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protocolSection identificationModule nctId: NCT06305546, orgStudyIdInfo id: 2911, briefTitle: Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Anam Sattar, class: OTHER, descriptionModule briefSummary: Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis, conditionsModule conditions: Gingivitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The trial was a double blinded (patients and investigators). We were helped from a member of our department who is not a part of the study, to transfer the gels from commercial tubes to blank containers. The randomization codes remained unknown until data analysis was completed. Randomization was done by computer-generated software., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Chlorhexidine Gluconate, interventions name: Metronidazole, interventions name: combination gel (chlorhexidine and metronidazole), interventions name: Placebo, outcomesModule primaryOutcomes measure: gingival index, primaryOutcomes measure: bleeding index, primaryOutcomes measure: orthodontic plaque index, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Dow University of Health Sciences, city: Karachi, state: Sindh, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06305533, orgStudyIdInfo id: 854623, briefTitle: Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Baghdad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is 3 arm, split-mouth, double blinded, randomized clinical trial. The first group will receive RSD only, the second group will be treated with RSD + aPDT with ICG as a PS, and the last group will receive RSD + Laser disinfection., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Sites will randomly be assigned to test or control groups according to a computer-generated list. Allocation concealment will be assured by opaque, sealed envelopes prepared and sequentially numbered by a person not otherwise involved in the study. The person responsible for delivering treatment will be aware about allocation of the groups, while the assessor will be blinded., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: LASER disinfection, interventions name: Photodynamic therapy, interventions name: Root surface debridement, outcomesModule primaryOutcomes measure: Probing Pocket Depth (PPD), secondaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Plaque index (PI), secondaryOutcomes measure: Clinical attachment loss (CAL), secondaryOutcomes measure: Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: College of Dentistry, University of Baghdad, status: RECRUITING, city: Baghdad, zip: 10047, country: Iraq, contacts role: CONTACT, phone: +964 14169394, email: master@codental.uobaghdad.edu.iq, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
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protocolSection identificationModule nctId: NCT06305520, orgStudyIdInfo id: BPLUS-NASAL-02, secondaryIdInfos id: CRIS NO. : KCT0008113, type: REGISTRY, domain: The Clinical Research Information Service (CRIS) in KOREA, briefTitle: Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds, acronym: BPLUS-02, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bioplus, class: INDUSTRY, collaborators name: Seoul National University Hospital, collaborators name: Asan Medical Center, collaborators name: Soonchunhyang University Hospital, descriptionModule briefSummary: Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory designTreatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)Population: Number of subject 100\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design)., conditionsModule conditions: Nasal Disease, conditions: Nasal Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Medical Device, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Investigational medical device (SkinPlus-HYAL Implant Lidocaine), interventions name: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine), outcomesModule primaryOutcomes measure: Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device, secondaryOutcomes measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application, secondaryOutcomes measure: Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application, secondaryOutcomes measure: Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application., eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, state: Jongnogu, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06305507, orgStudyIdInfo id: 30923-N, briefTitle: Differents Laser Applications on Plantar Fasciitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled \"Effect of different laser applications on Plantar Fasciitis\", is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep mode in the reduction of pain associated with plantar fasciitis.The main questions it seeks to answer are:* What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis?* What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis?Participants in this study will perform the following tasks:* Undergo low-level laser therapy sessions in local spot mode or sweep mode.* Comply with the instructions on the duration and frequency of the sessions.* Record the pain levels experienced before and after each session.The investigators will compare the group undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects., conditionsModule conditions: Fasciitis, Plantar, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Focussed laser therapy, interventions name: Shower laser therapy, outcomesModule primaryOutcomes measure: Pain Reduction in Patients with Plantar Fasciitis Treated with Laser Therapy (LLLT): Comparison between Local Spot Mode and Sweep Mode", secondaryOutcomes measure: Fascia thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Área Clínica de Podología, city: Sevilla, state: Andalucía, zip: 41004, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Facultad de Podologia, city: Sevilla, zip: 41009, country: Spain, contacts name: Aurora Castro, Prof titular, role: CONTACT, phone: 954486500, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False
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protocolSection identificationModule nctId: NCT06305494, orgStudyIdInfo id: HE671008, briefTitle: Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues.Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues.Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult.The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life., conditionsModule conditions: Atrophic Vaginitis, conditions: Gynecologic Cancer, conditions: Lower Urinary Tract Symptoms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 425, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prevalence of genitourinary syndrome of menopause, secondaryOutcomes measure: Severity of genitourinary syndrome of menopause, secondaryOutcomes measure: Quality of life of gynecologic cancer survivor, secondaryOutcomes measure: Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Khon Kaen University, status: RECRUITING, city: Khon Kaen, zip: 40002, country: Thailand, contacts name: Apiwat Jongjakapun, MD, role: CONTACT, email: apiwjo@kku.ac.th, geoPoint lat: 16.44671, lon: 102.833, hasResults: False
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protocolSection identificationModule nctId: NCT06305481, orgStudyIdInfo id: OPT1099, briefTitle: Glaucoma Evaluation With the P200TE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Optos, PLC, class: INDUSTRY, descriptionModule briefSummary: Images captured on the P200TE device on glaucoma patients, conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: P200TE, outcomesModule primaryOutcomes measure: Number of images collected, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Werner Optometry, status: RECRUITING, city: Cajon, state: California, zip: 92019, country: United States, contacts name: Kristen Mendenhall, role: CONTACT, phone: 619-937-1056, email: kristen@wernerod.com, geoPoint lat: 34.29889, lon: -117.45644, locations facility: Specialty Eyecare Centre, status: RECRUITING, city: Bellevue, state: Washington, zip: 98004, country: United States, contacts name: Renee Cook, role: CONTACT, phone: 425-454-3937, email: rcook@specialtyeyecarecentre.com, geoPoint lat: 47.61038, lon: -122.20068, hasResults: False
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protocolSection identificationModule nctId: NCT06305468, orgStudyIdInfo id: APHP240055, briefTitle: Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis, acronym: TOXIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients.This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression., conditionsModule conditions: Toxoplasmosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality rate in intensive care., secondaryOutcomes measure: Hospital mortality rate, secondaryOutcomes measure: Length of stay in intensive care, secondaryOutcomes measure: Duration of mechanical ventilation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cochin hospital, city: Paris, zip: 75014, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06305455, orgStudyIdInfo id: HSD135, briefTitle: Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: José Raimundo Araujo de Azevedo, class: OTHER, descriptionModule briefSummary: The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit., conditionsModule conditions: Antimicrobial Resistance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Escherichia coli ESBL, outcomesModule primaryOutcomes measure: Prevalence of Escherichia coli resistance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06305442, orgStudyIdInfo id: PR-24031, briefTitle: Microbiota Directed Food for Children With Moderate Acute Malnutrition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: International Centre for Diarrhoeal Disease Research, Bangladesh, class: OTHER, collaborators name: Washington University School of Medicine, descriptionModule briefSummary: Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF., conditionsModule conditions: Moderate Acute Malnutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, randomized, parallel group, clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: Microbiota-Directed Food, interventions name: Ready-to-Use Supplementary Food, outcomesModule primaryOutcomes measure: Mean change in Weight-for-Length Z-score (WLZ), secondaryOutcomes measure: Microbial community repair, secondaryOutcomes measure: Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden), secondaryOutcomes measure: Mean change in Weight-for-Age Z-score (WAZ), secondaryOutcomes measure: Mean change in Length-for-Age Z-score (LAZ), secondaryOutcomes measure: Mean change in body composition (% body fat mass and % fat-free mass), secondaryOutcomes measure: Bayley Scales of early childhood development (cognitive, motor, language development), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Mirpur Study site, city: Dhaka, country: Bangladesh, contacts name: Dr. Jinat Alam, MPH, MBBS, role: CONTACT, phone: +8801676742255, email: jinat.alam@icddrb.com, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
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protocolSection identificationModule nctId: NCT06305429, orgStudyIdInfo id: HABITE, briefTitle: Encouraging Positive Parenting Habits, acronym: HABITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: D'Or Institute for Research and Education, class: OTHER, collaborators name: Okinawa Institute of Science and Technology Graduate University, descriptionModule briefSummary: This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study., conditionsModule conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open, single-group trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: HabitE (effective parenting habit) program (in Brazilian Portuguese), outcomesModule primaryOutcomes measure: Number of videos viewed, primaryOutcomes measure: Percentage of completed daily ratings, primaryOutcomes measure: Participant satisfaction, secondaryOutcomes measure: Parent-rated child's difficulties with daily transitions, secondaryOutcomes measure: Parent-rated child's impairment related to transition difficulties, secondaryOutcomes measure: Inconsistent parenting, secondaryOutcomes measure: Use of physical control, secondaryOutcomes measure: Hostility toward child, secondaryOutcomes measure: Parent Stress, otherOutcomes measure: ADHD symptoms, otherOutcomes measure: ODD symptoms, otherOutcomes measure: Irritability, otherOutcomes measure: Proactive parenting, otherOutcomes measure: Use of positive reinforcement, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06305416, orgStudyIdInfo id: 2023/CT/01, briefTitle: A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Incepta Pharmaceuticals Ltd, class: INDUSTRY, collaborators name: Institute for Developing Science and Health Initiatives, Bangladesh, descriptionModule briefSummary: Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema.Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus.The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid., conditionsModule conditions: Diabetic Macular Edema, conditions: Diabetic Retinopathy, conditions: Macular Edema, conditions: Macular Degeneration, conditions: Retinal Disease, conditions: Retinal Degeneration, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Ranibizumab 10mg/ml Injection, interventions name: Lucentis, outcomesModule primaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA) from Baseline, primaryOutcomes measure: Changes in Central Subfield Thickness (CST) from Baseline, secondaryOutcomes measure: Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity, secondaryOutcomes measure: Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity, secondaryOutcomes measure: Evaluation and comparison of safety between reference vs. test drug., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bangladesh Eye Hospital & Institute, status: RECRUITING, city: Dhaka, zip: 1209, country: Bangladesh, contacts name: Dr. Niaz Abdur Rahman, role: CONTACT, phone: +8801711590333, email: drniazrahman@gmail.com, contacts name: Dr. Niaz Abdur Rahman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
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protocolSection identificationModule nctId: NCT06305403, orgStudyIdInfo id: VEXUS1, briefTitle: VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2025-05-18, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined., conditionsModule conditions: Sepsis, conditions: Acute Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: serum creatinin level, outcomesModule primaryOutcomes measure: ngal, primaryOutcomes measure: VEXUS, secondaryOutcomes measure: MORTALİTY, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06305390, orgStudyIdInfo id: 2022-003905-31, briefTitle: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer., acronym: RF2021-1237227, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa., conditionsModule conditions: Clinical Suspicion of Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 167, type: ESTIMATED, armsInterventionsModule interventions name: PET/MRI, outcomesModule primaryOutcomes measure: To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa), secondaryOutcomes measure: To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele, status: RECRUITING, city: Milano, zip: 20132, country: Italy, contacts name: Maria Picchio, MD, role: CONTACT, phone: 02-26436117, email: Picchio.maria@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06305377, orgStudyIdInfo id: DESPED-T1 study, briefTitle: Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Giulio Frontino, class: OTHER, descriptionModule briefSummary: The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Tandem Control IQ, outcomesModule primaryOutcomes measure: Glucometric data, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06305364, orgStudyIdInfo id: CL-1001, briefTitle: Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Jubaan Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance., conditionsModule conditions: Colorectal Neoplasms, conditions: Gastrointestinal Microbiome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, maskingDescription: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score., enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Gixam, outcomesModule primaryOutcomes measure: Primary Safety Endpoint - Number of device related adverse events and serious adverse events, primaryOutcomes measure: Primary Efficacy Endpoint - Gixam's diagnostic accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westside GI, status: RECRUITING, city: New York, state: New York, zip: 10019, country: United States, contacts name: Theodore Bortz, role: CONTACT, geoPoint lat: 40.71427, lon: -74.00597, locations facility: NewYork-Presbyterian / Columbia University Irving Medical Center, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Elissa Lynch, role: CONTACT, contacts name: Daniel Freedberg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06305351, orgStudyIdInfo id: K-757 P008, briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-07, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kallyope Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM), conditionsModule conditions: Obesity, conditions: Type 2 Diabetes Mellitus (T2DM), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: K-757 and K-833 QD, interventions name: K-757 and K-833 BID, interventions name: Matching placebo to K-757 and K-833 QD, interventions name: Matching placebo to K-757 and K-833 BID, outcomesModule primaryOutcomes measure: Proportion of participants who experienced 1 or more treatment-emergent AEs, primaryOutcomes measure: Proportion of participants who discontinued study medication due to an AE, secondaryOutcomes measure: Area under the concentration-time curve [AUC] of plasma K-757, secondaryOutcomes measure: AUC of plasma K-833, secondaryOutcomes measure: Maximum concentration [Cmax] of plasma K-757, secondaryOutcomes measure: Cmax of plasma K-833, secondaryOutcomes measure: Time of maximum concentration [Tmax] of plasma K-757, secondaryOutcomes measure: Tmax of plasma K-833, secondaryOutcomes measure: Clearance [Cl] of plasma K-757, secondaryOutcomes measure: Cl of plasma K-833, secondaryOutcomes measure: Volume of distribution at steady-state [Vdss] of plasma K-757, secondaryOutcomes measure: Vdss of plasma K-833, secondaryOutcomes measure: Half-life [t1/2] of plasma K-757, secondaryOutcomes measure: t1/2 of plasma K-833, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: QPS Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33143, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
