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<|newrecord|> nctId: NCT06274879 id: 1938 Ablatio-bilica id: SNCPT type: OTHER domain: Portal for clinical trials in Switzerland briefTitle: Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer acronym: Ablatio overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-02-23 date: 2024-02-23 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: Swiss Cancer League briefSummary: The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.
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Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.
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Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate. conditions: Bile Duct Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Gemcitabin, Cisplatin and Durvalumab name: Biliary Radiofrequency Ablation name: Endoscopic Retrograde Cholangio-Pancreatography with stenting measure: Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after enrolment. measure: Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions measure: Progression-free survival, which is defined as the time till the progression of disease or death, whatever comes first, from the time of enrolment to the end of follow-up. measure: Death from any cause from the time of enrolment to the end of follow-up (overall survival). measure: Development of disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle plus at 3 and 6 months from the start of the CICI treatment measure: Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30 measure: Stent patency at month 3 visit and end of study visit measure: Number of courses of CICI applied measure: Total dose of CICI applied measure: Details of adverse events measure: Prognostic significance of response to intraductal biliary RFA by genetic tumor characterization using next-generation sequencing measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital Bern University Hospital city: Bern state: Be zip: 3010 country: Switzerland name: Reiner Prof. Dr. med. Wiest role: CONTACT phone: +41 31 632 59 41 email: [email protected] name: Martin Prof. Dr. med. Berger role: CONTACT phone: +41 31 632 41 14 email: [email protected] name: Reiner Prof. Dr. med. Wiest role: PRINCIPAL_INVESTIGATOR name: Martin Prof. Dr. med. Berger role: SUB_INVESTIGATOR lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06274866 id: dsahinoglu briefTitle: Effects Of A Home Based Exercise Program Following Total Hip Arthroplasty overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-10 date: 2023-04-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Halic University class: OTHER briefSummary: The aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. Forty-four individuals with hip osteoarthritis were included in current study. Individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. Individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. Individuals in the control group were followed up with an exercise training brochure. The exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. All individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. Range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the Q angle was measured with a goniometer. In addition to these,Tampa kinesiophobia scale, Oxford hip score and international physical activity scale were used. Timed up-and-go test was used to evaluate functional performance. Foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control. conditions: PHYSİOTHERAPY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomize controlled two groups primaryPurpose: TREATMENT masking: NONE maskingDescription: no blinding count: 48 type: ACTUAL name: exercise program name: control group measure: OXFORD HİP SCORE measure: TAMPA SCALE FOR KINESİOPHOBİA measure: İNTERNATİONAL PHYSİCAL ACTİVİTY QUESTİONAİRE (SHORT FORM) measure: JOİNT POSİTİON SENSE ERROR TEST measure: FOUR SQUARE STEP TEST measure: THE TİMED UP and GO TEST measure: Assessment of Hip Muscle Strength measure: Assessment of Hip Joint Range of Motion measure: Assessment of Postural Control measure: MEASURİNG LEG LENGTH DİSCREPANCY measure: Q ANGLE sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeditepe Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06274853 id: 170327-0001 id: 6830/0003 type: OTHER domain: ICON plc briefTitle: GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12 date: 2024-12 date: 2024-02-23 date: 2024-02-23 name: National Center for Advancing Translational Sciences (NCATS) class: NIH name: Leidos Biomedical Research, Inc. name: ICON Government and Public Health Solutions, Inc briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.
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Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels. conditions: COVID-19 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: GS-441524 name: Placebo measure: Treatment-emergent adverse events (TEAEs) measure: Blood Pressure in mm/Hg measure: Pulse in beats/min measure: Respiratory Rate in breaths per minute measure: Body Temperature in degrees measure: Electrocardiogram (ECG) as measured by PR interval measure: Electrocardiogram (ECG) as measured by QT interval measure: Electrocardiogram (ECG) as measured by QT corrected (Fridericia's) measure: Plasma PK Parameter C-Max measure: Plasma PK Parameter t-max measure: Plasma PK Parameter t-lag measure: Plasma PK Parameter AUC 0-last measure: Plasma PK Parameter AUC 0-inf measure: Plasma PK Parameter t 1/2 measure: Plasma PK Parameter CL/F measure: Plasma PK Parameter Vz/F measure: Urine PK Parameter Ae urine measure: Urine PK Parameter Fe urine measure: Urine PK Parameter CL R measure: Plasma PK Parameter C trough measure: Plasma PK Parameter AUC 0-tau measure: Plasma PK Parameter CL/F ss measure: Plasma PK Parameter Vz/F ss measure: Plasma PK Parameter R ac sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06274840 id: CAR-CF briefTitle: COVID-19 Antibody Responses In Cystic Fibrosis acronym: CAR-CF overallStatus: RECRUITING date: 2022-08-08 date: 2024-05 date: 2024-05 date: 2024-02-23 date: 2024-02-23 name: Pilar Azevedo class: OTHER name: Queen's University, Belfast name: European Cystic Fibrosis Society - Clinical Trial Network name: Cystic Fibrosis Foundation name: Medical University Innsbruck briefSummary: Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres in Europe. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments.
