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protocolSection identificationModule nctId: NCT06377072, orgStudyIdInfo id: SHPL-W036-301, briefTitle: Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shanghai Hutchison Pharmaceuticals Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration., conditionsModule conditions: Cervical Spondylotic Myelopathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Shenqi Sherong Pill, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Modified Japanese Orthopaedic Association (mJOA) score, secondaryOutcomes measure: Change in mJOA score, secondaryOutcomes measure: Change in sensation of mJOA score, secondaryOutcomes measure: Changes in pain or stiffness score for neck and shoulder, secondaryOutcomes measure: Change in chest tightness score, secondaryOutcomes measure: Changes in hand and arm numbness scores, secondaryOutcomes measure: Change in numbness (or pain) scores from the chest to the toes, secondaryOutcomes measure: Change in Motor dysfunction of the upper extremities of mJOA score, secondaryOutcomes measure: Proportion of participants with at least 1 grade decline in Nurick grades, secondaryOutcomes measure: Change in Traditional Chinese medicine (TCM) syndrome integrality, secondaryOutcomes measure: Change in TCM syndrome score, otherOutcomes measure: Serious adverse events, otherOutcomes measure: Adverse events, otherOutcomes measure: Vital sign (systolic and diastolic blood pressure after 10-minute rest), otherOutcomes measure: Vital sign (body temperature), otherOutcomes measure: Vital sign (respiration), otherOutcomes measure: Vital sign (heart rate）, otherOutcomes measure: Laboratory test indicator (blood routine), otherOutcomes measure: Laboratory test indicator (liver function), otherOutcomes measure: Laboratory test indicator (kidney function), otherOutcomes measure: Laboratory test indicator (fasting glucose), otherOutcomes measure: Laboratory test indicator (urine routine and urinary sediment count), otherOutcomes measure: Laboratory test indicator (stool routine and occult blood), otherOutcomes measure: Electrocardiogram(ECG) QT Interval, otherOutcomes measure: ECG QTc Interval, otherOutcomes measure: ECG QRS Interval, otherOutcomes measure: ECG PR Interval, otherOutcomes measure: Pathological sign (Hoffmann sign), otherOutcomes measure: Pathological sign (Babinski sign), otherOutcomes measure: Concomitant medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377059, orgStudyIdInfo id: 2024-RH-phase1-WARD, briefTitle: Early Detection of Complications During Immunotherapy for Haematological Malignancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Aims* To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications* Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment., conditionsModule conditions: Hematologic Cancer, conditions: CRS - Cytokine Release Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: WARD, outcomesModule primaryOutcomes measure: CRS, secondaryOutcomes measure: Immune response, secondaryOutcomes measure: severe physiological deviations, secondaryOutcomes measure: clinical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377046, orgStudyIdInfo id: NL86643.068.24, briefTitle: Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial, acronym: PACE-AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.The main question it aims to answer is:- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.Secondary questions it aims to answer are:* To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.* To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:* NT pro BNP levels* device detected atrial fibrillation burden and daily activity* echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain, conditionsModule conditions: Atrial Fibrillation, conditions: Permanent Atrial Fibrillation, conditions: Persistent Atrial Fibrillation, conditions: Pacemaker DDD, conditions: Paroxysmal Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, single center, prospective, single blinded, parallel group, pilot-trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Accelerated pacing, interventions name: Current standard of care, outcomesModule primaryOutcomes measure: The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP., secondaryOutcomes measure: The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP)., secondaryOutcomes measure: The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO)., secondaryOutcomes measure: The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure., secondaryOutcomes measure: The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy., secondaryOutcomes measure: Palpitations experienced as a result of (accelerated) pacing., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377033, orgStudyIdInfo id: 10877980, briefTitle: Using the EHR to Advance Genomic Medicine Across a Diverse Health System, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management., conditionsModule conditions: Genetic Predisposition, conditions: Paraganglioma, conditions: Pheochromocytoma, conditions: ALS, conditions: Parkinson Disease, conditions: Polyneuropathies, conditions: Frontotemporal Dementia, conditions: Alzheimer Disease, conditions: Cardiomyopathy Non-ischemic, conditions: Thoracic Aortic Aneurysm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral nudge, outcomesModule primaryOutcomes measure: Rate of Genetic Testing, secondaryOutcomes measure: Rate of Genetic Test Orders/Referrals, secondaryOutcomes measure: Rate of Patient Engagement, secondaryOutcomes measure: Rate of Pathogenic variants and VUS, secondaryOutcomes measure: Rate of Clinician actions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06377020, orgStudyIdInfo id: 23-2490, briefTitle: Prevention and Choice for Type 2, acronym: PACT2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-23, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: American Diabetes Association, collaborators name: High Plains Research Network, descriptionModule briefSummary: People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2, PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited., conditionsModule conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single group pilot and feasibility study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: PACT2, outcomesModule primaryOutcomes measure: Body weight, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Energy intake, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: 24 hr glucose levels, secondaryOutcomes measure: Dietary adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Elizabeth Thomas, MD, role: CONTACT, phone: 303-808-2622, email: [email protected], geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06377007, orgStudyIdInfo id: WU66290, secondaryIdInfos id: WU66290, type: OTHER_GRANT, domain: Walailak individual grant, briefTitle: Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION), acronym: ORION, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Walailak University, class: OTHER, descriptionModule briefSummary: Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 142, type: ESTIMATED, armsInterventionsModule interventions name: IOLMaster 700 (Carl Zeiss Meditec AG), interventions name: Argos (Alcon Laboratories, Inc.), outcomesModule primaryOutcomes measure: Mean absolute prediction error, secondaryOutcomes measure: Proportion of eyes with an absolute prediction error equal to or less than 0.25, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Walailak University, status: RECRUITING, city: Nakhon Si Thammarat, zip: 80160, country: Thailand, contacts name: Jakkrit.ju Juhong, MD., role: CONTACT, phone: 0816773406, email: [email protected], geoPoint lat: 8.43333, lon: 99.96667, hasResults: False |
protocolSection identificationModule nctId: NCT06376994, orgStudyIdInfo id: IRB00407311, secondaryIdInfos id: 1U24HL169566-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1U24HL169566-01, briefTitle: Multi-Center Clean Air Randomized Controlled Trial in COPD, acronym: Clean Air, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: JHSPH Center for Clinical Trials, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), 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: 770, type: ESTIMATED, armsInterventionsModule interventions name: Air cleaner, interventions name: Sham air cleaner, outcomesModule primaryOutcomes measure: St. George's Respiratory Questionnaire (SGRQ), eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Wendy Lorizio, role: CONTACT, phone: 410-510-2449, email: [email protected], contacts name: Maggie Maly, role: CONTACT, phone: 410-550-9527, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06376981, orgStudyIdInfo id: CHD23_0025, briefTitle: Hyaluronic Acid in Shoulder Tendinopathy, acronym: ACCTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Departemental Vendee, class: OTHER, descriptionModule briefSummary: Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months., conditionsModule conditions: Shoulder Tendinitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Hyaluronic acid injection, interventions name: Corticosteroid injection, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Visual analog scale pain on activity ranging from 0 to 100 mm at month 3., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHD Vendée, city: La Roche-sur-Yon, country: France, contacts name: Céline COZIC, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.66667, lon: -1.43333, locations facility: CHU Nantes, city: Nantes, country: France, contacts name: Christelle DARRIEUTORT-LAFFITE, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, hasResults: False |
protocolSection identificationModule nctId: NCT06376968, orgStudyIdInfo id: BA-G-H-1604, briefTitle: Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: B.Braun Avitum AG, class: INDUSTRY, descriptionModule briefSummary: The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.A crossover design is used to compare treatments with or without the BioLogic Fusion function activated., conditionsModule conditions: Renal Dialysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: BioLogic Fusion, outcomesModule primaryOutcomes measure: Post-dialysis body weight, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione, status: RECRUITING, city: Bologna, state: Emilia Romagna, zip: 40138, country: Italy, contacts name: Annalisa Zucchelli, Prof., role: CONTACT, contacts name: Annalisa Zucchelli, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06376955, orgStudyIdInfo id: IRB00014233-1, briefTitle: High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity, acronym: diabetic, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Badr University, class: OTHER, descriptionModule briefSummary: Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications., conditionsModule conditions: Insulin Resistance, conditions: Abdominal Obesity, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: High intensity interval exercise, interventions name: Focused ultrasound, outcomesModule primaryOutcomes measure: Body mass index, primaryOutcomes measure: Waist circumference, primaryOutcomes measure: Skin fold, primaryOutcomes measure: Value of HbA1c and HOMA-IR hormone, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376942, orgStudyIdInfo id: Int/IEC/2024/SPL-5, briefTitle: A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy, acronym: NAFCOF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2025-04-25, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Post Graduate Institute of Medical Education and Research, Chandigarh, class: OTHER, descriptionModule briefSummary: No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy., conditionsModule conditions: Subjects Undergoing Flexible Bronchoscopy, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1050, type: ESTIMATED, armsInterventionsModule interventions name: Glycopyrronium, interventions name: Ipratropium, interventions name: Saline, outcomesModule primaryOutcomes measure: Cough count, secondaryOutcomes measure: Operator-estimated airway secretion, secondaryOutcomes measure: Operator-rated secretions on a visual analogue scale (VAS), secondaryOutcomes measure: Operator-rated cough intensity on a visual analogue scale (VAS), secondaryOutcomes measure: Patient-rated comfort on a visual analogue scale (VAS), secondaryOutcomes measure: Adverse reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bronchoscopy suite, PGIMER, city: Chandigarh, zip: 160012, country: India, geoPoint lat: 30.73629, lon: 76.7884, hasResults: False |
protocolSection identificationModule nctId: NCT06376929, orgStudyIdInfo id: oralcarbohydrateinpediatric, briefTitle: Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting., conditionsModule conditions: Postoperative Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized controlled, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: oral carbohydrate containing fluid, outcomesModule primaryOutcomes measure: Mean values of Intraoperative random blood sugar in mg/dl, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376916, orgStudyIdInfo id: IRB00110863, briefTitle: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR, acronym: ATRIUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Aurora Health Care, class: OTHER, descriptionModule briefSummary: The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR., conditionsModule conditions: Tachycardia Atrial, conditions: Atrial Fibrillation, conditions: Atrial Flutter With Rapid Ventricular Response, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule interventions name: Magnesium Sulfate 2 G, interventions name: Magnesium Sulfate 4 G, interventions name: Saline, outcomesModule primaryOutcomes measure: Ventricular rate control, secondaryOutcomes measure: Time to achieve goal HR (heart rate), secondaryOutcomes measure: Rate of conversion, secondaryOutcomes measure: Incidence of hypotension, secondaryOutcomes measure: Change in heart rate, secondaryOutcomes measure: Clinical need for rescue medication administration, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advocate Christ Medical Center Emergency Department (ACMC ED), city: Oak Lawn, state: Illinois, zip: 60453, country: United States, contacts name: Marc McDowell, PharmD, role: CONTACT, phone: 708-684-6230, email: [email protected], geoPoint lat: 41.71087, lon: -87.75811, hasResults: False |
