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The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week. conditions: Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pilot feasibility study primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Physical activity promotion measure: Weekly number of connections to the application over time measure: Response rate to the weekly questionnaires over time measure: Evolution of physical activity metrics measure: influence of pain on physical activity practice measure: influence of physical activity on pain report measure: long-term evolution of daily steps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg lat: 49.62056 lon: 6.07333 hasResults: False
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<|newrecord|> nctId: NCT06385015 id: IRB#23-001257 briefTitle: T-UP: Engaging Vulnerable Students in Diabetes Prevention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-04 date: 2024-05 date: 2025-06 date: 2024-04-25 date: 2024-04-26 name: University of California, Los Angeles class: OTHER name: American Diabetes Association briefSummary: The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity.
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The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP.
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The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey. conditions: Diabetes Mellitus, Type 2 conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 80 type: ACTUAL name: Tailored DPP Intervention measure: Change in weight (pounds, lbs) between baseline and 9-month follow-up measure: Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up sex: ALL minimumAge: 17 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-22 uploadDate: 2024-01-23T16:50 filename: ICF_000.pdf size: 203319 hasResults: False
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<|newrecord|> nctId: NCT06385002 id: 2024-0158 briefTitle: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-05-31 date: 2025-05-31 date: 2024-04-25 date: 2024-04-26 name: Pusan National University Yangsan Hospital class: OTHER briefSummary: Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone. conditions: Gynecological Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Remimazolam measure: time to emergence measure: time to tracheal extubation measure: usage of vasopressors measure: severity of cough measure: time to discharge from the recovery room measure: postoperative pain scores measure: scores for postoperative nausea and vomiting sex: FEMALE minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384989 id: MinnesotaHealthSolutions_LL briefTitle: Safety-Enhancing Motor Vehicle Child Safety Seat overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-08-15 date: 2024-04-25 date: 2024-04-25 name: Minnesota HealthSolutions class: INDUSTRY briefSummary: This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design. conditions: Motor Vehicle Injury conditions: Safety Issues studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Child restraint system with load leg feature measure: Correct use of load leg measure: Load leg error types measure: Other installation errors measure: Opinion on load leg design and instructions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Julie Mansfield, PhD role: CONTACT phone: 614-366-2101 email: [email protected] lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06384976 id: KYV101-007 briefTitle: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2029-01 date: 2024-04-25 date: 2024-04-25 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis conditions: Multiple Sclerosis, Primary Progressive conditions: Multiple Sclerosis, Secondary Progressive conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: KYV-101 name: Standard lymphodepletion regimen name: Anti-CD20 mAB measure: To evaluate efficacy of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To evaluate efficacy of KYV-101 measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacokinetics (PK) measure: To characterize the Pharmacodynamics (PD) measure: To characterize the Pharmacodynamics (PD) measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06384963 id: Cer22/02 briefTitle: Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF acronym: RSA-PACE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-04-01 date: 2024-04-25 date: 2024-04-25 name: Ceryx Medical Australia class: INDUSTRY name: Avania briefSummary: The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.
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The main questions the trial aims to answer are:
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* Is the new type of pacemaker safe?
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* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?
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Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. conditions: Heart Failure With Reduced Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Atrial pacing with respiratory sinus arrhythmia (RSA) variability name: Monotonic right atrial overdrive pacing measure: Number of arrhythmia episodes per patient during pacing sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Waikato Hospital city: Hamilton zip: 3240 country: New Zealand name: Martin Stiles, MB ChB role: CONTACT phone: +64 07 957 6080 email: [email protected] name: Kelly Henderson, BSc role: CONTACT phone: +64 0272564243 phoneExt: 25015 email: [email protected] lat: -37.78333 lon: 175.28333 hasResults: False
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<|newrecord|> nctId: NCT06384950 id: 2023-11-005A briefTitle: Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-29 date: 2025-03-21 date: 2024-04-25 date: 2024-04-25 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals.
