcomesModule primaryOutcomes measure: Fat Retention Rate, secondaryOutcomes measure: Patient Satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306313, orgStudyIdInfo id: ReoGo, briefTitle: Effects of Robot-Assisted Rehabilitation on Upper Extremity Functions in Chronic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The most common problem caused by stroke is motor activity limitation that reduces muscle movement and mobility. But stroke can also lead to sensory and cognitive impairment. Additionally, the ability to independently carry out activities of daily living and participate in social and community life is greatly reduced. Up to 85% of stroke patients experience hemiparesis immediately after stroke, while 55% to 75% of survivors continue to experience reduced quality of life with motor impairments.It requires long-term physical rehabilitation to achieve functional recovery in the upper extremity, maximum independence and the highest possible quality of life. Different methods can be used to achieve these results, but there is no clear evidence yet as to which treatment method gives the best results. Scientific evidence shows that a multifactorial approach and high-intensity treatment accelerates the motor recovery of the upper extremities in stroke rehabilitation. Passive and active upper extremity movements appear to increase motor recovery due to their effects on somatosensory input, motor planning, soft tissue properties and spasticity.In recent years, robotic devices have emerged that have been proven to improve the motor performance of the upper extremity in chronic stroke patients. There are also studies showing that robotic device-assisted upper extremity therapy can contribute to the development of sensorimotor skills in plegic patients. However, in the current literature, there is still a need for randomized controlled studies in this field. The aim of this study is to investigate the effects of robot-assisted therapy on upper extremity functions and daily living activities in the rehabilitation of chronic stroke patients. After the demographic data of the cases in both groups are obtained, evaluations will be made before the study. Then, the study group will receive conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks, and in addition robot-assisted therapy with the ReoGo Upper Extremity Exoskeleton Robot in a single session of 60 minutes a day, 5 days a week for 4 weeks. The control group will receive only conventional physiotherapy in a single session of 45 minutes a day, 3 days a week for 4 weeks. The initial evaluations will be repeated after the end of the treatment period., conditionsModule conditions: Stroke, conditions: Upper Extremity Paresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: ReoGo, interventions name: Conventional Physiotherapy, outcomesModule primaryOutcomes measure: Fugl Meyer Upper Extremity Evaluation Scale, primaryOutcomes measure: Functional Independence Scale, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pamukkale University, status: RECRUITING, city: Denizli, country: Turkey, contacts name: Fatih Tekin, Prof., role: CONTACT, phone: +90258 296 4264, email: fzt.ftekin@hotmail.com, geoPoint lat: 37.77417, lon: 29.0875, hasResults: False
protocolSection identificationModule nctId: NCT06306300, orgStudyIdInfo id: 445957/2020-4, briefTitle: Safety and Efficacy of Decentralized HCV Treatment vs Standard-of-Care in Rio de Janeiro (Brazil), acronym: HCVPCL05/20, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Oswaldo Cruz Foundation, class: OTHER, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, descriptionModule briefSummary: Up to 650,000 people in Brazil are living with chronic hepatitis c virus (HCV) infection. Hepatitis C is a silent disease, and up to 20% of cases can progress to liver cirrhosis and its complications. Rapid tests for diagnosis of HCV infection and non-invasive methods for detecting liver cirrhosis are available in the Brazilian Public Health System. Additionally, safe and highly effective drugs (direct-acting antivirals, DAAs) have been delivered for free for hepatitis C treatment by the Brazilian Unified Health System (Sistema Único de Saúde, SUS) since 2015. Sustained virological response (SVR) rates with DAAs in studies conducted in Brazil and Latin America were higher than 90%. Despite the availability of rapid tests for early diagnosis and effective drugs, the HCV continuum of care remains deficient in Brazil. It is estimated that only 10% of individuals known to have hepatitis C achieve HCV cure (SVR). This is explained by multiple barriers from diagnosis to treatment access, such as low rates of population screening (HCVST are not available in Brazil) and few available slots in tertiary centers for hepatitis C treatment by specialists. International studies have described that SVR rates by simplified hepatitis C treatment performed by non-specialists in the Primary Care System were similar to those treated in tertiary centers by specialists (standard-of-care). However, the optimal strategy for managing hepatitis C within the Brazilian-SUS remains unclear.This project aims to evaluate the improve of the HCV continuum of care by a implementation of a test-and-treat strategy in the Primary Care System in Brazil. The project consists of two parallel studies (and a sub-study).The project consists of two parallel studies (and a sub-study). Study I is a population-based cross-sectional screening study using rapid tests to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (participants included in Study I). Study II is a phase IV open-label randomized clinical trial to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study I is a population-based cross-sectional screening study (n=30,000 individuals) to determine the prevalence of HCV infection in people attending a Basic Health Care Unit. The sub-study associated with Study I is a cross-sectional study to assess the usability of a self-test for the detection of HCV antibodies in oral fluid (n=1,500 participants included in Study I). Study II is a phase IV open-label randomized clinical trial (1:1) to evaluate the non-inferiority of simplified and decentralized hepatitis C treatment ("Simplified-and-Decentralized (SD) HCV treatment"; experimental arm) compared to specialist reference treatment ("Standard-of-Care (SC) HCV treatment"; control arm) within the SUS., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30000, type: ESTIMATED, armsInterventionsModule interventions name: Specialist - Epclusa 400Mg-100Mg Tablet, interventions name: Non- specialist - Epclusa 400Mg-100Mg Tablet, outcomesModule primaryOutcomes measure: Prevalence of HCV infection, primaryOutcomes measure: The effectiveness of the HCV treatment with test results., primaryOutcomes measure: Usability of the result of a self-test HCV, secondaryOutcomes measure: Proportion between positive and negative, secondaryOutcomes measure: Participants with fibrosis/cirrhosis, secondaryOutcomes measure: Participants who denied the treatment, secondaryOutcomes measure: cost per detected participant, secondaryOutcomes measure: Unscheduled visits during treatment, secondaryOutcomes measure: Improvement of liver fibrosis stage, secondaryOutcomes measure: Quality of life data, secondaryOutcomes measure: Cost of treatment for participant, secondaryOutcomes measure: Adherence to treatment, otherOutcomes measure: Participant´s Ability to use the test, otherOutcomes measure: Participant preference for types of tests, otherOutcomes measure: Participant understanding to interpret his result, otherOutcomes measure: Test Performance, otherOutcomes measure: Test Accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Evandro Chagas National Institute of Infectious Diseases, status: RECRUITING, city: Rio de Janeiro, state: Rio De Janeiro/RJ, zip: 21040-360, country: Brazil, contacts name: Hugo Perazzo, PhD, role: CONTACT, phone: +5521 3865-9587, email: hugo.perazzo@ini.fiocruz.br, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Hugo Perazzo, status: RECRUITING, city: Rio De Janeiro, country: Brazil, contacts name: Hugo Perazzo, PhD, role: CONTACT, phone: +552138659587, email: hugo.perazzo@ini.fiocruz.br, geoPoint lat: -22.90278, lon: -43.2075, hasResults: False
protocolSection identificationModule nctId: NCT06306287, orgStudyIdInfo id: DA053660, briefTitle: Adolescent Screening and Personalized Intervention Resource for Enhancement of Behavioral Health and Substance Use, acronym: ASPIRE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Oregon Research Institute, class: OTHER, descriptionModule briefSummary: Only a small fraction of youth who are beginning to experience behavioral health problems and use alcohol or illicit drugs receive needed treatment services due to the lack of accessible, effective early intervention resources. The goal of this clinical trial is to compare a personalized brief web-based early intervention, eHealth Personalized Approach for Change Efficacy (ePACE), in which youth are offered choices regarding intervention content and desired level of engagement, to a "fixed", non-tailored brief intervention, eHealth Fixed Approach for Change Efficacy (eFACE) for adolescents with mild/moderate substance use and common co-occurring problems. Both ePACE and eFACE include a multi-problem screener that guides youths through a set of key integrated behavior change and counseling modules providing a cohesive focus on these four problem domains: drug abuse, interpersonal relations, negative emotions and stress. The main questions the trial aims to answer are:* Are substance use and co-occurring problem outcomes for ePACE and eFACE are superior to those for a waitlist comparison group (WC)* Are outcomes for ePACE are superior to those for eFACE* Are the direct effects of ePACE and eFACE (i.e., the improvements in substance use and co-occurring problem outcomes) associated with improvements in areas of functioning and new skills that are hypothesized to produce change -- that is, are the improvements shown in the ePACE and eFACE groups due to the mechanisms by which change is hypothesized to occur Participants in ePACE and eFACE will complete a baseline assessment prior to engaging in the intervention to which they are assigned and will complete post-intervention assessments 3 months and 6 months later. Participants in the WC group will complete three assessments: at baseline, 3-months, and 6-months., conditionsModule conditions: Substance Use, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Youth (n=120) will be randomly assigned to one of three conditions (40 youths per condition): ePACE, eFACE, or waitlist comparison (WC) condition., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The investigators and the assessors will not have access to the conditions to which participants are assigned until all data are collected., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ePACE Personalized Intervention, interventions name: eFACE Fixed Intervention, outcomesModule primaryOutcomes measure: Adolescent Substance Use from baseline to 3 months, primaryOutcomes measure: Adolescent Substance Use from baseline to 6 months, primaryOutcomes measure: Youth Report of Internalizing Problems from baseline to 3 months, primaryOutcomes measure: Youth Report of Internalizing Problems Change from baseline to 6-months, primaryOutcomes measure: Youth Report of Externalizing Problems from baseline to 3-months, primaryOutcomes measure: Youth Report of Externalizing Problems from baseline to 6-months, primaryOutcomes measure: Parent Report of Internalizing Problems from baseline to 3-months, primaryOutcomes measure: Parent Report Internalizing Problems from baseline to 6-months, primaryOutcomes measure: Parent Report Externalizing Problems from baseline to 3-months, primaryOutcomes measure: Parent Report Externalizing Problems from baseline to 6-months, secondaryOutcomes measure: Problem-Solving Inventory from baseline to 3-months, secondaryOutcomes measure: Problem-Solving Inventory from baseline to 6-months, secondaryOutcomes measure: Child Global Assessment Scale (CGAS) from baseline to 3-months, secondaryOutcomes measure: Child Global Assessment Scale (CGAS) from baseline to 6-months, secondaryOutcomes measure: Peer Encouragement and Influence from baseline to 3 months, secondaryOutcomes measure: Peer Encouragement and Influence from baseline to 6 months, otherOutcomes measure: Emotion Regulation from baseline to 3 months, otherOutcomes measure: Emotion Regulation - baseline to 6 months, otherOutcomes measure: Change in Urine assay - baseline to 3 months, otherOutcomes measure: Change in Urine assay - 3 months to 6 months, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Research Institute, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87109, country: United States, contacts name: Holly B Waldron, PhD, role: CONTACT, phone: 541-915-6196, email: hwaldron@ori.org, contacts name: Aleah A Montano, MA, role: CONTACT, phone: 5054538984, phoneExt: Waldron, email: hollybarrettwaldron@gmail.com, contacts name: Holly B Waldron, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ken C Winters, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Timothy J Ozechowski, PhD, role: SUB_INVESTIGATOR, contacts name: Hyman Hops, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 35.08449, lon: -106.65114, hasResults: False
protocolSection identificationModule nctId: NCT06306274, orgStudyIdInfo id: TACLE trial, briefTitle: Topical Tacrolimus for Breast Cancer-related Lymphedema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effect of tacrolimus ointment in women with stage I or II breast cancer-related lymphedema. The main question it aims to answer are:* How tacrolimus affects breast cancer related lymphedema regarding subjective and objective measures (e.g. arm volume, lymphedema index, lymphatic function, and quality of life).* If maintenance treatment is effective. Participants will be treated with either active drug or placebo once daily for six months followed by a six month maintenance periode with treatment twice weekly. Assessments will be performed at baseline, three, six, nine and 12 months., conditionsModule conditions: Lymphedema, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tacrolimus, interventions name: Placebo, outcomesModule primaryOutcomes measure: Lymphedema volume, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Odense University Hospital, city: Odense, zip: 5000, country: Denmark, contacts name: Frederik Gulmark Hansen, role: CONTACT, phone: +4521734450, email: frederik.c.gulmark.hansen@rsyd.dk, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Zealand University Hospital, city: Roskilde, zip: 4000, country: Denmark, contacts name: Michael Rose, role: CONTACT, geoPoint lat: 55.64152, lon: 12.08035, locations facility: Lillebaelt Hospital, city: Vejle, zip: 4000, country: Denmark, geoPoint lat: 55.70927, lon: 9.5357, hasResults: False