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protocolSection identificationModule nctId: NCT06305338, orgStudyIdInfo id: KUK-Ophthalmology-009, briefTitle: Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling, acronym: Tilt, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-12, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-26, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Johannes Kepler University of Linz, class: OTHER, descriptionModule briefSummary: During cataract surgery an artificial intraocular lens (IOL) is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt, one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric, or multifocal optics.Various methods to measure IOL misalignments have been described. Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt. The subjective grading at the slitlamp may display considerable variability between examiners. This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt. The fact that the patient has no standardized target to focus on makes the method even less reliable. Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. Scheimpflug camera images have been used for assessing IOL tilt previously, but erroneous results, often due to corneal magnification, have diminished their widespread use. Another possibility to assess tilt is the use of Purkinje reflexes. The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized. Since light is reflected at all interfaces of media with a difference in refractive index, these reflections, called Purkinje images, can be used to assess tilt and decentration of IOLs. Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt. The main problem with Purkinje meters is accessibility, as there are only a few prototypes available worldwide.The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: OCT based devices are available in most clinics, the resolution of modern OCT devices is high, and the measurements are reproducible.Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression. This method was developed by Wold and introduced to ophthalmology previously., conditionsModule conditions: Intraocular Lens, conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: Optical Coherence Tomography, outcomesModule primaryOutcomes measure: post operative IOL tilt, secondaryOutcomes measure: Comparison of tilt prediction, secondaryOutcomes measure: comparion of three measurement methods, secondaryOutcomes measure: Comparison of tilt pre- versus post operative, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Matthias Bolz, city: Linz, state: Oberösterreich, zip: 4020, country: Austria, geoPoint lat: 48.30639, lon: 14.28611, hasResults: False
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protocolSection identificationModule nctId: NCT06305325, orgStudyIdInfo id: 35957, briefTitle: Coparenting Intervention to Prevent Postpartum Depression, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-23, primaryCompletionDateStruct date: 2019-11-22, completionDateStruct date: 2020-02-22, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Brock University, class: OTHER, collaborators name: University of Toronto, descriptionModule briefSummary: The goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eACoP) in primiparous Pakistani women. The secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. Two hundred and twelve primiparous couples were randomized into an intervention or a control group from the Aga Khan University Hospital. Couples were randomized using consecutively numbered sealed envelopes. Couples in the intervention group received the eACoP intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. Both the intervention group and control group received standard care., conditionsModule conditions: Postpartum Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: coparenting framework: it has 3 levels. First is the individual level, which consists of the parent's individual characteristics, which comprises of attitudes, parental beliefs, and emotional and mental health. It has a bidirectional relationship with coparenting and the overall inter-parental relationship. Individual child factors, such as temperament may also play a role in shaping the coparenting relationship. The second level is the family level. It comprises the overall interpersonal relationship, referring to the existing ability of couples to demonstrate support and respect for each other. It could influence the coparental relationship or in reverse, the coparental relationship may influence the overall inter-parental relationship. The third level is the extra-familial level. It has two components: support and stress that are based on a stress-coping perspective. The role of environmental support is viewed as enhancing the coparenting relationship, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ACTUAL, armsInterventionsModule interventions name: eHealth Antenatal Coparenting Intervention, outcomesModule primaryOutcomes measure: feasibility-recruitment rate, adherence, and follow-up rate, primaryOutcomes measure: Acceptability- Participants satisfaction, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: anxiety, secondaryOutcomes measure: Coparenting Relationship, secondaryOutcomes measure: Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship., secondaryOutcomes measure: Postpartum Childcare Stress, secondaryOutcomes measure: Infant Development, secondaryOutcomes measure: partner support, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aga Khan University, city: Karachi, state: SinDH, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06305312, orgStudyIdInfo id: HCI166685, secondaryIdInfos id: 1R01CA282409-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01CA282409-01, briefTitle: Community Services Navigation to Advance Health Equity in Breast Cancer Screening, acronym: B-SINCERE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1450, type: ESTIMATED, armsInterventionsModule interventions name: Community Service Navigation, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener, primaryOutcomes measure: Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Elissa Ozanne, PhD, role: CONTACT, phone: 801-213-4130, email: Elissa.Ozanne@hsc.utah.edu, contacts name: Tracy Onega, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
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protocolSection identificationModule nctId: NCT06305299, orgStudyIdInfo id: LCCC2152-ATL, briefTitle: Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy., conditionsModule conditions: Ovary Neoplasm, conditions: Ovarian Cancer, conditions: Epithelial Ovarian Cancer, conditions: Recurrent, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: iC9-CAR.B7-H3 T cells, interventions name: Cyclophosphamide, interventions name: Fludarabine, outcomesModule primaryOutcomes measure: Toxicity: NCI-CTCAE, primaryOutcomes measure: Toxicity: Cytokine Release Syndrome (CRS), primaryOutcomes measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS), secondaryOutcomes measure: The recommended phase 2 dose (RP2D), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: The disease control rate (DCR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lineberger Comprehensive Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Caroline Babinec, role: CONTACT, email: Caroline_babinec@med.unc.edu, contacts name: Linda Van Le, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06305286, orgStudyIdInfo id: IRB23-1367, briefTitle: Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: Cure Alliance, descriptionModule briefSummary: AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells., conditionsModule conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: AT-1501, outcomesModule primaryOutcomes measure: Number of Participants who are insulin-independent post- first and final transplant, secondaryOutcomes measure: Number of Participants with glycosylated hemoglobin (HbA1c) <7.0%, otherOutcomes measure: Number of Participants with free of serious hypoglycemic events (SHEs) post-first and final transplant, otherOutcomes measure: Number of Participants with HbA1c ≤6.5% AND free from SHEs post-first and final transplant., otherOutcomes measure: Number of Participants with graft failure post final transplant., otherOutcomes measure: Number of participants with impaired awareness of hypoglycemia after final islet cell transplant and after discontinuation of AT-1501., otherOutcomes measure: Change in glycemic lability after final islet cell transplant and years after discontinuation of AT-1501, otherOutcomes measure: Change in albumin excretion ratio (AER) post-first and final transplant., otherOutcomes measure: Change in estimated glomerular filtration rate (eGFR) post-first and final transplant., otherOutcomes measure: Change in percent new macroalbuminuria post-first and final transplant., otherOutcomes measure: Change in variability after final islet cell transplant and years after discontinuation of AT-1501, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Piotr Witkowski, MD PhD, role: CONTACT, phone: 773-702-2447, email: pwitkowski@surgery.bs.uchicago.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06305273, orgStudyIdInfo id: 23-0150-A, briefTitle: Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mount Sinai Hospital, Canada, class: OTHER, descriptionModule briefSummary: It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees, it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study is a prospective randomized cross-over trial to be conducted at Mount Sinai Hospital (Toronto, Ontario, Canada)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Head position for face mask ventilation during induction supine, interventions name: Head position for face mask ventilation during induction head elevated, outcomesModule primaryOutcomes measure: Average tidal volume, secondaryOutcomes measure: Predictors for difficult mask ventilation like BMI, secondaryOutcomes measure: Predictors for difficult mask ventilation like presence of beard, secondaryOutcomes measure: Predictors for difficult mask ventilation like Mallampati classification III or IV, secondaryOutcomes measure: Predictors for difficult mask ventilation like age of 57 yo or older., secondaryOutcomes measure: Predictors for difficult mask ventilation like severely limited mandibular protrusion, secondaryOutcomes measure: Predictors for difficult mask ventilation like history of snoring., secondaryOutcomes measure: Oropharyngeal airway, secondaryOutcomes measure: Insufficient mask ventilation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06305260, orgStudyIdInfo id: STUDY00000324, briefTitle: LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40, acronym: LOTUS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: MetroHealth Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement., conditionsModule conditions: Obesity, Morbid, conditions: Labor Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar Ultrasound, outcomesModule primaryOutcomes measure: Epidural Redirects, secondaryOutcomes measure: Total time to epidural space, secondaryOutcomes measure: Number of attempts at a different level, secondaryOutcomes measure: Epidural replacement rate, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MetroHealth Hospital, city: Cleveland, state: Ohio, zip: 44109, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06305247, orgStudyIdInfo id: CLIN-01194-450, secondaryIdInfos id: 2023-506228-10-00, type: OTHER, domain: Ipsen, briefTitle: A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2028-03-20, completionDateStruct date: 2028-03-20, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ipsen, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.In this study, all participants will receive the study drug, which will be taken by mouth (orally)., conditionsModule conditions: Melanoma, conditions: Head and Neck Squamous Cell Carcinoma, conditions: Pancreatic Ductal Adenocarcinoma, conditions: Colorectal Cancer, conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase I is a dose escalation with backfill in participants with selected MAPKm advanced solid tumours.Phase IIa (cohort expansion) is an open label randomised study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: IPN01194, interventions name: IPN01194, outcomesModule primaryOutcomes measure: Phase 1: Percentage of participants with dose limiting toxicity (DLT), primaryOutcomes measure: Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs), primaryOutcomes measure: Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations, primaryOutcomes measure: Phase 2a: Objective response rate (ORR), secondaryOutcomes measure: Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194, secondaryOutcomes measure: Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state, secondaryOutcomes measure: Phase 1: Prolongation of corrected QT interval (QTc), secondaryOutcomes measure: Phase 1: Objective response rate (ORR), secondaryOutcomes measure: Phase 2a: Duration of response (DoR), secondaryOutcomes measure: Phase 2a: Progression-free survival (PFS), secondaryOutcomes measure: Phase 2a: PFS rate at 4 months, secondaryOutcomes measure: Phase 2a: Disease control rate (DCR), secondaryOutcomes measure: Phase 2a: Percentage of participants with TEAEs and TE SAEs, secondaryOutcomes measure: Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Angeles Clinic and Research Institute - California, status: NOT_YET_RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: UC San Diego Health System - La Jolla, status: NOT_YET_RECRUITING, city: San Diego, state: California, zip: 92037, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Yale Cancer Center - New Heaven, status: NOT_YET_RECRUITING, city: New Haven, state: Connecticut, zip: 06510, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Sarah Cannon Research Institute (SCRI) - Nashville, status: NOT_YET_RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Virginia Cancer Specialist, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Centre Léon Bérard - Lyon, status: NOT_YET_RECRUITING, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Paris Saint-Louis, status: NOT_YET_RECRUITING, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut de Cancerologie de l'Ouest (St-Herblain), status: NOT_YET_RECRUITING, city: Saint-Herblain, country: France, geoPoint lat: 47.21765, lon: -1.64841, locations facility: IGR-Villejuif, status: NOT_YET_RECRUITING, city: Villejuif, country: France, geoPoint lat: 48.7939, lon: 2.35992, locations facility: Barcelona - Val D'Hebron, status: NOT_YET_RECRUITING, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Fundacion Jimenez Diaz - Madrid, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: M.D. Anderson Cancer Center Madrid, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06305234, orgStudyIdInfo id: 165-503, briefTitle: A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2033-11-18, completionDateStruct date: 2033-11-18, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: BioMarin Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503., conditionsModule conditions: Phenylketonuria (PKU), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pegvaliase, outcomesModule primaryOutcomes measure: To evaluate immunologic and inflammatory responses associated with occurrences of, secondaryOutcomes measure: Evaluation of immunologic and/or inflammatory responses over time, secondaryOutcomes measure: Evaluation of immunologic responses over time, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tulane University School of Medicine, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70112, country: United States, geoPoint lat: 29.95465, lon: -90.07507, hasResults: False