protocolSection identificationModule nctId: NCT06376903, orgStudyIdInfo id: P.T.REC/012/004860, briefTitle: Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-08-20, completionDateStruct date: 2024-09-20, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: • This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women, conditionsModule conditions: Urinary Stress Incontinence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pilates exercise - pelvic floor exercise - home advices, outcomesModule primaryOutcomes measure: • Revised urinary incontinence scale, secondaryOutcomes measure: • Quality of Life Questionnaire (QOL) for stress urinary incontinence, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376890, orgStudyIdInfo id: Chile24, briefTitle: Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: New Mexico State University, class: OTHER, descriptionModule briefSummary: Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression., conditionsModule conditions: Prediabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A 3x2 model with 2 intervention groups (green and red chili) and a control group, and pre and post-intervention measures will be taken., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Only the primary investigator will know the intervention assigned to the participants., whoMasked: PARTICIPANT, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Red chili peppers, interventions name: Green Chili Pepper, interventions name: Placebo, outcomesModule primaryOutcomes measure: Concentration of resting and fasted blood glucose measured in mg/dl, primaryOutcomes measure: Concentration of resting and fasted insulin measured in pmol/L, primaryOutcomes measure: Concentration of circulating C-reactive protein reported as mg/dl., primaryOutcomes measure: Concentration of circulating interleukin (IL)-1 beta reported as pg/ml., primaryOutcomes measure: Concentration of circulating interleukin-6 (IL-6) reported as pg/ml., primaryOutcomes measure: Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml., secondaryOutcomes measure: Concentration of circulating superoxide dismutase (SOD) reported as ng/ml., secondaryOutcomes measure: Concentration of circulating glutathione peroxidase reported as pg/ml., secondaryOutcomes measure: Body composition measured as total fat mass and total fat free mass reported in kg., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376877, orgStudyIdInfo id: 2024P000900, briefTitle: Connectomic Targeted TMS Target for Refractory Anxiety, acronym: ConTRA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension., conditionsModule conditions: Anxiety Disorders, conditions: Mental Disorder, conditions: Psychiatric Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Nonresponders may have the option for open label active treatment., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial magnetic stimulation, interventions name: Sham transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Inventory of Depression and Anxiety Symptoms-II, secondaryOutcomes measure: Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors, secondaryOutcomes measure: State-Trait Anxiety Inventory, secondaryOutcomes measure: Penn State Worry Questionnaire (PSWQ), secondaryOutcomes measure: Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA), secondaryOutcomes measure: Anxiety Sensitivity Index (ASI), secondaryOutcomes measure: Intolerance of Uncertainty Scale (IUS), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: TCI-R140 (Temperament and character inventory, revised 140-question format), secondaryOutcomes measure: Emotional Conflict Resolution Task, secondaryOutcomes measure: Laboratory Fear Extinction Paradigm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emma Jones, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Emma Jones, role: CONTACT, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06376864, orgStudyIdInfo id: RC- FNRA-IG /20-21/SOSC/01, briefTitle: Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hong Kong Baptist University, class: OTHER, descriptionModule briefSummary: The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children., conditionsModule conditions: Child Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ACTUAL, armsInterventionsModule interventions name: Activity Breaks, outcomesModule primaryOutcomes measure: Executive function, primaryOutcomes measure: Psychological capacities, primaryOutcomes measure: Working memory, primaryOutcomes measure: Attention, secondaryOutcomes measure: Physical activity (min/week), secondaryOutcomes measure: Sedentary behavior (hour), secondaryOutcomes measure: Body weight (kg), secondaryOutcomes measure: Height (cm), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Sport, Physical Education, and Health, Hong Kong Bapist University, city: Kowloon Tong, country: Hong Kong, geoPoint lat: 22.33312, lon: 114.17969, hasResults: False |
protocolSection identificationModule nctId: NCT06376851, orgStudyIdInfo id: CP-910-001, briefTitle: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management, acronym: DECIDE, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-03-27, completionDateStruct date: 2030-03-27, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: HeartFlow, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA)., conditionsModule conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: AI-enabled quantitative coronary plaque analysis (AI-QCPA), outcomesModule primaryOutcomes measure: Primary Endpoint, secondaryOutcomes measure: Change in LDL levels, secondaryOutcomes measure: Change in HbA1c levels, secondaryOutcomes measure: Changes in Non HDL levels, secondaryOutcomes measure: Changes in HDL levels, secondaryOutcomes measure: Changes in TG levels, secondaryOutcomes measure: Changes in weight, secondaryOutcomes measure: Reclassification rate of medical management (across the groups), secondaryOutcomes measure: Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG), secondaryOutcomes measure: Number of CV hospitalizations, otherOutcomes measure: Number of MACE (CV-related death, MI, or CAD hospitalization), otherOutcomes measure: Timing of referral to other provider(s) for management, otherOutcomes measure: Timing of lab orders (Group 1 vs. Group 2), otherOutcomes measure: Change in Lp(a) (Group 2), otherOutcomes measure: Change in Lp(a) (Group 4 compared to Group 1), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moses Cone Memorial Hospital, city: Greensboro, state: North Carolina, zip: 27401, country: United States, geoPoint lat: 36.07264, lon: -79.79198, hasResults: False |
protocolSection identificationModule nctId: NCT06376838, orgStudyIdInfo id: DLV-001-02, briefTitle: To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet, acronym: dermal filler, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-07, primaryCompletionDateStruct date: 2021-10-15, completionDateStruct date: 2023-05-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: DEXLEVO, class: INDUSTRY, descriptionModule briefSummary: This clinical study is a confirmatory clinical study to prove that the test device, DLMR01, is non-inferior to the control device, Rejuran®, in terms of temporary wrinkle improvement effect on crow's feet and safety. After applying DLMR01, a test device, and Rejuran®, a control device, respectively to wrinkles around the eyes, randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices, subject-evaluator blinding, pair matching, It was designed as a comparative clinical study., conditionsModule conditions: Crow's Feet Lines, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 218, type: ACTUAL, armsInterventionsModule interventions name: DLMR01, interventions name: Rejuran, outcomesModule primaryOutcomes measure: Crow's Feet Grading Scale by independent evaluators after 12 weeks of using, secondaryOutcomes measure: (1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale, secondaryOutcomes measure: (2) The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the medical device both during rest and when smiling was evaluated., eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung-ang University Hospital, city: Seoul, state: Dongjak-gu, zip: 06973, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06376825, orgStudyIdInfo id: CSV202401, briefTitle: The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ahmet Nalbant, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are:* Does the program reduce the level of burnout in teachers?* Does the program contribute to an increased sense of meaning for teachers?* How much of the program do teachers finish?, conditionsModule conditions: Burnout, Professional, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will be a concurrent multiple-baseline single-case experimental study with participiants randomized to baseline durations., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: In this study participants will be randomized to different baseline durations and randomization will be done by one of the investigators who are blind to participants assessments., enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: MyLife: An internet-based self-help program to reduce burnout, outcomesModule primaryOutcomes measure: Burnout Assessment Tool, primaryOutcomes measure: Valued Living Questionnaire, secondaryOutcomes measure: Acceptance and Action Questionnaire-2, secondaryOutcomes measure: System Usability Scale, secondaryOutcomes measure: Attendance rate, otherOutcomes measure: Daily measures, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CanSagligi Foundation Center for Contextual Behavioral Science, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Eda Aksoy, role: CONTACT, phone: +90(216) 269 66 11, email: [email protected], contacts name: Ahmet Nalbant, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Havvanur Uysal Akdemir, MS, role: SUB_INVESTIGATOR, contacts name: Edanur Gürbüz, BA, role: SUB_INVESTIGATOR, contacts name: Meryem Gökçe Yavuz, BA, role: SUB_INVESTIGATOR, contacts name: Kaasım Fatih Yavuz, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06376812, orgStudyIdInfo id: 23-0320, briefTitle: No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-05, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: The University of Texas Medical Branch, Galveston, class: OTHER, descriptionModule briefSummary: This study will test the effects of a physical activity intervention among midlife Hispanic women., conditionsModule conditions: Elevated Blood Pressure, conditions: Perimenopause, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity intervention, outcomesModule primaryOutcomes measure: Days the activity monitor was worn, secondaryOutcomes measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of light intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of light intensity physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of total physical activity at 6 months, secondaryOutcomes measure: Physical activity as measured by minutes of total physical activity at 6 months, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Diastolic blood pressure, otherOutcomes measure: Abdominal circumference, otherOutcomes measure: Abdominal circumference, otherOutcomes measure: Body mass index, otherOutcomes measure: Body mass index, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376799, orgStudyIdInfo id: 38RC23.0437, secondaryIdInfos id: 2024-A00485-42, type: OTHER, domain: ID RCB, briefTitle: Which Health-care Professional(s) to Talk About Advance Care Planning ?, acronym: QPSPAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-02, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Grenoble, class: OTHER, descriptionModule briefSummary: The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning.To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format., conditionsModule conditions: Advance Care Planning, conditions: Patient Preference, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Self-questionnaire, outcomesModule primaryOutcomes measure: Determining the healthcare professional preferred by cancer patients to talk about advance care planning, secondaryOutcomes measure: Determining cancer patients' second choice of healthcare professional to talk about advance care planning, secondaryOutcomes measure: Evaluation of patient preferences regarding advance care planning, concerning the form, the moment it should be carried out, whether or not they wish to be accompanied by a relative, and the benefit of systematization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376786, orgStudyIdInfo id: ItaliTTP, briefTitle: Italian iTTP Registry, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2030-05-31, completionDateStruct date: 2030-05-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Fondazione Luigi Villa, class: OTHER, descriptionModule briefSummary: ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy.A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years., conditionsModule conditions: TTP - Thrombotic Thrombocytopenic Purpura, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Age at onset, primaryOutcomes measure: Sex, primaryOutcomes measure: Birth Country/Region, primaryOutcomes measure: Race, primaryOutcomes measure: Blood group, primaryOutcomes measure: BMI, primaryOutcomes measure: Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression., primaryOutcomes measure: Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs, primaryOutcomes measure: Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms, primaryOutcomes measure: Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin, primaryOutcomes measure: Cardiac troponin, primaryOutcomes measure: ADAMTS13 activity, primaryOutcomes measure: Anti-ADAMTS13 antibodies, primaryOutcomes measure: Number of daily therapeutic plasma exchange procedures, primaryOutcomes measure: Proportion of acute iTTP patients treated with rituximab, primaryOutcomes measure: Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab, primaryOutcomes measure: Proportion of iTTP patients treated with caplacizumab, primaryOutcomes measure: Incidence, type and severity of TTP-related drugs adverse events, primaryOutcomes measure: Proportion of iTTP patients achieving clinical remission, primaryOutcomes measure: Proportion of iTTP patients refractory to acute iTTP treatment, primaryOutcomes measure: Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications, primaryOutcomes measure: Proportion of iTTP patients experiencing clinical exacerbation, primaryOutcomes measure: Proportion of iTTP patients achieving ADAMTS13 remission, primaryOutcomes measure: Time to clinical response, primaryOutcomes measure: Time to clinical remission, primaryOutcomes measure: Time to ADAMTS13 remission, primaryOutcomes measure: Proportion of iTTP patients with a clinical relapse, primaryOutcomes measure: Proportion of iTTP patients with an ADAMTS13 relapse, primaryOutcomes measure: Time to clinical relapse, primaryOutcomes measure: Time to ADAMTS13 relapse, primaryOutcomes measure: Incidence, type and severity of pregnancy complications in iTTP pregnant women, secondaryOutcomes measure: iTTP incidence in Italy, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376773, orgStudyIdInfo id: 2022KY123, briefTitle: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications., conditionsModule conditions: Advanced Gastric Cancer, conditions: Neoadjuvant Therapy, conditions: Multi-omics Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 234, type: ACTUAL, armsInterventionsModule interventions name: combination chemotherapy with Apatinib or Camrelizumab, outcomesModule primaryOutcomes measure: overall survival, secondaryOutcomes measure: objective response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, zip: 350000, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06376760, orgStudyIdInfo id: KY2024-091-02, briefTitle: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern., conditionsModule conditions: Insomnia, conditions: Digestive Endoscopy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3360, type: ESTIMATED, armsInterventionsModule interventions name: No interventions, it is a observational study, outcomesModule primaryOutcomes measure: The total consumption of intravenous anesthetic drug, secondaryOutcomes measure: The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope, secondaryOutcomes measure: The occurrence of the respiratory and cardiovascular adverse events, secondaryOutcomes measure: The occurrence of the other adverse events, secondaryOutcomes measure: The incidence of intraoperative recall or awareness, secondaryOutcomes measure: The recovery time, secondaryOutcomes measure: Duration of patients' PACU stay, secondaryOutcomes measure: The ease of operation at this level of sedation evaluated by the gastroenterologists, secondaryOutcomes measure: The satisfaction degree of anesthesia effect evaluated by the gastroenterologists, secondaryOutcomes measure: Patients' satisfaction, secondaryOutcomes measure: Patients' willingness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, city: Beijing, state: Beijing, zip: 100070, country: China, contacts name: Fang Luo, M.D., role: CONTACT, phone: 13611326978, email: [email protected], contacts name: Fang Luo, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06376747, orgStudyIdInfo id: KDAR- PBM 2024, briefTitle: The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients, acronym: PEDPBM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Brno University Hospital, class: OTHER, descriptionModule briefSummary: The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system., conditionsModule conditions: Iatrogenic Anaemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, maskingDescription: Patients will be randomized into two groups: a group with standard blood sampling technique and a group with closed technique blood sampling by using randomizing software., whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: In line sampling, interventions name: Standard blood sampling technique, outcomesModule primaryOutcomes measure: Average amount of blood collected for laboratory diagnostic purposes, secondaryOutcomes measure: Cumulative amount of blood drawn per day of ICU hospitalization, secondaryOutcomes measure: Absolute amount of blood drawn and blood used for laboratory testing, secondaryOutcomes measure: Trend of haemoglobin decline over time, secondaryOutcomes measure: Incidence of anaemia, secondaryOutcomes measure: Incidence of anaemia up to transfusion trigger, secondaryOutcomes measure: Frequency of blood product transfusions and their quantity, secondaryOutcomes measure: Type and frequency of laboratory tests, secondaryOutcomes measure: Incidence of coagulopathy, secondaryOutcomes measure: Incidence of catheter-related complications, secondaryOutcomes measure: Time to catheter replacement in case of catheter exchange, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: KDAR - department of pediatrics anesthesia and resuscitation, city: Brno, zip: 62500, country: Czechia, geoPoint lat: 49.19522, lon: 16.60796, hasResults: False |