protocolSection identificationModule nctId: NCT06306261, orgStudyIdInfo id: TIMAEUS, briefTitle: Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis, acronym: TIMAEUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists., conditionsModule conditions: Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, outcomesModule primaryOutcomes measure: to evaluate mental stress/health as an impacting factor on UC progression, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Ospedale San Raffaele, city: Milano, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306248, orgStudyIdInfo id: PNRR-MAD-2022-12375716, briefTitle: Immune Activation, Neural Plasticity and Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2025-03-03, completionDateStruct date: 2025-05-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.Increasing evidence indicates a clear link between immune dysfunction and MDD.Moreover, an activation of inflammatory pathways is associated to a lack of clinical response to antidepressants. Thus, the regulation of inflammation represents a potential approach to modulate the link between the living environment and antidepressant outcome. Light therapy combined with sleep deprivation hastens recovery, with benefits that can be perceived by patients during the first week of treatment. Alteration of the sleep-wake cycle and of sleep structure are core symptoms of MDD.The aims of the present project are (i) to show that neural plasticity and the environmental context are moderating factors of the therapeutic outcome of immune modulation and (ii) to exploit their interplay to set up novel and effective therapeutic strategies for MDD.This is a observational prospective study with non-invasive add-on procedures (Magnetic Resonance without contrast). In this study, 60 patients with a depressive episode in course of MDD and treated with a chronobiological intervention including total sleep deprivation (TSD) + light therapy (LT), as performed in clinical practice, will be studied. All participants enrolled in the study will receive Treatment As Usual (TAU), i.e., pharmacotherapy, chronobiological intervention plus clinical management. Drug prescription will be performed during the clinical management sessions.The study will have a total duration of 24 months. Each subject will participate in the study for 6 months, will undergo Magnetic Resonance Imaging (MRI) and clinical evaluation at baseline, after one week of chronobiological treatment and at 6 months follow-up., conditionsModule conditions: Mood Disorders, conditions: Major Depressive Disorder, conditions: Sleep Deprivation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Total sleep deprivation, outcomesModule primaryOutcomes measure: BENEFICIAL EFFECT OF total sleep deprivation in inflamed vs non inflamed patients., secondaryOutcomes measure: Neurobiological markers of prediction and progression of antidepressant treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, state: Mi, zip: 20132, country: Italy, contacts name: Sara SP Poletti, phd, role: CONTACT, phone: 390226433156, email: poletti.sara@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306235, orgStudyIdInfo id: 20.84-reva20.06, briefTitle: Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-10-12, primaryCompletionDateStruct date: 2021-07-31, completionDateStruct date: 2021-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Jessa Hospital, class: OTHER, descriptionModule briefSummary: Patients who are eligible for cardiac rehabilitation but do not want to participate will be offered to participate in an interview (part A of the study) or a tablet questionnaire (part B of the study).Goal is to identify main barriers for conventional rehabilitation as well as to assess willingness to participate in cardiac telerehabilitation, main barriers and willingness-to-pay for cardiac telerehabilitation., conditionsModule conditions: Cardiac Rehabilitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Willingness to participate in telerehabilitation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jessa Hospital, city: Hasselt, state: Limburg, zip: 3500, country: Belgium, geoPoint lat: 50.93106, lon: 5.33781, hasResults: False
protocolSection identificationModule nctId: NCT06306222, orgStudyIdInfo id: GR-2021-12375430, briefTitle: Thulium Fiber Laser vs. Holmium:YAG Laser for the Ureteroscopic Treatment of Patients With Urinary Stone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-11-23, completionDateStruct date: 2026-02-23, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial which aims to compare the efficacy and safety of Thulium fiber laser (TFL) and holmium:yttrium-aluminum-garnet (Ho:YAG) laser ablation during the treatment of upper urinary tract stone disease with flexible ureteroscopy, demonstrating clinical superiority of TFL., conditionsModule conditions: Kidney Stone, conditions: Ureteral Stone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Laser lithotripsy, outcomesModule primaryOutcomes measure: Lithotripsy speed, secondaryOutcomes measure: Stone free rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Alessia D'Arma, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306209, orgStudyIdInfo id: DeFLAME, briefTitle: Inflammatory Control of Antidepressant Efficacy: a Pharmaco-epigenetic Approach, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-18, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-01-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Major depressive disorder (MDD) is a chronic, recurring and potentially life-threatening illness that affects up to 10% of the population across the globe.It posits that the increase in serotonin levels induced by Selective Serotonin Reuptake Inhibitors (SSRIs) does not affect mood per se, but enhances brain plasticity and thus amplifies the influence of the environment on the individual. Thus, SSRI treatment has not a univocal effect but, in a favorable environment, it would lead to a reduction of symptoms while in a stressful environment might lead to a worse prognosis.Such innovative view opens new perspectives on how to improve SSRI efficacy by controlling the environment. However, often it is not possible to act on the quality of the living environment because of constraints due to patient's personal history and unchangeable life circumstances. In these cases, the pharmacological modulation of the factors underlying the link between living environment and SSRI efficacy represents a novel and desirable strategy to improve treatment outcome even in patients living in adverse conditions, which are very common in depressed patients. Inflammatory levels are markedly affected by the socioeconomic status and thus by the quality of the living environment. The hypothesis of the present project is that inflammation mediates the influence of the environment on SSRI outcome.Therefore, the control of inflammatory levels is a promising strategy to improve treatment efficacy and overcome the limited SSRI efficacy, especially when administered in patients living in adverse conditions. A further hypothesis is that the influence of the environment on inflammation, in turn affecting SSRI efficacy, occurs through epigenetic modifications. Therefore, the project aims at developing a pharmaco-epigenetic approach as effective treatment for MDD. In addition, through neuroimaging investigations, it will provide important information about functional and structural brain modifications associated to SSRI efficacy in patients.Both males and females will be considered because MDD is twice as common in women than men, suggesting that different mechanisms may underlie the psychopathology in the two sexes., conditionsModule conditions: Mood Disorders, conditions: Major Depressive Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Treatment as usual (TAU), i.e., pharmacotherapy plus clinical management, outcomesModule primaryOutcomes measure: The potential role of inflammation as the causal link between the quality of the environment and SSRI efficacy, primaryOutcomes measure: interaction between early stress and recent stress on the response to treatment and the role of inflammation, primaryOutcomes measure: identification of neurobiological predictors of response to treatment, primaryOutcomes measure: identification of neurobiological predictors of response to treatment, primaryOutcomes measure: identification of neurobiological predictors of response to treatment, secondaryOutcomes measure: epigenetic changes in cytokine regulating genes which could mediate the effect of stress on response to treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, state: Mi, zip: 20132, country: Italy, contacts name: Sara sp Poletti, phd, role: CONTACT, phone: +390226433156, email: poletti.sara@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306196, orgStudyIdInfo id: IVI Hecolin S001, briefTitle: Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: International Vaccine Institute, class: OTHER, collaborators name: Xiamen Innovax Biotech Co., Ltd, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: The primary goal of this clinical trial is to demonstrate non-inferiority of 30 µg of Hecolin® in healthy children, compared to healthy adults as measured by seroresponse rates (SR) of anti-HEV IgG titers, 4 weeks after 3 doses (0, 1 and 6 months) and to assess and descriptively compare safety profile data intra and inter age Strata. As secondary objectives, Geometric Mean Concentration (GMC) of anti-HEV IgG ELISA will be evaluated 4 weeks after 3 doses (0, 1 and 6 months) and 4 weeks after 2 doses (0- and 6-months dose) in healthy children. SR and GMC will also be evaluated 24 weeks after 3 doses and 2 doses. The immune response will be compared among adult participants between HIV positive and HIV negative individuals and between virally suppressed and virally unsuppressed HIV positive individuals, conditionsModule conditions: Hepatitis E Virus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Single, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 860, type: ESTIMATED, armsInterventionsModule interventions name: Hecolin® Recombinant Hepatitis E Vaccine, interventions name: Isotonic Sodium Chloride injection, outcomesModule primaryOutcomes measure: Seroresponse rate, primaryOutcomes measure: Proportion of immediate adverse events, primaryOutcomes measure: Proportion of solicited local and systemic adverse events, primaryOutcomes measure: Proportion of unsolicited adverse events, primaryOutcomes measure: Proportion of SAEs, MAAEs and AESIs, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR and GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR, secondaryOutcomes measure: GMC of anti-HEV IgG, secondaryOutcomes measure: SR and GMC of anti-HEV IgG, otherOutcomes measure: SR and GMC of anti-HEV IgG, otherOutcomes measure: Safety in all participants as per gender distribution and serostatus, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306183, orgStudyIdInfo id: 2024-2829, briefTitle: Effect of Vitamin C on Pain Reduction After an Emergency Department Visit, acronym: Vicamed, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hopital du Sacre-Coeur de Montreal, class: OTHER, collaborators name: Hopital de l'Enfant-Jesus, collaborators name: The Ottawa Hospital, descriptionModule briefSummary: Emergency department (ED) clinicians often prescribe anti-inflammatory drugs (NSAIDs) to manage acute musculoskeletal (MSK) pain (e.g.: fracture, sprain, back pain). However, even short-term NSAIDs use can have significant gastrointestinal, cardiovascular, MSK and renal adverse effects. For this reason, some patients cannot take or tolerate NSAIDs. Recent evidence has shown that vitamin C has some analgesic and anti-inflammatory properties particularly in postoperative context and prevent specific types of chronic pain. Furthermore, vitamin C is safe and associated with very few adverse events. The primary objective of this study is to determine whether vitamin C can reduce pain intensity during a seven-day period following an ED visit for acute MSK pain.The investigators propose to compare two groups of patients, one receiving 900 mg of vitamin C to another receiving a placebo, twice a day for seven days. Both groups will consume acetaminophen slow release 650 mg two pills every eight hours regularly. Naproxen 500 mg (NSAID) will be used as a rescue medication if the patient's pain is not relieved. Participants will be ≥18 years of age, treated in ED for acute MSK pain present for less than 48 hours with pain intensity at triage of ≥ 4 on a 0-10 numeric rating scale, and discharged by an ED clinician with an NSAIDs prescription without opioids. The level of pain intensity during a seven-day period will be assessed daily using an electronic or paper diary, as well as pain relief, pain medication consumption, and adverse events. Three months after the injury, participants will also be contacted to assess the presence of chronic pain. The investigators hypothesized that vitamin C will reduce pain intensity and chronic pain development at three months.This research could provide a safe alternative to patients who are unable to take NSAIDs. It may also contribute to the reduction of the burden associated with chronic pain development., conditionsModule conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind randomized placebo-controlled trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 546, type: ESTIMATED, armsInterventionsModule interventions name: Acetaminophen and Vitamin C with Naproxen rescue, interventions name: Acetaminophen and Placebo with Naproxen rescue, outcomesModule primaryOutcomes measure: Daily pain intensity, secondaryOutcomes measure: NSAIDs consumption, secondaryOutcomes measure: Pain relief, secondaryOutcomes measure: New analgesic prescriptions, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Quality of life improvement at seven days, secondaryOutcomes measure: Quantity of Healthcare visits, secondaryOutcomes measure: Prevalence of chronic pain, secondaryOutcomes measure: Prevalence of complex regional pain syndromes for limb fractures, secondaryOutcomes measure: Quality of life improvement at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital du Sacre-Coeur de Montreal, city: Montreal, state: Quebec, zip: H4J 1C5, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06306170, orgStudyIdInfo id: GYN-ART, briefTitle: Advanced Radiotherapy (ART) in Gynecological Cancer Patients (GYN-ART), acronym: GYN-ART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2029-02-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is an observational mono-institutional study. Patients with gynecologic tumors treated with advanced radiotherapy- Image Guided Radiotherapy (IGRT), Intensity Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT)- will be included and toxicity and outcomes analyzed., conditionsModule conditions: Gynecologic Cancer, conditions: Radiotherapy Side Effect, conditions: Radiotherapy; Complications, conditions: Survivorship, conditions: Progression, Disease, conditions: Progression, Clinical, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Image Guided Radiotherapy, outcomesModule primaryOutcomes measure: Local Relapse Free Survival, primaryOutcomes measure: Regional Relapse Free Survival, primaryOutcomes measure: Distant Metastases Free Survival, primaryOutcomes measure: Disease Free Survival, primaryOutcomes measure: Overall Survival, primaryOutcomes measure: Cancer Specific Survival, secondaryOutcomes measure: Acute toxicity, secondaryOutcomes measure: Late toxicity, otherOutcomes measure: Predictive factors for disease progression and death, otherOutcomes measure: Radiomic predictive factors for disease progression and death, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Raffaele Scientific Institute, status: RECRUITING, city: Milan, state: MI, zip: 20132, country: Italy, contacts name: Andrei Fodor, M.D., role: CONTACT, phone: +390226437634, email: fodor.andrei@hsr.it, contacts name: Nadia G Di Muzio, Prof, role: CONTACT, phone: +390226437643, email: dimuzio.nadia@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306157, orgStudyIdInfo id: 2023-0667, briefTitle: Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome, acronym: LDN-CRPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospital for Special Surgery, New York, class: OTHER, descriptionModule briefSummary: Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study., conditionsModule conditions: Complex Regional Pain Syndrome, conditions: Chronic Pain, conditions: Causalgia, conditions: Complex Regional Pain Syndrome Type I, conditions: Complex Regional Pain Syndrome Type II, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a feasibility, randomized, placebo-controlled interventional drug study., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: A quadruple blinded study where the patient, research team, treating clinician, and outcomes assessor are unaware of the randomization results until after study conclusion. The research pharmacy will not be blinded and will be responsible for preparing the medication and securely handing it off to the research assistant according to the pre-approved dispensation plan., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Low dose naltrexone, interventions name: Placebo sugar capsules, outcomesModule primaryOutcomes measure: Number of study patients enrolled, primaryOutcomes measure: Number of study patients randomized, primaryOutcomes measure: Number of study patients who received the study medication, secondaryOutcomes measure: Incidence of side effects/adverse events, secondaryOutcomes measure: Average NRS pain, secondaryOutcomes measure: CRPS symptom severity, secondaryOutcomes measure: PROMIS-10 score, secondaryOutcomes measure: S-LANSS score, secondaryOutcomes measure: Blinding assessment, otherOutcomes measure: Enrollment rate, otherOutcomes measure: Study medication compliance, otherOutcomes measure: Reasons for study medication non-compliance, otherOutcomes measure: Drop-out rate, otherOutcomes measure: Reasons for drop-out, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital for Special Surgery, city: New York, state: New York, zip: 10021, country: United States, contacts name: Marlena Komatz, role: CONTACT, phone: 646-714-2901, email: komatzm@hss.