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Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed. conditions: COVID-19 conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: SARS-COV-2 seroprevalence measure: Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF measure: Longitudinal comparison of the detection measure: Serum proteomic and genomic responses of pwCF sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHLN status: RECRUITING city: Lisboa zip: 1800-268 country: Portugal name: Celeste Barreto role: CONTACT name: Ana Lopes role: CONTACT name: Celeste Barreto, MD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 hasResults: False
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<|newrecord|> nctId: NCT06274827 id: GO 22- 881 briefTitle: Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises overallStatus: COMPLETED date: 2022-09-25 date: 2023-04-30 date: 2023-06-20 date: 2024-02-23 date: 2024-02-26 name: Hacettepe University class: OTHER briefSummary: In shoulder rehabilitation, the inclusion of kinetic chain exercises is advocated in order to provide the necessary energy transfer to produce optimal force with minimal energy consumption. Closed kinetic chain (CKC) exercises are defined as exercises in which the distal segment is stabilized by encountering significant resistance while the proximal segment moves. In contrast, open kinetic chain (OKC) exercises allow the distal segment to move freely without any resistance. Recently, the importance of closed kinetic chain (CKC) exercises has increased in enhancing shoulder joint neuromuscular control by improving dynamic shoulder stability and joint position sense.
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The most current shoulder rehabilitation protocols include exercises for restoration of scapular muscle imbalances.There exist studies investigating the levels of scapular muscle activation during CKC exercises. Researchers have shown that most CKC exercises especially push-ups and plank variations with the shoulder in the 90° position, generally provide high SA activity and an optimal UT/SA ratio.In the literature, there is limited information on how the level of shoulder elevation affects scapular muscle activity and ratio during closed kinetic chain exercises in the prone position. To effectively prescribe CKC exercises commonly used in rehabilitation and athletic programs, a clear understanding of shoulder elevation changes muscle activity during these exercises is required.
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Our hypothesis is that glenohumeral joint elevation status will alter scapular muscle activation and activation rates. conditions: Shoulder Pain conditions: Shoulder Injuries conditions: Activation, Patient studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants will complete each stage in a randomized order. primaryPurpose: BASIC_SCIENCE masking: NONE count: 22 type: ACTUAL name: Superficial Electromyography measure: Muscle activation recorded with surface electromyography (sEMG) during CKC sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Hacettepe University city: Ankara zip: 06430 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06274814 id: AP23.501.038 briefTitle: U/S Guided Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block vs Type 2 Pectoral Nerve Block overallStatus: RECRUITING date: 2023-06-01 date: 2024-04-01 date: 2024-05-01 date: 2024-02-23 date: 2024-03-13 name: National Cancer Institute, Egypt class: OTHER briefSummary: The aim of this study is to compare between U/S Guided Rhomboid Intercostal Block Combined with Sub-Serratus Plane Block vs type 2 Pectoral Nerve Block in Analgesia for Breast Cancer Surgery by measuring intraoperative hemodynamics, postoperative pain scores and morphine consumption in the first 24 h postoperative. conditions: Breast Neoplasm Female conditions: Analgesics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 69 type: ESTIMATED name: U/S guided Rhomboid intercostal block (RIB) name: U/S guided RIB combined with the sub-serratus plane block (RISS) measure: Total morphine consumption measure: Visual Analog scale score postoperative measure: Intraoperative fentanyl consumption measure: Heart rate intraoperative measure: Timing of first rescue analgesia sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National cancer Insititute status: RECRUITING city: Cairo zip: 11796 country: Egypt name: attef, lecturer role: CONTACT phone: +20225328286 email: [email protected] name: ahmed soliman role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06274801 id: GB002-3102 id: 2023-506334-75 type: EUDRACT_NUMBER briefTitle: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2026-12 date: 2024-02-23 date: 2024-02-23 name: GB002, Inc. class: INDUSTRY briefSummary: This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Seralutinib name: Gereic Dry Powder Inhaler measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Changes in distance achieved on the Six-Minute Walk Test (6MWT) measure: Changes in NT-proBNP sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: Pulmonary Associates of Richmond, Inc. city: Richmond state: Virginia zip: 23230 country: United States lat: 37.55376 lon: -77.46026 hasResults: False