protocolSection identificationModule nctId: NCT06376734, orgStudyIdInfo id: 2024p000528, briefTitle: Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness, acronym: Searchlight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2030-06-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits., conditionsModule conditions: Major Depressive Disorder, conditions: Obsessive-Compulsive Disorder, conditions: Schizophrenia, conditions: Generalized Anxiety Disorder, conditions: Mood Disorders, conditions: Psychiatric Disorder, conditions: Mental Disorder, conditions: Depression, Anxiety, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind, randomized controlled crossover trial. Participants will be stimulated at a random location in the prefrontal cortex, which will be mapped to its underlying brain network to determine which network was stimulated., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: All participants will receive real open-label TMS, so there will be no conventional masking. However, participants and investigators will be blinded to which network is being stimulated., enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: TMS, outcomesModule primaryOutcomes measure: Clustering of multiple behavioral measures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376721, orgStudyIdInfo id: TREC2024-KY016, briefTitle: Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment., conditionsModule conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, conditions: T-lymphoblastic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Linperlisib, interventions name: Camrelizumab, interventions name: Pegaspargase, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: The best objective response rate（ORR） over 6 treatment cycles, secondaryOutcomes measure: Objective Response Rate（ORR）, secondaryOutcomes measure: Complete Response （CR）, secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease Control Rate（DCR）, otherOutcomes measure: Drug safety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Liang Wang, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Liang Wang, M.D., role: CONTACT, phone: +8615001108693, email: [email protected], contacts name: Liang Wang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06376708, orgStudyIdInfo id: 3-3-13, briefTitle: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin, conditionsModule conditions: Maxillary Sinus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: use of platelet rich fibrin after maxillary sinus elevation using PEEK, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: platelet rich fibrin, interventions name: Polyether ether ketone, outcomesModule primaryOutcomes measure: Bone quantity, secondaryOutcomes measure: Bone quality, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Cairo University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06376695, orgStudyIdInfo id: RADX-P-2407, briefTitle: Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Radicle Science, class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes, conditionsModule conditions: Abdominal Pain, conditions: GI Disorders, conditions: Digestion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be stratified based on gender at birth then randomized to one of the study arms, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ACTUAL, armsInterventionsModule interventions name: Radicle GI Health Placebo Control Form 1, interventions name: Radicle GI Health Active Study Product 1.1 Usage, outcomesModule primaryOutcomes measure: Change in GI (Gastrointestinal) Health (1), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (2), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (3), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (4), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (5), primaryOutcomes measure: Change in GI (Gastrointestinal) Health (6), secondaryOutcomes measure: Change in feelings of anxiety, secondaryOutcomes measure: Change in GI-related Quality of Life (QOL), secondaryOutcomes measure: Change in mood (emotional distress-depression), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (1), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (2), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (3), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (4), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (5), secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI Health (6), secondaryOutcomes measure: Minimal clinically important difference (MCID) in feelings of anxiety, secondaryOutcomes measure: Minimal clinically important difference (MCID) in GI-related QOL, secondaryOutcomes measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression), otherOutcomes measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 105 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Radicle Science, Inc, city: Del Mar, state: California, zip: 92014, country: United States, geoPoint lat: 32.95949, lon: -117.26531, hasResults: False |
protocolSection identificationModule nctId: NCT06376682, orgStudyIdInfo id: CA-BO-CIP-0060, briefTitle: EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy, acronym: EPIBONE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Quantum Surgical, class: INDUSTRY, descriptionModule briefSummary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures., conditionsModule conditions: Bone Metastases, conditions: Fractures, Bone, conditions: Bone Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: CT-guided bone percutaneous procedure, outcomesModule primaryOutcomes measure: Successful instrument insertion with the EPIONE device., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376669, orgStudyIdInfo id: J2421, secondaryIdInfos id: IRB00427823, type: OTHER, domain: JHM IRB, briefTitle: Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma, acronym: SPARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2030-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, class: OTHER, descriptionModule briefSummary: This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival., conditionsModule conditions: Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Proton Stereotactic Body Radiation therapy (SBRT), outcomesModule primaryOutcomes measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels, primaryOutcomes measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values, secondaryOutcomes measure: Number of PROTON-BASED SBRT treatment Adverse Events, secondaryOutcomes measure: Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions, secondaryOutcomes measure: Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions, secondaryOutcomes measure: Time to locoregional progression, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376656, orgStudyIdInfo id: LRGS/1/2019/SYUC/02/1, briefTitle: Successful Aging and Age-related Decline, acronym: MyAgeWell, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-20, primaryCompletionDateStruct date: 2029-05, completionDateStruct date: 2030-05, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Sunway University, class: OTHER, descriptionModule briefSummary: Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline., conditionsModule conditions: Aging, conditions: Elderly, conditions: Cognitive Decline, conditions: Physical Decline, conditions: Intervention Study, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A cohort of older Malaysian adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive stimulation, interventions name: Physical activity, outcomesModule primaryOutcomes measure: Changes in cognitive scores, primaryOutcomes measure: Changes in electroencephalogram (EEG), primaryOutcomes measure: Changes in structural magnetic resonance imaging (MRI), primaryOutcomes measure: Cost-benefit analysis of intervention, primaryOutcomes measure: Changes in levels of human salivary lactoferrin, primaryOutcomes measure: Changes in levels of human salivary C-reactive proteins, primaryOutcomes measure: Changes in salivary telomere length, secondaryOutcomes measure: Changes in depression scores, secondaryOutcomes measure: Changes in anxiety scores, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sunway University, status: RECRUITING, city: Petaling Jaya, state: Selangor, zip: 47500, country: Malaysia, contacts name: Michael J Jenkins, PhD, role: CONTACT, phone: +60374918622, phoneExt: 7183, email: [email protected], geoPoint lat: 3.10726, lon: 101.60671, hasResults: False |
protocolSection identificationModule nctId: NCT06376643, orgStudyIdInfo id: InterFACE-AR, briefTitle: Augmented Reality to Support Cardiopulmonary Resuscitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Johan Siebert, MD, class: OTHER, collaborators name: Geneva Children's Hospital, Geneva, Switzerland, collaborators name: Alberta Children's Hospital, Calgary, Canada, descriptionModule briefSummary: A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine., conditionsModule conditions: Cardiopulmonary Arrest, conditions: Resuscitation, conditions: Pediatric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-label, prospective, multicenter, cluster randomized controlled clinical trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: It will not be possible to blind study participants to study arm allocation due to the nature of the intervention(s), but they will be blinded to study objectives. The statistician will be blinded regarding the allocation of participants to the study arms for results analysis., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Augmented reality supportive tool, interventions name: Conventional method (AHA pocket reference card), outcomesModule primaryOutcomes measure: Time to first dose of epinephrine, secondaryOutcomes measure: Time to initiation of cardiopulmonary resuscitation, secondaryOutcomes measure: Time to defibrillation, secondaryOutcomes measure: Time to delivery of epinephrine, secondaryOutcomes measure: Time to delivery of amiodarone, secondaryOutcomes measure: Time to secure definitive airway, secondaryOutcomes measure: Medication dosage errors, secondaryOutcomes measure: Types of Medication Errors, secondaryOutcomes measure: Frequency of Medication Errors, secondaryOutcomes measure: Frequency of pauses in cardiopulmonary resuscitation, secondaryOutcomes measure: Duration of pauses in cardiopulmonary resuscitation, secondaryOutcomes measure: Causes of pauses in cardiopulmonary resuscitation, secondaryOutcomes measure: Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation, secondaryOutcomes measure: Cardiopulmonary resuscitation quality: Chest compression fraction, secondaryOutcomes measure: Cardiopulmonary resuscitation quality: Peri-shock pause duration, secondaryOutcomes measure: Provider workload (NASA-TLX), secondaryOutcomes measure: User Experience Questionnaire (UEQ), secondaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT), secondaryOutcomes measure: State-Trait Anxiety Inventory (STAI) form Y-1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alberta Children's Hospital, city: Calgary, state: Alberta, zip: AB T3B 6A8,, country: Canada, contacts name: Adam Cheng, Prof, role: CONTACT, phone: 403 955 2633, email: [email protected], contacts name: Jennifer Davidson, RN BSc, role: CONTACT, email: [email protected], contacts name: Kangsoo Kim, Ass Prof, role: SUB_INVESTIGATOR, contacts name: Yiqun Lin, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Geneva Children's Hospital, Geneva University Hospitals, city: Geneva, zip: 1205, country: Switzerland, contacts name: Johan N Siebert, MD, PD, role: CONTACT, phone: 795534072, phoneExt: +41, email: [email protected], contacts name: Delphine Courvoisier, Prof, role: SUB_INVESTIGATOR, contacts name: Frederic Ehrler, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False |
protocolSection identificationModule nctId: NCT06376630, orgStudyIdInfo id: 298-2024, briefTitle: Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI, acronym: ESMO-VASCMI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2029-01-29, completionDateStruct date: 2030-01-29, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, class: OTHER_GOV, descriptionModule briefSummary: Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction.First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement.Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection.Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \> 12 months post-infarction.Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement., conditionsModule conditions: Myocardial Infarction, conditions: Coronary Stenosis, conditions: Coronary Microvascular Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 300 pts with MI are to be enrolled. Among them 100 pts with STEMI will be included into the substudy evaluating cardioprotective effects of early iv administration of esmolol. They will be randomized 1:1 by in arms receiving esmolol or no IV beta-blockers. In the esmolol arm the infusion will begin immediately on admission. 200 pts with MI and multivessel disease with non-IRA lesions of 50-85% diameter stenosis will be included into another substudy investigating coronary physiology. All patients will undergo PCI with IRA stenting. 50 stable patients will undergo invasive measurements of coronary physiology. Those will also undergo cardiac MRI. Other 150 pts will not undergo invasive measurements of coronary physiology during initial hospitalization. Pts in both groups will be hospitalized again in 30-40 days after MI. They will undergo stress SPECT or stress echocardiography. All patients will undergo a follow-up coronary angiography with invasive measurement of coronary physiology., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: envelopes, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Esmolol Hcl 10Mg/Ml Inj, outcomesModule primaryOutcomes measure: Composite of adverse cardiac outcomes, secondaryOutcomes measure: Degree of microvascular obstruction, secondaryOutcomes measure: Infarct size, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NMRCCardiologyRu, status: RECRUITING, city: Moscow, country: Russian Federation, contacts name: Andrey Komarov, PhD, role: SUB_INVESTIGATOR, contacts name: Tatiana Sukhinina, PhD, role: SUB_INVESTIGATOR, contacts name: Mariy Terenicheva, PhD, role: SUB_INVESTIGATOR, contacts name: Olga Stukalova, PhD, role: SUB_INVESTIGATOR, contacts name: Sergey Ternovoy, Academic, role: SUB_INVESTIGATOR, contacts name: Goar Arutiunian, PhD, role: SUB_INVESTIGATOR, contacts name: Evgeniy Merkulov, PhD, role: SUB_INVESTIGATOR, contacts name: Viktor Shitov, MD, role: SUB_INVESTIGATOR, contacts name: Marina Saidova, PhD, role: SUB_INVESTIGATOR, contacts name: Aleksey Ansheles, PhD, role: SUB_INVESTIGATOR, contacts name: Vladimir Sergienko, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False |
protocolSection identificationModule nctId: NCT06376617, orgStudyIdInfo id: MS.24.03.2743, briefTitle: Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-04-20, completionDateStruct date: 2025-05-20, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This study is to assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma, conditionsModule conditions: Bronchial Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: fibroptic bronchoscopy, outcomesModule primaryOutcomes measure: assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06376604, orgStudyIdInfo id: LNT55, briefTitle: Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-08, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: L-Nutra Inc, class: INDUSTRY, collaborators name: University of Tennessee Medical Center, descriptionModule briefSummary: This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies., conditionsModule conditions: Cancer, Ovarian, conditions: Chemotherapy Effect, conditions: Calorie Deficiency, conditions: Fasting, Intermittent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Outcomes Assessor, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fasting Mimicking Diet, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire, primaryOutcomes measure: Rate of Adherence, secondaryOutcomes measure: Change in Body Weight, secondaryOutcomes measure: Change in Body Composition, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in Insulin Like Growth Factor 1 (IGF-1) Concentration, secondaryOutcomes measure: Change in Fasting Insulin Concentration, secondaryOutcomes measure: Change in Fasting Glucose Concentration, secondaryOutcomes measure: Change in High-sensitivity C reactive protein Concentration, secondaryOutcomes measure: Change in Leptin Concentration, secondaryOutcomes measure: Change in planned chemotherapy regimen, secondaryOutcomes measure: Number of Hospitalization Days, secondaryOutcomes measure: Rate of Chemotherapy Side Effects, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Tennessee Medical Center, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: Jonathan D Boone, MD, role: CONTACT, phone: 865-305-5622, email: [email protected], geoPoint lat: 35.96064, lon: -83.92074, hasResults: False |