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06306144, orgStudyIdInfo id: 69HCL23_0691, briefTitle: Early-phase Telecare Programs for Minor Stroke, acronym: COGaDOM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Minor strokes (few acute neurological symptoms ; NIHSS score \<5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation., conditionsModule conditions: Minor Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation, interventions name: Computerised Cognitive Stimulation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke., secondaryOutcomes measure: to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), secondaryOutcomes measure: to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Bordeaux, city: Bordeaux, zip: 33000, country: France, contacts name: GLIZE Bertrand, role: CONTACT, phone: 05 56 79 56 79, email: bertrand.glize@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Lille, city: Lille, zip: 59037, country: France, contacts name: ALLART Etienne, Dr, role: CONTACT, phone: 03 20 44 48 71, email: etienne.allart@chu-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Hôpital Henry Gabrielle, city: Saint-Genis-Laval, zip: 69230, country: France, contacts name: PUGNIET Virginie, role: CONTACT, phone: 04.78.86.50.64, email: virginie.pugniet@chu-lyon.fr, geoPoint lat: 45.69558, lon: 4.7934, hasResults: False
protocolSection identificationModule nctId: NCT06306131, orgStudyIdInfo id: IG-23-002, secondaryIdInfos id: 1R43HD107861-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R43HD107861-01A1, briefTitle: Phase II Study of Ovulation in Obese Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-10, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: InnovaGyn, Inc., class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The goal of this clinical trial is to compare the delay in ovulation between placebo to levonorgestrel plus meloxicam in obese women with normal menses. The main questions it aims to answer are:1. Ovulation will be delayed by ≥7 days following the first dose of levonorgestrel plus meloxicam compared to ovulation within 3 days following the first dose of placebo.2. There will be no difference in unscheduled vaginal bleeding or adverse events between the two treatments \[placebo versus levonorgestrel plus meloxicam\].Participants will:* undergo two treatment cycles the 1st uses placebo and the 2nd is levonorgestrel plus meloxicam,* maintain daily diary logs for adverse events, unscheduled bleeding, and onset, cessation, and amount of menstrual bleeding,* collect daily first morning voided urine from menstrual day 9 to 24,* undergo transvaginal ultrasound for ovarian follicle development on menstrual days 9, 11,13 and 14.* allow a blood sample to be drawn on days with ultrasound scans.* Take 1st placebo and levonorgestrel plus meloxicam under observation when dominant ovarian follicle is 17 ±1.0 millimeters (mm) in diameter and 2nd dose 48 hours later.Researchers will compare the placebo cycle to levonorgestrel plus meloxicam to see if ovulation is delayed, there is unscheduled vaginal bleeding, menstrual onset is delayed or there is an abnormal amount or duration of menses, there is any difference in treatment emergent side effects and any change in vital signs, conditionsModule conditions: Pregnancy Prevention, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Placebo controlled in first cycle with levonorgestrel plus meloxicam in second menstrual cycle., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: The intervention will be masked to the laboratory preforming the analysis of the urinary metabolites. The statistician, clinicians, coordinators and participants will be aware of the medication being studied., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Levonorgestrel 0.15 milligram, interventions name: Meloxicam 15 milligram, interventions name: calcium carbonate 750 milligram, outcomesModule primaryOutcomes measure: Interval from first dose to evidence of ovulation., secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in Pulse, otherOutcomes measure: Unscheduled endometrial bleeding and changes in interval, amount and duration of menstrual bleeding., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Carolina Women's Research and Wellness Center, status: RECRUITING, city: Raleigh, state: North Carolina, zip: 27713, country: United States, contacts name: Andrea S. Lukes, MD, role: CONTACT, phone: 919-251-9223, email: andrealukes@cwrwc.com, contacts name: Janet F. Davis, role: CONTACT, phone: 9192519223, email: janet@cwrwc.com, contacts name: Andrea S. Lukes, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.7721, lon: -78.63861, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-17, uploadDate: 2023-10-16T10:12, filename: ICF_000.pdf, size: 336680, hasResults: False
protocolSection identificationModule nctId: NCT06306118, orgStudyIdInfo id: 35-046 ex 22/23, briefTitle: Autoguide Positioning Device for Multiple Stereotactic Biopsies, acronym: AMB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, descriptionModule briefSummary: The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision., conditionsModule conditions: Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection, outcomesModule primaryOutcomes measure: Biopsy Results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, status: RECRUITING, city: Graz, state: Styria, zip: 8036, country: Austria, contacts name: Stefan Wolfsberger, Prof., role: CONTACT, phone: +43031638583102, email: stefan.wolfsberger@medunigraz.at, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
protocolSection identificationModule nctId: NCT06306105, orgStudyIdInfo id: 23-118-B, briefTitle: Assessment of Anti-aging Efficacy of Marine Collagen Peptides, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: TCI Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human, conditionsModule conditions: Skin Condition, conditions: Hair Fragility, conditions: Nails, Ingrown, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Marine Collagen Peptides, interventions name: placebo drink, outcomesModule primaryOutcomes measure: The change of skin hydation, primaryOutcomes measure: The change of skin wrinkles, primaryOutcomes measure: The change of skin elasticity, primaryOutcomes measure: The change of skin collagen density, primaryOutcomes measure: The change of hair diameters, primaryOutcomes measure: The change of hair loss amount, primaryOutcomes measure: The change of hair roots diameters, primaryOutcomes measure: The change of hair density, primaryOutcomes measure: The change of hair follicle strength, primaryOutcomes measure: The change of thumbs nail color, primaryOutcomes measure: The change of nails appearence, primaryOutcomes measure: The change of nails growth, primaryOutcomes measure: The degree of nails fragility, secondaryOutcomes measure: The change of self-assessment skin, hair, and nails condition, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chia Nan University of Pharmacy & Science, status: RECRUITING, city: Pingtung, zip: 928, country: Taiwan, contacts name: Chia-Hua Liang, role: CONTACT, phone: +886-06-2664911, phoneExt: 2441, email: tinna_ling@mail.cnu.edu.tw, contacts name: Ping Lin, role: CONTACT, phone: +886-02-879778111, email: candice.lin@tci-bio.com, geoPoint lat: 22.67135, lon: 120.48814, hasResults: False
protocolSection identificationModule nctId: NCT06306092, orgStudyIdInfo id: 2023-02885-01, briefTitle: Promoting Teenage Sleep for Improved Mental Health and School Performance, acronym: TeenSleep, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2030-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kristianstad University, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Örebro University, Sweden, collaborators name: Academic Primary Health Care Centre, Region Stockholm, descriptionModule briefSummary: The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms. The programs will be offered to students aged 13-19 at Swedish high schools and upper secondary schools at the classroom level. The students will be compared to teaching as usual (control group)., conditionsModule conditions: Mental Health Issue, conditions: Insomnia, conditions: Depression, conditions: Anxiety, conditions: Daytime Sleepiness, conditions: Wellness, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Sleep on Schedule, interventions name: Technology restriction, outcomesModule primaryOutcomes measure: Change in sleep duration, hours and minutes, secondaryOutcomes measure: Change in Hospital Anxiety and Depression Scale scores, secondaryOutcomes measure: Change in Adolescent Sleep Hygiene Scale scores, secondaryOutcomes measure: Change in Insomnia Severity Index score, secondaryOutcomes measure: Change in EuroQol Visual Analog Scale (EQ VAS) score, secondaryOutcomes measure: Change in CHU9D Child Health Utility 9D (CHU9D) scores, secondaryOutcomes measure: Change in Sleep knowledge, secondaryOutcomes measure: Change in electronic media use, secondaryOutcomes measure: Change in sleep habits, secondaryOutcomes measure: Change in meta-cognitions, secondaryOutcomes measure: Change in motivation, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-23, uploadDate: 2024-03-07T03:17, filename: Prot_SAP_000.pdf, size: 264890, hasResults: False
protocolSection identificationModule nctId: NCT06306079, orgStudyIdInfo id: KKUMC, secondaryIdInfos id: Abdullah Al Assiri, type: OTHER, domain: King Khalid University Medical City, secondaryIdInfos id: Prof Pip Logan, type: OTHER, domain: Professor of Rehabilitation Research, University of Nottingham, UK., secondaryIdInfos id: Professor Ana Valdes, type: OTHER, domain: Professor of Molecular & Genetic Epidemiology, University of Nottingham, UK., secondaryIdInfos id: Dr. Benjamin Smith, type: OTHER, domain: Doctor of Physiotherapy, Division of Rehabilitation and Ageing, University of Nottingham. UK., briefTitle: Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-13, primaryCompletionDateStruct date: 2022-10-15, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: King Khalid University, class: OTHER, collaborators name: University of Nottingham, descriptionModule briefSummary: A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation.Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists.This study aims to answer the following:* Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration?* In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future?The participants will be conducted over three phases:1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1.2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2).3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2)., conditionsModule conditions: Osteoarthritis, Knee, conditions: Pain, conditions: Biomechanical Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A gait modification (Lateral wedge insole) program will be conducted over 4 to 6 weeks in the physiotherapy gym or adjusted treadmill and outside the clinic during the day (at least 8 hours per day).* During the session, the researcher will observe participants inside the clinic and ensure that the modified gait application is applied, and outside the clinic will be followed by telephone.* Participants will walk on the gym floor or an adjusted treadmill for at least 15 to 20 minutes during each session. Participants will be instructed to use the mirror for feedback and achieve the target modified gait procedure. However, it will be emphasised gait modification procedures exhibited at baseline pain and function, and then at the end of the trial, it will focus on subjects' acceptability., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ACTUAL, armsInterventionsModule interventions name: Lateral Wedge insole, outcomesModule primaryOutcomes measure: Pain level, primaryOutcomes measure: Western Ontario and McMaster Universities Arthritis Index-total, primaryOutcomes measure: Likert scale, primaryOutcomes measure: Likert scale, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Faisal Specialist Hospital & Research Centre, city: Jeddah, state: Western, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-01-04, uploadDate: 2024-03-07T05:51, filename: Prot_000.pdf, size: 234397, hasResults: False