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<|newrecord|> nctId: NCT06274788 id: OMEG-054-CP4 briefTitle: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-01 date: 2027-03-01 date: 2024-02-23 date: 2024-03-12 name: Fresenius Kabi class: INDUSTRY briefSummary: This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population conditions: Parenteral Nutrition Associated Liver Disease (PNALD) conditions: Essential Fatty Acid Deficiency conditions: Malnutrition conditions: Pediatric ALL studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Omegaven® (fish oil triglycerides) Injectable Emulsion measure: Incidence of essential fatty acid deficiency (EFAD) measure: Incidence of clinical EFAD measure: Time from treatment start to EFAD diagnosis measure: Incidence of adverse events (AEs)/serious adverse events (SAEs) measure: Routine laboratory tests: Direct or conjugated bilirubin measure: Routine laboratory tests: triglycerides measure: Fatty acid profiles: α-linolenic acid measure: Fatty acid profiles: linoleic acid measure: Fatty acid profiles: arachidonic acid measure: Fatty acid profiles: mead acid measure: Fatty acid profiles: oleic acid measure: Fatty acid profiles: docosahexaenoic acid (DHA) measure: Fatty acid profiles: eicosapentaenoic acid (EPA) measure: Anthropometric measures: body weight measure: Anthropometric measures: body height/length measure: Anthropometric measures: head circumference sex: ALL minimumAge: 1 Day maximumAge: 17 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06274775 id: 23-12026811 briefTitle: Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-02-23 date: 2024-04-12 name: Weill Medical College of Cornell University class: OTHER briefSummary: The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures. conditions: Anxiety conditions: Literacy conditions: Satisfaction, Patient studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Educational Video measure: Anxiety, as measured by the State Trait Anxiety Inventory measure: Anxiety, as measured by the Amsterdam Preoperative Anxiety and Information Scale measure: Need for information, as measured by the Amsterdam Preoperative Anxiety and Information Scale measure: Health literacy, as measured by 4 domains of The Health Literacy Questionnaire measure: Patient satisfaction, as measured by a patient satisfaction survey measure: Quality of video intervention for intervention participants, as measured by a qualitative feedback survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine city: New York state: New York zip: 10065 country: United States name: Shari R. Lipner, MD, PhD role: CONTACT email: [email protected] name: Rachel C Hill, BS role: CONTACT phone: 5024170984 email: [email protected] lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06274762 id: MARU-SBF-ROKÇ-01 briefTitle: Visually Impaired Women Model-based Cancer Education and Breast Self-examination overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-03-31 date: 2025-03-31 date: 2024-02-23 date: 2024-02-23 name: Marmara University class: OTHER briefSummary: The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination. conditions: Breast Cancer Awareness and BSE in Visually Impaired Women studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done. primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Training and BSE application on a model measure: Champion health belief model scale sex: FEMALE minimumAge: 20 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University city: Istanbul country: Turkey name: Marmara University role: CONTACT email: [email protected] name: Seval Saraydemir Kıromeroglu role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06274749 id: 10001930 id: 001930-AG briefTitle: Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial overallStatus: RECRUITING date: 2024-05-01 date: 2027-03-31 date: 2027-03-31 date: 2024-02-23 date: 2024-04-26 name: National Institute on Aging (NIA) class: NIH briefSummary: Background:
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As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.
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Objective:
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To learn if UA improves levels of insulin and other hormones that help control blood glucose.
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Eligibility:
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People aged 55 years and older with a body mass index of 27 or higher.
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Design:
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Participants will have 6 clinic visits over 8 weeks.
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Participants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.
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UA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.
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Participants will have tests during the study including:
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Oral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.
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Continuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.
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Exercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.
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Imaging scans of the thigh; scans of the brain are optional.... conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Urolithin A name: Placebo measure: To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation. measure: To determine if UA supplementation will increase incretin secretion in response to oral glucose at 4 and 8 weeks after the supplementation. measure: To determine if UA supplementation will enhance mitochondria respiration, based on p31 spectroscopy by thigh MRI/MRS at baseline and 8 weeks after supplementation. measure: To determine if UA will increase brain oxidative metabolism, based on brain MRS at baseline and 8 weeks after supplementation. measure: To determine if UA supplementation will alter gut microbiome composition. sex: ALL minimumAge: 55 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Aging, Clinical Research Unit status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Josephine Egan, M.D. role: CONTACT phone: 410-558-8414 email: [email protected] lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06274736 id: CLINP-001012 briefTitle: Safety and Performance of Motiva® Sizers overallStatus: RECRUITING date: 2023-04-10 date: 2027-04-10 date: 2027-07-10 date: 2024-02-23 date: 2024-02-23 name: Establishment Labs class: INDUSTRY briefSummary: The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
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The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica.