protocolSection identificationModule nctId: NCT06376591, orgStudyIdInfo id: LUMHS/B12/Temp/12.04.2024, briefTitle: Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Liaquat University of Medical & Health Sciences, class: OTHER, descriptionModule briefSummary: Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being., conditionsModule conditions: Vitamin B 12 Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Oral Vitamin B12 supplement, interventions name: Control group, outcomesModule primaryOutcomes measure: Supplementation effect on circulatory vitamin B12 levels, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Liaquat University of Medical and Health Sciences, city: Jamshoro, zip: 76090, country: Pakistan, contacts name: Dr. Ikram Ujjan, MBBS, PhD, role: CONTACT, phone: 03000506955, email: [email protected], geoPoint lat: 25.43773, lon: 68.28522, hasResults: False |
protocolSection identificationModule nctId: NCT06376578, orgStudyIdInfo id: 245256, briefTitle: Exercise Interventions for Improving Health in Breast Cancer Survivors, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-05, primaryCompletionDateStruct date: 2020-01-30, completionDateStruct date: 2020-01-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, descriptionModule briefSummary: Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure., conditionsModule conditions: Breast Cancer Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Exercise intervention, interventions name: Polar A380 wristwatch physical activity tracker, outcomesModule primaryOutcomes measure: Change in VO2max (maximum oxygen uptake), secondaryOutcomes measure: Change in Body composition, otherOutcomes measure: Change in physical functioning, otherOutcomes measure: Change in Psychological measures, otherOutcomes measure: Change in immune profiles and function, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bath, city: Bath, zip: BA2 7AY, country: United Kingdom, geoPoint lat: 51.3751, lon: -2.36172, hasResults: False |
protocolSection identificationModule nctId: NCT06376565, orgStudyIdInfo id: 22-000647, secondaryIdInfos id: NCI-2024-02090, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: R01CA271034, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA271034, briefTitle: Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps., conditionsModule conditions: Colorectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Communication Intervention, interventions name: Communication Intervention, interventions name: Communication Intervention, interventions name: Interview, interventions name: Interview, outcomesModule primaryOutcomes measure: Stakeholder perspectives on the multilevel intervention (Aim 1), primaryOutcomes measure: Completion of surveillance colonoscopy (Aim 2), primaryOutcomes measure: Implementation quality (Aim 3a), primaryOutcomes measure: Cost effectiveness (Aim 3b), secondaryOutcomes measure: Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Folasade P. May, role: CONTACT, phone: 617-620-7806, email: [email protected], contacts name: Folasade P. May, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06376552, orgStudyIdInfo id: AI4Cardio, briefTitle: Artificial Intelligence for the Prioritization of Genetic Background in Brugada Syndrome, acronym: AI4Cardio, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-19, primaryCompletionDateStruct date: 2022-06-06, completionDateStruct date: 2022-06-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Brugada Syndrome (BS) is an inherited heart condition that can cause sudden cardiac arrest in young individuals. It's diagnosed through specific changes seen on an electrocardiogram (ECG). Currently, the only treatment option is a cardioverter defibrillator (ICD). Despite advances, much about BS remains unclear, including its genetic basis. This study aims to use advanced genetic sequencing and artificial intelligence to uncover new genetic factors contributing to BS. By understanding these factors better, we hope to improve risk assessment and treatment for affected individuals., conditionsModule conditions: Brugada Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: New candidate genes, likely associated with Brugada Syndrome using an AI based approach., secondaryOutcomes measure: Identification of genetic risk factors associated with the worse phenotype., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Milano-Bicocca University, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06376539, orgStudyIdInfo id: CEAVEC: 111/2024/Oss/IOR, briefTitle: Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor., acronym: FISIO-ONCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved., conditionsModule conditions: Bone Neoplasm, conditions: Rehabilitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Toronto Extremity Salvage Score (TESS), primaryOutcomes measure: Toronto Extremity Salvage Score (TESS), secondaryOutcomes measure: Range of motion (ROM), secondaryOutcomes measure: Rang of motion - 2 (ROM), secondaryOutcomes measure: Number of participants able to walk, secondaryOutcomes measure: Time Up and Go -2 (TUG), secondaryOutcomes measure: Time Up and Go (TUG), secondaryOutcomes measure: Muscle Strength, secondaryOutcomes measure: Muscle Strength-2, secondaryOutcomes measure: Number of day from surgery to first walking, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376526, orgStudyIdInfo id: 20230236, briefTitle: IMMUNOPLANT for Newly Diagnosed Multiple Myeloma, acronym: IMMUNOPLANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dickran Kazandjian, MD, class: OTHER, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Linvoseltamab, outcomesModule primaryOutcomes measure: Minimal Residual Disease (MRD) Negativity Rate, secondaryOutcomes measure: Sustained MRD-Negativity Rate, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of Participants Experiencing Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Dickran Kazandjian, MD, role: CONTACT, phone: 305-243-5001, email: [email protected], contacts name: Dickran Kazandjian, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False |
protocolSection identificationModule nctId: NCT06376513, orgStudyIdInfo id: 69HCL24_0031, briefTitle: Evaluation of Penile Prosthesis Pump Manipulation, acronym: ECM3P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration.Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners.These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses.Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction.In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation.The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with* Rigidity of erections with penile prosthesis* Patient's sexual satisfaction* Partner's sexual satisfaction* Satisfaction related to pump manipulation, conditionsModule conditions: Penile Prosthesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation, outcomesModule primaryOutcomes measure: Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength, primaryOutcomes measure: Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength, primaryOutcomes measure: Describing the manipulation abilities of patients with penile prosthesis : proprioception, primaryOutcomes measure: Describing the manipulation abilities of patients with penile prosthesis :discrimination, primaryOutcomes measure: Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living, secondaryOutcomes measure: Correlation of manipulation parameters (main outcome) with rigidity of erections, secondaryOutcomes measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS, secondaryOutcomes measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP, secondaryOutcomes measure: Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction, secondaryOutcomes measure: Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire), eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Urology, Lyon Sud Hospital,, city: Pierre-Bénite, zip: 69310, country: France, contacts name: Nicolas MOREL, role: CONTACT, phone: + 33 4 72 6788 37, email: [email protected], contacts name: Clément PARAT, role: CONTACT, phone: + 33 4 72 6788 37, email: [email protected], geoPoint lat: 45.7009, lon: 4.82511, hasResults: False |
protocolSection identificationModule nctId: NCT06376500, orgStudyIdInfo id: HSEARS20240223001, briefTitle: Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI., conditionsModule conditions: Transcranial Direct Current Stimulation, conditions: Post-Concussion Syndrome, conditions: Functional Magnetic Resonance Imaging, conditions: Magnetic Resonance Spectroscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: tDCS with cognitive training programme, outcomesModule primaryOutcomes measure: Executive function, secondaryOutcomes measure: Change in CANTAB® cognitive test - Reaction Time (RTI), secondaryOutcomes measure: Change in CANTAB® cognitive test - Multitasking Test (MTT), secondaryOutcomes measure: Change in CANTAB® cognitive test - Spatial Working Memory (SWM), otherOutcomes measure: Exploratory mediator - default mode network (DMN) activation, otherOutcomes measure: Exploratory mediator - excitability-inhibitory (E/I) ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Hung Hom, state: Kowloon, country: Hong Kong, geoPoint lat: 22.30715, lon: 114.18532, hasResults: False |
protocolSection identificationModule nctId: NCT06376487, orgStudyIdInfo id: 75202423.2.0000.0071, briefTitle: Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Israelita Albert Einstein, class: OTHER, collaborators name: Fundação de Amparo à Pesquisa do Estado de São Paulo, collaborators name: Feculdade de Medicina da Universidade de Sao Paulo - Brasil, descriptionModule briefSummary: The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question\[s\] it aims to answer are:* If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated* If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluatedThe belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance.Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages., conditionsModule conditions: Bronchiolitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A prospective clinical study to evaluated four different flow rate in infants with bronchiolitis using high flow nasal cannula, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Patient will not know the flow rate sequence used during the assessment, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Flow rate evaluation, outcomesModule primaryOutcomes measure: diaphragm thickening fraction, primaryOutcomes measure: abdominal muscle thickening fraction, primaryOutcomes measure: EELZ (end-expiration lung impedance), eligibilityModule sex: ALL, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Israelita Albert Eisntein, status: RECRUITING, city: São Paulo, zip: 05653000, country: Brazil, contacts name: Milena S Nascimento, role: CONTACT, phone: 55 11 984520061, email: [email protected], geoPoint lat: -23.5475, lon: -46.63611, hasResults: False |
protocolSection identificationModule nctId: NCT06376474, orgStudyIdInfo id: HM005PS1S06, briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ganzhou Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Hemay005, outcomesModule primaryOutcomes measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf), primaryOutcomes measure: Relevant pharmacokinetic parameters，half-life (T1/2), primaryOutcomes measure: Relevant pharmacokinetic parameters，clearance (CL/F), primaryOutcomes measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376461, orgStudyIdInfo id: 333874, briefTitle: Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients, acronym: GUTPHOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospitals of North Midlands NHS Trust, class: OTHER, descriptionModule briefSummary: Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders., conditionsModule conditions: Gastrointestinal Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Data collection, outcomesModule primaryOutcomes measure: 28 day outcome, primaryOutcomes measure: 90 day outcome, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: Free of organ support, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals of North Midlands NHS Trust, city: Stoke-on-Trent, country: United Kingdom, geoPoint lat: 53.00415, lon: -2.18538, hasResults: False |
protocolSection identificationModule nctId: NCT06376448, orgStudyIdInfo id: cc-obs-01, briefTitle: An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-24, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2025-02-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hull University Teaching Hospitals NHS Trust, class: OTHER_GOV, descriptionModule briefSummary: Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period., conditionsModule conditions: Chronic Cough, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients, secondaryOutcomes measure: measure of cough severity, secondaryOutcomes measure: describe any correlation between severity of cough and cough pattern, secondaryOutcomes measure: reproducibility of questionnnare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital, status: RECRUITING, city: Cottingham, state: East Yorkshiure, zip: HU16 5JQ, country: United Kingdom, contacts name: Caroline Wright, role: CONTACT, phone: 01482624067, email: [email protected], contacts name: Rachel H Thompson, Bsc, role: CONTACT, phone: 01482 461800, phoneExt: Thompson, email: [email protected], contacts name: Caroline Wright, Bsc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.50243, lon: -0.7554, hasResults: False |
protocolSection identificationModule nctId: NCT06376435, orgStudyIdInfo id: HBHQ-CTIT-RWS, briefTitle: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Fourth Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy., conditionsModule conditions: Cancer, Therapy-Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Herombopag Olamine Tablets, outcomesModule primaryOutcomes measure: The proportion of patients recovered to 100×109/L, secondaryOutcomes measure: The proportion of patients recovered to 75×109/L, secondaryOutcomes measure: Time for platelet recovery to 100×109/L, secondaryOutcomes measure: Proportion of patients with treatment delay or dose reduction, secondaryOutcomes measure: TRAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06376422, orgStudyIdInfo id: EU-CT-2023-508271-36-00, briefTitle: Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2031-04-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Privatpraxis für Knie- und Schulterchirurgie, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are:* Can partial meniscal replacement improve knee function?* Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function.Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery., conditionsModule conditions: Meniscus Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no masking, patient decides which group, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Spongioflex®, interventions name: non-operated, outcomesModule primaryOutcomes measure: To evaluate efficacy of the procedure, primaryOutcomes measure: Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better), primaryOutcomes measure: Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better), primaryOutcomes measure: Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better), secondaryOutcomes measure: Safety of the patient (adverse events (AE) and serious adverse events (SAE)), secondaryOutcomes measure: Efficacy of the procedure, progression to osteoarthrosis, secondaryOutcomes measure: Menuiscus size, secondaryOutcomes measure: extrusion of meniscus, secondaryOutcomes measure: Size of meniscal extrusion, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Privatpraxis für Knie und Schulterchirurgie, status: RECRUITING, city: Dortmund, zip: 44137, country: Germany, contacts name: Sven Behrendt, MD, role: CONTACT, phone: +49231 8626064, email: [email protected], contacts name: Sven Behrendt, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.51494, lon: 7.466, hasResults: False |