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protocolSection identificationModule nctId: NCT06305221, orgStudyIdInfo id: opioid-free analgesia, briefTitle: Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-09, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain., conditionsModule conditions: Opioid-Free Anesthesia, conditions: Laparoscopic Sleeve Gastrectomy, conditions: Postoperative Vomiting, conditions: Postoperative Recovery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Opioid-free Analgesics (esketamine, dexmedetomidine), interventions name: Opioid Anesthetics (sufentanil and remifentanil), outcomesModule primaryOutcomes measure: 15-item recovery quality scale score 48 hours after surgery, primaryOutcomes measure: 15-item recovery quality scale score 24 hours before surgery, secondaryOutcomes measure: Dosage of postoperative analgesics, secondaryOutcomes measure: Duration of until postoperative PACU Aldrete score> 9 points, secondaryOutcomes measure: anesthesia-related complication, secondaryOutcomes measure: time to first exhaust gas after surgery, secondaryOutcomes measure: time of first postoperative mobilization, secondaryOutcomes measure: Overall benefit of analgesic score satisfaction in pain treatment, secondaryOutcomes measure: Acute pain numeric rating scale score, secondaryOutcomes measure: Rhodes Index of Nausea, Vomiting, and Retching, secondaryOutcomes measure: Rhodes Index of Nausea, Vomiting, and Retching, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: bijia Song, status: RECRUITING, city: Beijing, country: China, contacts name: bijia Song, role: CONTACT, phone: 18309845273, email: songbijia@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06305208, orgStudyIdInfo id: CCLR-23-018, briefTitle: A UK Registry for Metabolic and Bariatric Endoscopic Interventions, acronym: UK-ENDOMAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2034-02-01, completionDateStruct date: 2039-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Cleveland Clinic London, class: OTHER, descriptionModule briefSummary: In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments., conditionsModule conditions: Obesity, conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic gastric suturing, interventions name: Endoscopic gastric plication, interventions name: Revisional gastroplasty, interventions name: Transoral outlet reduction endoscopy (TORe), interventions name: Duodenal mucosal resurfacing (DMR), interventions name: Intragastric balloon(s), outcomesModule primaryOutcomes measure: Total body weight loss percentage (TBWL%), primaryOutcomes measure: Change in glycated haemoglobin (HbA1c; mmol/mol), primaryOutcomes measure: Change in the number and dose of anti-diabetic medications, secondaryOutcomes measure: Procedure time (mins), secondaryOutcomes measure: Inpatient stay (days), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Change in systolic blood pressure measurements (mmHg), secondaryOutcomes measure: Change in diastolic blood pressure measurements (mmHg), secondaryOutcomes measure: Changes in number and dose of anti-hypertensive medications (n), secondaryOutcomes measure: Changes in low-density lipoprotein cholesterol (mmol/L), secondaryOutcomes measure: Changes in triglycerides (mmol/L), secondaryOutcomes measure: Changes in high-density lipoprotein cholesterol (mmol/L), secondaryOutcomes measure: Changes in total cholesterol (mmol/L), secondaryOutcomes measure: Changes in alanine transaminase (IU/L), secondaryOutcomes measure: Changes in aspartate aminotransferase (IU/L), secondaryOutcomes measure: Changes in Fibrosis-4 Index for Liver Fibrosis, secondaryOutcomes measure: Changes in non-alcoholic fatty liver disease fibrosis score, secondaryOutcomes measure: Changes in weight (kg), secondaryOutcomes measure: Changes in body mass index (kg/m2), secondaryOutcomes measure: Changes in glycated haemoglobin (HbA1c; mmol/mol), secondaryOutcomes measure: Changes in number and dose of anti-diabetic medications (n), secondaryOutcomes measure: Changes in number and dose of anti-obesity medications (n), secondaryOutcomes measure: Changes in health-related quality of life scores (EuroQol-5D-5L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic London, status: RECRUITING, city: London, zip: SW1X 7HY, country: United Kingdom, contacts name: Benjamin Norton, MD, role: CONTACT, email: cclendoscopyresearch@ccf.org, contacts name: Rehan Haidry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06305195, orgStudyIdInfo id: 0107766, briefTitle: Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-23, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2026-10-21, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators., conditionsModule conditions: Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 155, type: ESTIMATED, armsInterventionsModule interventions name: heart rate variability test, outcomesModule primaryOutcomes measure: Beat-to-beat Heart rate variability, primaryOutcomes measure: body mass index, primaryOutcomes measure: Valsalva ratio, primaryOutcomes measure: Stand 30:15 ratio, primaryOutcomes measure: deep breath test interpretation, secondaryOutcomes measure: Framingham risk score (FRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alexandria university, status: RECRUITING, city: Alexandria, country: Egypt, contacts name: Hala A. Abo El-Hassan, MSc, role: CONTACT, phone: 02/01114851485, email: hala.aboelhassan@pua.edu.eg, contacts name: Noha A. Hamdy, Dr, role: CONTACT, phone: 02/01005182151, email: noha.alaaeldine@alexu.edu.eg, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06305182, orgStudyIdInfo id: BASEC 2022-01328, briefTitle: Metreleptin in Anorexia Nervosa, acronym: METRAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Gabriella Milos, class: OTHER, descriptionModule briefSummary: The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight., conditionsModule conditions: Anorexia Nervosa, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Placebo-controlled, double-blind, randomized trial. The efficacy of Metreleptin in Anorexia Nervosa patients will be tested against an inactive Placebo., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Metreleptin, interventions name: Sodium chloride, outcomesModule primaryOutcomes measure: Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, primaryOutcomes measure: Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Subjective depression by the Beck Depression Inventory-II (BDI-II) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, city: Zurich, zip: 8091, country: Switzerland, contacts name: Florian Remund, MSc. Business Administration, role: CONTACT, contacts name: Gabriella Milos, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Lisa Guth, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06305169, orgStudyIdInfo id: 1.4, briefTitle: Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Sandwell & West Birmingham Hospitals NHS Trust, class: OTHER, descriptionModule briefSummary: Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: Gastropanel, outcomesModule primaryOutcomes measure: Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer, secondaryOutcomes measure: Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sandwell General Hospital, city: Birmingham, state: West Midlands, zip: B71 4HJ, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False
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protocolSection identificationModule nctId: NCT06305156, orgStudyIdInfo id: CT_BMD_1, briefTitle: Protocol Optimization in CT for the Quantification of BMD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Hatem Alkadhi, class: OTHER, descriptionModule briefSummary: Bone mineral density is an important measurement to detect osteoporosis.The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA* How can we optimize the CT scan for bone mineral densityParticipants will undergo:* Clinically indicated CT scan on day of inclusion* Study related DXA scan on a separate appointment, conditionsModule conditions: Osteoporosis, Osteopenia, conditions: Bone Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Bone Mineral Density quantification, outcomesModule primaryOutcomes measure: Bone mineral density CT, primaryOutcomes measure: Bone mineral density Dual-energy x-ray absorptiometry (DXA), secondaryOutcomes measure: Correlation between age and bone mineral density, secondaryOutcomes measure: Correlation between sex and bone mineral density, secondaryOutcomes measure: Correlation between height and bone mineral density, secondaryOutcomes measure: Correlation between weight and bone mineral density, secondaryOutcomes measure: Correlation between body mass index (BMI) and bone mineral density, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diagnostic and Interventional Radiology, University Hospital Zurich, status: RECRUITING, city: Zürich, zip: 8091, country: Switzerland, contacts name: Hatem Alkadhi, MD, MPH, role: CONTACT, phone: +41 44 255 36 62, email: hatem.alkadhi@usz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06305143, orgStudyIdInfo id: YFZXYDK202402, briefTitle: Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Shanghai Eye Disease Prevention and Treatment Center, class: OTHER, collaborators name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, descriptionModule briefSummary: The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).The main questions it aims to answer are:* mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment* proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment* proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment* mean changes in BCVA and CMT from baseline to monthly follow-up time point* complications and adverse effects, conditionsModule conditions: Diabetic Macular Edema, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Conbercept, outcomesModule primaryOutcomes measure: improvement of visual acuity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Eye Diseases Prevention &Treatment Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 201103, country: China, contacts name: Tao Sun, role: CONTACT, phone: +8618916576690, email: drsuntao@yeah.net, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06305130, orgStudyIdInfo id: KMUHIRB-E(I)-20180214, briefTitle: Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 1988-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University, class: OTHER, descriptionModule briefSummary: Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.Methods: multicentered cohort study, conditionsModule conditions: Carcinoma, Transitional Cell (RENI), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2515, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Overall survival, primaryOutcomes measure: Cancer-specific survival, primaryOutcomes measure: Disease-free survival, primaryOutcomes measure: Bladder recurrence-free survival, secondaryOutcomes measure: Number of patients with major postoperative complication, secondaryOutcomes measure: Number of patients with postoperative renal failure, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06305117, orgStudyIdInfo id: PP202304-37-1, secondaryIdInfos id: 101227, type: OTHER_GRANT, domain: Association Ruban Rose, briefTitle: Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1, acronym: VRtuose1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: International Agency for Research on Cancer, class: OTHER, collaborators name: Centre Leon Berard, descriptionModule briefSummary: The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work., conditionsModule conditions: Breast Cancer, 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: Distraction strategy, outcomesModule primaryOutcomes measure: Patients' acceptance rate regarding the use of the distraction strategy., secondaryOutcomes measure: Accessibility of the strategy, secondaryOutcomes measure: Duration of use of the strategy by patients, secondaryOutcomes measure: Type of video content chosen by participants, secondaryOutcomes measure: Type of music content chosen by participants, secondaryOutcomes measure: Patients' perception of factors limiting the use of the strategy, secondaryOutcomes measure: Healthcare providers' perception of factors limiting the use of the strategy, secondaryOutcomes measure: Workload for strategy administrators, secondaryOutcomes measure: Strategy administrators ability to use the strategy, secondaryOutcomes measure: Patients' satisfaction regarding the use of the strategy, secondaryOutcomes measure: Healthcare providers' satisfaction regarding the strategy, secondaryOutcomes measure: Prevalence of adverse events related to the use of the strategy, secondaryOutcomes measure: Type of adverse events related to the use of the strategy, secondaryOutcomes measure: Severity of adverse events related to the use of the strategy, otherOutcomes measure: Acceptance rate to fill in questionnaires measuring clinical outcomes, otherOutcomes measure: Time taken to fill in questionnaires measuring clinical outcomes, otherOutcomes measure: Completeness of questionnaires measuring clinical outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Olivier Trédan, MD, role: CONTACT, email: olivier.tredan@lyon.unicancer.fr, contacts name: Olivier Trédan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06305104, orgStudyIdInfo id: KN-EEC-II, briefTitle: Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Chengdu CoenBiotech Co., Ltd, class: INDUSTRY, collaborators name: Beijing Chest Hospital, Capital Medical University, collaborators name: Wuhan Institute for Tuberculosis Control, collaborators name: The Public Health Clinical Center of Chengdu, collaborators name: Xuzhou Infectious Disease Hospital, collaborators name: Jiangsu Province Centers for Disease Control and Prevention, collaborators name: Changde First People's Hospital, descriptionModule briefSummary: This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old, and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: 2.5μg/ml EEC, interventions name: 5μg/ml EEC, interventions name: 5 unit（U） EC, outcomesModule primaryOutcomes measure: Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ;, primaryOutcomes measure: specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ;, primaryOutcomes measure: The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive., secondaryOutcomes measure: Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug., secondaryOutcomes measure: Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug., secondaryOutcomes measure: In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC, EC and IGRA were evaluated respectively., secondaryOutcomes measure: Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Chest Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 101149, country: China, contacts name: Tongqun Zhang, role: CONTACT, phone: 010-89509134, email: Zhangtongqun@sina.com, contacts name: Naihui Chu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Wuhan Institute for Tuberculosis Control, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430000, country: China, contacts name: Min Wang, role: CONTACT, phone: 13871221841, email: whsfkyyllsc@163.com, contacts name: Juan Du, Bachelor, role: PRINCIPAL_INVESTIGATOR, contacts name: Ronghui Du, Bachelor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Changde First People's Hospital, status: RECRUITING, city: Changde, state: Hunan, zip: 415000, country: China, contacts name: Shuxiang Zhou, role: CONTACT, phone: 0736-7788890, email: 450717196@qq.com, contacts name: Tianli Wang, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Jiangsu Province Centers for Disease Control and Prevention, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 212400, country: China, contacts name: Xiaoyan Ding, role: CONTACT, phone: 025-83759406, email: ec@jscdc.cn, contacts name: Limei Zhu, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Xuzhou Infectious Disease Hospital, status: RECRUITING, city: Xuzhou, state: Jiangsu, country: China, contacts name: Tingting Liu, role: CONTACT, phone: 0516-68900929, email: xcyllb123@163.com, contacts name: Ruimei Zhang, Bachelor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Public health clinical center of chengdu, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610066, country: China, contacts name: Qing Yang, role: CONTACT, phone: 028-64369118, email: crbykjk@126.com, contacts name: Guihui Wu, master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06305091, orgStudyIdInfo id: 1681559, briefTitle: DNA Methylation Markers in Veterans Exposed to Open Burn Pits, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Central Arkansas Veterans Healthcare System, class: FED, collaborators name: United States Department of Defense, collaborators name: University of Arkansas, descriptionModule briefSummary: Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems.Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high., conditionsModule conditions: Open Burn Pit Exposure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Health survey for physical and mental health comorbidities, epigenetic marker and heavy metals in blood and urine samples, outcomesModule primaryOutcomes measure: DNA methylation markers and heavy metals, secondaryOutcomes measure: Physical and mental health comorbidities, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Arkansas Veterans Healthcare System (3J/NLR), status: RECRUITING, city: North Little Rock, state: Arkansas, zip: 72114, country: United States, contacts name: Kalpana Padala, MD, role: CONTACT, phone: 501-257-2044, email: kalpana.padala@va.gov, contacts name: Trent Trice, BS, role: CONTACT, phone: 501-257-2403, email: trent.trice@va.gov, contacts name: Kalpana Padala, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.76954, lon: -92.26709, hasResults: False
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protocolSection identificationModule nctId: NCT06305078, orgStudyIdInfo id: 2023-0528, briefTitle: Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Medical Center, Cincinnati, class: OTHER, descriptionModule briefSummary: The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial., conditionsModule conditions: Attention Deficit Hyperactivity Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open Label Trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: None (open-label), enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Personalized ADHD Medication Experiment, outcomesModule primaryOutcomes measure: Decision-Making Involvement Scale, primaryOutcomes measure: Decisional Conflict Scale (DCS), primaryOutcomes measure: Behavioral Intention Questions, primaryOutcomes measure: System Usability Scale, primaryOutcomes measure: Implementation of Decision, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cincinnati Children's Hospital Medical Center, status: RECRUITING, city: Cincinnati, state: Ohio, zip: 45220, country: United States, contacts name: William Brinkman, MD, role: CONTACT, phone: 513-636-2576, email: bill.brinkman@cchmc.org, contacts name: William Brinkman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-10, uploadDate: 2024-01-26T17:55, filename: Prot_SAP_000.pdf, size: 1393239, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-10, uploadDate: 2024-01-26T18:00, filename: ICF_001.pdf, size: 1084823, hasResults: False