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The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined. whoMasked: PARTICIPANT count: 450 type: ESTIMATED name: ChatGPT name: patient education with traditional methods. measure: Health literacy score of patients measure: Satisfaction score with medical care measure: Degree of patient anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06384937 id: GCA-PRO-2022-001-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-25 date: 2024-04-25 name: [Redacted] hasResults: False
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<|newrecord|> nctId: NCT06384924 id: SBU-RAMAN-SKINCANCER briefTitle: Raman Spectroscopy and Skin Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-04-30 date: 2024-04-25 date: 2024-04-25 name: Renee Cattell class: OTHER briefSummary: The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:
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-Can Raman Spectroscopy help figure out how far a tumor spreads?
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This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin. conditions: Skin Cancer conditions: Basal Cell Carcinoma conditions: Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Raman Spectroscopy handheld probe (EmVision, FL, USA) name: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. measure: Compare the size of clinically defined margin and Raman-defined margin measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stony Brook Hospital city: Stony Brook state: New York zip: 11794 country: United States name: Renee Cattell, PhD role: CONTACT email: [email protected] name: Renee Cattell, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False
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<|newrecord|> nctId: NCT06384911 id: STUDY00004543 briefTitle: InvesT1D: Promoting Adolescent Investment in Diabetes Care overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-08 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Seattle Children's Hospital class: OTHER name: Harvard Pilgrim Health Care briefSummary: The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.
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Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Financial Incentives Program measure: Time In Range measure: Time Above Range measure: Time Below Range measure: Hemoglobin A1c (HbA1c) measure: Diabetes Distress measure: Diabetes Family Conflict measure: Adolescent Quality of Life measure: Caregiver Quality of Life measure: Diabetic Ketoacidosis measure: Severe Hypoglycemia measure: Insulin Adminstration sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06384898 id: STUDY00002259 id: UH3AT012413 type: OTHER_GRANT domain: National Center for Complementary and Integrative Health briefTitle: Remote Tai Chi for Knee Osteoarthritis acronym: TAICHIKNEE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-10 date: 2024-04-25 date: 2024-04-25 name: Tufts Medical Center class: OTHER name: Boston Medical Center name: University of California, Los Angeles name: The Cleveland Clinic name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:
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* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)
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* Does remote tai chi decreases healthcare utilization?
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Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Remote Tai Chi measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: WOMAC total score measure: WOMAC total score measure: WOMAC total score measure: SF-12 PCS score measure: SF-12 PCS score measure: SF-12 PCS score measure: Number of knee joint injections measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC function score measure: WOMAC function score measure: WOMAC function score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: Patient's global assessment score measure: Patient's global assessment score measure: Patient's global assessment score measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: SF-12 MCS score measure: SF-12 MCS score measure: SF-12 MCS score measure: Receipt of knee surgery measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: Pain medication use measure: Pain medication use measure: Pain medication use sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Sherwood Alexis, MHA, MBA role: CONTACT phone: 617-636-5405 email: [email protected] name: Chenchen Wang, MD role: PRINCIPAL_INVESTIGATOR name: Tim McAlindon, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06384885 id: 2024-079 briefTitle: Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes acronym: SIPE overallStatus: RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2025-12-01 date: 2024-04-25 date: 2024-04-25 name: Rocky Vista University, LLC class: OTHER briefSummary: Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality. conditions: Swimming Induced Pulmonary Edema studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Ultrasound measure: Lung ultrasound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Vista University status: RECRUITING city: Parker state: Colorado zip: 80012 country: United States name: Kathryn A Vidlock, MD role: CONTACT phone: 651-226-1642 email: [email protected] name: Brady Patterson role: PRINCIPAL_INVESTIGATOR name: Harrison Steins role: PRINCIPAL_INVESTIGATOR lat: 39.5186 lon: -104.76136 hasResults: False
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<|newrecord|> nctId: NCT06384872 id: 230042_RRI_Interv5 briefTitle: Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk acronym: RRI_Interv5 overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-09-30 date: 2025-12-31 date: 2024-04-25 date: 2024-04-26 name: Luxembourg Institute of Health class: OTHER_GOV name: DECATHLON SA briefSummary: The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if
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1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials;
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2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part;
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3. Effects of cushioning material and position depend on the runner's body mass;
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4. Perception of cushioning is related to both shoe cushioning and injury risk;
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5. Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury.