protocolSection identificationModule nctId: NCT06376409, orgStudyIdInfo id: NW-HGN-02, briefTitle: Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Nutraceutical Wellness Inc., class: INDUSTRY, descriptionModule briefSummary: A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair., conditionsModule conditions: Hair Thinning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Nutrafol Women's Hair Growth Supplement, interventions name: Nutrafol Women's Balance Hair Growth Supplement, interventions name: Nutrafol Women's Vegan Hair Growth Supplement, interventions name: Nutrafol Women's Postpartum Hair Growth Supplement, outcomesModule primaryOutcomes measure: The percent change in hair growth rate at Day 180 relative to baseline (Day 0), secondaryOutcomes measure: The percent change in hair growth rate at Day 90 relative to baseline (Day 0), secondaryOutcomes measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days, secondaryOutcomes measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days, secondaryOutcomes measure: The change in terminal to vellus ratio, secondaryOutcomes measure: The change in terminal to vellus ratio, secondaryOutcomes measure: The change in anagen to telogen ratio, secondaryOutcomes measure: The change in anagen to telogen ratio, secondaryOutcomes measure: The change in average number of hairs per follicular unit, secondaryOutcomes measure: The change in average number of hairs per follicular unit, secondaryOutcomes measure: The change in total hair width per cm2, secondaryOutcomes measure: The change in total hair width per cm2, secondaryOutcomes measure: The change in mean inter-follicular distance, secondaryOutcomes measure: The change in mean inter-follicular distance, secondaryOutcomes measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days, secondaryOutcomes measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Integrative Skin Science and Research, city: Sacramento, state: California, zip: 95815, country: United States, contacts name: Nasima Afzal, role: CONTACT, phone: 916-750-2463, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False |
protocolSection identificationModule nctId: NCT06376396, orgStudyIdInfo id: 101103306, briefTitle: Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis, acronym: NeuroSolve, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: R-Evolution Worldwide S.r.l. Impresa Sociale, class: OTHER, collaborators name: Muhimbili University of Health and Allied Sciences, collaborators name: National Institute for Medical Research, Tanzania, collaborators name: Sokoine University of Agriculture, collaborators name: University of Zambia, collaborators name: University Ghent, descriptionModule briefSummary: The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis., conditionsModule conditions: Neurocysticercosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: albendazole and praziquantel, interventions name: Albendazole, outcomesModule primaryOutcomes measure: Cyst resolution or reduction in both study arms, secondaryOutcomes measure: Seizures frequency, secondaryOutcomes measure: Quality of Life questionnaire, secondaryOutcomes measure: Headache, secondaryOutcomes measure: Serological test results correlation with neuroimaging results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376383, orgStudyIdInfo id: TETT-RHG, secondaryIdInfos id: 110500, type: OTHER, domain: The Central Denmark Region Committees on Health Research Ethics, briefTitle: Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity., conditionsModule conditions: Obstructive Sleep Apnea, conditions: Tonsillar Hypertrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 464, type: ESTIMATED, armsInterventionsModule interventions name: Tonsillectomy, interventions name: Tonsillotomy, outcomesModule primaryOutcomes measure: Postoperative hemorrhage, primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Recovery time - Sick leave, primaryOutcomes measure: Morbidity, secondaryOutcomes measure: AHI, secondaryOutcomes measure: DISE - VOTE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376370, orgStudyIdInfo id: 16.04.24/2, briefTitle: The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-07-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life., conditionsModule conditions: Epilepsy, conditions: Computer-assisted Cognitive Rehabilitation, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Application of computer-assisted cognitive rehabilitation program, outcomesModule primaryOutcomes measure: Mini Mental State Test, primaryOutcomes measure: Epilepsy Quality of Life Scale, primaryOutcomes measure: MOXO Test, primaryOutcomes measure: Epilepsy Self-Management Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: ülkü Saygili Düzova, city: Selçuklu, state: Konya, country: Turkey, geoPoint lat: 37.8842, lon: 32.49222, hasResults: False |
protocolSection identificationModule nctId: NCT06376357, orgStudyIdInfo id: 16.04.24/1, briefTitle: The Effect of Foot Massage With Roles on Cancer Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-27, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life., conditionsModule conditions: Breast Neoplasms, conditions: Over Cancer, conditions: Foot Massage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Foot Massage with roller, outcomesModule primaryOutcomes measure: EORTC QLQ C-30 Quality of Life Scale, primaryOutcomes measure: CIPN20 Neuropathy Scale, primaryOutcomes measure: One Leg Standing Test, primaryOutcomes measure: Brief Pain Inventory BPI, primaryOutcomes measure: Pain Threshold Assessment Test, primaryOutcomes measure: Two Point Discrimination, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ülkü Saygili Düzova, city: Selçuklu, state: Konya, country: Turkey, geoPoint lat: 37.8842, lon: 32.49222, hasResults: False |
protocolSection identificationModule nctId: NCT06376344, orgStudyIdInfo id: 16.04.24, briefTitle: The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy., conditionsModule conditions: Cancer, conditions: Neuropathy, conditions: Therapy-Associated Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: myofascial release with tennis ball, outcomesModule primaryOutcomes measure: EORTC QLQ C-30- CIPN20 Scale, primaryOutcomes measure: One Leg Standing Test, primaryOutcomes measure: Lateral Reach Test, primaryOutcomes measure: Pain Assessment, primaryOutcomes measure: Pressure Pain Threshold Assessment, primaryOutcomes measure: Two Point Discrimination, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ülkü Saygili Düzova, city: Selçuklu, state: Konya, country: Turkey, geoPoint lat: 37.8842, lon: 32.49222, hasResults: False |
protocolSection identificationModule nctId: NCT06376331, orgStudyIdInfo id: ADHD20240403, briefTitle: Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, collaborators name: SIR RUN RUN hospital of Nanjing Medical University, descriptionModule briefSummary: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism., conditionsModule conditions: Attention-deficit/Hyperactivity Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: washed microbiota transplantation, outcomesModule primaryOutcomes measure: change of Swanson, Nolan and Pelham-IV (SNAP-IV)., primaryOutcomes measure: change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ)., secondaryOutcomes measure: change of the Sleep Disturbance Scale for Children (SDSC)., secondaryOutcomes measure: change of the Gastrointestinal Symptom Rating Scale (GSRS) ., secondaryOutcomes measure: the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome., secondaryOutcomes measure: the difference of the serum neurotransmitters between children with ADHD and healthy children, secondaryOutcomes measure: intestinal barrier, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, country: China, contacts name: Faming Zhang, PhD, role: CONTACT, phone: 086-025-58509883, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: SIR RUN RUN hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06376318, orgStudyIdInfo id: 19-138, briefTitle: Shock and Acute Conditions OutcOmes Platform, acronym: ShockCO-OP, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Saint-Louis Hospital, Paris, France, class: OTHER, collaborators name: University of Helsinki, collaborators name: University of Ottawa, collaborators name: University of Leipzig, collaborators name: University of Nancy, collaborators name: McGill University, collaborators name: Mayo Clinic, collaborators name: University of Paris 5 - Rene Descartes, collaborators name: University of Toronto, descriptionModule briefSummary: In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention.To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials.This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature)., conditionsModule conditions: Circulatory Shock, conditions: Sepsis, conditions: Cardiogenic Shock, conditions: Major Trauma, conditions: Surgical Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Inotrope, interventions name: Mechanical circulatory support, interventions name: anti-bodies, outcomesModule primaryOutcomes measure: Mortality rate, secondaryOutcomes measure: Mortality rate, secondaryOutcomes measure: Renal replacement therapy use rate, secondaryOutcomes measure: Mechanical circulatory support use rate, secondaryOutcomes measure: Vasopressors and inotropes-free days, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Michael's Hospital, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06376305, orgStudyIdInfo id: 176786, briefTitle: EndoBarrier in Obstructive Sleep Apnoea Study, acronym: End-OSA, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-03, primaryCompletionDateStruct date: 2019-12, completionDateStruct date: 2019-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dr Bob Ryder, class: OTHER, collaborators name: Association of British Clinical Diabetologists, descriptionModule briefSummary: Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment., conditionsModule conditions: Type 2 Diabetes, conditions: Obstructive Sleep Apnoea, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: EndoBarrier, outcomesModule primaryOutcomes measure: Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months, secondaryOutcomes measure: Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months, secondaryOutcomes measure: Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months, secondaryOutcomes measure: Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months, secondaryOutcomes measure: Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months, secondaryOutcomes measure: Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months, secondaryOutcomes measure: Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months, secondaryOutcomes measure: Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI, secondaryOutcomes measure: Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months, secondaryOutcomes measure: Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months, secondaryOutcomes measure: Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months, secondaryOutcomes measure: Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City Hospital, city: Birmingham, zip: B18 7QH, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False |
protocolSection identificationModule nctId: NCT06376292, orgStudyIdInfo id: Y⒛24-0106, briefTitle: A Prospective Study of Whole-Brain RT Combined With Thiotepa Sheath Injection Combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa sheath injection combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid TumorsHow works well was the combined therapy？ How safe was combined therapy？ Participants will receive whole brain radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. Evaluate the efficacy and safety every 2 cycles.Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies., conditionsModule conditions: Solid Tumor Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: OS, secondaryOutcomes measure: 3-month PFS, secondaryOutcomes measure: 6-month PFS, secondaryOutcomes measure: 1-year PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Zhejiang University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Ting Zhang, Prof., role: CONTACT, phone: +8615157125533, email: [email protected], geoPoint lat: 30.29365, lon: 120.16142, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-12, uploadDate: 2024-03-13T09:04, filename: Prot_000.pdf, size: 320618, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-12, uploadDate: 2024-03-13T09:05, filename: ICF_001.pdf, size: 156721, hasResults: False |
protocolSection identificationModule nctId: NCT06376279, orgStudyIdInfo id: 2008/351-31, briefTitle: Genetic Diagnosis in Inborn Errors of Metabolism, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2008-04-29, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Region Stockholm, class: OTHER_GOV, collaborators name: Karolinska Institutet, descriptionModule briefSummary: Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism., conditionsModule conditions: Metabolic Disease, conditions: Mitochondrial Diseases, conditions: Epilepsy in Children, conditions: Epilepsy, conditions: LHON, conditions: Motor Neuron Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: IEM-EP, outcomesModule primaryOutcomes measure: Genetic variant identification using NGS for diagnosis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376266, orgStudyIdInfo id: 202305083RSC, briefTitle: Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2023-12-29, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: nutritional supplements, outcomesModule primaryOutcomes measure: the scale of sarcopenia, primaryOutcomes measure: the scale of sarcopenia, primaryOutcomes measure: the scale of sarcopenia, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: Ding-cheng Chan, DR, role: CONTACT, phone: +886-2-23123456, phoneExt: 67095, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06376253, orgStudyIdInfo id: CGIZ943A12101, secondaryIdInfos id: 2023-507674-41-00, type: OTHER, domain: CTIS, briefTitle: A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-06, primaryCompletionDateStruct date: 2030-08-30, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC)., conditionsModule conditions: Ovarian Cancer, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: [68Ga]Ga-EVS459, interventions name: [177Lu]Lu-EVS459, outcomesModule primaryOutcomes measure: Number of participants with dose limiting toxicities of [177Lu]Lu-EVS459, primaryOutcomes measure: Incidence and severity of adverse events and serious adverse events of [177Lu]Lu- EVS459, primaryOutcomes measure: Dose modifications for [177Lu]Lu- EVS459, primaryOutcomes measure: Dose intensity for [177Lu]Lu- EVS459, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Area Under the Curve (AUC) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Total body clearance of [177Lu[Lu-EVS459, secondaryOutcomes measure: Observed maximum plasma concentration (Cmax) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Terminal elimination half-life (T1/2) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA), secondaryOutcomes measure: Renal clearance of [177Lu]Lu- EVS459, secondaryOutcomes measure: Absorbed dose of [177Lu]Lu- EVS459, secondaryOutcomes measure: Time-activity curves (TACs) related to [177Lu]Lu-EVS459 uptake in organs and tumor lesions, secondaryOutcomes measure: Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-EVS459, secondaryOutcomes measure: Visual and quantitative assessment of [68Ga]Ga-EVS459 uptake in normal tissues and tumor lesions over time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376240, orgStudyIdInfo id: NL85203.068.23, briefTitle: The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes, acronym: PYRAMID, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, collaborators name: Diabetes Fonds, descriptionModule briefSummary: Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation., conditionsModule conditions: Type 2 Diabetes, conditions: Microvascular Function, conditions: Retinopathy, Diabetic, conditions: Nephropathy, Diabetic, conditions: Neuropathy, Diabetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Pyridoxamine 300mg per day, interventions name: Placebo 300mg placebo per day, outcomesModule primaryOutcomes measure: Central retinal artery equivalent of the eye, otherOutcomes measure: eGFR, otherOutcomes measure: Microvascular function in skin, otherOutcomes measure: Markers of endothelial function and glycation in blood plasma., otherOutcomes measure: Advanced glycation end products in skin, otherOutcomes measure: Advanced glycation end products in blood plasma and urine, otherOutcomes measure: Adipokines and inflammatory markers in blood plasma, otherOutcomes measure: Methylglyoxal, glyoxal and 3-deoxyglucose in blood plasma., otherOutcomes measure: Markers of dicarbonyl stress and oxidative stress in urine, otherOutcomes measure: Glucose metabolism, otherOutcomes measure: Liver fat, otherOutcomes measure: Systolic and diastolic blood pressure, otherOutcomes measure: Microvascular function eye, otherOutcomes measure: Urinary albumin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Hospital Maastricht, status: RECRUITING, city: Maastricht, zip: 6229 HX, country: Netherlands, contacts name: CTCM Clinical Trial Center Maastricht, role: CONTACT, phone: + 31 (0) 43 387 20 40, email: [email protected], geoPoint lat: 50.84833, lon: 5.68889, hasResults: False |