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protocolSection identificationModule nctId: NCT06305065, orgStudyIdInfo id: 2024.089, briefTitle: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments., conditionsModule conditions: Knee Osteoarthritis, conditions: Total Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded., enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: KUNWU Navigation TKA procedure, interventions name: CORI Surgical System TKA procedure, interventions name: Conventional TKA procedure, outcomesModule primaryOutcomes measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis), secondaryOutcomes measure: Lateral View, secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA), secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA), secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral component rotation (FCR), secondaryOutcomes measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA), secondaryOutcomes measure: Standard Radiographic Evaluation - Tibial slope, secondaryOutcomes measure: Standard Radiographic Evaluation - Joint line distance, secondaryOutcomes measure: Knee Society Score (KSS), secondaryOutcomes measure: Oxford Knee Score (OKS), secondaryOutcomes measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L, secondaryOutcomes measure: Forgotten Joint Score (FJS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06305052, orgStudyIdInfo id: estimulation-taste-olfactory, secondaryIdInfos id: 65635922.0.0000.5201, type: OTHER, domain: CAAE (Certificate of Presentation of Ethical Review), briefTitle: Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Professor Fernando Figueira Integral Medicine Institute, class: OTHER, descriptionModule briefSummary: The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding., conditionsModule conditions: Weight, Birth, conditions: Premature Birth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 63, type: ACTUAL, armsInterventionsModule interventions name: Milk, interventions name: Water, outcomesModule primaryOutcomes measure: Comparison of the period between the beginning of the intervention and enteral feeding., secondaryOutcomes measure: Describe the gestational age of the newborn, secondaryOutcomes measure: Describe the sex of the newborn., secondaryOutcomes measure: Describe the type of birth., secondaryOutcomes measure: Describe the APGAR score., secondaryOutcomes measure: Describe birth weight and birth weight z-score., secondaryOutcomes measure: Describe head circumference at birth and head circumference z-score at birth, secondaryOutcomes measure: Describe birth length and birth length z-score., secondaryOutcomes measure: Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h., secondaryOutcomes measure: Compare the time, in days, of feeding via oral/nasal gastric tube., secondaryOutcomes measure: Compare the total duration, in days, of parenteral nutrition (TPN) use., secondaryOutcomes measure: Compare the type of food at discharge (natural, artificial or mixed)., secondaryOutcomes measure: Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU., secondaryOutcomes measure: Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU., secondaryOutcomes measure: Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis., secondaryOutcomes measure: Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours., eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 32 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Instituto de Medicina Integral Professor Fernando Figueira, city: Recife, state: Pernambuco, zip: 50070-550, country: Brazil, geoPoint lat: -8.05389, lon: -34.88111, hasResults: False
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protocolSection identificationModule nctId: NCT06305039, orgStudyIdInfo id: 2089705, secondaryIdInfos id: 1R01DC020506-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DC020506-01A1, briefTitle: Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2028-05-31, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Maryland, College Park, class: OTHER, collaborators name: National Institute on Deafness and Other Communication Disorders (NIDCD), collaborators name: Walter Reed National Military Medical Center, collaborators name: Vanderbilt University, descriptionModule briefSummary: Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs., conditionsModule conditions: Hearing Loss, conditions: Hearing Loss, Sensorineural, conditions: Cochlear Hearing Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic tests of cochlear implant or acoustic hearing function, interventions name: Targeted aural rehabilitation of the poorer performing ear, outcomesModule primaryOutcomes measure: Perceptual responses to sound level, primaryOutcomes measure: Speech understanding in the presence of masking sounds, primaryOutcomes measure: Computed-tomography scan, primaryOutcomes measure: Electrode impedance (transelectrode impedance matrix), primaryOutcomes measure: Electrically evoked compound action potentials (ECAPs), secondaryOutcomes measure: Sound Localization, secondaryOutcomes measure: Perceptual Fusion, secondaryOutcomes measure: Spectrotemporal ripple sensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Walter Reed National Military Medical Center, city: Bethesda, state: Maryland, zip: 20889, country: United States, geoPoint lat: 38.98067, lon: -77.10026, locations facility: University of Maryland, College Park, city: College Park, state: Maryland, zip: 20742, country: United States, geoPoint lat: 38.98067, lon: -76.93692, hasResults: False
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protocolSection identificationModule nctId: NCT06305026, orgStudyIdInfo id: S-20190160, briefTitle: Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospital of South West Jutland, class: OTHER, collaborators name: Odense University Hospital, descriptionModule briefSummary: Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM.Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria).Data collection: Will be done as study subjects are included and stored in REDCAP.Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests.Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series.Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia.Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test., conditionsModule conditions: Rheumatoid Arthritis, conditions: Fibromyalgia, Secondary, conditions: Widespread Chronic Pain, conditions: Muscle Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Muscle- and skin biopsies, outcomesModule primaryOutcomes measure: Muscle pathology, primaryOutcomes measure: Skin biopsies, secondaryOutcomes measure: Cold pressure test, secondaryOutcomes measure: Pain pressure threshold (PPT), secondaryOutcomes measure: Computerized Cuff pressure algometry (CPA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Esbjerg Hospital, status: RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Philip R LageHansen, MD, role: CONTACT, phone: +4530114582, email: philip.rask.lage-hansen3@rsyd.dk, contacts name: Philip LageHansen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Torkell Ellingsen, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.47028, lon: 8.45187, hasResults: False
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protocolSection identificationModule nctId: NCT06305013, orgStudyIdInfo id: SIMU PEA 2024, briefTitle: PEA: The Ability of Nurses To Recognize It (PEA: ANTRI), acronym: PEARECOG, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Brno University Hospital, class: OTHER, collaborators name: Department of Simulation Medicine, Faculty of Medicine, Masaryk University, descriptionModule briefSummary: The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized., conditionsModule conditions: Pulseless Electrical Activity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Pulseless electrical activity recognition, outcomesModule primaryOutcomes measure: Pulseless electrical activity recognition,, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty hospital Brno, status: RECRUITING, city: Brno, state: Jihomoravský Kraj, zip: 62500, country: Czechia, contacts name: Martina Kosinova, MD., Ph.D., role: CONTACT, phone: 532234692, phoneExt: 00420, email: kosinova.martina@fnbrno.cz, geoPoint lat: 49.19522, lon: 16.60796, hasResults: False
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protocolSection identificationModule nctId: NCT06305000, orgStudyIdInfo id: 2015-KAEK-80-23-25, briefTitle: Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-03-10, completionDateStruct date: 2025-05-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Biruni University, class: OTHER, descriptionModule briefSummary: This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?Our study consists of 4 groups:Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis., conditionsModule conditions: Peri-implant Mucositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Non-surgical treatment, interventions name: Free gingival graft, outcomesModule primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, primaryOutcomes measure: Inflammatory parameter levels in peri-implant crevicular fluid, secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Plaque index (Silness & Löe, 1964), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Gingival Index ( Löe & Silness,1963), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Bleeding on probing (Ainamo & Bay 1975), secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Keratinized mucosa width, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, secondaryOutcomes measure: Probing depth, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biruni University, city: Istanbul, country: Turkey, contacts name: Ayse E Selman, role: CONTACT, phone: +905366393184, email: aselman@biruni.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06304987, orgStudyIdInfo id: BFH-niCRT-05, briefTitle: Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, collaborators name: Peking Union Medical College Hospital, collaborators name: Peking University Cancer Hospital & Institute, collaborators name: Changhai Hospital, descriptionModule briefSummary: This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer., conditionsModule conditions: Locally Advanced Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor, interventions name: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor, outcomesModule primaryOutcomes measure: CR, primaryOutcomes measure: AE rate, secondaryOutcomes measure: NAR score, secondaryOutcomes measure: OPR, secondaryOutcomes measure: ORR, secondaryOutcomes measure: immune-related adverse event rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06304974, orgStudyIdInfo id: BL-B01D1-305, briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 488, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Irinotecan, interventions name: paclitaxel, interventions name: docetaxel, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Cmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06304961, orgStudyIdInfo id: D9180C00011, briefTitle: A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-09-05, completionDateStruct date: 2024-09-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Tozorakimab, outcomesModule primaryOutcomes measure: Area under the concentration-time curve from time 0 to infinity (AUCinf), primaryOutcomes measure: Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast), primaryOutcomes measure: Maximum observed drug concentration (Cmax), secondaryOutcomes measure: Time to reach peak or maximum observed concentration following tozorakimab administration (tmax), secondaryOutcomes measure: Terminal elimination half-life (t1/2), secondaryOutcomes measure: Terminal rate constant (λz), secondaryOutcomes measure: Apparent total body clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution based on the terminal phase (Vz/F), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with presence of Anti-Drug Anitbodies (ADAs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Berlin, zip: 14050, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
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protocolSection identificationModule nctId: NCT06304948, orgStudyIdInfo id: Vitamin D and migraine, briefTitle: The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.3. To correlate the serum level of glutamate with gene expression of in migraine, conditionsModule conditions: Migraine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 72, type: ESTIMATED, outcomesModule primaryOutcomes measure: The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304935, orgStudyIdInfo id: IPRF effect post tonsillectomy, briefTitle: Injectable Platelet Rich Fibrin Post Tonsillectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy, conditionsModule conditions: IPRF Post Tonsillectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control, outcomesModule primaryOutcomes measure: IPRF effect on healing, primaryOutcomes measure: IPRF effect on post tonsillectomy pain and bleeding, eligibilityModule sex: ALL, minimumAge: 5 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304922, orgStudyIdInfo id: BRCA 1/2 in cancer ovary, briefTitle: BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary, 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: Assiut University, class: OTHER, descriptionModule briefSummary: The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer., conditionsModule conditions: Ovarian Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer, outcomesModule primaryOutcomes measure: Objective response rate., primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival and toxicity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304909, orgStudyIdInfo id: 2080278, briefTitle: Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block., conditionsModule conditions: Trauma Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine injection, outcomesModule primaryOutcomes measure: The incidence of rebound pain., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304896, orgStudyIdInfo id: #18240343, briefTitle: Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy, acronym: BASiC-CIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Arab Contractors Medical Centre, class: OTHER, descriptionModule briefSummary: BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality., conditionsModule conditions: Chemotherapy Induced Systolic Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Carvedilol, interventions name: Ramipril, interventions name: Rosuvastatin, interventions name: Colchicine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Chemotherapy-induced cardiomyopathy, primaryOutcomes measure: Chemotherapy-induced cardiomyopathy, secondaryOutcomes measure: Major Adverse Cardiovascular Events, secondaryOutcomes measure: All-Cause Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arab Contractors Medical Centre, city: Cairo, country: Egypt, contacts name: Eslam Abbas, MBChB, MSc, role: CONTACT, phone: 01023054574, phoneExt: +2, email: islam.omr@med.au.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06304883, orgStudyIdInfo id: ALZ-801-AD351, briefTitle: Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects, acronym: APOLLOE4-LTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Alzheon Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801., conditionsModule conditions: Early Alzheimer's Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multi-center, open-label, single group, long-term extension study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 285, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: ALZ-801, outcomesModule primaryOutcomes measure: Primary cognitive efficacy endpoint 1, primaryOutcomes measure: Primary cognitive efficacy endpoint 2, primaryOutcomes measure: Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs), primaryOutcomes measure: Primary imaging biomarker endpoint 1, primaryOutcomes measure: Primary imaging biomarker endpoint 2, secondaryOutcomes measure: Secondary functional efficacy endpoint, secondaryOutcomes measure: Secondary global assessment efficacy endpoint, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 1, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 2, secondaryOutcomes measure: Secondary cognitive efficacy endpoint 3, secondaryOutcomes measure: Secondary imaging biomarker endpoint, secondaryOutcomes measure: Secondary fluid biomarker endpoint, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xenoscience, Inc., city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Stephen Flitman, role: CONTACT, phone: 602-274-9500, email: sflitman@xenoscience.com, contacts name: Stephen Flitman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Banner Sun Health Research Institute, city: Sun City, state: Arizona, zip: 85351, country: United States, contacts name: Michele R Gutierrez, role: CONTACT, phone: 623-832-5706, email: Michele.Gutierrez@bannerhealth.com, contacts name: Alireza Atri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.59754, lon: -112.27182, locations facility: ATP Clinical Research, city: Costa Mesa, state: California, zip: 92626, country: United States, contacts name: Bobby Shih, role: CONTACT, phone: 714-277-4472, email: bshih@atpcr.com, contacts name: Gustavo Alva, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Torrance Clinical Research Institute, city: Lomita, state: California, zip: 90717, country: United States, contacts name: Valeria Herrera, role: CONTACT, phone: 310-373-8120, email: mraikhel@msn.com, contacts name: Marina Raikhel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.79224, lon: -118.31507, locations facility: Sutter Health, city: Sacramento, state: California, zip: 95816, country: United States, contacts name: Dawn R Lenakakis, role: CONTACT, phone: 916-887-4734, email: Dawn.Lenakakis@sutterhealth.org, contacts name: Shawn Kile, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Tilda Research, Inc., city: Tustin, state: California, zip: 92780, country: United States, contacts name: Shahrnaz Jamshidi, role: CONTACT, phone: 949-569-6444, email: shahrnaz.jamshidi@tilda.bio, contacts name: Erik Geiger, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.74585, lon: -117.82617, locations facility: JEM Research Institute, Headlands Site, city: Atlantis, state: Florida, zip: 33462, country: United States, contacts name: Mark Goldstein, role: CONTACT, phone: 561-968-2933, email: Mgoldstein@jemri.net, contacts name: Mark Goldstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.5909, lon: -80.10088, locations facility: Bradenton Research Center, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Michelle Scott, role: CONTACT, phone: 941-708-0005, email: michellescott@bradentonresearch.com, contacts name: Eric Folkens, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.49893, lon: -82.57482, locations facility: Alphab Global Research, city: Jupiter, state: Florida, zip: 33458, country: United States, contacts name: Teresa Villena, role: CONTACT, phone: 561-301-8286, email: t.villena@aol.com, contacts name: Gerald O'Connor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.93422, lon: -80.09421, locations facility: K2 Medical Research, LLC, city: Maitland, state: Florida, zip: 32751, country: United States, contacts name: Gina Cedano, role: CONTACT, phone: 321-221-7806, email: Gina.Cedano@k2med.com, contacts name: Brandon Lenox, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.62778, lon: -81.36312, locations facility: Mount Sinai Medical Center, city: Miami Beach, state: Florida, zip: 33140, country: United States, contacts name: Mileidys Herrera, role: CONTACT, phone: 350-674-2121, phoneExt: 54881, email: Mileidys.herrera@msmc.com, contacts name: Ranjan Duara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.79065, lon: -80.13005, locations facility: Aqualane Clinical Research, city: Naples, state: Florida, zip: 34105, country: United States, contacts name: Kelly Calistri, role: CONTACT, phone: 239-434-0332, email: Kelly@aqualaneresearch.com, contacts name: William Justiz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.14234, lon: -81.79596, locations facility: Headlands Research Orlando, city: Orlando, state: Florida, zip: 32819, country: United States, contacts name: Jennifer Thompson, role: CONTACT, phone: 407-705-3471, email: jennifer.thompson@headlandsresearch.com, contacts name: Theodore Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Progressive Medical Research, city: Port Orange, state: Florida, zip: 32127, country: United States, contacts name: Chantelle Funge, role: CONTACT, phone: 386-304-7070, phoneExt: 3205, email: chantellef@progressivemedicalresearch.com, contacts name: Alexander White, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.13832, lon: -80.99561, locations facility: ALZ Research and Treatment Center (A.R.T.C.), city: Stuart, state: Florida, zip: 34997, country: United States, contacts name: David Watson, role: CONTACT, phone: 772-675-0000, email: dwatson@researchalz.com, contacts name: David Watson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.19755, lon: -80.25283, locations facility: ALZ Research and Treatment Center (A.R.T.C.), city: Wellington, state: Florida, zip: 33414, country: United States, contacts name: David Watson, role: CONTACT, phone: 561-209-2400, email: dwatson@researchalz.com, contacts name: David Watson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.65868, lon: -80.24144, locations facility: Premiere Research Institute, city: West Palm Beach, state: Florida, zip: 33407, country: United States, contacts name: Paul Winner, role: CONTACT, phone: 561-845-0500, phoneExt: 102, email: Pwinner777@aol.com, contacts name: Paul Winner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.71534, lon: -80.05337, locations facility: Charter Research, city: Winter Park, state: Florida, zip: 32792, country: United States, contacts name: Celynez Gomez, role: CONTACT, phone: 407-337-1000, phoneExt: 3001, email: celynez.gomez@charterresearch.com, contacts name: Edgardo J Rivera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.6, lon: -81.33924, locations facility: Columbus Memory Center, city: Columbus, state: Georgia, zip: 31909, country: United States, contacts name: Jonathan Liss, role: CONTACT, phone: 706-653-8455, email: jliss@researchcmc.com, contacts name: Jonathan Liss, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Fort Wayne Neurological Center, city: Fort Wayne, state: Indiana, zip: 46804, country: United States, contacts name: Patti Case, role: CONTACT, phone: 260-436-3991, phoneExt: 2202, email: pcase@fwnc.com, contacts name: James Stevens, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.1306, lon: -85.12886, locations facility: Headlands Research Eastern MA, city: Plymouth, state: Massachusetts, zip: 02360, country: United States, contacts name: Brandon Hatch, role: CONTACT, phone: 508-746-5060, email: brandon.hatch@headlandsresearcheema.com, contacts name: Donald Marks, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.95844, lon: -70.66726, locations facility: Advanced Memory Research Center, city: Toms River, state: New Jersey, zip: 08755, country: United States, contacts name: Anna Brocco, role: CONTACT, phone: 732-341-9500, email: ABrocco@amrinj.com, contacts name: Sanjiv Sharma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95373, lon: -74.19792, locations facility: Neurological Associates of Albany, city: Albany, state: New York, zip: 12208, country: United States, contacts name: Richard Holub, role: CONTACT, phone: 518-426-0575, email: research@naaresearch.com, contacts name: Richard Holub, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.65258, lon: -73.75623, locations facility: NYU Alzheimer's Disease Research Center, city: New York, state: New York, zip: 10016, country: United States, contacts name: Brittany Marti, role: CONTACT, phone: 212-263-5708, email: Brittany.Marti@nyulangone.org, contacts name: Thomas Wisniewski, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Kline Institute for Psychiatric Research, city: Orangeburg, state: New York, zip: 10962, country: United States, contacts name: Nunzio Pomara, role: CONTACT, phone: 845-398-5579, email: Nunzio.Pomara@nki.rfmh.org, contacts name: Nunzio Pomara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.04649, lon: -73.94958, locations facility: University of Rochester Medical Center, city: Rochester, state: New York, zip: 14620, country: United States, contacts name: Nancy A Kowalski, role: CONTACT, phone: 585-602-5205, email: Nancy_Kowalski@urmc.rochester.edu, contacts name: Emily Clark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Triad Clinical Trials, city: Greensboro, state: North Carolina, zip: 27410, country: United States, contacts name: Scott Whitt, role: CONTACT, phone: 336-235-0991, email: swhitt@triadclinicaltrials.com, contacts name: Richard Montgomery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: AMC Research, city: Matthews, state: North Carolina, zip: 28105, country: United States, contacts name: Shereen Bolouri, role: CONTACT, phone: 704-364-4000, phoneExt: 235, email: ssbolouri@amcneurology.com, contacts name: Mohammad R Bolouri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.11681, lon: -80.72368, locations facility: Center for Cognitive Health, city: Portland, state: Oregon, zip: 97225, country: United States, contacts name: Ericka Eyton, role: CONTACT, phone: 503-548-0908, email: ericka@centerforcognitivehealth.com, contacts name: Michael Mega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Abington Neurological Associates, city: Abington, state: Pennsylvania, zip: 19001, country: United States, contacts name: Kareema Murray, role: CONTACT, phone: 215-957-9250, email: kareemamurray.ana@gmail.com, contacts name: David Weisman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.12067, lon: -75.11795, locations facility: Rhode Island Mood & Memory Research Institute, city: East Providence, state: Rhode Island, zip: 02914, country: United States, contacts name: Lynn Rainville, role: CONTACT, phone: 401-435-8950, email: lrainville@rimmri.com, contacts name: John Stoukides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.81371, lon: -71.37005, locations facility: UT Health Science Center at Houston, city: Houston, state: Texas, zip: 77054, country: United States, contacts name: Alexa Bavero, role: CONTACT, phone: 713-486-0501, email: Alexa.Bavero@uth.tmc.edu, contacts name: Paul Schulz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Re:Cognition Health, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Maria Toor, role: CONTACT, phone: 703-520-9703, email: mtoor@re-cognitionhealth.com, contacts name: Raymond S Turner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Northwest Clinical Research Center, city: Bellevue, state: Washington, zip: 98007, country: United States, contacts name: Arifulla Khan, role: CONTACT, phone: 425-453-0404, email: study.coordinator@nwcrc.net, contacts name: Arifulla Khan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.61038, lon: -122.20068, locations facility: OCT Research ULC (dba Okanagan Clinical Trials), city: Kelowna, state: British Columbia, zip: V1Y 1Z9, country: Canada, contacts name: Robert Goldberg, role: CONTACT, phone: 250-862-8141, email: Robert@oktrials.ca, contacts name: Eugene Okorie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.88307, lon: -119.48568, locations facility: Centricity Research, city: Halifax, state: Nova Scotia, zip: B3S 1N2, country: Canada, contacts name: Gagan Oberoi, role: CONTACT, phone: 902-431-8783, phoneExt: 7107, email: Gagan.oberoi@centricityresearch.com, contacts name: Fred Archibald, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic, city: Ottawa, state: Ontario, zip: K1Z 1G3, country: Canada, contacts name: Richard Bergeron, role: CONTACT, phone: 613-702-1000, email: rbergeron@cliniquememoire.ca, contacts name: Richard Bergeron, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Kawartha Centre - Redefining Healthy Aging, city: Peterborough, state: Ontario, zip: K9H 2P4, country: Canada, contacts name: Jill MacPhee, role: CONTACT, phone: 705-749-3906, phoneExt: 213, email: jill@kawarthacentre.com, contacts name: Katie Krause, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.30012, lon: -78.31623, locations facility: Toronto Memory Program, city: Toronto, state: Ontario, zip: M3B 2S7, country: Canada, contacts name: Justine Reaume, role: CONTACT, phone: 416-386-9761, phoneExt: 364, email: jreaume@memorydisorders.ca, contacts name: Sharon Cohen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Re-Cognition Health Ltd Plymouth, city: Plymouth, state: Devon, zip: PL6 8BT, country: United Kingdom, contacts name: Victoria Evans, role: CONTACT, phone: +44 1752875604, email: vevans@re-cognitionhealth.com, contacts name: Stephen Pearson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.37153, lon: -4.14305, locations facility: Re-Cognition Health Ltd London, city: London, state: Greater London, zip: W1G 9JF, country: United Kingdom, contacts name: Josephine E MacSweeney, role: CONTACT, phone: +44 2033553536, email: emacsweeney@re-cognitionhealth.com, contacts name: Josephine E MacSweeney, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: NeuroClin Glasgow Ltd, city: Motherwell, state: North Lanarkshire, zip: ML1 4UF, country: United Kingdom, contacts name: Jennifer Lynch, role: CONTACT, phone: +44 1419480206, email: jennifer.lynch@neuroclin.co.uk, contacts name: Jennifer Lynch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.78924, lon: -3.99187, locations facility: Re-Cognition Health Ltd Guildford, city: Guildford, state: Surrey, zip: GU2 7YD, country: United Kingdom, contacts name: Nicholas Mannering, role: CONTACT, phone: +44 1483941982, email: NMannering@re-cognitionhealth.com, contacts name: Nicholas Mannering, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.23536, lon: -0.57427, locations facility: Re-Cognition Health Ltd Birmingham, city: Birmingham, state: West Midlands, zip: B16 8LT, country: United Kingdom, contacts name: Conor Clerkin-Oliver, role: CONTACT, phone: +44 1216550166, email: cclerkin@re-cognitionhealth.com, contacts name: Conor Clerkin-Oliver, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Re-Cognition Health Ltd Bristol, city: Bristol, zip: BS32 4SY, country: United Kingdom, contacts name: Daniel Lashley, role: CONTACT, phone: +44 1174623600, email: dlashley@re-cognitionhealth.com, contacts name: Daniel Lashley, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Re-Cognition Health Ltd Winchester, city: Winchester, zip: SO21 1HU, country: United Kingdom, contacts name: Anna Podonyi, role: CONTACT, phone: +44 1962588420, email: apodonyi@re-cognitionhealth.com, contacts name: Steven J Allder, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.06513, lon: -1.3187, hasResults: False
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protocolSection identificationModule nctId: NCT06304870, orgStudyIdInfo id: SYB-reflux, briefTitle: Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Lidocaine, interventions name: Injection, outcomesModule primaryOutcomes measure: Rosenbek penetration-aspiration scale, secondaryOutcomes measure: Gastroesophageal Reflux Disease Questionnaire, secondaryOutcomes measure: Pressure pain threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304857, orgStudyIdInfo id: 2022/ABM/01/00039, secondaryIdInfos id: 2023-506631-15-00, type: OTHER, domain: EUCT, briefTitle: CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL, acronym: PROTECTAA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: 4th Military Clinical Hospital with Polyclinic, Poland, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment., conditionsModule conditions: Breast Cancer, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 188, type: ESTIMATED, armsInterventionsModule interventions name: Dapagliflozin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months., secondaryOutcomes measure: Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months., secondaryOutcomes measure: Change in left ventricular ejection fraction at 6 and 12 months., secondaryOutcomes measure: Change in left ventricular diastolic function at 6 and 12 months., secondaryOutcomes measure: Change in Troponin I after 6 and 12 months., secondaryOutcomes measure: Change in NTproBNP levels at 6 and 12 months., secondaryOutcomes measure: Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire., secondaryOutcomes measure: Occurrence of death from any cause., secondaryOutcomes measure: Composite endpoint of cardiovascular events., secondaryOutcomes measure: Occurrence of death from any cardiovascular reasons., secondaryOutcomes measure: Occurrence of non-fatal myocardial infarction., secondaryOutcomes measure: Occurrence of non-fatal stroke., secondaryOutcomes measure: Occurrence of hypoglycaemia., secondaryOutcomes measure: Occurrence of ionic disorders., secondaryOutcomes measure: Occurrence of renal failure., secondaryOutcomes measure: Occurrence of hypersensitivity to investigated drug., secondaryOutcomes measure: Occurrence of allergic reactions., secondaryOutcomes measure: Occurrence of infection., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 4th Military Clinical Hospital with Polyclinic, status: RECRUITING, city: Wrocław, state: Dolnośląskie, zip: 50-981, country: Poland, contacts name: Bartosz Krakowiak, PhD, MD, role: CONTACT, phone: +48 261 660 234, email: bkrakowiak@4wsk.pl, geoPoint lat: 51.1, lon: 17.03333, locations facility: Lower Silesian Centre for Oncology, Lung Diseases and Hematology, status: RECRUITING, city: Wrocław, state: Dolnośląskie, zip: 53-413, country: Poland, contacts name: Rafał Matkowski, PhD, MD, role: CONTACT, geoPoint lat: 51.1, lon: 17.03333, locations facility: Military Medical Institute, status: NOT_YET_RECRUITING, city: Warsaw, state: Mazowieckie, zip: 04-141, country: Poland, contacts name: Paweł Krzesiński, PhD, MD, role: CONTACT, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False
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protocolSection identificationModule nctId: NCT06304844, orgStudyIdInfo id: Soh-Med-24-02-06MD, briefTitle: Risk of CKD in Diabetic Patients With MAFLD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions., conditionsModule conditions: Type 2 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: transient elastography (Fibroscan), outcomesModule primaryOutcomes measure: Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304831, orgStudyIdInfo id: SwissTI, briefTitle: Use of Facility Ratings to Improve Satisfaction With Heath Care for Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-14, completionDateStruct date: 2024-09-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Swiss Tropical & Public Health Institute, class: OTHER, collaborators name: Lao Tropical and Public Health Institute, descriptionModule briefSummary: Despite increasing options for public and private health care providers in Laos, choosing a high-quality health provider or a facility is difficult because timely and reliable information about providers is not readily available. People rely on social networks or previous experiences to select providers. However, in Laos, only 28% describe their recent visit to a health care provider as high-quality suggesting that while there are increasing options for care, people may need support to find providers that meet their quality needs. Rapid adoption of mobile phones in Laos, particularly in urban areas, offer opportunities to enhance people's access to timely quality information about health care providers. The study team will use mobile phones to collect and disseminate quality information about providers - known to be valued by Laotians - to improve their access to quality care as well as their overall satisfaction with care., conditionsModule conditions: Quality of Health Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: This study consists of a randomized controlled experiment involving 660 mothers with children less than 2 years old. Participants will be randomly assigned to one of two groups: 1) a control group that will not receive any information about providers and 2) an intervention group that will receive biweekly updates about quality ratings based on reviews collected from mothers of young children in the study areas. The unit of randomization will be the individual participant. A simple random number draw generated by the ODK package installed on the tablets will be used to assign participants to treatment and control with equal probability., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 660, type: ESTIMATED, armsInterventionsModule interventions name: Quality ratings of health care providers for children, outcomesModule primaryOutcomes measure: Proportion of mothers that change their preferred health care providers for children for non-urgent care, secondaryOutcomes measure: Proportion of mothers satisfied with health care for their children of their most recent visit, secondaryOutcomes measure: Number and type of health care providers used in the past 3 months, secondaryOutcomes measure: Proportion of mothers that change their most recently visited health care providers for children, secondaryOutcomes measure: Proportion of mothers choosing the preferred facility for non-urgent care because of online or digital information sources, secondaryOutcomes measure: Proportion of mothers that change their preferred health care providers for children for urgent care, secondaryOutcomes measure: Proportion of mothers confident they can identify the best place for getting care for sick children, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lao Tropical and Public Health Institute, status: RECRUITING, city: Vientiane, state: Vientiane Capital, country: Lao People's Democratic Republic, contacts name: Dr Somphou Sayasane, PhD, role: CONTACT, phone: +856 20 55 679 60, email: somphou.sayasone@gmail.com, geoPoint lat: 17.96667, lon: 102.6, hasResults: False