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This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities.
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Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches and their respective app via Strava. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up).
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Primary hypothesis:
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- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners.
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Secondary hypothesis:
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* Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners.
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* Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties.
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* Greater perceived cushioning is related to lower injury risk. conditions: Running-related Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Participants will be stratified according to their sex. Two pre-established randomization list will be prepared by a statistician not involved in any other part of the study before the beginning of the study. To ensure allocation concealment, the study groups as well as the shoes will be coded and the randomization lists will be uploaded in the electronic system by an IT specialist who will not be involved in any other part of the study. The electronic system will provide the investigator with a study group code for each participant, according to the randomization lists. The investigator will upload the shoe ID according to shoe size and study group so that a cross validation will be performed by the electronic system. The investigators in charge of the recruitment, follow-up and data validity check, as well as the participants, will be blinded regarding the shoe version distributed. The shoe code will be broken after completion of data analysis. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1068 type: ESTIMATED name: Shoe Cushioning Position and Properties measure: First running-related injury with a duration of minimum one week measure: First one-day time loss running-related injury measure: First running-related musculoskeletal complaint to the lower limb measure: First substantial running-related injury measure: First overuse running-related injury sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg name: Laetitia Garcia, Msc role: CONTACT phone: +352 26970957 email: [email protected] lat: 49.62056 lon: 6.07333 hasResults: False
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<|newrecord|> nctId: NCT06384859 id: Pending briefTitle: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:
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Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?
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Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.
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Participants will:
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* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
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* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score conditions: Insertional Achilles Tendinopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: ESWT name: PRP measure: VAS measure: VAS-FA measure: FFI measure: FAAM sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ramathibodi hospital city: Ratchathewi state: Bangkok zip: 10400 country: Thailand name: Prapan Wongrungrote, MD role: CONTACT phone: +66 0810688654 email: [email protected] name: Sukij Laohajaroensombat, MD role: CONTACT phone: +66 022011589 email: [email protected] lat: 13.759 lon: 100.53358 hasResults: False
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<|newrecord|> nctId: NCT06384846 id: AI ACS briefTitle: AI Algorithms in Prediction of ACS Based on Leukocyte Properties overallStatus: RECRUITING date: 2024-02-01 date: 2026-07-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: RobotDreams GmbH class: INDUSTRY briefSummary: The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is:
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- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS.
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Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself. conditions: Acute Coronary Syndrome conditions: Angina Pectoris conditions: NSTEMI - Non-ST Segment Elevation MI conditions: STEMI - ST Elevation Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2700 type: ESTIMATED measure: Training of AI models measure: Testing of AI models measure: Training of AI models measure: Testing of AI models: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Landeskrankenhaus-Universitätsklinikum Graz status: RECRUITING city: Graz state: Styria / Steiermark zip: 8036 country: Austria name: Heiko Bugger, MD role: CONTACT phone: +43 316 385 30177 email: [email protected] lat: 47.06667 lon: 15.45 hasResults: False
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<|newrecord|> nctId: NCT06384833 id: Rama briefTitle: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:
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Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.
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Participants will:
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Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Ascorbic acid name: N-acetyl cysteine name: placebo measure: ASES score measure: UCLA shoulder scale measure: WORC index measure: Tendon healing at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384820 id: R3767-ONC-2330 id: 2023-510514-38-00 type: REGISTRY domain: EU CT Number briefTitle: Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) overallStatus: NOT_YET_RECRUITING date: 2024-11-14 date: 2026-06-08 date: 2030-05-06 date: 2024-04-25 date: 2024-04-25 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).
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The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.