protocolSection identificationModule nctId: NCT06306066, orgStudyIdInfo id: 2015/962-31, briefTitle: Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-09-02, primaryCompletionDateStruct date: 2021-06-07, completionDateStruct date: 2022-12-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Abbott, descriptionModule briefSummary: Patients scheduled for elective coronary angiography due to chronic coronary syndrome are recruited at admission to hospital before the coronary anatomy is known. Immediately after coronary angiography measures thermo-dilution derived flow indices are obtained in the left left anterior descending artery (LAD). The patients are followed through telephone-calls and medical records at 1 and 2 years after inclusion and at completion of the study. The hypothesis is that elevated index of microcirculatory resistance (IMR),(\>25) is associated with all-cause death, myocardial infarction (MI) and hospitalization due to congestive heart failure (CHF).The primary analysis is the relationship between IMR and the composite outcome all-cause death, MI and hospitalization due to CHF., conditionsModule conditions: Coronary Artery Disease, conditions: Microvascular Angina, conditions: Coronary Microvascular Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 505, type: ACTUAL, outcomesModule primaryOutcomes measure: Rate of all-cause mortality, MI and/or hospitalization due to CHF, secondaryOutcomes measure: Rate of all-cause mortality, secondaryOutcomes measure: Rate of hospitalization due to CHF., secondaryOutcomes measure: Rate of all-cause mortality and/or MI, secondaryOutcomes measure: Rate of MI, secondaryOutcomes measure: Rate of stroke, secondaryOutcomes measure: Rate of ischemic stroke, secondaryOutcomes measure: Rate of unscheduled revascularization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danderyd University Hospital and Karolinska Institutet Danderyds University Hospital (KI DS), city: Stockholm, zip: 182 88, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06306053, orgStudyIdInfo id: 2022/ST/217, briefTitle: A New Treatment for Chronic Pain Combining Neuromodulation, Computer Assisted Training and Telemonitoring, acronym: TechNoPain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: ASST Santi Paolo e Carlo, class: OTHER, collaborators name: University of Milan, collaborators name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, collaborators name: Istituto Europeo di Oncologia, descriptionModule briefSummary: Chronic pain (CP) is a leading cause of medical disability, healthcare expenditure, and reduced psychological well-being. Given the limited mobility, travel burden, and cost, access to care can be problematic for patients suffering from this disease, driving the recent shift toward care through telehealth programs. Given the complex interrelationship of physical and psychosocial aspects related to chronic pain, in this project the investigators propose to validate and investigate the effectiveness of new integrated health interventions by combining the technique of transcranial direct current stimulation (tDCS), complementary therapies and telemonitoring. The investigators hypothesize that this novel combined approach will provide a more effective strategy to overcome the classic barriers of pharmacological treatments and access to healthcare due to lack of mobility. To do this, the investigators will rely on a previously developed integrated platform that enables effective delivery of non-pharmacological interventions and outcome assessment. Many patients do not benefit from pharmacological and invasive treatments, leading to the development of alternative therapeutic options such as non-invasive brain stimulation (e.g. tDCS) and complementary interventions to improve physical and psychological well-being. These complementary interventions reduced pain intensity and psychological distress by improving individuals' ability to manage and cope with their pain. However, due to the multiple co-occurring factors associated with chronic pain, a multidisciplinary and integrated treatment approach is challenging. Technology ecosystems can be a reliable tool to achieve such a diverse personalized approach and evaluate their results. In a previous project, the investigators developed PainRE-Life, a dynamic and integrated technology ecosystem to enable continuity of care for CP patients, including personalized applications, training tools and telemonitoring tools for outcome assessment., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: tDCS+EuleriaLab, interventions name: tDCS, interventions name: EuleriaLab, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), secondaryOutcomes measure: 12-item Short Form Survey (SF12), secondaryOutcomes measure: Hospital Anxiety and Depression scale (HADS), secondaryOutcomes measure: Brief Pain Inventory (BPI), secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Shared Decision-Making Questionnaire 9-Item (SDM-Q-9), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST-Santi Paolo e Carlo Hospital, city: Milan, country: Italy, contacts name: Alberto Priori, PhD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, city: Milan, country: Italy, contacts name: Fabiana Ruggiero, PsYD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituto Europeo di Oncologia, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, PhD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06306040, orgStudyIdInfo id: Analgesia effect as on EA, briefTitle: Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-11-03, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: • Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.• Secondary outcome:* Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.* Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score* Parental satisfaction scores, conditionsModule conditions: Emergence Delirium, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery* Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery* Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery, whoMasked: PARTICIPANT, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Nalbuphine Versus Magnesium Sulfate, outcomesModule primaryOutcomes measure: compare between analgesia effect on pediatric patient, eligibilityModule sex: MALE, minimumAge: 3 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06306027, orgStudyIdInfo id: 2023/024, briefTitle: The Impact of Web-Based Education on Self-Care Power, Self-Efficacy, and Quality of Life in Knee Arthroplasty Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: The knee joint, which we use actively every day, is the largest joint in our body that bears the weight, allowing various movements such as walking, running, squatting, and standing. It involves the largest load-bearing structures in the body, including bones, cartilage, surrounding muscles, and ligaments, facilitating the mobilization of the joint. Due to constant use, the knee joint is susceptible to injuries and wear. Total knee arthroplasty (TKA) surgery involves replacing a degenerated joint surface, often due to conditions like osteoarthritis or rheumatoid arthritis, with a metal or polyethylene prosthesis. TKA, a widely used and highly successful surgical intervention in recent years, reduces pain, enhances functional range of motion, and improves independence and quality of life. Severe pain following TKA surgery restricts the movement of the knee joint and daily life activities, leading to the patient's inadequacy in self-care. Patients undergoing TKA surgery often face a lack of information after discharge. This lack of knowledge, coupled with uncertainty about the disease, limits the patient's self-efficacy. As the self-care power diminishes for patients struggling with daily life activities, their self-efficacy is negatively affected. The continuity of education becomes crucial since the verbal and written instructions given after surgery may not be sustained, causing a gradual decline in an individual's self-efficacy. As seen in the literature, studies have shown that postoperative pain, swelling, joint stiffness, fear, and movement limitations negatively impact the quality of life for patients undergoing TKA. Consequently, the self-care capacity, self-efficacy levels, and quality of life for individuals who have undergone TKA are adversely affected, as indicated in the literature.Ensuring continuity of care at home is crucial not only during the early postoperative period in the clinic but also after discharge. The nurse plays a significant role as an educator/advisor after discharge. The nurse provides counseling to patients discharged after Total Knee Arthroplasty (TKA) on pain management, disease progression, rehabilitation process, exercises, and considerations during daily activities (such as walking, bathing, toileting). Additionally, the nurse offers guidance on late-stage complications that may arise at home due to surgery and situations requiring hospitalization. While web-based educational interventions have been conducted for various patient groups, a web-based education program specifically for TKA surgery has not been identified. Having web-based post-TKA patient education allows continuous monitoring, assesses attendance and effectiveness remotely, and enables individuals to convey requests and questions to researchers through live support, ultimately enhancing the effectiveness of education. This approach is believed to prevent complications, reduce patient care costs and readmissions, increase patients' self-sufficiency in self-care, and consequently elevate their self-efficacy levels and quality of life. Close monitoring of postoperative patients is expected to improve their quality of life and self-care abilities, leading to increased satisfaction with healthcare services., conditionsModule conditions: Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Web-based education, outcomesModule primaryOutcomes measure: Personal Information Form, secondaryOutcomes measure: Self-Care Power Scale, otherOutcomes measure: Self-Efficacy - Competence Scale, otherOutcomes measure: Short Form 36 Quality of Life Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Konya City Hospital, status: RECRUITING, city: Konya, zip: 42020, country: Turkey, contacts name: Esra Nur BOZTAŞ, MScN, role: CONTACT, phone: 05312958337, email: esranurboztas44@gmail.com, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06306014, orgStudyIdInfo id: 69HCL22_980, secondaryIdInfos id: 2023-506232-32-00, type: OTHER, domain: EU CT Number, briefTitle: Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients, acronym: LIVEDIFF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, collaborators name: Exeliom Biosciences, descriptionModule briefSummary: Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.Among the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.The aim of this Phase I/II trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm)., conditionsModule conditions: Clostridioides Difficile Infection, conditions: Recurrent Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Part A = Single Arm open label. Part B = Randomised, placebo-controlled, double-blind., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Part A: None (Open-label). Part B: Double-blind., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: EXL01, interventions name: EXL01, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, primaryOutcomes measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence, secondaryOutcomes measure: Evaluation of the efficacy of EXL01 in preventing recurrence of C. difficile infection in patients at high risk of recurrence, secondaryOutcomes measure: Evaluation of the safety and tolerability profile of oral EXL01, secondaryOutcomes measure: Number of stools per day over the past 24 hours, secondaryOutcomes measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours, secondaryOutcomes measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale, secondaryOutcomes measure: Number of stools per day over the past 24 hours, secondaryOutcomes measure: Stool consistency, as assessed by the Bristol scale, over the past 24 hours, secondaryOutcomes measure: Abdominal discomfort assessed by a validated irritable bowel syndrome scale, secondaryOutcomes measure: Assessment of patient quality of life during treatment and follow-up, secondaryOutcomes measure: Assessment of recurrence of C. difficile infection, secondaryOutcomes measure: Evaluation of the presence of EXL01 in the fecal microbiota, secondaryOutcomes measure: Assessment of EXL01 persistence in the intestinal microbiota, secondaryOutcomes measure: 16S rRNA sequencing or shotgun, secondaryOutcomes measure: 16S rRNA sequencing or shotgun, secondaryOutcomes measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study., secondaryOutcomes measure: Assessment of the persistence of toxigenic C. difficile in the stool of patients in clinical remission during the study., secondaryOutcomes measure: Assessment of recurrences of C. difficile infection requiring hospitalization, secondaryOutcomes measure: Assessment of recurrences of C. difficile infection requiring hospitalization, secondaryOutcomes measure: Assessment of recurrences of C. difficile infection requiring surgery, secondaryOutcomes measure: Assessment of recurrences of C. difficile infection requiring surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service d'hépato-gastroentérologie - CHU Estaing, city: Clermont-Ferrand, zip: 63003, country: France, contacts name: Julien SCANZI, MD, role: CONTACT, phone: 04 73 75 02 35, email: jscanzi@chu-clermontferrand.fr, contacts name: Julien SCANZI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Service d'Hépato-gastroentérologie Hôpital de la Croix Rousse, city: Lyon, zip: 69004, country: France, contacts name: Nicolas BENECH, MD, role: CONTACT, phone: 04 26 10 94 35, phoneExt: +33, email: nicolas.benech@chu-lyon.fr, contacts name: Fanny JOUBERT, role: CONTACT, phone: 04 26 73 27 27, phoneExt: +33, email: Fanny.joubert@chu-lyon.fr, contacts name: Nicolas BENECH, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP), city: Paris, zip: 75012, country: France, contacts name: Paul MCLELLAN, MD, role: CONTACT, phone: 01 49 28 20 00, phoneExt: +33, email: Paul.mclellan@aphp.fr, contacts name: Paul MCLELLAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Service d'infectiologie - Hôpital Nord / CHU Saint Etienne, city: Saint-Étienne, zip: 42100, country: France, contacts name: Elisabeth BOTHELO-NEVERS, Pr, role: CONTACT, phone: 04 77 12 77 89, phoneExt: +33, email: elisabeth.botelho-nevers@chu-st-etienne.fr, contacts name: Elisabeth BOTHELO-NEVERS, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, locations facility: Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Laurent ALRIC, Pr, role: CONTACT, phone: 05 61 32 37 54, email: Alric.l@chu-toulouse.fr, contacts name: Laurent ALRIC, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Service de Maladies Infectieuses - CH de Valence, city: Valence, zip: 26000, country: France, contacts name: Julien SAISON, MD, role: CONTACT, phone: 04 75 62 57 32, phoneExt: +33, email: jsaison@ch-valence.fr, contacts name: Julien SAISON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.93333, lon: 4.9, hasResults: False