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protocolSection identificationModule nctId: NCT06304818, orgStudyIdInfo id: SCTB14-X101, briefTitle: Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2028-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sinocelltech Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial., conditionsModule conditions: Advanced Malignant Solid Tumours, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 515, type: ESTIMATED, armsInterventionsModule interventions name: SCTB14, outcomesModule primaryOutcomes measure: Dose-Limiting toxicity(DLT), primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304805, orgStudyIdInfo id: TGRX-326-1002, briefTitle: TGRX-326 Phase I/II Pharmacokinetic Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2024-01-12, completionDateStruct date: 2024-01-19, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shenzhen TargetRx, Inc., class: INDUSTRY, collaborators name: First Affiliated Hospital Bengbu Medical College, descriptionModule briefSummary: A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment, conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is a PK assessment study, hence only bio-sample analysis personnel were masked for the type of treatment received for each sample to avoid bias in analysis. Other study personnel, including participants, investigators and staffs were not masked for treatment types., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: cycle 1: treatment drug, interventions name: cycle 1: reference drug, interventions name: cycle 1: fasted, interventions name: cycle 1: food, interventions name: cycle 2: treatment drug, interventions name: cycle 2: reference drug, interventions name: cycle 2: fasted, interventions name: cycle 2: food, interventions name: cycle 3: treatment drug, interventions name: cycle 3: reference drug, interventions name: cycle 3: fasted, interventions name: cycle 3: food, outcomesModule primaryOutcomes measure: Plasma Cmax, primaryOutcomes measure: Plasma AUC(0-t), primaryOutcomes measure: Plasma AUC(0-inf), secondaryOutcomes measure: Plasma Tmax, secondaryOutcomes measure: terminal elimination rate constant (lambda-z), secondaryOutcomes measure: Elimination half-life (T1/2-Z), secondaryOutcomes measure: AUC(%Extrap), secondaryOutcomes measure: Plasma volume of distribution (Vz/F), secondaryOutcomes measure: Plasma clearance (CL/F), secondaryOutcomes measure: Adverse events/serious adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital Bengbu Medical College, city: Bengbu, state: Anhui, zip: 233004, country: China, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False
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protocolSection identificationModule nctId: NCT06304792, orgStudyIdInfo id: H-22030591, briefTitle: Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate., conditionsModule conditions: Infertility, conditions: IVF, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 464, type: ESTIMATED, armsInterventionsModule interventions name: Immediate FET in a stimulated or programmed cycle, outcomesModule primaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Live birth rate per blastocyst transfer, secondaryOutcomes measure: Ongoing pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Cancelled cycle rate and reason for cancelled cycles, secondaryOutcomes measure: Endocrinology of the luteal phase, secondaryOutcomes measure: Number of ovarian follicular structures >10 mm, secondaryOutcomes measure: Time-to-pregnancy, secondaryOutcomes measure: Time-to-live-birth, secondaryOutcomes measure: Pregnancy related complications, secondaryOutcomes measure: Neonatal outcomes (weight in kilograms), secondaryOutcomes measure: Neonatal outcomes (length in cm), secondaryOutcomes measure: Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum), secondaryOutcomes measure: Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertility Departmen, Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Anja B. Pinborg, Prof., DMSC, role: CONTACT, phone: 0045 35 45 64 30, email: anja.bisgaard.pinborg@regionh.dk, contacts name: Clara Colombo, MD, role: CONTACT, email: clara.colombo@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06304779, orgStudyIdInfo id: V3.0.2023.11.29, briefTitle: The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Tianjin Medical University General Hospital, collaborators name: The Affiliated Hospital of Xuzhou Medical University, collaborators name: West China Hospital, descriptionModule briefSummary: The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively., conditionsModule conditions: Postoperative Pulmonary Complications, conditions: Intra-abdominal Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Lidocaine group: Patients receive a loading dose of 1.5 mg/kg 2% lidocaine at anesthesia induction, followed by continuous intravenous infusion at 1.5 mg/kg/h until 24 hours postoperatively Control group: Patients receive an equivalent volume of normal saline at anesthesia induction and throughout the perioperative period until 24 hours postoperatively., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Lidocaine, interventions name: Placebo, outcomesModule primaryOutcomes measure: The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI., secondaryOutcomes measure: the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, otherOutcomes measure: To observe the impact of continuous perioperative lidocaine infusion on the levels of neutrophil extracellular traps (NETs) postoperatively, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital,Fudan university, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06304766, orgStudyIdInfo id: H-23015954, briefTitle: Open Versus Laparoscopic Ablation of Liver Malignancies, acronym: OPTIMAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Cholangiocarcinoma, conditions: Liver Metastases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Approximately 80 patients will be randomized 1:1 between laparoscopic or open ablation after operability assesment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopic ablation, interventions name: Open ablation, outcomesModule primaryOutcomes measure: Complications measured by the comprehensive complication index., secondaryOutcomes measure: Tumor ablation completeness., secondaryOutcomes measure: Quality of Recovery score (QoR), secondaryOutcomes measure: Quality of Life score (QoL), secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Hans-Christian Pommergaard, MD DMSc PhD, role: CONTACT, email: hans-christian.pommergaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-01, uploadDate: 2023-10-06T05:58, filename: Prot_SAP_000.pdf, size: 192543, hasResults: False
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protocolSection identificationModule nctId: NCT06304753, orgStudyIdInfo id: BOT119435, briefTitle: ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction, acronym: BOT-IMPROVE-HF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: I.M. Sechenov First Moscow State Medical University, class: OTHER, descriptionModule briefSummary: BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes., conditionsModule conditions: Chronic Heart Failure With Low Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Telebot, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Heart failure decompensation, secondaryOutcomes measure: Change in NT-proBNP, secondaryOutcomes measure: Change in Quality of life, secondaryOutcomes measure: Changes in medical adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University, status: RECRUITING, city: Moscow, zip: 119435, country: Russian Federation, contacts name: Maria Kozhevnikova, role: CONTACT, phone: +7 (499) 248-46-43, email: kozhevnikova_m_v@staff.sechenov.ru, contacts name: Aleksei Emelianov, role: CONTACT, phone: +7 (999) 830-57-85, email: emelyanov_a_v@staff.sechenov.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow"., status: RECRUITING, city: Moscow, zip: 129327, country: Russian Federation, contacts name: Maria Kozhevnikova, role: CONTACT, phone: +74992484643, email: kozhevnikova_m_v@staff.sechenov.ru, contacts name: Aleksei Emelianov, role: CONTACT, phone: +79998305785, email: emelyanov_a_v@staff.sechenov.ru, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
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protocolSection identificationModule nctId: NCT06304740, orgStudyIdInfo id: IMG-007-102, briefTitle: Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Inmagene LLC, class: INDUSTRY, descriptionModule briefSummary: This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: IMG-007, interventions name: Placebo, outcomesModule primaryOutcomes measure: Adverse Event Evaluation, secondaryOutcomes measure: Pharmacokinetic Parameters, Cmax, secondaryOutcomes measure: Pharmacokinetic Parameters, Tmax, secondaryOutcomes measure: Pharmacokinetic Parameters, AUC0-t, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Linear Clinical Research, status: RECRUITING, city: Perth, country: Australia, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False
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protocolSection identificationModule nctId: NCT06304727, orgStudyIdInfo id: 23-5064, secondaryIdInfos id: Easydore, type: OTHER, domain: 69HCL23_0736, briefTitle: Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment, acronym: 1TreSBCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-21, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management., conditionsModule conditions: Bronchiolitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: clinical data review, outcomesModule primaryOutcomes measure: Feasibility of the short enteral feeding protocol, eligibilityModule sex: ALL, minimumAge: 8 Weeks, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Hopital Femme Mere Enfant, status: RECRUITING, city: Bron, country: France, contacts name: Dominique PLOIN, MD, role: CONTACT, phone: 0427855642, phoneExt: +33, email: dominique.ploin@chu-lyon.fr, contacts name: Côme HORVAT, MD, role: CONTACT, phone: 0427855634, phoneExt: +33, email: come.horvat@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False
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protocolSection identificationModule nctId: NCT06304714, orgStudyIdInfo id: 20_RIPH3-16, secondaryIdInfos id: 2022-A00162-41, type: OTHER, domain: ANSM (National Agency for the Safety of Medicines and other health products ), briefTitle: Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana, acronym: WBOTHROPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-08, completionDateStruct date: 2025-10-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University Hospital Center of Martinique, class: OTHER, collaborators name: University Hospital, Lille, descriptionModule briefSummary: In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients., conditionsModule conditions: Snake Envenomation, conditions: Thrombi, conditions: Coagulopathy, conditions: Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Patients suffering from envenomation by Bothrops, outcomesModule primaryOutcomes measure: Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®)., secondaryOutcomes measure: Plasma VW factor activity (VW:Act/VW:Ag ratio), otherOutcomes measure: Hemostasis abnormalities, otherOutcomes measure: Plasma levels of high-molecular-weight VW factor multimers assessed by electrophoresis technique, otherOutcomes measure: Plasma concentrations of soluble forms of the endothelial adhesion molecules, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304701, orgStudyIdInfo id: PI-2023-08, briefTitle: Handwritten Text Production in Adults With Autism, acronym: PEMTAA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-29, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Niort, class: OTHER, collaborators name: University of Poitiers, descriptionModule briefSummary: The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.The secondary objectives are:* Identifying links between specific deficits of ASD and difficulties in written production.* Identifying links between the severity of ASD and difficulties in written production.The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).The secondary evaluation criteria are:* Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).* Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).* Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC)., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is part of category 2 of research involving humans and which corresponds to an interventional study with minimal risks and constraints. The patient is asked to return to carry out this study., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive and writing tests, outcomesModule primaryOutcomes measure: Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd), secondaryOutcomes measure: Identifying links between specific deficits of ASD and difficulties in written production, secondaryOutcomes measure: Identifying links between the severity of ASD and difficulties in written production, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Niort, status: RECRUITING, city: Niort, zip: 79000, country: France, contacts name: Diane D Chuillet-Moreau, Mrs, role: CONTACT, phone: +33549782049, email: diane.chuillet-moreau@ch-niort.fr, geoPoint lat: 46.32313, lon: -0.45877, hasResults: False
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protocolSection identificationModule nctId: NCT06304688, orgStudyIdInfo id: University of Jaén_24, briefTitle: Yoga and Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-02-05, completionDateStruct date: 2024-02-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Jaén, class: OTHER, descriptionModule briefSummary: Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted. Also, Nutrition plays a fundamental role in the health and well-being of individuals at all stages of life, but it is especially crucial in old age due to the physiological and metabolic changes that occur during the aging process. Maintaining a healthy and balanced diet is essential for providing the necessary nutrients for proper body function, strengthening the immune system, and maintaining the health of bone and cardiovascular structures. Specifically, the Mediterranean diet is a traditional dietary pattern based on foods commonly consumed in Mediterranean regions such as Greece, Italy, and Spain. It is characterized by high consumption of fruits, vegetables, legumes, nuts, whole grains, fish, and olive oil, along with moderate intake of dairy and red wine, and limited con-sumption of red meat and processed products. This eating style has been the subject of numerous scientific studies highlighting its multiple health benefits. Apart from the physical health benefits for older adults, the Mediterranean diet has consistently been associated with positive effects such as reduced risk of cardiovascular pathologies, de-creased chronic diseases and pro-inflammatory factors, as well as contributing to the prevention of obesity and cognitive decline., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 125, type: ACTUAL, armsInterventionsModule interventions name: Yoga and Mediterranean Diet intervention, outcomesModule primaryOutcomes measure: TMT (Trail Making Test), primaryOutcomes measure: SFT (Senior Fitness Test), primaryOutcomes measure: Handgrip Strength, primaryOutcomes measure: Mindful Attention Awareness Scale (MAAS), primaryOutcomes measure: Digit symbol substitution test (DSST), primaryOutcomes measure: D2 test, primaryOutcomes measure: Isaac test, primaryOutcomes measure: Anxiety and Depression, primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Balance, primaryOutcomes measure: Nutritional status, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Agustín Aibar Almazán, city: Jaén, zip: 23007, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False
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protocolSection identificationModule nctId: NCT06304675, orgStudyIdInfo id: 905055423985, briefTitle: Manageable Environmental Factors in Migraine, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Samsun University, class: OTHER, descriptionModule briefSummary: There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups., conditionsModule conditions: Migraine, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: 1. Environmental factors/triggers affecting the chronicity of migraine, secondaryOutcomes measure: 2.Environmental factors/triggers and migraine treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsun University, city: Samsun, zip: 55100, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False
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protocolSection identificationModule nctId: NCT06304662, orgStudyIdInfo id: *University of Jaén, briefTitle: Yoga for Physical and Mental Health, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-02-09, completionDateStruct date: 2024-02-19, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Jaén, class: OTHER, descriptionModule briefSummary: In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 142, type: ACTUAL, armsInterventionsModule interventions name: Yoga intervention, outcomesModule primaryOutcomes measure: D2 test, primaryOutcomes measure: Mindful Attention Awareness Scale (MAAS), primaryOutcomes measure: Handgrip Strength, primaryOutcomes measure: Anxiety and Depression, primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Stress level, primaryOutcomes measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), primaryOutcomes measure: State Anxiety Inventory (STAI), primaryOutcomes measure: Attentional Control: Shifting and Distraction (AC-S and AC-D), primaryOutcomes measure: Positive and Negative Affect Schedule, primaryOutcomes measure: Difficulties in Emotion Regulation Scale (DERS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Agustín Aibar Almazán, city: Jaén, zip: 23007, country: Spain, geoPoint lat: 37.76922, lon: -3.79028, hasResults: False