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The study is looking at several other research questions, including:
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* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
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* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
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* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
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* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
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* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects) conditions: Cutaneous Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: cemiplimab name: fianlimab measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) measure: pCR rate by local pathological review measure: Major pathological response (MPR) measure: Event-free survival (EFS) measure: Disease free survival (DFS) measure: Objective response rate (ORR) prior to surgery measure: Overall survival (OS) measure: Occurrence of treatment-emergent adverse events (TEAEs) measure: Occurrence of immune-mediated adverse events (imAEs) measure: Occurrence of treatment-related TEAEs measure: Occurrence of adverse event of special interest (AESI) measure: Occurrence of treatment-emergent serious adverse events (SAEs) measure: Occurrence of laboratory abnormalities measure: Occurrence of death due to TEAE measure: Occurrence of interruption of study drug(s) due to TEAEs measure: Occurrence of discontinuation of study drug(s) due to TEAEs measure: Occurrence of cancellation of surgery due to TEAE measure: Occurrence of delay to surgery due to TEAE measure: Concentrations of cemiplimab in serum measure: Concentrations of fianlimab in serum measure: Concentrations of other experimental agents (as applicable) in serum measure: Incidence of anti-drug antibodies (ADA) to cemiplimab measure: Incidence of ADA to fianlimab measure: Incidence of ADA to other experimental agents (as applicable) measure: Titer of ADA to cemiplimab measure: Titer of ADA to fianlimab measure: Titer of ADA to other experimental agents (as applicable) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384807 id: BHV1510-101 (PBI-410-101) briefTitle: A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-02 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Pyramid Biosciences class: INDUSTRY briefSummary: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation followed by enrollment in signal-finding cohorts. primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: PBI-410 measure: Phase 1: Number of patients with adverse events (AEs) measure: Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD) measure: Phase 2: Objective Response Rate (ORR) measure: Phase 2: Number of patients with AEs measure: Phase 2: Duration of Response (DoR) measure: Phase 1 and 2: Maximum Plasma Concentration (Cmax) of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time Curve (AUClast) from the end of infusion to the last measurable concentration of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) measure: Phase 1 and 2: Elimination half-life (t1/2) of PBI-410 in plasma measure: Phase 1: ORR measure: Phase 1: Duration of Response (DoR) measure: Phase 1 and 2: Immunogenicity of PBI-410 measure: Phase 2: Disease control rate (DCR) measure: Phase 2: Progression free survival (PFS) measure: Phase 2: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384794 id: 2211-VLC-157-MD briefTitle: Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy. acronym: ZYMOT2 overallStatus: RECRUITING date: 2023-06-29 date: 2025-07-01 date: 2026-12-31 date: 2024-04-25 date: 2024-04-29 name: Instituto Valenciano de Infertilidad, IVI VALENCIA class: OTHER name: IVI Madrid briefSummary: It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes. conditions: Infertility, Male conditions: Sperm Count, Low studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric, prospective, experimental study. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Embryologists performing IVF/ICSI are blinded to the treatment the sample has undergone. All samples are labeled with the patients Identification number. This is a unique code per patient that does not allow identification of which arm the sample belongs to. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Sperm capacitation through the ZyMōt®Sperm Separation Device® name: Swim-up measure: EUPLOIDY RATE measure: MOBILITY RATE measure: VITALITY RATE measure: DNA FRAGMENTATION RATE measure: SPERM RETRIEVAL RATE measure: FERTILIZATION RATE measure: USEFUL BLASTOCYS RATE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ivirma Madrid status: RECRUITING city: Madrid zip: 28023 country: Spain name: MONICA TORIBIO role: CONTACT phone: +34 651 79 10 00 email: [email protected] name: Alberto Pacheco, PhD role: SUB_INVESTIGATOR name: Lucía Sánchez, MSc role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Ivirma Valencia status: RECRUITING city: Valencia zip: 46015 country: Spain name: Maria Jose Delossantos, PhD role: CONTACT phone: 34963050900 email: [email protected] name: Laura Caracena, Mrs role: CONTACT phone: 34963050900 phoneExt: 11054 email: [email protected] name: Maria Jose Delossantos, PhD role: PRINCIPAL_INVESTIGATOR name: José María Delosantos, PhD role: SUB_INVESTIGATOR name: Angel Martín, MSc role: PRINCIPAL_INVESTIGATOR name: David Ortega, MSs role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False