protocolSection identificationModule nctId: NCT06376227, orgStudyIdInfo id: jamesdukeryan, briefTitle: Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2023-12-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: Brief SummaryBackground The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function., conditionsModule conditions: Rectal Cancer, conditions: Left Colic Artery Stenosis (Diagnosis), conditions: Robotic Assisted Laparoscopic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1164, type: ACTUAL, armsInterventionsModule interventions name: with or without Left Colic Artery Preservation, outcomesModule primaryOutcomes measure: The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation., secondaryOutcomes measure: The genitourinary function of the patients after the radical resection with or without left colic artery preservation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University, Yangzhou, city: Yangzhou, state: Jiangsu, zip: 225001, country: China, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False |
protocolSection identificationModule nctId: NCT06376214, orgStudyIdInfo id: 2024-02, briefTitle: Daratumumab for Patients With Light Chain Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Nanjing University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis., conditionsModule conditions: Light Chain (AL) Amyloidosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Dratumumab / Hyaluronidase Injection [Darzalex Faspro], interventions name: Pomalidomide 4 MG, interventions name: autologous stem cell transplantation (ASCT), outcomesModule primaryOutcomes measure: Hematological complete response rate, primaryOutcomes measure: Organ response rate, secondaryOutcomes measure: Time to Next Treatment, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Clinical Research Center for Kidney Diseases, Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210016, country: China, contacts name: Xianghua Huang, MD, role: CONTACT, phone: 02580862351, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06376201, orgStudyIdInfo id: NFEC-2024-018, briefTitle: A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed., conditionsModule conditions: Invasive Fungal Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Amphotericin B cholesterol-sulfate complex for injection, outcomesModule primaryOutcomes measure: Treatment is effective, secondaryOutcomes measure: Incidence of the single index in the five criteria of treatment success, secondaryOutcomes measure: Completion rate of ABCD treatment for at least 14 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376188, orgStudyIdInfo id: 1582/2021 SimCom, briefTitle: Improving Breaking Bad News in Pediatrics by Simulated Communication, acronym: SimCom, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2022-08-31, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication, conditionsModule conditions: Communication, conditions: End of Life, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: communication training, outcomesModule primaryOutcomes measure: score by simulation parents, secondaryOutcomes measure: score by participants, secondaryOutcomes measure: score of video analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, city: Vienna, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False |
protocolSection identificationModule nctId: NCT06376175, orgStudyIdInfo id: LL-016, briefTitle: Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lumos Labs, Inc., class: INDUSTRY, descriptionModule briefSummary: Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games., conditionsModule conditions: Healthy Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: BOLD response during gameplay, primaryOutcomes measure: Responder rates, primaryOutcomes measure: Structural MRI volumetrics: Volume, primaryOutcomes measure: Structural MRI volumetrics: Cortical thickness, primaryOutcomes measure: Structural MRI volumetrics: Brain-Predicted Age Difference, primaryOutcomes measure: Behavior response: Game score, primaryOutcomes measure: BAMS-7 (Brief Attention and Mood Scale of 7 Items), primaryOutcomes measure: VGPQ (Video Game Playing Questionnaire), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: UC Davis Imaging Research Center (IRC), city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Kevin Madore, PhD, role: CONTACT, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False |
protocolSection identificationModule nctId: NCT06376162, orgStudyIdInfo id: ITCC-101/APAL2020K, secondaryIdInfos id: 2023-505262-28-00, type: CTIS, briefTitle: Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: LLS PedAL Initiative, LLC, class: OTHER, collaborators name: Kura Oncology, descriptionModule briefSummary: The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK)., conditionsModule conditions: Relapsed/Refractory KMT2A-r Acute Leukemia, conditions: Relapsed/Refractory NUP98-r Acute Leukemia, conditions: Relapsed/Refractory NPM1-m Acute Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ziftomenib, interventions name: Cytarabine, interventions name: Fludarabine, outcomesModule primaryOutcomes measure: Number of Participants Who Experience a Dose-limiting Toxicity (DLT), primaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of Ziftomenib, secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of AEs by Severity, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of Ziftomenib, secondaryOutcomes measure: Minimum Observed Plasma Concentration (Cmin) of Ziftomenib, secondaryOutcomes measure: Time to Cmax (Tmax), secondaryOutcomes measure: Truncated AUC (AUC0-t) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Extrapolated AUC (AUC0-∞) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Oral Plasma Clearance (CL/F) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Volume of Distribution (Vz/F) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Terminal Elimination Half-life (t1/2) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: HSCT Rate, secondaryOutcomes measure: Morphological Overall Response Rate (ORR), secondaryOutcomes measure: Flow-based ORR, secondaryOutcomes measure: Flow-based Measurable Residual Disease (MRD) Negativity Rate, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Event-free Survival (EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Cumulative Incidence of Relapse (CIR), eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376149, orgStudyIdInfo id: 124973, briefTitle: M3-JIA: Making Mindfulness Matter for Children With JIA, acronym: M3-JIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, collaborators name: Brain Canada, descriptionModule briefSummary: The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level., conditionsModule conditions: Juvenile Idiopathic Arthritis, conditions: Children, conditions: Mental Health, conditions: Mental Well-being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The primary objective is to conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s).Measures will be obtained via questionnaires at 3 time points: baseline, 9 weeks and 2 months post-intervention.Additionally, at the start of each session, parents will complete a one-page semi-structured questionnaire evaluating treatment fidelity and at home utilization of M3© skills. At the end of each session, parent participants will complete a one-page structured questionnaire providing feedback on the session, and facilitators will complete the M3© Adherence Checklist, evaluating whether planned activities were completed, and any modifications made., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants will be blinded to their group assignment: all participants will be told that they will receive the intervention. Program facilitators will be blinded to participant group assignment order, since sessions for both study arms would run on a rolling basis. The statistician will also be blinded to the group assignment and order., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: M3 Intervention group, interventions name: M3 Waitlist Group, outcomesModule primaryOutcomes measure: conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s)., secondaryOutcomes measure: Effects of M3 on health related quality of life of children with JIA, secondaryOutcomes measure: Effects of M3 on health quality of life for parents, secondaryOutcomes measure: Does M3 have a positive effect on children's severity of JIA, secondaryOutcomes measure: Does M3 have a positive effect on children's executive function, otherOutcomes measure: Does M3 have a positive effect on parents' stress, otherOutcomes measure: Does M3 have a positive effect on parents' depression and anxiety, otherOutcomes measure: Does M3 have a positive effect on Child's' depression and anxiety, otherOutcomes measure: Does M3 have a positive effect on children's resiliency, otherOutcomes measure: Does M3 have a positive effect on parent resiliency, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: McMaster Children's Hospital,, city: Hamilton, state: Ontario, zip: L8N 3Z5, country: Canada, contacts name: Karen Beatie, role: CONTACT, phone: (905) 521-2100, email: [email protected], contacts name: Michelle Dr. Batthish, role: CONTACT, phone: (905) 521-2100, email: [email protected], contacts name: Michelle Batthish, role: SUB_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: London Health Sciences Centre- Children's Hosptial, city: London, state: Ontario, zip: N6J 4L8, country: Canada, contacts name: Sarah Wells, role: CONTACT, phone: 519-685-8500, phoneExt: 56816, email: [email protected], contacts name: Roberta Berard, role: CONTACT, phone: 519-685-8500, phoneExt: 52479, email: [email protected], contacts name: Roberta Berard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Sickids, city: Toronto, state: Ontario, zip: M5G 1E8, country: Canada, contacts name: Andrea Knight, role: CONTACT, phone: (416) 813-1500, email: [email protected], contacts name: Andrea Dr. Knight, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06376136, orgStudyIdInfo id: BAT-8010+1006-001-CR, briefTitle: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2026-12-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Bio-Thera Solutions, class: INDUSTRY, descriptionModule briefSummary: This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: BAT8010 for Injection, interventions name: BAT1006 for Injection, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: vital signs, primaryOutcomes measure: Physical examination, primaryOutcomes measure: Adverse events, primaryOutcomes measure: Clinical laboratory tests, primaryOutcomes measure: Number of participants with abnormal clinical auxiliary tests, primaryOutcomes measure: Duration of Response(DOR), primaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Antibody, secondaryOutcomes measure: Antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06376123, orgStudyIdInfo id: Nkangarli001, briefTitle: Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly., conditionsModule conditions: One-lung Ventilation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Alveolo-arterial gradient, primaryOutcomes measure: Alveolo-arterial gradient, secondaryOutcomes measure: Alveolo-arterial gradient change, secondaryOutcomes measure: Alveolo-arterial gradient change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem Vakif University Dragos Hospital, city: Istanbul, state: Maltepe, zip: 34844, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06376110, orgStudyIdInfo id: AviClear-001, briefTitle: Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Austin Institute for Clinical Research, class: NETWORK, collaborators name: SkinCeuticals, descriptionModule briefSummary: This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI., conditionsModule conditions: Acne, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Topical Antioxidant Serum, interventions name: AviClear Laser, outcomesModule primaryOutcomes measure: Change in Product Tolerability, primaryOutcomes measure: Change in Product Efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376097, orgStudyIdInfo id: D5162R00036, briefTitle: Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-19, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Absolute number and frequency of false-negative lung nodules ., secondaryOutcomes measure: Assess adherence to smoking cessation treatment in active smokers who enter screening., secondaryOutcomes measure: Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic., secondaryOutcomes measure: Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB), status: RECRUITING, city: Botucatu, state: São Paulo, zip: 18618-686, country: Brazil, contacts name: Erica Hasimoto, role: CONTACT, phone: (14) 99792-0222, email: [email protected], geoPoint lat: -22.88583, lon: -48.445, hasResults: False |
protocolSection identificationModule nctId: NCT06376084, orgStudyIdInfo id: D5161R00055, briefTitle: Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC, acronym: FOREFRONT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-24, primaryCompletionDateStruct date: 2028-02-28, completionDateStruct date: 2028-02-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, conditions: Lung Neoplasms, conditions: Respiratory Tract Neoplasms, conditions: Thoracic Neoplasms, conditions: Neoplasms by Site, conditions: Neoplasms, conditions: Lung Diseases, conditions: Respiratory Tract Diseases, conditions: Carcinoma, Bronchogenic, conditions: Bronchial Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 700, type: ESTIMATED, outcomesModule primaryOutcomes measure: Real-World Progression Free Survival (rwPFS), secondaryOutcomes measure: Chemotherapy regimen, secondaryOutcomes measure: Duration of chemotherapy (induction and maintenance cycles), secondaryOutcomes measure: Response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: Rong LI, role: CONTACT, phone: +8621-22200000-5451, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06376071, orgStudyIdInfo id: fungal rhinosiusitis, briefTitle: Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis ., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::1. anatomical variations and correlate radiological finding with intraoperative finding.2. other associated factors like demographic ,environmental, immunological and climatic risk factors ., conditionsModule conditions: Allergic Fungal Rhinosinusitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: functional endoscopic sinus surgery, outcomesModule primaryOutcomes measure: Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376058, orgStudyIdInfo id: 434/06-06-2022, briefTitle: Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section, acronym: annie-mariana, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2026-01-10, completionDateStruct date: 2026-01-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Aretaieion University Hospital, class: OTHER, descriptionModule briefSummary: This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections, conditionsModule conditions: Cesarean Section, conditions: Local Anesthetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Chloroprocaine 1% Injectable Solution, interventions name: Ropivacaine 0.75% Injectable Solution, outcomesModule primaryOutcomes measure: Time from spinal anesthesia to T10 block (min), primaryOutcomes measure: Time from spinal anesthesia to T4 block (min), primaryOutcomes measure: Time of spinal anesthesia to Bromage =3, primaryOutcomes measure: level of sensory block every 3 min, primaryOutcomes measure: level of sensory block every 15 min, primaryOutcomes measure: highest level of sensory block, primaryOutcomes measure: time from spinal anesthesia to highest level of sensory block, primaryOutcomes measure: duration of sensory block, primaryOutcomes measure: pain at surgical incision, primaryOutcomes measure: pain at neonatal delivery, primaryOutcomes measure: pain at peritoneal manipulation, primaryOutcomes measure: pain at Post Anesthesia Care Unit (PACU) admission, primaryOutcomes measure: pain at Post Anesthesia Care Unit (PACU) discharge, primaryOutcomes measure: need for rescue analgesia intraoperatively, primaryOutcomes measure: Bromage scale every 3 min after spinal anesthesia, primaryOutcomes measure: Bromage scale every 15 min, primaryOutcomes measure: duration of motor block, primaryOutcomes measure: duration of staying in PACU, secondaryOutcomes measure: Neonatal Apgar score at 1 minute, secondaryOutcomes measure: Neonatal Apgar score at 5 minutes, secondaryOutcomes measure: neonatal blood gases, secondaryOutcomes measure: incidence of neonatal acidosis, secondaryOutcomes measure: incidence of hypotension, secondaryOutcomes measure: incidence of bradycardia, secondaryOutcomes measure: need for vasoconstrictor, secondaryOutcomes measure: need for atropine, secondaryOutcomes measure: incidence of nausea/vomiting, secondaryOutcomes measure: incidence of dizziness, secondaryOutcomes measure: incidence of drowsiness, secondaryOutcomes measure: incidence of discomfort, secondaryOutcomes measure: incidence of shivering, secondaryOutcomes measure: need for rescue analgesia in PACU, secondaryOutcomes measure: time from spinal anesthesia to rescue analgesia in PACU, secondaryOutcomes measure: incidence of neurological symptoms during hospital stay, secondaryOutcomes measure: incidence of neurological symptoms 2 months after the operation, secondaryOutcomes measure: incidence of low back pain, secondaryOutcomes measure: time from spinal anesthesia to mobilization, secondaryOutcomes measure: mother's satisfaction from anesthesia, secondaryOutcomes measure: gynecologist's satisfaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aretaieion University Hospital, status: RECRUITING, city: Athens, zip: 11528, country: Greece, contacts name: Kassiani Theodoraki, PhD, DESA, role: CONTACT, phone: 6974634162, email: [email protected], contacts name: Marianna Mavromati, MD, role: CONTACT, email: [email protected], geoPoint lat: 37.97945, lon: 23.71622, hasResults: False |