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protocolSection identificationModule nctId: NCT06304649, orgStudyIdInfo id: Cast21CHLA2023Study1SAP, briefTitle: Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures, acronym: Cast21 SAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cast21, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product., conditionsModule conditions: Fractures, Closed, conditions: Fractures Bone, conditions: Fracture, conditions: Fractures, conditions: Radius; Fracture, Lower or Distal End, conditions: Ulna Fractures, conditions: Radius Distal Fracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cast or brace alternative, outcomesModule primaryOutcomes measure: Clinical determination of healing (standard of care), primaryOutcomes measure: Range of Motion (standard of care), secondaryOutcomes measure: Patient Reported Outcomes - Pain, secondaryOutcomes measure: Patient Reported Outcomes - Satisfaction, secondaryOutcomes measure: Physical Therapy Referral, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06304636, orgStudyIdInfo id: DC15-MM-01, briefTitle: Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma, acronym: DC15-MM-01, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cartesian Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15, conditionsModule conditions: Refractory Multiple Myeloma, conditions: Relapsed Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Study consists of two parts. Part 1 is a single-arm dose escalation study. Part 2 is a dose-expansion study with 2 arms., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 41, type: ESTIMATED, armsInterventionsModule interventions name: Descartes-15, outcomesModule primaryOutcomes measure: Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM), secondaryOutcomes measure: To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Cancer and Blood Disorders (AON), status: RECRUITING, city: Bethesda, state: Maryland, zip: 20817, country: United States, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06304623, orgStudyIdInfo id: CIRE.112, briefTitle: SVF for Treating Pulmonary Fibrosis Post COVID-19, acronym: SVFCOVID-19, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-05-05, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Michael H Carstens, class: OTHER, collaborators name: Ministerio de Salud de Nicaragua, collaborators name: Wake Forest University, collaborators name: National Autonomous University of Nicaragua, descriptionModule briefSummary: General description of the studyThis is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.Primary objectiveThe purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.Secondary objectiveTo evaluate the efficacy of the initial treatment with SVF IV., conditionsModule conditions: Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Autologous adipose-derived SVF IV administration, outcomesModule primaryOutcomes measure: Safety of treatment with SVF IV, secondaryOutcomes measure: Efficacy of the initial treatment with SVF IV, otherOutcomes measure: Effectiveness of the initial treatment with SVF IV, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), city: León, state: Leon, zip: 21000, country: Nicaragua, geoPoint lat: 12.43787, lon: -86.87804, locations facility: Hospital Escuela Cesar Amador Molina, city: Matagalpa, zip: 61000, country: Nicaragua, geoPoint lat: 12.92559, lon: -85.91747, hasResults: False
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protocolSection identificationModule nctId: NCT06304610, orgStudyIdInfo id: ONZ-2024-0044, briefTitle: Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador, acronym: ELEVATE-Pilot, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, collaborators name: Horizon 2020 - European Commission, collaborators name: Universidad de Cuenca, descriptionModule briefSummary: ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):* AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test* ELISA protein detection: only available comparison testIn order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):• HPV DNA Mole Bioscience testConcordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes., conditionsModule conditions: Cervical Cancer, conditions: HPV Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: all participants receive the same tests, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, interventions name: HPV self-sample, interventions name: Endocervical sample, outcomesModule primaryOutcomes measure: Clinical validation, secondaryOutcomes measure: Concordance, secondaryOutcomes measure: HPV DNA test validation, secondaryOutcomes measure: Protein test validation, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent University Hospital, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Steven Weyers, MD,PhD,Prof, role: CONTACT, phone: 09 332 37 83, email: steven.weyers@uzgent.be, contacts name: Philippe Tummers, MD,PhD,Prof, role: CONTACT, phone: 09 332 37 83, email: philippe.tummers@uzgent.be, contacts name: Philippe Tummers, MD,PhD,Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Heleen Vermandere, PhD, role: SUB_INVESTIGATOR, contacts name: Marie Hendrickx, MSC, role: SUB_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: SOLCA University Hospital, city: Cuenca, country: Ecuador, contacts name: Bernardo José Vega Crespo, role: CONTACT, phone: 0998276441, email: bernardo.vegac@ucuenca.edu.ec, contacts name: Bernardo José Vega Crespo, role: PRINCIPAL_INVESTIGATOR, contacts name: Dayanara Delgado, role: SUB_INVESTIGATOR, contacts name: Vivian Alejandra Neira Molina, role: SUB_INVESTIGATOR, geoPoint lat: -2.90055, lon: -79.00453, hasResults: False
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protocolSection identificationModule nctId: NCT06304597, orgStudyIdInfo id: 17651, briefTitle: Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy, acronym: PREDICT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Imfinzi, interventions name: Opdivo, outcomesModule primaryOutcomes measure: Safety of nivolumab-800CW in combination with durvalumab-680LT, primaryOutcomes measure: To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect nivolumab-800CW and durvalumab-680LT signals indicating PD1 and PD-L1 expression., primaryOutcomes measure: Heart rate, primaryOutcomes measure: Blood pressure systolic and diastolic, primaryOutcomes measure: Temperature, secondaryOutcomes measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC., secondaryOutcomes measure: Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC., secondaryOutcomes measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression, secondaryOutcomes measure: Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression, secondaryOutcomes measure: Perform real-time polymerase chain reaction (qPCR) and western blot on biopsies to determine whether there is genetic downregulation or protein degradation of PD-1 and PD-L1 after chemoradiotherapy, secondaryOutcomes measure: Compare immune cell composition between the radiated and non-radiated area of the bowel., secondaryOutcomes measure: Evaluate targeted detection with nivolumab-800CW and durvalumab-680LT of the tumor by ex vivo visualization of the resection specimen with PEARL Trilogy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Groningen, city: Groningen, zip: 9713 GZ, country: Netherlands, contacts name: Wouter B Nagengast, Prof., role: CONTACT, email: w.b.nagengast@umcg.nl, contacts name: Lisanne E van Heijst, Bsc., role: SUB_INVESTIGATOR, contacts name: Pia Volkmer, Drs., role: SUB_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06304584, orgStudyIdInfo id: P-2023-143, briefTitle: Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University Hospital Bispebjerg and Frederiksberg, class: OTHER, collaborators name: Frederiksberg Municipality, descriptionModule briefSummary: The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.The main questions aim to answer:* how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered* what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fractureParticipants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation., conditionsModule conditions: Hip Fractures, conditions: Rehabilitation, conditions: Recovery of Function, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, outcomesModule primaryOutcomes measure: Recovery of pre-fracture function, secondaryOutcomes measure: Basic mobility, secondaryOutcomes measure: 30 second chair stand test (CST), secondaryOutcomes measure: Timed Up & Go test (TUG), secondaryOutcomes measure: Hip related pain, secondaryOutcomes measure: Hand Grip Strength (HGS), secondaryOutcomes measure: Health questionnaire, secondaryOutcomes measure: Physical activity (weekly), secondaryOutcomes measure: Physical activity / upright time (time standing and walking), secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Fear of falling, secondaryOutcomes measure: Comorbidity, secondaryOutcomes measure: Cognitive status, secondaryOutcomes measure: Number of falls, secondaryOutcomes measure: Residential status / discharge destination, secondaryOutcomes measure: Length of stay in acute hospital, secondaryOutcomes measure: Number of weekly exercise sessions with therapist in all settings, secondaryOutcomes measure: Number of rehab weeks, secondaryOutcomes measure: Type of training in Municipality, secondaryOutcomes measure: Training after discharge from 24-hour setting, secondaryOutcomes measure: Home care, nurse/other health assistance, times pr week, secondaryOutcomes measure: Data 30 days post-discharge, secondaryOutcomes measure: Data 3 months post-discharge, secondaryOutcomes measure: Data 1 year post-discharge, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg, status: RECRUITING, city: Copenhagen, zip: 2400, country: Denmark, contacts name: Morten T Kristensen, Professor, role: CONTACT, email: morten.tange.kristensen@regionh.dk, contacts name: Camilla K Zilmer, MSc, PT, role: CONTACT, email: camilla.kampp.zilmer@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06304571, orgStudyIdInfo id: HC006-001, briefTitle: A Study of HC006 in Subjects With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2026-03-15, completionDateStruct date: 2026-07-16, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: HC Biopharma Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: HC006, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicities(DLTs), primaryOutcomes measure: Incidence of adverse events(AEs), primaryOutcomes measure: Incidence of Serious adverse events(SAEs), primaryOutcomes measure: Clinically Significant changes in safety assessments, secondaryOutcomes measure: Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax), secondaryOutcomes measure: PK Parameter:Time to reach Cmax (Tmax), secondaryOutcomes measure: PK Parameter:Area Under the Concentration-time Curve (AUC), secondaryOutcomes measure: Immunogenicity, secondaryOutcomes measure: Objective Response Rate (ORR) per RECIST 1.1, secondaryOutcomes measure: progression-Free Survival (PFS) per RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate (DCR) per RECIST 1.1, secondaryOutcomes measure: Duration of response (DOR) per RECIST 1.1, secondaryOutcomes measure: Time to progression (TTP) per RECIST 1.1, secondaryOutcomes measure: Time To Response (TTR) per RECIST 1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai East Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: Ye Guo, MD, role: CONTACT, email: pattrickguo@gmail.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06304558, orgStudyIdInfo id: CI 240228, 2024-480, briefTitle: "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results., conditionsModule conditions: Sexual Satisfaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Non-Invasive Neuromodulation (NESA), outcomesModule primaryOutcomes measure: Sexual satisfaction, secondaryOutcomes measure: Stress levels, secondaryOutcomes measure: Blood Pressure (Sistolic and diastolic), secondaryOutcomes measure: Heartbeats per minute, secondaryOutcomes measure: Sleep Quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06304545, orgStudyIdInfo id: SHR-1210-HLJ-081, briefTitle: Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-08-16, completionDateStruct date: 2027-03-15, 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, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Chemotherapy, interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: Pathological Complete Response rate, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Anal preservation rate, secondaryOutcomes measure: Disease-free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: AEs, secondaryOutcomes measure: 3-years Overall Survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304532, orgStudyIdInfo id: HU123, briefTitle: Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2024-03-05, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Hamdard University, class: OTHER, descriptionModule briefSummary: Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy., conditionsModule conditions: H. Pylori Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 69, type: ACTUAL, outcomesModule primaryOutcomes measure: H. pylori stool for antigen test will screened before and after treatment., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shifa Ul Memorial Hospital-Hamdard University, city: Karachi, state: Sindh, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06304519, orgStudyIdInfo id: 1986626-1, briefTitle: Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Delaware, class: OTHER, descriptionModule briefSummary: Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic ankle-foot orthosis, outcomesModule primaryOutcomes measure: Mechanical Cost of Transport of the Lower Extremities, primaryOutcomes measure: Sagittal plane ankle moment during stance, primaryOutcomes measure: Sagittal plane ankle angle during stance, primaryOutcomes measure: Self-selected walking speed, primaryOutcomes measure: a candidate set of clinical outcome measures, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Delaware STAR Campus, status: RECRUITING, city: Newark, state: Delaware, zip: 19713, country: United States, contacts name: Elisa Arch, Ph.D., role: CONTACT, phone: 302-831-7268, email: schranke@udel.edu, geoPoint lat: 39.68372, lon: -75.74966, hasResults: False
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protocolSection identificationModule nctId: NCT06304506, orgStudyIdInfo id: 514-0894/23-3000, briefTitle: Effect of Obesity on Extracellular Matrix Composition, acronym: EOBECM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.The main questions to answer,- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men, conditionsModule conditions: Adipose Tissue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cross sectional study with three groups, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cross sectional study, outcomesModule primaryOutcomes measure: The effect of obesity and age on adipose tissue extracellular matrix composition, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen, status: RECRUITING, city: Copenhagen, zip: 2200, country: Denmark, contacts name: Jørn M Helge, PhD, role: CONTACT, phone: +4528757506, email: jhelge@sund.ku.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06304493, orgStudyIdInfo id: 23-2470, briefTitle: REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders., conditionsModule conditions: Postoperative Atelectasis, conditions: Postoperative Hypoxemia, conditions: Postoperative Pneumonia, conditions: Postoperative Pulmonary Complications, conditions: Patient Adherence, conditions: Incentive Spirometry, conditions: Respiratory Therapy, conditions: Respiratory Insufficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pragmatic single-center cluster study of surgical patients receiving incentive spirometry devices during their PACU stay, with either automatic alarms "ON" or "OFF" in alternating weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Outcome collection and data analysis will be performed by investigators blinded to the patient's cluster allocation (alarms "ON" or "OFF")., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Alarms, outcomesModule primaryOutcomes measure: Rate of adequate IS breaths achieved in PACU, secondaryOutcomes measure: Rate of IS breaths attempted in PACU, secondaryOutcomes measure: Time to first adequate IS breath, secondaryOutcomes measure: Duration of postoperative O2 therapy, secondaryOutcomes measure: Presence of postoperative pulmonary complications, secondaryOutcomes measure: Individual postoperative pulmonary complications, secondaryOutcomes measure: Need for ICU Admission after PACU, secondaryOutcomes measure: PACU Length of Stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CU Anschutz, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Emily G Helmer, role: CONTACT, phone: 303-724-2938, email: emily.helmer@cuanschutz.edu, contacts name: Carolyn Gronowski, role: CONTACT, email: carolyn.gronowski@cuanschutz.edu, contacts name: Ana Fernandez-Bustamante, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