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<|newrecord|> nctId: NCT06384781 id: 2130836 id: R61DA059892-01 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA059892-01 briefTitle: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: Prisma Health-Upstate class: OTHER name: Clemson University name: National Institute on Drug Abuse (NIDA) briefSummary: This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD. conditions: Opioid Use Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Phase 1: Conceptualization measure: Phase 2: Conceptulization measure: Phase 3: Refinement measure: Phase 4: Validation measure: Phase 5: Preliminary efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Addiction Medicine Center - Mobile Health Clinic status: RECRUITING city: Clinton state: South Carolina zip: 29325 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: [email protected] name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.47263 lon: -81.88066 facility: Prisma - Addiction Medicine Center Mobile Health Clinic status: RECRUITING city: Seneca state: South Carolina zip: 29672 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: [email protected] name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.68566 lon: -82.9532 hasResults: False
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<|newrecord|> nctId: NCT06384768 id: EBIst id: 1919B012104428 type: OTHER_GRANT domain: TUBITAK briefTitle: Video Training on Pre-Pregnancy Fear of Birth in Male Partners overallStatus: COMPLETED date: 2022-02-01 date: 2022-05-01 date: 2022-08-30 date: 2024-04-25 date: 2024-04-26 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \"Descriptive Information Form\" and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners. conditions: Fear of Childbirth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 43 type: ACTUAL name: Video training measure: Fear of Childbirth sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06384755 id: 645788 id: 2022_HE2_409659 type: OTHER_GRANT domain: The Dam Foundation id: 645788 type: OTHER domain: Regional Ethics Committee (REK), South-East Norway briefTitle: Honest Open Proud for Psychotic and Bipolar Disorder in Norway acronym: HOP-NOR overallStatus: RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Oslo University Hospital class: OTHER name: University of Oslo briefSummary: The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting. conditions: Psychotic Disorders conditions: Bipolar Disorder conditions: Disclosure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Honest Open Proud program measure: Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) measure: Disclosure Distress (Rüsch et al., 2014a) measure: Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007) measure: Satisfaction with life (Lehman, 1988) measure: The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007) measure: Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014) measure: Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009) measure: Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006) measure: Disclosure measure: Feasibility of HOP program measure: Acceptability of HOP program participants measure: Acceptability of HOP peer facilitators sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital status: RECRUITING city: Oslo zip: 0351 country: Norway name: Mari Husa, MD role: CONTACT phone: 0047 95837846 email: [email protected] name: Magnus Engen, PhD role: CONTACT phone: 0047 41004660 email: [email protected] lat: 59.91273 lon: 10.74609 facility: Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital status: NOT_YET_RECRUITING city: Oslo zip: 1281 country: Norway name: Hilde Daler, MSc role: CONTACT phone: 0047 23023100 email: [email protected] name: Marit Haram, PhD role: CONTACT phone: 0047 21077000 email: [email protected] lat: 59.91273 lon: 10.74609 hasResults: False
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<|newrecord|> nctId: NCT06384742 id: K23HL157698 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL157698 briefTitle: Shift Worker Intervention for Sleep Health acronym: SWISH overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-25 date: 2024-04-25 name: Oregon State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers. conditions: Shift Work Type Circadian Rhythm Sleep Disorder conditions: Insomnia, Psychophysiological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Shift Worker Intervention for Sleep Health measure: Retention Rate measure: Session Attendance measure: Implementation Assessment Measure measure: Patient Adherence measure: Therapist Fidelity measure: Acceptability of Study Procedures and SWISH measure: Mean 24-hour sleep duration and efficiency measure: Change in Fatigue Severity Scale measure: Change in Epworth Sleepiness Scale measure: Executive functioning measure: PROMIS Sleep Related Impairment measure: PROMIS Sleep Disturbances sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon State University city: Corvallis state: Oregon zip: 97331-1102 country: United States name: Jessee Dietch, PhD role: CONTACT phone: 541-737-1358 email: [email protected] name: Jessee Dietch, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.56457 lon: -123.26204 hasResults: False
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<|newrecord|> nctId: NCT06384729 id: 123 briefTitle: Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Abstract:
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Background:
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Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions.