protocolSection identificationModule nctId: NCT06376045, orgStudyIdInfo id: 20220093, briefTitle: A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2026-08-10, completionDateStruct date: 2026-10-02, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Rocatinlimab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period, secondaryOutcomes measure: Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1), secondaryOutcomes measure: Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period, secondaryOutcomes measure: Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48, secondaryOutcomes measure: Change From Baseline in Pre-BD FEV1, secondaryOutcomes measure: Change From Baseline in Asthma Symptom Diary (ASD) Score, secondaryOutcomes measure: Number of Participant Achieving ACQ-6 Response at Week 48, secondaryOutcomes measure: Change From Baseline in ACQ-6, secondaryOutcomes measure: Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score, secondaryOutcomes measure: Number of Participants Achieving AQLQ (S) Response at Week 48, secondaryOutcomes measure: Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period, secondaryOutcomes measure: Time to First Asthma Exacerbation Event, secondaryOutcomes measure: Time to First CompEx Event, secondaryOutcomes measure: Number of Participants with a CompEx Event During the Double Blinded Treatment Period, secondaryOutcomes measure: Annualized Rate of CompEx Events, secondaryOutcomes measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels, secondaryOutcomes measure: Serum Rocatinlimab Concentrations, secondaryOutcomes measure: Trough Concentration (Ctrough) of Rocatinlimab, secondaryOutcomes measure: Number of Participants with Treatment-emergent Adverse Events, secondaryOutcomes measure: Number of Participants with Serious Adverse Events, secondaryOutcomes measure: Number of Participants with Anti-rocatinlimab Antibody Formation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06376032, orgStudyIdInfo id: Akili-068, briefTitle: EndeavorOTC® Research Study in College Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Akili Interactive Labs, Inc., class: INDUSTRY, collaborators name: Landmark College, collaborators name: Villa Maria College, descriptionModule briefSummary: The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students., conditionsModule conditions: Attention, conditions: Cognition, conditions: University Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Eligible students will be randomized\* to two cohorts: the first will receive immediate access to AKL-T01, and the second will complete weekly online surveys and receive access to AKL-T01 after the first group has completed the recommended 6 weeks of use. Regardless of group assignment, all participants will receive full 12-weeks of access to AKL-T01 during the course of the study.\*Depending on enrollment numbers for a given semester (e.g., if \<100 students are enrolled and the study is underpowered to conduct between-group comparisons), all participants may be assigned to receive treatment immediately (i.e., single-arm design) and primary study hypotheses may be evaluated according to within-person changes in outcomes., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: EndeavorOTC®, outcomesModule primaryOutcomes measure: Computerized Adaptive Test, Mental Health (CAT-MH®), primaryOutcomes measure: PROMIS Cognitive Function v2.0 - Short Form, primaryOutcomes measure: PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0), primaryOutcomes measure: General Academic Self-Efficacy scale (GASE), primaryOutcomes measure: Mental Health Quality of Life Scale (MHQoL), primaryOutcomes measure: Adult ADHD Self-Report Scale (ASRS), primaryOutcomes measure: Patient Health Questionnaire-4 (PHQ-4), otherOutcomes measure: System Usability Scale (SUS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Villa Maria College, status: RECRUITING, city: Cheektowaga, state: New York, zip: 14225, country: United States, contacts name: Laura Pietak, role: CONTACT, phone: 716-961-2869, email: [email protected], geoPoint lat: 42.90339, lon: -78.75475, locations facility: Landmark College, status: RECRUITING, city: Putney, state: Vermont, zip: 05346, country: United States, contacts name: Rick Bryck, PhD, role: CONTACT, phone: 802-387-6306, email: [email protected], geoPoint lat: 42.9748, lon: -72.52176, hasResults: False |
protocolSection identificationModule nctId: NCT06376019, orgStudyIdInfo id: FDASU-RecID11352, briefTitle: Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture., conditionsModule conditions: Edentulous Jaw, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: the statistician will be the only one to be blinded, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: solitary Implant loading with ball attachment, interventions name: splinted Implant loading with intra oral welding, interventions name: complete denture, outcomesModule primaryOutcomes measure: Assessment of occlusion/disocclusion time, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Ain Shams University, city: Cairo, zip: 11361, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06376006, orgStudyIdInfo id: 1798538, briefTitle: Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees, acronym: EMR-STAT, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-05-11, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AdventHealth, class: OTHER, collaborators name: Duke University, collaborators name: University of South Florida, collaborators name: Stony Brook University, collaborators name: Atrium Medical Center, collaborators name: Hofstra University, collaborators name: Long Island Jewish Medical Center, collaborators name: Vanderbilt University, collaborators name: Yale University, collaborators name: Columbia University, collaborators name: Geisinger Clinic, collaborators name: Unity Health Toronto, collaborators name: University of Virginia, collaborators name: Baylor University, collaborators name: University of Kentucky, collaborators name: Cedars-Sinai Medical Center, collaborators name: University of Chicago, collaborators name: University of California, Irvine, collaborators name: University of Alabama at Birmingham, collaborators name: Beth Israel Deaconess Medical Center, descriptionModule briefSummary: Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs)., conditionsModule conditions: Competence, conditions: Assessment, Self, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: EMR STAT - Survey, outcomesModule primaryOutcomes measure: Primary Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AdventHealth Orlando, city: Orlando, state: Florida, zip: 32804, country: United States, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False |
protocolSection identificationModule nctId: NCT06375993, orgStudyIdInfo id: ADI-202300103, briefTitle: A Phase 1 Study of ADI-001 in Lupus Nephritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Adicet Bio, Inc, class: INDUSTRY, descriptionModule briefSummary: ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion safety/efficacy study in patients with lupus nephritis. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up, conditionsModule conditions: Lupus Nephritis, conditions: Autoimmune Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 3+3 Dose Escalation Design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ADI-001, interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort, primaryOutcomes measure: Proportion of treatment emergent and treatment related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375980, orgStudyIdInfo id: ANKARA_OR_MP, briefTitle: Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, class: OTHER, descriptionModule briefSummary: This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. We record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively, conditionsModule conditions: Lung Injury, conditions: Pulmonary Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 207, type: ACTUAL, armsInterventionsModule interventions name: Intraoperative Mechanical Ventilation Strategies, outcomesModule primaryOutcomes measure: Relationship between mechanical power and postoperative pulmonary complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Oncology Training and Research Hospital, city: Ankara, zip: 06200, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06375967, orgStudyIdInfo id: CARPEGIEM, briefTitle: EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial), acronym: CARPEGIEM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital General Universitario de Alicante, collaborators name: Hospital Mutua de Terrassa, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital General Universitario de Castellón, collaborators name: Complejo Hospitalario de Navarra, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Hospital de Sant Pau, collaborators name: University of Salamanca, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: Complejo Hospitalario Universitario de Vigo, descriptionModule briefSummary: The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Biliary Tract Neoplasms, conditions: Pancreatic Cancer Non-resectable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic biliary drainage, interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), outcomesModule primaryOutcomes measure: SAFETY (ADVERSE EVENTS), primaryOutcomes measure: Recurrent biliary obstruction, secondaryOutcomes measure: CLINICAL SUCCESS, secondaryOutcomes measure: TECHNICAL SUCCESS, secondaryOutcomes measure: BILIARY REINTERVENTIONS (BRI), secondaryOutcomes measure: HOSPITAL STAY, secondaryOutcomes measure: MORTALITY, secondaryOutcomes measure: COST ANALYSIS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari de Bellvitge, city: L'Hospitalet De Llobregat, state: Barcelona, Catalonia, zip: 08907, country: Spain, contacts name: Joan B Gornals, PhD, role: CONTACT, phone: +34 93 260 76 82, phoneExt: 2624, email: [email protected], contacts name: Julia Escuer Turu, MD, role: CONTACT, phone: +34 618 27 28 24, email: [email protected], contacts name: Maria Puigcerver Mas, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Albert Garcia-Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Julio G Velasquez-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Carme Loras, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charly Guarner Argente, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose R Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rafa Pedraza, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Rodriguez D'Jesus, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Alvarez, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vicente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False |
protocolSection identificationModule nctId: NCT06375954, orgStudyIdInfo id: CARPEDIEM-2, briefTitle: EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, collaborators name: Hospital Mutua de Terrassa, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital General Universitario de Alicante, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital General Universitario de Castellón, collaborators name: Hospital Álvaro Cunqueiro, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Complejo Hospitalario de Navarra, collaborators name: Hospital de Sant Pau, collaborators name: University of Salamanca, descriptionModule briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Pancreatic Cancer, conditions: Biliary Tract Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic biliary drainage, interventions name: Self-expandable metallic stent (SEMS), interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), outcomesModule primaryOutcomes measure: Delay in days between endoscopic biliary drainage and chemotherapy treatment start, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Clinical success, secondaryOutcomes measure: AE - biliary drainage, secondaryOutcomes measure: AE - surgery, secondaryOutcomes measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari de Bellvitge, city: L'Hospitalet de Llobregat, state: Barcelona, zip: 08907, country: Spain, contacts name: Joan B Gornals, MD, PhD, role: CONTACT, phone: + 34 93 260 7682, phoneExt: 2624, email: [email protected], contacts name: Maria Puigcerver-Mas, MD, role: CONTACT, phone: +34 687332007, email: [email protected], contacts name: Julia Escuer, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Julio G Velasquez-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Albert Garcia-Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna-Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Berta Laquente, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Juli Busquets, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Carme Loras, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: VIcente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose R Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eduardo Redondo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charly Guarner-Argente, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Antonio Rodriguez D'Jesus, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alberto Alvarez, MD, pHD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False |
protocolSection identificationModule nctId: NCT06375941, orgStudyIdInfo id: ProStars, briefTitle: Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars, acronym: ProStars, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2034-04-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Italian Sarcoma Group, class: NETWORK, descriptionModule briefSummary: This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS., conditionsModule conditions: Angiosarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Observational, outcomesModule primaryOutcomes measure: Demographic characteristics, primaryOutcomes measure: General characteristics, primaryOutcomes measure: Cancer data, primaryOutcomes measure: Origin of Tumor, primaryOutcomes measure: Tumor characteristics, primaryOutcomes measure: Tumor size, primaryOutcomes measure: Tumor aspects, primaryOutcomes measure: Pathological characteristics, primaryOutcomes measure: Tumor phenotype, primaryOutcomes measure: Molecular characteristics, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Nazionale Tumori - Milano, status: RECRUITING, city: Milano, zip: 20133, country: Italy, contacts name: Palassini Elena, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06375928, orgStudyIdInfo id: CARPEDIEM-1, briefTitle: EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari de Bellvitge, class: OTHER, collaborators name: Hospital Mutua de Terrassa, collaborators name: Hospital Clínico Universitario de Valencia, collaborators name: Hospital General Universitario de Alicante, collaborators name: Hospital Universitario Ramon y Cajal, collaborators name: Hospital General Universitario de Castellón, collaborators name: Hospital Álvaro Cunqueiro, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: University Hospital Virgen de las Nieves, collaborators name: Complejo Hospitalario de Navarra, collaborators name: Hospital de Sant Pau, collaborators name: University of Salamanca, descriptionModule briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction., conditionsModule conditions: Malignant Biliary Obstruction, conditions: Pancreatic Cancer Resectable, conditions: Biliary Tract Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic biliary drainage, interventions name: Self-expandable metallic stent (SEMS), interventions name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS), outcomesModule primaryOutcomes measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP), secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Clinical success, secondaryOutcomes measure: AE - biliary drainage, secondaryOutcomes measure: AE - surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari de Bellvitge, city: L'Hospitalet de Llobregat, state: Barcelona, Catalonia, zip: 08907, country: Spain, contacts name: Joan B Gornals, MD, PhD, role: CONTACT, phone: +34 93 260 76 82, phoneExt: 2624, email: [email protected], contacts name: Maria Puigcerver-Mas, MD, role: CONTACT, phone: +34 687332007, email: [email protected], contacts name: Julia Escuer-Turu, MD, role: SUB_INVESTIGATOR, contacts name: Daniel Luna Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Albert Sumalla, MD, role: SUB_INVESTIGATOR, contacts name: Berta Laquente, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Juli Busquets, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Julio Velasquez Rodriguez, MD, role: SUB_INVESTIGATOR, contacts name: Sandra Maisterra, MD, role: SUB_INVESTIGATOR, contacts name: Carme Loras, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Charly Guarner Argente, MD, PHD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Lariño, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Rafael Pedraza, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jose Ramon Aparicio, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Vicente Sanchiz, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eduardo Redondo, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan J Vila, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False |