protocolSection identificationModule nctId: NCT06306001, orgStudyIdInfo id: IIRP-2023-1820/F1, briefTitle: Intravenous Methylene Blue for Treating Refractory Neonatal Septic Shock, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: Preterm infants (born at less than 37 weeks of pregnancy) sometimes develop a serious blood infection leading to low blood pressure, which does not respond to saline or to the standard medicines for increasing blood pressure, such as dopamine and epinephrine. The goal of this research study is to compare the effect of giving an injectable medicine called Methylene blue (MB) versus not giving MB to such preterm infants who are unresponsive to standard treatment. The main questions that this study aims to answer is:1. Whether MB treatment reduces death to any cause as compared to no MB treatment.2. Whether treatment with MB reduces the time to achieve normal blood pressure3. Whether treatment with MB reduces the time to stoppage of all blood pressure medications, steroids and normal saline.4. Whether treatment with MB improves heart function as measured by echocardiography at 24 and 48 hours., conditionsModule conditions: Neonatal Sepsis, conditions: Shock, Septic, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomly allocated to an intervention arm and a placebo arm. The 2 arms of the trial will run concurrently., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The random allocation will be concealed using serially numbered opaque sealed envelopes. After opening the envelope, a research nurse will administer a bolus of the study drug or placebo behind a screen, shielded from other staff. The infusion will be drawn up in an opaque syringe by the research nurse and infused through an intravenous tubing covered completely with aluminum foil. The research nurses will not be masked to the study drug. The parents of the subject, the regular staff nurses and doctors working in the unit and the project coordinator will be masked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Methylene Blue, interventions name: Placebo, outcomesModule primaryOutcomes measure: All-cause mortality within 7 days after randomization, secondaryOutcomes measure: Time taken to achieve therapeutic end-points within 7 days after randomization, secondaryOutcomes measure: Time taken to stop all inotrope/vasopressor treatment within 7 days after randomisation, secondaryOutcomes measure: Echocardiographic fractional shortening at 24 hour after randomization, secondaryOutcomes measure: Left ventricular end-diastolic diameter (LVEDD) by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Aortic diameter by echocardiography at 24 hour after randomization, secondaryOutcomes measure: Velocity time integral (LVI) by echocardiography at 24 hours after randomization, secondaryOutcomes measure: Echocardiographic fractional shortening at 48 hour after randomization, secondaryOutcomes measure: Left ventricular end-diastolic diameter (LVEDD) on echocardiography at 48 hour after randomization, secondaryOutcomes measure: Left ventricular end-systolic diameter (LVESD) by echocardiography at 48 hour after randomization, secondaryOutcomes measure: Aortic diameter by echocardiography at 48 hour after randomization, secondaryOutcomes measure: Velocity time integral (LVI) by echocardiography at 48 hours after randomization, secondaryOutcomes measure: Time taken to stop vasopressor treatment, secondaryOutcomes measure: Mortality during hospital stay, secondaryOutcomes measure: Serious adverse effects, secondaryOutcomes measure: Septic shock-related mortality, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Post Graduate Institute of Medical Education and Research (PGIMER), city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-22, uploadDate: 2024-03-01T05:10, filename: Prot_SAP_000.pdf, size: 210368, hasResults: False
protocolSection identificationModule nctId: NCT06305988, orgStudyIdInfo id: LYG2023021, briefTitle: Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Jian-Jun Ou, class: OTHER, descriptionModule briefSummary: In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed., conditionsModule conditions: ASD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial direct current stimulation, outcomesModule primaryOutcomes measure: Autism assessment assessment index, secondaryOutcomes measure: EEG physiological detection index, secondaryOutcomes measure: Social Communication Changes index, secondaryOutcomes measure: Stereotyped behavior index, secondaryOutcomes measure: Sensory index, secondaryOutcomes measure: Abnormal behavior indicator, secondaryOutcomes measure: Sleep index, otherOutcomes measure: Plasma Metabolite Levels Assessment, otherOutcomes measure: Safety evaluation SAFTEE indicator, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Psychiatry, Xiangya Second Hospital, Central South University, status: RECRUITING, city: Changsha, state: Hunan, zip: 410000, country: China, contacts name: Jianjun Ou, doctor, role: CONTACT, phone: 17775861486, email: oujianjun@csu.edu.cn, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06305975, orgStudyIdInfo id: STUDY00003169, briefTitle: Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery, acronym: BluntFascial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cedars-Sinai Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique., conditionsModule conditions: Laparoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Blunt fascial abdominal entry, interventions name: Veress needle abdominal entry, outcomesModule primaryOutcomes measure: Insufflation time, primaryOutcomes measure: Success upon peritoneal entry, secondaryOutcomes measure: Intraoperative complications, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Patients pain scores, secondaryOutcomes measure: Analgesics use, secondaryOutcomes measure: Length of hospital stay, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305962, orgStudyIdInfo id: 177Lu-RAD204.2023.0001, briefTitle: 177Lu-anti-PD-L1 sdAb in Metastatic Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Radiopharm Theranostics, Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, open-label study consisting of a Screening Period, an Imaging Period, and a Treatment Period in eligible non-small lung cancer patients who are positive for the biomarker PDL-1. The Screening period lasts up to 4 weeks. The Phase 0 (Imaging Period) is used to determine if patient's tumor(s) are still positive for the biomarker, as well as radiation dosimetry with low dose 177Lu-RAD204im (for a period of up to 2 weeks following the first injection of 177Lu-RAD204im), to assess the safety of the drug. Following the 2 week safety assessment, the subject is eligible to enter Phase I (Treatment Period) with gradual dose increases of 177Lu-RAD204tr. The Treatment Period lasts up to 3 cycles every 6 weeks, with additional extension to a maximum study dose interval of 12 weeks to be approved on a case-by-case basis in discussion with study Sponsor. During the Treatment Period, subjects will be assessed for both safety and treatment response using conventional images and clinical laboratory tests., conditionsModule conditions: PDL1 Gene Mutation, conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-RAD204, outcomesModule primaryOutcomes measure: Time Activity Curves (TACs), primaryOutcomes measure: Radiation dosimetry of Lu177-RAD204im, primaryOutcomes measure: Pharmacokinetics of 177Lu-RAD204im, primaryOutcomes measure: Biokinetics of 177Lu-RAD204im, primaryOutcomes measure: Safety and tolerability of 177Lu-RAD204tr, primaryOutcomes measure: Recommended dose(s) of 177Lu-RAD204tr for future exploration, secondaryOutcomes measure: Safety and tolerability of a single dose of 177Lu-RAD204im, secondaryOutcomes measure: Recommended dose(s) of 177Lu-RAD204im for future exploration, secondaryOutcomes measure: Preliminary antitumor activity of 177Lu-RAD204tr, secondaryOutcomes measure: Radiation dosimetry of 177Lu-RAD204tr, otherOutcomes measure: Level of agreement between 177Lu-RAD204im and standard of care imaging, otherOutcomes measure: Effect of 177Lu-RAD204im and 177Lu-RAD204tr on tumor markers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Alexandra Hospital, status: RECRUITING, city: Woolloongabba, state: Queensland, zip: 4102, country: Australia, contacts name: Kenneth O'Byrne, MD, role: CONTACT, phone: +610449091958, email: kenneth.obyrne@health.qld.gov.au, geoPoint lat: -27.48855, lon: 153.03655, locations facility: Hollywood Private Hospital, status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Joe Cardaci, MD, role: CONTACT, phone: 0893862844, email: jcardaci@dni.com.au, geoPoint lat: -31.98184, lon: 115.8073, hasResults: False
protocolSection identificationModule nctId: NCT06305949, orgStudyIdInfo id: XC23DDDS0098, briefTitle: Clinical Trial on the Safety and Efficacy of Optimized Transcranial Direct Current Stimulation for the Swallowing Function in Patients With Post-Stroke Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NEUROPHET, class: INDUSTRY, collaborators name: Bucheon St. Mary's Hospital, collaborators name: Saint Vincent's Hospital, Korea, collaborators name: National Traffic Injury Rehabilitation Hospital, collaborators name: Pusan National University Yangsan Hospital, descriptionModule briefSummary: The goal of this clinical trial is to evaluate whether the application of optimized transcranial direct current stimulation is more effective compared to sham stimulation for temporary improvement of swallowing function in patients with post-stroke dysphagia., conditionsModule conditions: Deglutition Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Personalized transcranial Direct Current Stimulation, outcomesModule primaryOutcomes measure: Functional Oral Intake Scale (FOIS), primaryOutcomes measure: Penetration-aspiration Scale (PAS), secondaryOutcomes measure: Functional Oral Intake Scale (FOIS), secondaryOutcomes measure: Penetration-aspiration Scale (PAS), secondaryOutcomes measure: Videofluoroscopic Dysphagia Scale (VDS), secondaryOutcomes measure: Korean Mann Assessment of Swallowing Ability (K-MASA), secondaryOutcomes measure: Speech Mechanism Screening Test (SMST), secondaryOutcomes measure: Urimal Test of Articulation and Phonology (U-TAP), secondaryOutcomes measure: modified Rankin Scale (mRS), secondaryOutcomes measure: Gugging Swallowing Screen, secondaryOutcomes measure: Eating Assessment Tool-10 (EAT-10), secondaryOutcomes measure: Iowa Oral Performance Instrument (IOPI), secondaryOutcomes measure: Motor-Evoked Potential (MEP), secondaryOutcomes measure: Grade, Roughness, Breathiness, Asthenia and Strain scale(GRBAS scale), secondaryOutcomes measure: Respiratory muscle strength, secondaryOutcomes measure: Peak cough flow, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305936, orgStudyIdInfo id: PLATE H-23042292, briefTitle: Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis, acronym: PLATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bispebjerg Hospital, class: OTHER, collaborators name: Glostrup University Hospital, Copenhagen, descriptionModule briefSummary: In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised feasibility study of an intervention group, receiving 100% plant-based diet and a control group, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intervention with 100% plant-based diet, outcomesModule primaryOutcomes measure: Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires, primaryOutcomes measure: Evaluation of Study Acceptance, primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, primaryOutcomes measure: Intervention adherence, secondaryOutcomes measure: Disease Activity Score (DAS28), secondaryOutcomes measure: Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ), secondaryOutcomes measure: Pain (VAS), secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Anxiety/depression, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Impact of rheumatoid arthritis (RA), secondaryOutcomes measure: The EuroQuality of Life (EQ-5D), secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Waist- and hip circumference, secondaryOutcomes measure: Disease activity, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Quantification of tender and swollen joints, secondaryOutcomes measure: C-reactive Protein (CRP), secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Thrombocytes, secondaryOutcomes measure: Hemoglobin (HbA1c), secondaryOutcomes measure: D-vitamin, secondaryOutcomes measure: Low-density lipoprotein (LDL), secondaryOutcomes measure: High-density lipoprotein (HDL), secondaryOutcomes measure: Triglyceride, secondaryOutcomes measure: Total cholesterol, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Clinical Research and Prevention, BispebjergH, status: ACTIVE_NOT_RECRUITING, city: Frederiksberg, zip: DK 2000, country: Denmark, geoPoint lat: 55.67938, lon: 12.53463, locations facility: The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup, status: RECRUITING, city: Glostrup, zip: 2600, country: Denmark, contacts name: Tanja Thomsen, Ph.D., role: CONTACT, phone: +4538163107, email: tanja.thomsen@regionh.dkdkTanja.thomsen@regionh.dk, contacts name: Kamille Torp, Ph.D., role: CONTACT, phone: +4538163113, email: kamille.almer.bernsdorf.torp@regionh.dk, contacts name: Bente Appel Esbensen, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 55.6666, lon: 12.40377, hasResults: False
protocolSection identificationModule nctId: NCT06305923, orgStudyIdInfo id: RNN/275/21/KE, secondaryIdInfos id: 503/3-066-02/503-31-001, type: OTHER_GRANT, domain: Medical University of Lodz, briefTitle: The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin, acronym: COLMATSKIN, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical University of Lodz, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about colostrum as a cosmetic in mature skin. . The aim of the study was to examine the effect of a cosmetic preparation containing sheep colostrum on skin with signs of aging in mature women Participants will be given the creams and asked to apply one -two doses in the evening after nighttime facial cleaning. They were also asked to use sunscreens during the day. During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results were averaged.Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to., conditionsModule conditions: Skin Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: colostrum cream, interventions name: placebo cream, outcomesModule primaryOutcomes measure: hydration, primaryOutcomes measure: transepidermal water loss, primaryOutcomes measure: erythema and melanin content, primaryOutcomes measure: sebum, secondaryOutcomes measure: firmness of the skin, secondaryOutcomes measure: firmness of the skin, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Lodz, city: Lodz, zip: 90-419, country: Poland, geoPoint lat: 51.75, lon: 19.46667, hasResults: False
protocolSection identificationModule nctId: NCT06305910, orgStudyIdInfo id: CMN-DMGVac-01, briefTitle: CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: OX2 Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG)., conditionsModule conditions: Diffuse Midline Glioma, H3 K27M-Mutant, conditions: Recurrent High Grade Glioma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: 3+3 design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Treatment with CD200AR-L, outcomesModule primaryOutcomes measure: Maximum Tolerated Dose (MTD) of CD200AR-L, secondaryOutcomes measure: Incidence of serious adverse events (SAEs), secondaryOutcomes measure: Time to progression (TTP) by 24 months, secondaryOutcomes measure: Progression free survival (PFS) by 24 months, secondaryOutcomes measure: Overall survival (OS) by 24 months, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Children's Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, contacts name: Anne Bendel, MD, role: CONTACT, phone: 612-813-5940, email: anne.bendel@childrensmn.org, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False