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Objective:
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To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS.
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Methods:
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A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0.
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Results:
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Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests.
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Conclusion:
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This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 22 type: ESTIMATED name: EXOPULSE Mollii Ⓡ measure: referred pain measure: Balance measure: gait speed and distance measure: fall risk measure: perception of walking difficulties measure: perceived quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Villaviciosa De Odón state: Madrid zip: 28670 country: Spain name: Cecilia Estrada Barranco, PhD role: CONTACT phone: 686166483 email: [email protected] lat: 40.35692 lon: -3.90011 hasResults: False
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<|newrecord|> nctId: NCT06384716 id: CEB briefTitle: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-02-19 date: 2024-07-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control. conditions: Multiple Sclerosis conditions: Pelvic Floor Disorders conditions: Incontinence, Urinary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: rehabilitation programme based on motor control of core muscles measure: Difference in the percentage of initial and final maximum activity of the pelvic floor muscles. measure: - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound. measure: - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire. measure: - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire measure: - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity. measure: - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound. measure: - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1) measure: differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP). measure: balance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Madrid country: Spain name: Cecilia Estrada-Barranco, PhD role: CONTACT phone: 686166483 email: [email protected] name: Esther Delgado, PhD role: CONTACT email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06384703 id: 201518015 briefTitle: The Relationship Between Microbiota and Coronary Ectasia overallStatus: COMPLETED date: 2020-11-03 date: 2021-04-25 date: 2021-06-18 date: 2024-04-25 date: 2024-04-25 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV name: Necmettin Erbakan University briefSummary: Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases. conditions: Coronary Ectasia conditions: Microbial Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: Taking blood for kit study measure: death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University city: Konya zip: 42050 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06384690 id: 4331899 briefTitle: Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend overallStatus: RECRUITING date: 2024-02-01 date: 2024-11-30 date: 2025-08-31 date: 2024-04-25 date: 2024-04-25 name: University of Exeter class: OTHER name: Advanced Growers Limited name: Ecog Pro Limited briefSummary: Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants. conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Micro-vegetable blend name: Placebo measure: Tandem Mass Tag (TMT) global proteomics measure: Concentration of broad panel of inflammatory cytokines measure: Concentration of circulating bioactive components measure: Microbiome measure: Simple Reaction Time measure: Digit Vigilance measure: Choice Reaction Time measure: Pattern Separation sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Public Health and Sports Sciences, University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Cealan Henry role: CONTACT email: [email protected] lat: 50.7236 lon: -3.52751 hasResults: False
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<|newrecord|> nctId: NCT06384677 id: 03.03.2023/371 briefTitle: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery overallStatus: COMPLETED date: 2023-04-20 date: 2024-02-01 date: 2024-02-01 date: 2024-04-25 date: 2024-04-25 name: Marmara University class: OTHER briefSummary: This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects. conditions: Abdominal Cancer conditions: Abdomen Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 43 type: ACTUAL name: M-Tapa Block measure: Opioid Consumption measure: NRS Scores measure: the need for rescue analgesia measure: side effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Pendik Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06384664 id: HUM00241242 briefTitle: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-25 date: 2024-04-25 name: University of Michigan class: OTHER name: AtriCure, Inc. briefSummary: The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block. conditions: Pain, Postoperative conditions: Intrathoracic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Atricure's crysoSPHERE probe name: Standard of Care measure: Severity of pain in the peri-operative period measure: Inflammatory cytokine levels as measured by blood samples measure: Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score measure: Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Quality of life score as measured by SF-36 Health questionnaire measure: Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) measure: Workflow/time measure: Complications following surgery measure: Length of stay measure: Time to ambulation measure: Chronic Pain medication use through 6 months measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Incentive spirometry volumes in the peri-operative period (POD 1 and 2) measure: Oxygen requirement measure: Hospital charges and hospital reimbursement by different payors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Shari L Barnett role: CONTACT phone: 734-936-4561 email: [email protected] name: Rishindra Reddy, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06384651 id: PRO00037789 briefTitle: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty acronym: IOTAA overallStatus: RECRUITING date: 2023-12-13 date: 2027-04 date: 2027-12 date: 2024-04-25 date: 2024-04-25 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).