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protocolSection identificationModule nctId: NCT06304480, orgStudyIdInfo id: AFCRO-179, briefTitle: Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University College Cork, class: OTHER, collaborators name: AIT Austrian Institute of Technology GmbH, descriptionModule briefSummary: There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens., conditionsModule conditions: Gut Microbiome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised, open label, controlled, parallel study in healthy males and females., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Randomised, open label, controlled, parallel study in healthy males and females., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 100g fermented Tofu, outcomesModule primaryOutcomes measure: To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition., secondaryOutcomes measure: To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement., secondaryOutcomes measure: To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement., secondaryOutcomes measure: To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype., secondaryOutcomes measure: To measure the effect of the meat substitution on cholesterol and serum triglycerides., secondaryOutcomes measure: To measure the effect of the meat substitution on blood pressure., secondaryOutcomes measure: To measure the effect of the meat substitution on body mass index (BMI)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304467, orgStudyIdInfo id: IRB#23-001133, briefTitle: CM for Patients With ALD After Liver Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Arpan A. Patel, MD, class: OTHER, descriptionModule briefSummary: Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use.The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility., conditionsModule conditions: Alcohol Use Disorder, conditions: Alcohol; Liver, conditions: Post Liver Transplant, conditions: Contingency Management, conditions: Alcohol Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Contingency Management, outcomesModule primaryOutcomes measure: Number of Non-Drinking Days, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr)), secondaryOutcomes measure: Client Satisfaction Questionnaire-8., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304454, orgStudyIdInfo id: P5_BG, briefTitle: Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Brain In Game scientific-technical service, class: OTHER, descriptionModule briefSummary: Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group., conditionsModule conditions: Kindergarten Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster RCT, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Double (outcomes assessor and participants), whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Board game intervention, outcomesModule primaryOutcomes measure: Visual Memory, primaryOutcomes measure: Processing speed and inhibition, primaryOutcomes measure: Affect recognition, secondaryOutcomes measure: Hollingshead Index (Hollingshead, 1975), secondaryOutcomes measure: CHEXI (Giménez et al. 2022), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of Education, Psychology and Social Work; University of Lleida, city: Lleida, zip: 25001, country: Spain, geoPoint lat: 41.61674, lon: 0.62218, hasResults: False
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protocolSection identificationModule nctId: NCT06304441, orgStudyIdInfo id: IPVO, briefTitle: Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined., conditionsModule conditions: Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib, interventions name: Pemetrexed, outcomesModule primaryOutcomes measure: Clinical response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University), status: RECRUITING, city: Huizhou, state: Guangdong, country: China, contacts name: Zhenyu Pan, role: CONTACT, phone: +8615804302753, email: dr-zypan@163.com, contacts name: Guozi Yang, role: CONTACT, phone: +8615804302755, email: guoziyang_1982@163.com, geoPoint lat: 23.11147, lon: 114.41523, hasResults: False
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protocolSection identificationModule nctId: NCT06304428, orgStudyIdInfo id: Pro00114580, briefTitle: Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications, acronym: PRISM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2028-07-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Patient-Centered Outcomes Research Institute, collaborators name: Hebrew SeniorLife, collaborators name: Brown University, collaborators name: The American Health Care Association, collaborators name: University of North Carolina, Chapel Hill, descriptionModule briefSummary: The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.The main questions this study aims to answer are:* Which of the three models is more effective in preventing falls with fractures?* What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.* What are the differences in osteoporosis treatment and medication burden?The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol., conditionsModule conditions: Accidental Falls/Prevention and Control, conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3780, type: ESTIMATED, armsInterventionsModule interventions name: Deprescribing Care Model, interventions name: Bone Health Service Model, interventions name: Injury Prevention Service Model, outcomesModule primaryOutcomes measure: Injurious falls, secondaryOutcomes measure: Number of patients who initiate treatment for osteoporosis, secondaryOutcomes measure: Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims, secondaryOutcomes measure: Number of patients who had deprescribing ordered, secondaryOutcomes measure: Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims, secondaryOutcomes measure: Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3)., secondaryOutcomes measure: Patient falls self-efficacy (i.e. fear of falling), measured via Falls Efficacy Scale, secondaryOutcomes measure: Patient pain, measured via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form, secondaryOutcomes measure: Patient depression, measured via Patient Health Questionnaire survey (PHQ-8), secondaryOutcomes measure: Patient anxiety, measured via PROMIS anxiety short form survey, secondaryOutcomes measure: Patient sleep, measured via PROMIS sleep disturbance short form, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304415, orgStudyIdInfo id: CIRB2023/2651, briefTitle: Elevated Lipoprotein(a) in Hospital Staff, acronym: LPACO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2035-12-01, completionDateStruct date: 2036-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Changi General Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population., conditionsModule conditions: Hypercholesterolemia, conditions: Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2800, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Distribution and prevalence of elevated Lipoprotein(a), secondaryOutcomes measure: Correlation of lipoprotein(a) with cardiovascular outcomes, secondaryOutcomes measure: Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Trials & Research Unit, city: Singapore, zip: 529889, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06304402, orgStudyIdInfo id: 7978-GOA, briefTitle: Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications., conditionsModule conditions: Sports Physical Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: The Percussive Massage Treatment, interventions name: The Proprioceptive Neuromuscular Facilitation Stretching, outcomesModule primaryOutcomes measure: Shoulder internal rotation range of motion, secondaryOutcomes measure: Attack Speed, eligibilityModule sex: FEMALE, minimumAge: 14 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation, status: RECRUITING, city: İzmir, state: Balçova, zip: 35340, country: Turkey, contacts name: Gonca Sahiner, PhD, role: CONTACT, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06304389, orgStudyIdInfo id: BLUELIGHT-VNS, briefTitle: Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy, acronym: BLUELIGHTVNS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS., conditionsModule conditions: Refractory Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with refractory epilepsy (divided in non responders \& responders), and healthy subjects, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, interventions name: transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration, outcomesModule primaryOutcomes measure: Effect of blue light on VNS biomarkers, primaryOutcomes measure: Effect of blue light on VNS biomarkers, primaryOutcomes measure: Effect of blue light on VNS biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cliniques Universitaires Saint Luc, status: RECRUITING, city: Woluwe-Saint-Lambert, zip: 1200, country: Belgium, contacts name: Inci Cakiroglu, Phd student, role: CONTACT, phone: +32470612917, email: inci.cakiroglu@uclouvain.be, contacts name: Inci Cakiroglu, Phd student, role: SUB_INVESTIGATOR, geoPoint lat: 50.84389, lon: 4.42912, hasResults: False
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protocolSection identificationModule nctId: NCT06304376, orgStudyIdInfo id: OMFS/FSDC002, briefTitle: Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting, acronym: Alveolar cleft, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-12, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-02-22, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, collaborators name: Ministry of Health, Kuwait, descriptionModule briefSummary: This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT., conditionsModule conditions: Alveolar Cleft, conditions: Alveolar Ridge Cleft, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Alveolar ridge grafting, outcomesModule primaryOutcomes measure: Volumetric bone gain, secondaryOutcomes measure: Eruption of the tooth in the cleft, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ministry of Health, Farwaniya Hospital, city: Al Farwānīyah, zip: 81004, country: Kuwait, geoPoint lat: 29.2775, lon: 47.95861, hasResults: False
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protocolSection identificationModule nctId: NCT06304363, orgStudyIdInfo id: Braining booster, briefTitle: Braining - Evaluation of Acute Effects of Physical Exercise, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Karolinska Institutet, descriptionModule briefSummary: "Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes., conditionsModule conditions: Psychiatric Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Braining, outcomesModule primaryOutcomes measure: Anxiety Visual Analogue Scale (VAS), secondaryOutcomes measure: Beck Anxiety Inventory BAI, secondaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale MADRS, secondaryOutcomes measure: High sensitivity C-reactive protein hsCRP, secondaryOutcomes measure: Brain-derived neurotrophic factor BDNF, secondaryOutcomes measure: Telomerase activity, secondaryOutcomes measure: Motivational factors of continued exercise, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest), city: Stockholm, zip: 14186, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06304350, orgStudyIdInfo id: SGHDOT-24-20, briefTitle: Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-17, primaryCompletionDateStruct date: 2026-02-25, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Tongji University, class: OTHER, descriptionModule briefSummary: This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study, conditionsModule conditions: Esophageal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Combination of pembrolizumab and platinum containing dual drugs, outcomesModule primaryOutcomes measure: Pathological complete remission (pCR), secondaryOutcomes measure: Major pathological remission (MPR), secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Total survival time (OS), secondaryOutcomes measure: Safety (incidence of adverse drug reactions), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai General Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200080, country: China, contacts name: Jiang Fan, MD, role: CONTACT, phone: 02163240090, email: fan_jiang@tongji.edu.cn, contacts name: Jiang Fan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06304337, orgStudyIdInfo id: YXLL-KY-2023(162), briefTitle: Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-10-10, completionDateStruct date: 2025-03-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Qianfoshan Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2\<90%, t\>10s) and severe hypoxia (Spo2\<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients., conditionsModule conditions: Airway Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: New oropharyngeal airway group, outcomesModule primaryOutcomes measure: Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation, secondaryOutcomes measure: The incidence of choking, reflux aspiration and laryngeal spasm were recorded, secondaryOutcomes measure: The dose of additional drugs during the operation, secondaryOutcomes measure: Endoscopist satisfaction, secondaryOutcomes measure: Record adverse events that occur throughout the process, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 95 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304324, orgStudyIdInfo id: 18/2023, briefTitle: Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Poznan University of Medical Sciences, class: OTHER, descriptionModule briefSummary: Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery., conditionsModule conditions: Ankle Disease, conditions: Ankle Injuries and Disorders, conditions: Foot Injury, conditions: Foot Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: 0.9% Sodium chloride, interventions name: 0.1mg/kg Dexamethasone, interventions name: 0.05ug/kg Dexmedetomidine, outcomesModule primaryOutcomes measure: time to the first need of opiate following the procedure, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale, secondaryOutcomes measure: Neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: Platelet-to-lymphocyte ratio, secondaryOutcomes measure: Platelet-to-lymphocyte ratio, secondaryOutcomes measure: Time to mobilization, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland, city: Poznań, state: Wielkopolska, zip: 61-545, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
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protocolSection identificationModule nctId: NCT06304311, orgStudyIdInfo id: MAHSA/PHD/SON/2024/01, briefTitle: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-02, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2024-01-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Lahore, class: OTHER, collaborators name: Mahsa University, descriptionModule briefSummary: The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes., conditionsModule conditions: Labor Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Routine Obstetrics care & Lamaze breathing techniques and backside massage, outcomesModule primaryOutcomes measure: Labour pain intensity, primaryOutcomes measure: Anxiety level, primaryOutcomes measure: Duration of Labour, primaryOutcomes measure: Maternal self-efficacy, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lady Wallingdon Hospital, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06304298, orgStudyIdInfo id: 10/2023, briefTitle: NLR and PLR Levels Following iPACK Block in Knee Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Poznan University of Medical Sciences, class: OTHER, descriptionModule briefSummary: Effect of iPACK block on NLR and PLR following knee arthroplasty, conditionsModule conditions: Knee Arthropathy, conditions: Knee Osteoarthritis, conditions: Knee Pain Chronic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 0.9% Sodium Chloride Injection, interventions name: Ropivacaine 0.2% Injectable Solution, outcomesModule primaryOutcomes measure: Neutrophil-to-lymphocyte ratio, primaryOutcomes measure: Neutrophil-to-lymphocyte ratio, primaryOutcomes measure: Neutrophil-to-lymphocyte ratio, secondaryOutcomes measure: PLR, secondaryOutcomes measure: PLR, secondaryOutcomes measure: PLR, secondaryOutcomes measure: first need of opiate, secondaryOutcomes measure: Opioid Consumption, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Pain score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304285, orgStudyIdInfo id: 2023-ky421, briefTitle: A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of University of Science and Technology of China, class: OTHER, descriptionModule briefSummary: The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD, conditionsModule conditions: Parkinson's Disease, conditions: Chronic Appendicitis, conditions: Acupuncture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture treatment, interventions name: Sham acupuncture treatment, outcomesModule primaryOutcomes measure: Score of MDS Unified-Parkinson Disease Rating Scale III, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of University of Science and Technology of China, status: RECRUITING, city: Hefei, state: Anhui, zip: 230001, country: China, contacts name: Yuhua Chen, M.M.S., role: CONTACT, phone: +8615955236270, email: yh1215@mail.ustc.edu.cn, contacts name: Chao Han, M.D., role: CONTACT, phone: +8615255629713, email: chaohan@ustc.edu.cn, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06304272, orgStudyIdInfo id: Irrigation, briefTitle: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Patan Academy of Health Sciences, class: OTHER, descriptionModule briefSummary: There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference., conditionsModule conditions: Trauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double blinded, parallel, non-inferiority trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: Irrigating Traumatic Wound with Drinking Water, outcomesModule primaryOutcomes measure: Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06304259, orgStudyIdInfo id: 24428, briefTitle: Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab., conditionsModule conditions: Endodontic Disease, conditions: Endodontically Treated Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Saline, interventions name: Saline, outcomesModule primaryOutcomes measure: postoperative pain, primaryOutcomes measure: postoperative pain, primaryOutcomes measure: postoperative pain, secondaryOutcomes measure: Substance P level, secondaryOutcomes measure: Substance P level, secondaryOutcomes measure: Substance P level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Ain shams University, city: Cairo, zip: 4543070, country: Egypt, contacts name: Yara Adel, BDs, role: CONTACT, phone: 00201000099191, email: yara.adel170496@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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