protocolSection identificationModule nctId: NCT06305897, orgStudyIdInfo id: CS5_10B, briefTitle: Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face, acronym: CS5_10B, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Cryonove Pharma, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the 3 different prototype of cyto-selective cryotherapy devices (name of the devices : CRYONOVE) use in brown spots on the face of subject from different ethnicities. The main questions it aims to answer are:* the tolerance of 3 prototypes of cyto-selective cryotherapy treatments* the performance of 3 prototypes of cyto-selective cryotherapy treatmentsParticipants will be treated for each spots with a definied prototype during 6 treatment visits.Researchers will compare the tolerance and performance of the 3 prototypes., conditionsModule conditions: Lentigo, conditions: Solar Lentigo, conditions: Post Inflammatory Hyperpigmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Proof of concept study concerning 3 prototypes of cyto-selective cryotherapy devices corresponding to a modified CE marked medical device (ref: 822-v1)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: CRYONOVE (EC14_4osc), interventions name: CRYONOVE (EC+05_1osc), interventions name: CRYONOVE (EC+05_2osc), outcomesModule primaryOutcomes measure: Tolerance, secondaryOutcomes measure: Performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305884, orgStudyIdInfo id: OSU-21287, secondaryIdInfos id: NCI-2023-03077, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Transcutaneous Sensors for the Detection of Cancer-Related Lymphedema, Project Limb Rescue Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home., conditionsModule conditions: Hematopoietic and Lymphoid System Neoplasm, conditions: Lymphedema, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Bioelectric Impedance Analysis, interventions name: Exercise, interventions name: Photoplethysmography, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Unique signature describing photoplethysmography and bioimpedance at rest and during activity, secondaryOutcomes measure: Patient reported outcomes, secondaryOutcomes measure: Tolerability of sensors, secondaryOutcomes measure: Likely classification for lymphedema, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Carlo M. Contreras, MD, role: CONTACT, phone: 614-293-3465, email: Carlo.Contreras@osumc.edu, contacts name: Carlo M. Contreras, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06305871, orgStudyIdInfo id: 2023-NHLHCRF-YYPPLC-ZR-09, briefTitle: Clinical Study of Ultrasound-guided Radiofrequency Ablation in the Treatment of Refractory Hyperthyroidism, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Zhang Bo, class: OTHER, descriptionModule briefSummary: Hyperthyroidism is an endocrine disease with a high incidence rate, and some patients are difficult to effectively control the condition after long-term drug treatment, and the disease recurs, forming refractory hyperthyroidism. The search for a new safe, effective and minimally invasive treatment has become a research hotspot. Ultrasound-guided radiofrequency ablation is a hot spot in clinical research due to its advantages of low trauma, high safety, precise inactivation of lesions, and multiple ablation. However, there is no unified standard for the number and scope of ablation in the treatment of refractory hyperthyroidism by radiofrequency ablation, and there is a lack of data on the effectiveness and safety of the treatment with large samples and long-term effects. Therefore, how to establish a standardized treatment strategy and appropriate plan for ablation of refractory hyperthyroidism based on clinical practice is an urgent problem to be solved. The purpose of this study was to prospectively include refractory hyperthyroidism for ultrasound-guided radiofrequency ablation, and to evaluate the efficacy and safety of hyperthyroidism ablation by comparing the changes in symptoms and signs, serology, and imaging of patients before and after ablation. The relevant factors affecting the efficacy of ablation were analyzed and the most appropriate ablation scope was determined. Radiofrequency ablation was retrospectively compared with traditional surgery and 131I treatment, and the near- and medium-term treatment effects, incidence of adverse reactions and complications, as well as the economic benefits and sociopsychological differences of the three treatment methods were compared.The expected outcome of this study is to establish a research cohort of hyperthyroidism ablation based on a large sample population, and to establish the most appropriate and effective regimen for radiofrequency ablation of refractory hyperthyroidism compared with traditional surgery and 131I treatment with safety and near- and medium-term efficacy. The Department of Ultrasound Medicine of China-Japan Friendship Hospital has accumulated rich experience in the ablation treatment of benign and malignant thyroid nodules and hyperthyroidism, and has completed more than 200 cases of thyroid ablation in the past two years. Under the leadership of Professor Zhang Bo, the research team of this project has conducted a number of clinical studies on the ultrasound diagnosis and treatment of thyroid diseases, presided over and participated in more than 20 national, provincial and university-level scientific research courses, and the first author or corresponding author wrote more than 70 articles in related fields, which laid a solid research foundation for the conduct of this study., conditionsModule conditions: Hyperthyroidism/Thyrotoxicosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ablation therapy, outcomesModule primaryOutcomes measure: Discontinuation rate, primaryOutcomes measure: Recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China-Japan friendship hospital, city: Beijing, state: Beijing, zip: 100000, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06305858, orgStudyIdInfo id: UKA - PFJ, briefTitle: Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.The population consists of 48 adult patients with gonarthrosis divided into two groups:24 patients Group A experimental group: partial denture surgical procedure24 patients Group B control group: total denture surgical procedure with patellar resurfacing, conditionsModule conditions: Knee Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Prosthetic Surgical Procedure, outcomesModule primaryOutcomes measure: Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Clinico San Siro, status: RECRUITING, city: Milan, country: Italy, contacts name: Elena Cittera, role: CONTACT, phone: 0283502224, email: elena.cittera@grupposandonato.it, contacts name: Andrea Parente, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06305845, orgStudyIdInfo id: 152012023, briefTitle: Digital Crowns Versus Prefabricated Crowns on Primary Teeth, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-09-20, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: National Research Centre, Egypt, class: OTHER, descriptionModule briefSummary: Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months., conditionsModule conditions: Dental Caries in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a randomized clinical trial with two parallel arms, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: participants will not be informed of which crown they will receive, whoMasked: PARTICIPANT, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Digital crowns, outcomesModule primaryOutcomes measure: Patient and parent satisfaction, secondaryOutcomes measure: Crown retention, secondaryOutcomes measure: Gingival inflammation, secondaryOutcomes measure: Color match, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: National Research Centre, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06305832, orgStudyIdInfo id: IUNU-PC-120, briefTitle: Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-07, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP)., conditionsModule conditions: Prostate Cancer, conditions: Biochemical Recurrence, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Rezvilutamide, interventions name: Androgen deprivation therapy (ADT), interventions name: SRT, outcomesModule primaryOutcomes measure: 3-year biochemical progression-free survival, secondaryOutcomes measure: progression-free survival (PFS), secondaryOutcomes measure: metastasis-free survival (MFS), secondaryOutcomes measure: percentage of undetectable PSA, secondaryOutcomes measure: ctDNA-positive rate, secondaryOutcomes measure: ctDNA clearance rate, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Shun Zhang, role: CONTACT, phone: 15050589789, phoneExt: 15050589789, email: explorershun@126.com, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Hongqian Guo, Phd, role: CONTACT, phone: 13605171690, email: dr.ghq@nju.edu.cn, contacts name: Shun Zhang, role: CONTACT, contacts name: Hongqian Guo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06305819, orgStudyIdInfo id: 2023057, briefTitle: Effectiveness of a Self-management Program After Traumatic Injury, acronym: SEMPO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Oslo University Hospital, class: OTHER, collaborators name: South-Eastern Norway Regional Health Authority, collaborators name: Sunnaas Rehabilitation Hospital, collaborators name: University of Oslo, descriptionModule briefSummary: Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury.The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual., conditionsModule conditions: Trauma Injury, conditions: Trauma, Multiple, conditions: Polytrauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: self-management support program, interventions name: Control group, outcomesModule primaryOutcomes measure: Trauma Coping Self-Efficacy, secondaryOutcomes measure: Rivermead Post-Concussion Symptom Questionnaire, secondaryOutcomes measure: Fatigue Severity Scale, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Brief Pain Inventory -short form, secondaryOutcomes measure: International Physical Activity Questionnaire, secondaryOutcomes measure: Cognitive Failures Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Generalised Anxiety Disorder-7, secondaryOutcomes measure: Impact of Event Scale - Revised, secondaryOutcomes measure: Return to work, otherOutcomes measure: Resilience Scale for Adults, otherOutcomes measure: EuroQol five-dimensional questionnaire, otherOutcomes measure: Target Outcomes, otherOutcomes measure: Patient Global Impression of Change, otherOutcomes measure: Intervention acceptability and satisfaction, otherOutcomes measure: Intervention satisfaction, otherOutcomes measure: WHO Disability Assessment Scale, otherOutcomes measure: Glasgow Outcome Scale - Extended, otherOutcomes measure: Communication with physicians, otherOutcomes measure: Health Literacy Questionnaire, otherOutcomes measure: Received health care services, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Mari Storli Rasmussen, PhD, role: CONTACT, phone: +4799797575, email: masras@ous-hf.no, contacts name: Solveig L. Hauger, PhD, role: CONTACT, phone: +4791310358, email: solveig.hauger@gmail.com, geoPoint lat: 59.91273, lon: 10.74609, hasResults: False
protocolSection identificationModule nctId: NCT06305806, orgStudyIdInfo id: Pro00112597_B, secondaryIdInfos id: OTA-21-015G, type: OTHER, domain: NIH Grant to RTI; RTI subcontracting with DCRI, briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine), statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Kanecia Obie Zimmerman, class: OTHER, descriptionModule briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs., conditionsModule conditions: Long COVID, conditions: Long Covid19, conditions: Long Covid-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Ivabradine, interventions name: Ivabradine Placebo, interventions name: Coordinated Care, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score, secondaryOutcomes measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31), secondaryOutcomes measure: Change in Malmo POTS Symptom Score, secondaryOutcomes measure: Change in Active Stand Test, secondaryOutcomes measure: Change in blood pressure (BP), secondaryOutcomes measure: Change in heart rate (HR), secondaryOutcomes measure: Change in 6-min Walk Test, secondaryOutcomes measure: Change in PROMIS-29 + 2 Questionnaire, secondaryOutcomes measure: Change in step count as measured by a wearable device, secondaryOutcomes measure: Change in heart rate as measured by a wearable device, secondaryOutcomes measure: Proportion of participants who experience individual SAEs, secondaryOutcomes measure: Proportion who experience any one or more SAEs, secondaryOutcomes measure: Incidence of SAEs leading to discontinuation, secondaryOutcomes measure: Incidence of Events of Special Interest (ESIs), otherOutcomes measure: Changes in Autonomic Function Testing, otherOutcomes measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS), otherOutcomes measure: Change in PASC Symptom Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: All sites listed under NCT06305780, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
protocolSection identificationModule nctId: NCT06305793, orgStudyIdInfo id: Pro00112597_A, secondaryIdInfos id: OTA-21-015G, type: OTHER, domain: NIH Grant to RTI; RTI subcontracting with DCRI, briefTitle: RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG), statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kanecia Obie Zimmerman, class: OTHER, descriptionModule briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs., conditionsModule conditions: Long COVID, conditions: Long Coronavirus Disease 2019 (Covid19), conditions: Long Covid-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: IVIG (intravenous immunoglobulin), interventions name: IVIG Placebo, interventions name: Coordinated Care, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score, secondaryOutcomes measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31), secondaryOutcomes measure: Change in Malmo POTS Symptom Score, secondaryOutcomes measure: Change in Active Stand Test, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in heart rate (HR), secondaryOutcomes measure: Change in 6-min Walk Test, secondaryOutcomes measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-29) + 2 Questionnaire, secondaryOutcomes measure: Change in step count as measured by a wearable device, secondaryOutcomes measure: Change in heart rate as measured by a wearable device, secondaryOutcomes measure: Proportion of participants who experience individual (SAEs, secondaryOutcomes measure: Proportion who experience any one or more ( Serious Adverse Event) SAEs, secondaryOutcomes measure: Incidence of SAEs leading to discontinuation, secondaryOutcomes measure: Incidence of Events of Special Interest (ESIs), otherOutcomes measure: Changes in Autonomic Function Testing, otherOutcomes measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS), otherOutcomes measure: Change in PASC Symptom Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: All sites listed under NCT06305780, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