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Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
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Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups. conditions: Infections conditions: Ankle Arthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Intraosseous Vancomycin Injection name: Intravenous Vancomycin measure: Systemic Sample Vancomycin Tissue Concentration - Start of Case measure: Systemic Sample Vancomycin Tissue Concentration - End of Case measure: Capsule or Synovium Sample Vancomycin Tissue Concentration measure: Distal Tibia Sample Vancomycin Tissue Concentration measure: Talar Bone Sample Vancomycin Tissue Concentration measure: 90 day post-operative wound complication and infection rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Thomas C Sullivan, BS role: CONTACT phone: 346-238-1603 email: [email protected] name: Jason S Ahuero, MD role: PRINCIPAL_INVESTIGATOR name: Kevin Varner, MD role: SUB_INVESTIGATOR name: Kwan J Park, MD role: SUB_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06384638 id: coconut periodontitis briefTitle: Coconut Oil in Treatment of Periodontitis overallStatus: COMPLETED date: 2022-02-15 date: 2024-01-16 date: 2024-02-09 date: 2024-04-25 date: 2024-04-25 name: Misr University for Science and Technology class: OTHER briefSummary: Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: topical application of coconut oil name: scaling and debridement measure: clinical parameters measure: clinical parameters measure: Biological parameters sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of dentistry at MUST city: Giza zip: 02 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06384625 id: 361378 briefTitle: Air Pollution Intervention for Cardiovascular Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-01 date: 2025-02-01 date: 2024-04-25 date: 2024-04-25 name: University of Montana class: OTHER name: Providence Heart Institute briefSummary: This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance. conditions: Coronary Heart Disease conditions: Cardiovascular Diseases conditions: Environmental Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: AIRWISE measure: Evaluate the implementation of an indoor air pollution intervention. measure: Fine particulate matter (PM2.5) measure: Life's Essential 8 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384612 id: Adnan Menderes U briefTitle: The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng overallStatus: COMPLETED date: 2021-09-13 date: 2022-05-22 date: 2023-07-13 date: 2024-04-25 date: 2024-04-25 name: Aydin Adnan Menderes University class: OTHER briefSummary: The aim of this study is to examine the effect of the use of pocket cards by students taking the "Care of a Child with Special Needs" course on students' self-efficacy perceptions and course success.
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1. H01. There is no difference between the self-efficacy perception scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards.