protocolSection identificationModule nctId: NCT06375915, orgStudyIdInfo id: PM-CARE, secondaryIdInfos id: PNRR-MAD-2022-12375905, type: OTHER_GRANT, domain: Italian Ministry of Health, briefTitle: Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy, acronym: PM-CARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Francesco De Cobelli, class: OTHER, collaborators name: Cardarelli Hospital, collaborators name: A.O. Ospedale Papa Giovanni XXIII, collaborators name: AOU Pisana, Pisa, Italy, descriptionModule briefSummary: Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments., conditionsModule conditions: Intrahepatic Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: radioembolization with Y-90, interventions name: Durvalumab, interventions name: Cisplatin, interventions name: Gemcitabine, outcomesModule primaryOutcomes measure: Overall response rate (ORR), primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Median progression free survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor circulating markers, secondaryOutcomes measure: Tumor tissue based evaluation, secondaryOutcomes measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers, secondaryOutcomes measure: Quantitative imaging based biomarkers, secondaryOutcomes measure: Quantitative biomarkers, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Radiology, IRCCS Ospedale San Raffaele, city: Milano, zip: 20132, country: Italy, contacts name: Francesco De Cobelli, MD, role: CONTACT, phone: +39022643, phoneExt: 2529, email: [email protected], contacts name: Stephanie Steidler, PhD, role: CONTACT, phone: +39022643, phoneExt: 6111, email: [email protected], contacts name: Francesco De Cobelli, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Francesca Ratti, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06375902, orgStudyIdInfo id: 2022289RNA, briefTitle: The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them, acronym: FRAME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique, conditionsModule conditions: Schizophrenia; Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: PragmaCom, outcomesModule primaryOutcomes measure: Tracking down the difficulties in metaphor comprehension via a behavioural task, primaryOutcomes measure: Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording, secondaryOutcomes measure: Evaluation of psychopathology, secondaryOutcomes measure: Evaluation of cognition, secondaryOutcomes measure: Evaluation of Theory of Mind, secondaryOutcomes measure: Evaluation of functioning, secondaryOutcomes measure: Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375889, orgStudyIdInfo id: 69HCL24_0250, secondaryIdInfos id: 2024-A00796-41, type: OTHER, domain: ID-RCB, briefTitle: Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage, acronym: APICRASH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2025-06-13, completionDateStruct date: 2025-06-13, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology., conditionsModule conditions: Aneuvrysmal Subarachnoid Hemorrhage, conditions: Delayed Cerebral Ischemia, conditions: Endotheliopathy, conditions: Platelets Kinetic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: blood test, outcomesModule primaryOutcomes measure: The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital, city: Bron, state: Auvergne-Rhône-Alpes, zip: 69005, country: France, contacts name: Nicolas Chardon, MD;Msc, role: CONTACT, phone: 683396245, phoneExt: 33, email: [email protected], contacts name: Nicolas Chardon, MD;msc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Neurovascular intensive care unit department, Pierre Wertheimer hospital, city: Bron, state: Auvergnes-Rhones-Alpes, zip: 69005, country: France, contacts name: Nicolas Chardon, MD;Msc, role: CONTACT, phone: 683396245, phoneExt: 33, email: [email protected], contacts name: Nicolas Chardon, MD;Msc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, hasResults: False |
protocolSection identificationModule nctId: NCT06375876, orgStudyIdInfo id: 2000034173, secondaryIdInfos id: 15JOVW-22-GG-04755-STOP, type: OTHER_GRANT, domain: Office on Violence Against Women (OVW), briefTitle: Single Session Intervention to Promote Hope, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: Office on Violence Against Women (OVW), descriptionModule briefSummary: The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage., conditionsModule conditions: Domestic Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: Single-session intervention (SSI), outcomesModule primaryOutcomes measure: Feasibility assessed by percent enrolled, primaryOutcomes measure: Feasibility assessed by time to complete, primaryOutcomes measure: Feasibility assessed by post-intervention survey/process supplement, primaryOutcomes measure: Acceptability/likability assessed using the Program Feeback Scale, primaryOutcomes measure: Safety assessed using end of study survey, primaryOutcomes measure: Change in Hope assessed using Herth Hope Index, primaryOutcomes measure: Change in Hope assessed using Trait Hope Scale, primaryOutcomes measure: Change in Hope assessed using Beck Hopelessness Scale (single item), secondaryOutcomes measure: Change in Self-worth, secondaryOutcomes measure: Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R), secondaryOutcomes measure: Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2), secondaryOutcomes measure: Change in Emotional wellbeing measured by the State Joy Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Consultation Center at Yale, city: New Haven, state: Connecticut, zip: 06511, country: United States, contacts name: Ashley Clayton, role: CONTACT, phone: 203-623-9830, email: [email protected], geoPoint lat: 41.30815, lon: -72.92816, hasResults: False |
protocolSection identificationModule nctId: NCT06375863, orgStudyIdInfo id: 44-2023, briefTitle: QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2023-05-29, completionDateStruct date: 2023-05-29, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Haseki Training and Research Hospital, class: OTHER, descriptionModule briefSummary: QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death.Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation.Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population.To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients., conditionsModule conditions: Anesthesia, Spinal, conditions: Sevoflurane, conditions: Long QT Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: QT and QTc interval, outcomesModule primaryOutcomes measure: QTc interval, secondaryOutcomes measure: QT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Science University, Haseki Training and Research Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06375850, orgStudyIdInfo id: Effects of topical sesame oil, briefTitle: Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-05, primaryCompletionDateStruct date: 2025-02-11, completionDateStruct date: 2025-05-11, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitario Marqués de Valdecilla, class: OTHER, descriptionModule briefSummary: Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis., conditionsModule conditions: Phlebitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Sesame oil, interventions name: Saline solution, outcomesModule primaryOutcomes measure: Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically, secondaryOutcomes measure: Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Marqués de Valdecilla, status: RECRUITING, city: Santander, state: Cantabria, zip: 39008, country: Spain, contacts name: Virginia Meneses Campos, role: CONTACT, phone: +34942202520, email: [email protected], contacts name: Virginia Meneses Campos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, hasResults: False |
protocolSection identificationModule nctId: NCT06375837, orgStudyIdInfo id: bioactive-NCCLs, briefTitle: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2026-06-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests., conditionsModule conditions: Tooth Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: an alkasite-based restorative material, interventions name: hybrid resin composite, interventions name: a highly filled flowable resin composite, outcomesModule primaryOutcomes measure: Clinical performances of different restorative systems according to FDI criteria (Esthetic properties), secondaryOutcomes measure: Clinical performances of different restorative systems according to FDI criteria (Functional properties), otherOutcomes measure: Clinical performances of different restorative systems according to FDI criteria (Biological properties), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Fatma Oz, role: CONTACT, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06375824, orgStudyIdInfo id: TCM for Pre-COPD, briefTitle: Bufei Recipe Reduces the Incidence Rate of COPD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Henan University of Traditional Chinese Medicine, class: OTHER, collaborators name: West China Hospital, collaborators name: The First Affiliated Hospital of Zhejiang Chinese Medical University, descriptionModule briefSummary: Establish early TCM prevention and treatment program to reduce the incidence rate of COPD., conditionsModule conditions: Preserved Ratio Impaired Spirometry, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Bufei Recipe, interventions name: Bufei Recipe placebo, outcomesModule primaryOutcomes measure: Incidence rate of COPD, secondaryOutcomes measure: FVC, secondaryOutcomes measure: FEV1, secondaryOutcomes measure: FEV1% pred, secondaryOutcomes measure: FEV1/FVC, secondaryOutcomes measure: IPAG-Q, secondaryOutcomes measure: LFQ, secondaryOutcomes measure: COPD-PS, secondaryOutcomes measure: CAT, secondaryOutcomes measure: SF-36, secondaryOutcomes measure: Clinical symptoms, secondaryOutcomes measure: Biochemical indicators, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06375811, orgStudyIdInfo id: 2000027121_temp, briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp, acronym: PREGnant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: University of Colorado, Denver, collaborators name: Northwestern University, collaborators name: University of North Carolina, collaborators name: Duke University, collaborators name: Johns Hopkins University, descriptionModule briefSummary: A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist., conditionsModule conditions: Infertility, conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Half of the subjects (200, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (200, placebo or SOC IVF). Elagolix or placebo will be taken for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo) is received no more than 24 hours before start of IVF treatment protocol., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: For participants who agree to be randomized, a computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Elagolix 200 MG, interventions name: Placebo or SOC IVF, outcomesModule primaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Fertilization rate, secondaryOutcomes measure: Number of embryos transferred, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: Biochemical pregnancy rate, secondaryOutcomes measure: Clinical pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Overall pregnancy complication rate, secondaryOutcomes measure: Gestation age at delivery, secondaryOutcomes measure: Infant birth weight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Department of Obstetrics & Gynecology, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Katherine Kuhn, role: CONTACT, phone: 303-724-5276, email: [email protected], contacts name: Nanette Santoro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06520, country: United States, contacts name: Michele Frank, role: CONTACT, phone: 203-785-6949, email: [email protected], contacts name: Hugn Taylor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Northwestern University Department of Obstetrics and Gynecology, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Jessica Almgren-Bell, role: CONTACT, phone: 312-503-4118, email: [email protected], contacts name: Emily Jungheim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Gaelle Massoud,, role: CONTACT, phone: 410-583-2763, email: [email protected], contacts name: James Segars, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Duke Fertility, status: RECRUITING, city: Morrisville, state: North Carolina, zip: 27560, country: United States, contacts name: Tifani Panek, role: CONTACT, phone: 773-706-4202, email: [email protected], contacts name: Steven Young, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.82348, lon: -78.82556, hasResults: False |
protocolSection identificationModule nctId: NCT06375798, orgStudyIdInfo id: 2020137, briefTitle: Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-11-19, primaryCompletionDateStruct date: 2026-11-19, completionDateStruct date: 2026-11-19, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Fourth Hospital, class: OTHER, descriptionModule briefSummary: A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery., conditionsModule conditions: Breast Cancer, conditions: HER2-negative Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 620, type: ESTIMATED, armsInterventionsModule interventions name: radiotherapy, outcomesModule primaryOutcomes measure: LRFS, eligibilityModule sex: FEMALE, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Hospital of Hebei Medical University, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: qimei wang, attending, role: CONTACT, phone: 18633051639, email: [email protected], geoPoint lat: 38.04139, lon: 114.47861, hasResults: False |
protocolSection identificationModule nctId: NCT06375785, orgStudyIdInfo id: LSVT-BIG vs Otago, briefTitle: Two Different Exercise Methods in Geriatrics, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Halic University, class: OTHER, collaborators name: Fenerbahce University, collaborators name: Istanbul Galata University, collaborators name: Biruni University, descriptionModule briefSummary: The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people, conditionsModule conditions: Elderly People, conditions: Nursing Homes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Otago-based (slow rhythmic) exercise group, interventions name: LSVT BIG-based (large amplitude) exercise group, outcomesModule primaryOutcomes measure: Timed Up &Go Test, primaryOutcomes measure: Performanz Balance System, primaryOutcomes measure: Functional Reaching Test, primaryOutcomes measure: Six Minute Walking Test, primaryOutcomes measure: Tinetti Balance and Gait Assessment, secondaryOutcomes measure: Activity-Specific Balance and Confidence Scale, secondaryOutcomes measure: Five Times Sit to Stand, secondaryOutcomes measure: Montreal Cognitive Assessment Test, secondaryOutcomes measure: KATZ Activities of Daily Living Scale, secondaryOutcomes measure: Clinical Frailty Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 80 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haliç University, city: Istanbul, state: Eyüpsultan, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
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