protocolSection identificationModule nctId: NCT06305780, orgStudyIdInfo id: Pro00112597, secondaryIdInfos id: OTA-21-015G, type: OTHER, domain: NIH Grant to RTI; RTI subcontracting with DCRI, briefTitle: RECOVER-AUTONOMIC Platform Protocol, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kanecia Obie Zimmerman, class: OTHER, descriptionModule briefSummary: This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs., conditionsModule conditions: Long COVID, conditions: Long Covid19, conditions: Long Covid-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In each Appendix trial, each participant will be assigned with equal probability to one of the factorial combinations based on two factors: (1) a study intervention/control and (2) non-pharmacologic intervention/control if the participant is eligible for the study intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: IVIG + Coordinated Care, interventions name: IVIG Placebo + Coordinated Care, interventions name: Ivabradine + Coordinated Care, interventions name: Ivabradine Placebo + Coordinated Care, interventions name: IVIG + Usual Care, interventions name: IVIG Placebo + Usual Care, interventions name: Ivabradine + Usual Care, interventions name: Ivabradine Placebo + Usual Care, outcomesModule primaryOutcomes measure: Change in Orthostatic Hypotension Questionnaire (OHQ)/Orthostatic Intolerance Questionnaire (OIQ) Composite Score, secondaryOutcomes measure: Change in Composite Autonomic Symptoms Score 31 (COMPASS-31), secondaryOutcomes measure: Change in Malmo POTS Symptom Score, secondaryOutcomes measure: Change in Active Stand Test, secondaryOutcomes measure: Change in blood pressure, secondaryOutcomes measure: Change in heart rate (HR), secondaryOutcomes measure: Change in 6-min Walk Test, secondaryOutcomes measure: Change in PROMIS-29 + 2 Questionnaire, secondaryOutcomes measure: Change in step count as measured by a wearable device, secondaryOutcomes measure: Change in heart rate as measured by a wearable device, secondaryOutcomes measure: Proportion of participants who experience individual SAEs, secondaryOutcomes measure: Proportion who experience any one or more SAEs, secondaryOutcomes measure: Incidence of SAEs leading to discontinuation, secondaryOutcomes measure: Incidence of Events of Special Interest (ESIs), otherOutcomes measure: Changes in Autonomic Function Testing, otherOutcomes measure: Change in Vanderbilt Orthostatic Symptoms Score (VOSS), otherOutcomes measure: Change in PASC Symptom Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus Clinical and Translational Research Center (CTRC) - Appendix A & B, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Rush University Medical Center - Appendix A & B, city: Chicago, state: Illinois, zip: 60612, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: NorthShore University HealthSystem - Evanston Hospital - Appendix B Only, city: Evanston, state: Illinois, zip: 60201, country: United States, geoPoint lat: 42.04114, lon: -87.69006, locations facility: University of Kansas Medical Center CTSU Fairway - Appendix A & B, city: Fairway, state: Kansas, zip: 66205, country: United States, geoPoint lat: 39.02223, lon: -94.6319, locations facility: St. Lawrence Health Medical Campus - Appendix A & B, city: Canton, state: New York, zip: 13617, country: United States, geoPoint lat: 44.59562, lon: -75.16909, locations facility: Sentara Norfolk General Hospital - Appendix A and B, city: Norfolk, state: Virginia, zip: 23507, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: Providence Medical Research Center - Appendix A & B, city: Spokane, state: Washington, zip: 99204, country: United States, geoPoint lat: 47.65966, lon: -117.42908, hasResults: False
protocolSection identificationModule nctId: NCT06305767, orgStudyIdInfo id: V940-005, secondaryIdInfos id: V940-005, type: OTHER, domain: Merck, secondaryIdInfos id: U1111-1292-1952, type: OTHER, domain: WHO, secondaryIdInfos id: 2023-505658-17, type: OTHER, domain: EU CT, briefTitle: A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2031-04-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: ModernaTX, Inc., descriptionModule briefSummary: The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab, interventions name: V940, interventions name: Placebo, outcomesModule primaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Distant Metastasis-Free Survival (DMFS), secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102), status: RECRUITING, city: Orlando, state: Florida, zip: 32804, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 205-520-6512, geoPoint lat: 28.53834, lon: -81.37924, locations facility: One Clinical Research ( Site 1807), status: RECRUITING, city: Nedlands, state: Western Australia, zip: 6009, country: Australia, contacts name: Study Coordinator, role: CONTACT, phone: +61862799466, geoPoint lat: -31.98184, lon: 115.8073, locations facility: Centre Hospitalier de l'Université de Montréal ( Site 0005), status: RECRUITING, city: Montréal, state: Quebec, zip: H2X 3E4, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 5148908000, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, status: RECRUITING, city: Quebec City, state: Quebec, zip: G1J 1Z4, country: Canada, contacts name: Study Coordinator, role: CONTACT, phone: 4185254444, geoPoint lat: 46.81228, lon: -71.21454, locations facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801), status: RECRUITING, city: Bydgoszcz, state: Kujawsko-pomorskie, zip: 85-796, country: Poland, contacts name: Study Coordinator, role: CONTACT, phone: 48501446778, geoPoint lat: 53.1235, lon: 18.00762, locations facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003), status: RECRUITING, city: Pozuelo de Alarcon, state: Madrid, zip: 28223, country: Spain, contacts name: Study Coordinator, role: CONTACT, phone: +34914521987, geoPoint lat: 40.43293, lon: -3.81338, hasResults: False
protocolSection identificationModule nctId: NCT06305754, orgStudyIdInfo id: 2870-009, secondaryIdInfos id: 2023-504910-31, type: REGISTRY, domain: EU CT, secondaryIdInfos id: U1111-1288-3804, type: OTHER, domain: UTN, secondaryIdInfos id: MK-2870-009, type: OTHER, domain: Merck, briefTitle: Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2028-09-12, completionDateStruct date: 2030-06-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS)., conditionsModule conditions: Non-small Cell Lung Cancer (NSCLC), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Unblinded Open-label, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab tirumotecan, interventions name: Pemetrexed, interventions name: Carboplatin, interventions name: Antihistamine, interventions name: H2 Receptor Antagonist, interventions name: Acetaminophen (or equivalent), interventions name: Dexamethasone (or equivalent), outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS), primaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, secondaryOutcomes measure: Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30, secondaryOutcomes measure: Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13), secondaryOutcomes measure: Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30, secondaryOutcomes measure: TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13, secondaryOutcomes measure: Number of Participants Who Experience One or More Adverse Events (AEs), secondaryOutcomes measure: Number of Participants Who Discontinue Study Treatment Due to an AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06305741, orgStudyIdInfo id: 24-060, briefTitle: A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers., conditionsModule conditions: Cancer Patients, conditions: Care Givers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Managing Anxiety from Cancer (MAC), outcomesModule primaryOutcomes measure: percentage of participants to complete all study procedures, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (All Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (All Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (All Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All protocol activities), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (All Protocol Activities), status: RECRUITING, city: Rockville Centre, state: New York, zip: 11553, country: United States, contacts name: Kelly McConnell, PhD, role: CONTACT, phone: 646-888-0026, geoPoint lat: 40.65871, lon: -73.64124, hasResults: False
protocolSection identificationModule nctId: NCT06305728, orgStudyIdInfo id: 23-367, briefTitle: A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2030-03-04, completionDateStruct date: 2030-03-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:* The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1* The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan), conditionsModule conditions: Pancreatic Cyst, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: 89Zr-DFO-HuMab-5B1 immunoPET, interventions name: HP MRI, interventions name: Blood assay, outcomesModule primaryOutcomes measure: Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited protocol activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All protocol activites), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Kevin Soares, MD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Weill Cornell Medical Center (Specimen Analysis Only), status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: David Lyden, MD, role: CONTACT, phone: 212-746-6565, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites), status: RECRUITING, city: Rockville Centre, state: New York, zip: 11553, country: United States, contacts name: Kevin Soares, PhD, role: CONTACT, phone: 212-639-3195, geoPoint lat: 40.65871, lon: -73.64124, hasResults: False
protocolSection identificationModule nctId: NCT06305715, orgStudyIdInfo id: IIT-THOMPSON-RADIANCE-LUNG-X, briefTitle: Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-06-15, completionDateStruct date: 2028-06-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, descriptionModule briefSummary: This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI)., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Radiation Therapy, interventions name: Targeted TKI therapy, outcomesModule primaryOutcomes measure: Progression Free Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Froedtert Hospital & the Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts name: Jonathan Thompson, MD, MS, role: CONTACT, phone: 414-805-4600, email: jrthomps@mcw.edu, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
protocolSection identificationModule nctId: NCT06305702, orgStudyIdInfo id: LZRXN-001, briefTitle: Real-world Study of Inetetamab in HER2-positive Metastatic Breast Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Liaoning Tumor Hospital & Institute, class: OTHER, descriptionModule briefSummary: A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy., conditionsModule conditions: HER2-positive Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: inetetamab, outcomesModule primaryOutcomes measure: Progression Free Survival(PFS), secondaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: Adverse events (AEs), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liaoning Cancer Hospital &Institue, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
protocolSection identificationModule nctId: NCT06305689, orgStudyIdInfo id: 79144, briefTitle: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*, acronym: ITW, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shriners Hospitals for Children, class: OTHER, descriptionModule briefSummary: To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW., conditionsModule conditions: Idiopathic Toe Walking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Serial Casting, outcomesModule primaryOutcomes measure: Gait parameters: Velocity, primaryOutcomes measure: Gait Paremeters:Stride Length (m), primaryOutcomes measure: Three dimensional Gait Analysis:Kinematics (degrees), primaryOutcomes measure: Dynamic Motor Control Index during Walking (Walk-DMC), primaryOutcomes measure: Three dimensional Gait Analysis:Kinetics (nm/kg), primaryOutcomes measure: Quantitative Assessment of Toe Walking, primaryOutcomes measure: Pediatric Outcomes Data Collection Instrument, secondaryOutcomes measure: Passive Range of Motion, secondaryOutcomes measure: Muscle Strength, otherOutcomes measure: The Toe Walking Tool, otherOutcomes measure: Selective Motor Control, otherOutcomes measure: Coactivation Tool, otherOutcomes measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), otherOutcomes measure: Genomics, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Vincent Basas, role: CONTACT, phone: 916-453-2132, email: vincent.basas@shrinenet.org, contacts name: Jon R Davids, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Chicago, state: Illinois, zip: 60707, country: United States, contacts name: Ann Flanagan, role: CONTACT, phone: 773-622-5400, email: aflanagan@shrinenet.org, contacts name: Kelsey Davidson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40508, country: United States, contacts name: Daniella Hudgins, role: CONTACT, phone: 859-268-5772, email: Daniella.Hudgins@shrinenent.org, contacts name: Rebekah Leet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Paige Lemhouse, role: CONTACT, phone: 971-544-3377, email: plemhouse@shrinenet.org, contacts name: Jeremy Bauer, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Susan Sienko, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19140, country: United States, contacts name: Natalie Williams, role: CONTACT, phone: 215-430-4248, email: Natalie.Wiliams@shrinenet.org, contacts name: Sean Waldron, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Greenville, state: South Carolina, zip: 29605, country: United States, contacts name: Brittney Southerland, role: CONTACT, phone: 864-255-7955, email: Brittney.Southerland@shrinenet.org, contacts name: Lauren Hyer, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: David Westberry, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.85262, lon: -82.39401, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84103, country: United States, contacts name: Lisa Certer, role: CONTACT, phone: 801-536-3807, email: Lcarter@shrinenet.org, contacts name: Kristin Carroll, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Bruce MacWilliams, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Shriners Children's Spokane, status: RECRUITING, city: Spokane, state: Washington, zip: 99204, country: United States, contacts name: Charlotte Preuschoff, role: CONTACT, phone: 509-623-0427, email: cpreuschoff@shrinenet.org, contacts name: Ted Sousa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.65966, lon: -117.42908, hasResults: False
protocolSection identificationModule nctId: NCT06305676, orgStudyIdInfo id: MCC-23073, briefTitle: Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC), acronym: BASH OPC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh)., conditionsModule conditions: Oropharyngeal Cancer, conditions: HPV-Related Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: combined HPV 16 DNA and host gene methylation oral biomarker panel, outcomesModule primaryOutcomes measure: Diagnostic Sensitivity, primaryOutcomes measure: Diagnostic Specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Kimberly Isaacs-Soriano, role: CONTACT, phone: 813-745-6992, email: kimberly.Isaacs-Soriano@moffitt.org, contacts name: Anna Giuliano, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Amelio, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jimmy Caudell, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Christine Chung, MD, role: SUB_INVESTIGATOR, contacts name: Bruce Wenig, MD, role: SUB_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Jose P. Zevallos, MD, PhD, role: CONTACT, email: zevallosjp@upmc.edu, contacts name: Robert Ferris, PhD, role: CONTACT, email: ferrrl@UPMC.EDU, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