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2. H02. There is no significant difference between the course success scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards. conditions: Student conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental primaryPurpose: OTHER masking: NONE count: 128 type: ACTUAL name: use of pocket cards measure: Self-Efficacy Perception Scale sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: Bircan Kahraman Berberoğlu city: Efeler state: Aydin zip: 0900 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06384599 id: CS-190 briefTitle: VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-25 date: 2024-04-25 name: Adagio Medical class: INDUSTRY briefSummary: The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia. conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: VT Cryoablation System measure: Primary Performance Endpoint measure: Primary Safety Endpoint measure: Secondary Performance Endpoint measure: Secondary Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essex Cardiothoracic Centre city: Basildon state: Essex zip: SS16 5NL country: United Kingdom name: Neil Srinivasan role: CONTACT lat: 51.56844 lon: 0.45782 hasResults: False
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<|newrecord|> nctId: NCT06384586 id: CD J8855 briefTitle: Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood overallStatus: COMPLETED date: 2022-11-17 date: 2022-12-22 date: 2022-12-22 date: 2024-04-25 date: 2024-04-25 name: The Water Street Collective class: INDUSTRY name: HCD Research name: British American Tobacco (Investments) Limited briefSummary: This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants. conditions: Cognition conditions: Mental Fatigue conditions: Mood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: Placebo shot name: Functional energy shot measure: Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. measure: Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot. measure: Change in performance on Corsi blocks task for functional energy shot versus placebo measure: Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo measure: Change in performance on Numeric working memory for functional energy shot versus placebo measure: Change in performance on Serial subtraction task for functional energy shot versus placebo measure: Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo measure: Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Schlesinger Group New Jersey city: Iselin state: New Jersey zip: 08330 country: United States lat: 40.57538 lon: -74.32237 hasResults: False
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<|newrecord|> nctId: NCT06384573 id: DIAN-TU-003 id: The Alzheimer's Association type: OTHER_GRANT domain: DIAN-TU-OLE-21-725093 briefTitle: DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease acronym: DIAN-TU overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-11 date: 2029-11 date: 2024-04-25 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: Alzheimer's Association name: Eisai Inc. briefSummary: This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression. conditions: Alzheimer's Disease conditions: Dementia conditions: Alzheimer's Disease, Familial studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: lecanemab measure: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama in Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Erik Roberson role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California San Diego Medical Center city: La Jolla state: California zip: 92037 country: United States name: Doug Galasko role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Indiana University School of Medicine city: Indianapolis state: Indiana zip: 46202 country: United States name: Jared Brosch role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Washington University in St. Louis city: Saint Louis state: Missouri zip: 63110 country: United States name: Barbara Snider role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sarah Berman role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States name: Suman Jayadev role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 facility: Neuroscience Research Australia city: Randwick state: New South Wales zip: 2031 country: Australia name: William Brooks role: PRINCIPAL_INVESTIGATOR lat: -33.91439 lon: 151.24895 facility: The National Hospital for Neurology and Neurosurgery city: London state: Greater London zip: WC1B 3BG country: United Kingdom name: Catherine Mummery role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06384560 id: 2023-508707-20-00 briefTitle: Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5) acronym: PREOPANC-5 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-03 date: 2028-03 date: 2024-04-25 date: 2024-04-25 name: Amsterdam UMC, location VUmc class: OTHER name: Maastricht University Medical Center name: Erasmus Medical Center name: St. Antonius Hospital briefSummary: Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC. conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Pembrolizumab measure: Percentage of patients with progression free survival at 18 months (RECIST 1.1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06384547 id: VRDN-001-303 briefTitle: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-01 date: 2024-04-25 date: 2024-04-25 name: Viridian Therapeutics, Inc. class: INDUSTRY briefSummary: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, active controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 212 type: ESTIMATED name: VRDN-001 10 mg/kg name: VRDN-001 3 mg/kg measure: Treatment Emergent Adverse Event (TEAE) incidence rate measure: Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United Medical Research Institute city: Inglewood state: California zip: 90301 country: United States name: James Peace, MD role: CONTACT phone: 310-645-4673 lat: 33.96168 lon: -118.35313 hasResults: False
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<|newrecord|> nctId: NCT06384534 id: PVD_6MWD_SOT briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-25 date: 2024-04-25 name: University of Zurich class: OTHER briefSummary: The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). conditions: Pulmonary Vascular Disorder conditions: Chronic Thromboembolic Pulmonary Hypertension conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant is its own control primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: 6-minute walk distance (6MWD) test on ambient air name: 6-minute walk distance test with supplemental oxygen measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zürich city: Zurich zip: 8091 country: Switzerland name: Silvia Ulrich, Prof. Dr. role: CONTACT phone: 0041 44 255 22 20 email: [email protected] name: Mona Lichtblau, Dr. role: CONTACT phone: +41442552220 email: [email protected] name: Silvia Ulrich, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06384521 id: STUDY00000500 briefTitle: Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial acronym: MIND overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-05 date: 2024-04-25 date: 2024-04-25 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are:
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* Does Lifestyle MIND improve diabetes control among people with SMI?
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* Will the effect of Lifestyle MIND be sustained 10 weeks after program completion?
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* From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI?
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