protocolSection identificationModule nctId: NCT06305663, orgStudyIdInfo id: 921, briefTitle: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule briefSummary: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children, conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The identity of the study eye will be masked to subjects, assessors, and other masked personnel while masking is maintained.., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 418, type: ESTIMATED, armsInterventionsModule interventions name: Bausch + Lomb (kalifilcon A) Myopia Control Soft (Hydrophilic), interventions name: CooperVision MiSight (omafilcon A/60%) Myopia Control one day Soft Contact Lens, outcomesModule primaryOutcomes measure: Mean change from baseline in axial length., primaryOutcomes measure: Mean change from baseline in cycloplegic SERE., eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Site 105, city: Beijing, state: Beijing, zip: 100044, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Site 107, city: Dongcheng, state: Beijing, zip: 100730, country: China, locations facility: Site 109, city: Xiamen, state: Fujian, zip: 361004, country: China, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Site 111, city: Haikou, state: Hainan, zip: 570311, country: China, geoPoint lat: 20.04583, lon: 110.34167, locations facility: Site 110, city: Wuhan, state: Hubei, zip: 430012, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Site 102, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Site 106, city: Taiyuan, state: Shanxi, zip: 030072, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Site 108, city: Shenzhen, state: Shenzhen, zip: 518040, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Site 103, city: Chengdu, state: Sichaun Province, zip: 610044, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Site 104, city: Nankai, state: Tianjin, zip: 300392, country: China, locations facility: Site 101, city: Wenzhou, state: Zhejiang, zip: 325027, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False
protocolSection identificationModule nctId: NCT06305650, orgStudyIdInfo id: WK2024001, briefTitle: Probiotic Influence on Obesity-Related Lipidemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Wecare Probiotics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements., conditionsModule conditions: Overweight or Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Double(Participant,Investigator), whoMasked: PARTICIPANT, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, outcomesModule primaryOutcomes measure: Effect on body mass index (BMI) values., eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, zip: 471000, country: China, contacts name: Ying Wu, Dr., role: CONTACT, phone: +86 18639283502, email: wuying2000@126.com, geoPoint lat: 34.68361, lon: 112.45361, hasResults: False
protocolSection identificationModule nctId: NCT06305637, orgStudyIdInfo id: KTCS-2302, briefTitle: A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-02-10, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Taro Pharmaceuticals USA, class: INDUSTRY, descriptionModule briefSummary: To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor., conditionsModule conditions: Tinea Versicolor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 430, type: ACTUAL, armsInterventionsModule interventions name: Ketoconazole Shampoo, 2%, interventions name: Ketoconazole Shampoo, 2% (Reference Standard), interventions name: Placebo, outcomesModule primaryOutcomes measure: To demonstrate the therapeutic equivalence and safety of the Investigational Product, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taro, city: Hawthorne, state: New York, zip: 10532, country: United States, geoPoint lat: 41.10732, lon: -73.79597, hasResults: False
protocolSection identificationModule nctId: NCT06305624, orgStudyIdInfo id: 2024-0130, secondaryIdInfos id: 1R01DA047279-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA047279-01, secondaryIdInfos id: A532000, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 2/21/2024, type: OTHER, domain: UW Madison, briefTitle: Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease, acronym: IMPACT-ALD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months., conditionsModule conditions: Alcohol Use Disorder, conditions: Alcohol-related Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, controlled, Type 1 hybrid implementation-effectiveness trial., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 298, type: ESTIMATED, armsInterventionsModule interventions name: Connections App, outcomesModule primaryOutcomes measure: Days of Alcohol Abstinence in ALD Participants, primaryOutcomes measure: Number of Standard Drinks Consumed in ALD Participants, secondaryOutcomes measure: Change in Patient Health Questionnaire (PHQ-8) Score, secondaryOutcomes measure: Change in PROMIS Global Health Score, secondaryOutcomes measure: Change in Generalized Anxiety Disorder (GAD-7) Score, secondaryOutcomes measure: Change in Insomnia Severity Index (ISI) Score, secondaryOutcomes measure: Change in Pain Interference (PEG) Score, secondaryOutcomes measure: Change in Drinking Motivations Questionnaire - Adult (DMQ-A) Score, secondaryOutcomes measure: Change in CHESS Bonding Scale Score, secondaryOutcomes measure: Change in Drug-Taking Confidence Questionnaire (DTCQ-8A) Score, secondaryOutcomes measure: Change in Treatment Self-Regulation Questionnaire (TSRQ) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UM General Hepatology Clinic, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: UM Multidisciplinary ALD Clinic, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: UW General Hepatology Clinic, city: Madison, state: Wisconsin, zip: 53705, country: United States, geoPoint lat: 43.07305, lon: -89.40123, locations facility: UW Multidisciplinary ALD Clinic, city: Madison, state: Wisconsin, zip: 53705, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06305611, orgStudyIdInfo id: KIWI, briefTitle: European and North Indian Cohort of KaWasaki dIsease, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-13, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success., conditionsModule conditions: Kawasaki Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 103, type: ESTIMATED, outcomesModule primaryOutcomes measure: IVIG resistance rate, primaryOutcomes measure: percentage of IVIG-resistant patients, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Universidade Federal do Rio de Janeiro, status: RECRUITING, city: Rio de Janeiro, country: Brazil, contacts name: Adriana Fonseca, role: CONTACT, geoPoint lat: -22.90278, lon: -43.2075, locations facility: Children's Hospital Zagreb, status: RECRUITING, city: Zagreb, country: Croatia, contacts name: Alenka Gagro, role: CONTACT, geoPoint lat: 45.81444, lon: 15.97798, locations facility: University Hospital Centre Zagreb, University School of Medicine, status: RECRUITING, city: Zagreb, country: Croatia, contacts name: Marija Jelusic, role: CONTACT, geoPoint lat: 45.81444, lon: 15.97798, locations facility: Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI, status: NOT_YET_RECRUITING, city: Le Kremlin-Bicêtre, country: France, contacts name: Isabelle Koné-Paut, role: CONTACT, geoPoint lat: 48.81471, lon: 2.36073, locations facility: Manipal Hospital, status: NOT_YET_RECRUITING, city: Bangalore, country: India, contacts name: Anand Prahalad Rao, role: CONTACT, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Postgraduate Institute of Medical Education and Research, status: RECRUITING, city: Chandigarh, country: India, contacts name: Vignesh Pandiarajan, role: CONTACT, geoPoint lat: 30.73629, lon: 76.7884, locations facility: Sri Ramachandra Medical Centre, status: NOT_YET_RECRUITING, city: Chennai, country: India, contacts name: Mahesh Janarthanan, role: CONTACT, geoPoint lat: 13.08784, lon: 80.27847, locations facility: Amrita Institute of Medical Sciences, status: NOT_YET_RECRUITING, city: Kochi, country: India, contacts name: Suma Balan, role: CONTACT, geoPoint lat: 9.93988, lon: 76.26022, locations facility: Institute of Child Health, status: RECRUITING, city: Kolkata, country: India, contacts name: Priyankar Pal, role: CONTACT, geoPoint lat: 22.56263, lon: 88.36304, locations facility: Vivekananda Institute of Medical Sciences, status: NOT_YET_RECRUITING, city: Kolkata, country: India, contacts name: SUPARNA GUHA, role: CONTACT, geoPoint lat: 22.56263, lon: 88.36304, locations facility: Meir Medical Centre, status: NOT_YET_RECRUITING, city: Kfar Saba, country: Israel, contacts name: Ruby Haviv, role: CONTACT, geoPoint lat: 32.175, lon: 34.90694, locations facility: ASST Papa Giovanni XXIII, status: RECRUITING, city: Bergamo, country: Italy, contacts name: Lucio Verdoni, role: CONTACT, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Spedali Civili, status: RECRUITING, city: Brescia, country: Italy, contacts name: Marco Cattalini, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Gabriele Simonini, role: CONTACT, email: gabriele.simonini@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Istituto Giannina Gaslini, status: RECRUITING, city: Genova, country: Italy, contacts name: Silvia Rosina, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, status: NOT_YET_RECRUITING, city: Milano, country: Italy, contacts name: Giovanni Filocamo, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: P.O. "Giovanni Di Cristina", status: NOT_YET_RECRUITING, city: Palermo, country: Italy, contacts name: Maria Cristina Maggio, role: CONTACT, geoPoint lat: 38.13205, lon: 13.33561, locations facility: Università di Torino, status: RECRUITING, city: Torino, country: Italy, contacts name: Francesco Licciardi, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: IRCCS Burlo Garofolo, status: RECRUITING, city: Trieste, country: Italy, contacts name: andrea Taddio, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Beatrix Kinderkliniek, University Medical Center, status: NOT_YET_RECRUITING, city: Groningen, country: Netherlands, contacts name: Wineke Armbrust, role: CONTACT, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Hospital de Sabadell, status: RECRUITING, city: Barcellona, country: Spain, contacts name: Judith Sanchez Manubens, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Sant Joan de Déu, status: RECRUITING, city: Barcellona, country: Spain, contacts name: Jordi Anton, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Chiang Mai University Hospital, status: RECRUITING, city: Chiang Mai, country: Thailand, contacts name: Watchareewan Sontichai, role: CONTACT, geoPoint lat: 18.79038, lon: 98.98468, locations facility: Hacettepe University Children's Hospital, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Seza Ozen, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Health Sciences University, Umraniye Education and Research Hospital, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Betul Sozeri, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul Uni. Istanbul Med.Fac, status: NOT_YET_RECRUITING, city: Istanbul, country: Turkey, contacts name: Nuray Aktay Ayaz, role: CONTACT, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Royal Hospital for Children, status: RECRUITING, city: Bristol, country: United Kingdom, contacts name: Athimalaipet Ramanan, role: CONTACT, geoPoint lat: 51.45523, lon: -2.59665, hasResults: False
protocolSection identificationModule nctId: NCT06305598, orgStudyIdInfo id: I-3298823, secondaryIdInfos id: NCI-2024-01390, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3298823, type: OTHER, domain: Roswell Park Cancer Institute, briefTitle: Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression., conditionsModule conditions: Castration-Resistant Prostate Carcinoma, conditions: Metastatic Prostate Carcinoma, conditions: Stage IVB Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Bone Scan, interventions name: Computed Tomography, interventions name: Leuprolide Acetate, interventions name: Magnetic Resonance Imaging, interventions name: Survey Administration, interventions name: Testosterone Cypionate, outcomesModule primaryOutcomes measure: Androgen receptor (AR) activity, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of serious adverse events, secondaryOutcomes measure: Prostate specific antigen (PSA) 50, secondaryOutcomes measure: Measurable disease response, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Assess Quality of life, secondaryOutcomes measure: Assess Quality of Life, secondaryOutcomes measure: Assess Fatigue, secondaryOutcomes measure: Assess change in Fatigue, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, status: RECRUITING, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Gurkamal S. Chatta, role: CONTACT, phone: 716-845-3117, email: Gurkamal.Chatta@RoswellPark.org, contacts name: Gurkamal S. Chatta, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
protocolSection identificationModule nctId: NCT06305585, orgStudyIdInfo id: IRB# 23-214, briefTitle: Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Idaho, class: OTHER, collaborators name: CJ Brush, collaborators name: Jayme Baker, collaborators name: Sydney Leverett, descriptionModule briefSummary: Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs., conditionsModule conditions: Psychological Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Primal Reflex Release Technique (PRRT), outcomesModule primaryOutcomes measure: ECG Data, primaryOutcomes measure: ICG Data, primaryOutcomes measure: Depression Anxiety Stress Scale-21 (DASS-21) - Depression, primaryOutcomes measure: Depression Anxiety Stress Scale-21 (DASS-21) - Anxiety, primaryOutcomes measure: Depression Anxiety Stress Scale-21 (DASS-21) - Stress, primaryOutcomes measure: Simple Physical Activity Questionnaire (SIMPAQ), primaryOutcomes measure: Self Assessment Manikin (SAM) - Valence, primaryOutcomes measure: Self Assessment Manikin (SAM) - Arousal, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: ISMaRT Clinic, city: Moscow, state: Idaho, zip: 83843, country: United States, contacts name: Jayme Baker, DPT, role: CONTACT, phone: 208-885-1055, email: jaymeb@uidaho.edu, geoPoint lat: 46.73239, lon: -117.00017, hasResults: False
protocolSection identificationModule nctId: NCT06305572, orgStudyIdInfo id: H-1903-013-1014, briefTitle: Diagnostic Accuracy of Quantitative Flow Ratio, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-30, primaryCompletionDateStruct date: 2023-03-25, completionDateStruct date: 2023-09-26, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Inje University Ilsan Paik Hospital, collaborators name: Keimyung University Dongsan Medical Center, collaborators name: Ulsan Medical Center, collaborators name: Bucheon Sejong Hospital, collaborators name: Chosun University Hospital, collaborators name: Severance Hospital, collaborators name: Ulsan University Hospital, collaborators name: Uijeongbu Eulji Medical Center, descriptionModule briefSummary: The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 280, type: ACTUAL, armsInterventionsModule interventions name: QFR, outcomesModule primaryOutcomes measure: Diagnostic accuracy of QFR, secondaryOutcomes measure: Sensitivity of QFR, secondaryOutcomes measure: Specificity of QFR, secondaryOutcomes measure: Correlation, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06305559, orgStudyIdInfo id: OBEZ-302, briefTitle: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque, acronym: REMBRANDT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NewAmsterdam Pharma, class: INDUSTRY, descriptionModule briefSummary: This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA)., conditionsModule conditions: Lipidemia, conditions: Coronary Artery Disease, conditions: Plaque, Atherosclerotic, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up), whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: obicetrapib 10 mg + ezetimibe 10 mg FDC daily, interventions name: Placebo, outcomesModule primaryOutcomes measure: • To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months., secondaryOutcomes measure: Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo., secondaryOutcomes measure: Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo., secondaryOutcomes measure: Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo, secondaryOutcomes measure: Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo., secondaryOutcomes measure: Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo., eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False