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The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates.
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After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook. conditions: Breast Implant; Complications conditions: Breast Implantation; Methods, Safety and Performance conditions: Mammaplasty conditions: Breast Reconstruction conditions: Breast Augmentation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 330 type: ESTIMATED name: Motiva Sizer measure: Motiva Sizers Safety (complications) measure: Motiva Sizers Performance (satisfaction) measure: Motiva Sizers Safety (reoperations) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Establishment Labs status: RECRUITING city: Coyol state: Alajuela zip: 20102 country: Costa Rica lat: 10.00126 lon: -84.26124 hasResults: False
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<|newrecord|> nctId: NCT06274723 id: STUDY00001220 id: 1K99CA281094-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1K99CA281094-01A1 briefTitle: Responses to E-cigarette Message Source and Presentation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: University of Massachusetts, Worcester class: OTHER name: National Cancer Institute (NCI) briefSummary: The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. conditions: Vaping studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 800 type: ESTIMATED name: Expert name: Peer name: 1 Sided name: 2 Sided measure: Message acceptance measure: Harm perceptions measure: Psychological reactance measure: Message liking measure: Source trust measure: Attitudes measure: Behavioral intentions to vape or try vaping sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-01-31T10:44 filename: SAP_000.pdf size: 176839 hasResults: False
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<|newrecord|> nctId: NCT06274710 id: 23-5554 briefTitle: ODYSSEE Kidney Health Trial acronym: ODYSSEE-KH overallStatus: RECRUITING date: 2023-12-13 date: 2026-04-13 date: 2026-04-13 date: 2024-02-23 date: 2024-02-23 name: University Health Network, Toronto class: OTHER name: Sunnybrook Health Sciences Centre name: Scarborough General Hospital name: The Ottawa Hospital briefSummary: INTRODUCTION
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Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life.
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HYPOTHESES
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The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months).
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The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures.
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RECRUITMENT
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Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital.
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DESIGN
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ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked.
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ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account.
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ANALYSIS
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Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 344 type: ESTIMATED name: ODYSSEE-KH measure: Incidence of home RRT measure: Improvement of Home RRT measure: Improvement of RRT preparation with planned dialysis access measure: Incidence of annual hospitalization rate measure: Engagement with RRT education and CKD self-care counselling resources measure: Self-reported engagement in activities for living well measure: Self-reported assessment for health-related quality of life due to kidney disease measure: Self-reported assessment of people's aspirations and goals measure: Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning) measure: Self-reported depression measure: Self-reported perceived social support measure: Self-reported psychological wellbeing measure: Self-reported anxiety measure: Self-reported feeling of value to self and others measure: Self-reported measure of psychological wellbeing and happiness measure: Self-reported measure of overall life experience measure: Self-reported measure of well-being measure: Self-reported readiness for change (motivation) measure: Self-reported confidence in doing life activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network status: RECRUITING city: Toronto state: Ontario zip: M2N 7A2 country: Canada name: Robert P Nolan, PhD role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: [email protected] name: Karly Gunson, HBA, BHSc role: CONTACT phone: (416) 340-4800 phoneExt: 6400 email: [email protected] lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06274697 id: RECHMPL22_0391 id: 2023-A01784-41 type: REGISTRY domain: ID-RCB briefTitle: Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites acronym: COMADO overallStatus: RECRUITING date: 2024-04-02 date: 2025-04 date: 2025-04 date: 2024-02-23 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER name: phymedexp briefSummary: The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.
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The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.
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Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease. conditions: Lower Extremity Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 70 type: ESTIMATED name: Evaluation by magnetic sensor measure: Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery measure: Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other measure: Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording measure: Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Center status: RECRUITING city: Montpellier country: France name: Gudrun BOGE, MD role: CONTACT phone: 467336279 phoneExt: 33 email: [email protected] name: Gudrun BOGE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06274684 id: 2023-01100 briefTitle: Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia. overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2025-05-01 date: 2025-07-01 date: 2024-02-23 date: 2024-02-28 name: University Hospital, Geneva class: OTHER briefSummary: The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia.
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The main question it aims to answer:
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- Is there a significant decrease on anxiety level thanks to VR-assistance?
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Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure.
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Researchers will compare standardised anxiety scores with a control group. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Use of Virtual Reality Assistance during prostate biopsies measure: Anxiety level measure: Anxiety level of the surgeon measure: Biopsies complications sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274671 id: 23-24-09 briefTitle: Glymphatic MRI in Clinically Isolated Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-05-15 date: 2025-05-15 date: 2024-02-23 date: 2024-02-23 name: University of Exeter class: OTHER briefSummary: The brain possesses a system to get rid of unwanted substances, named Glymphatic System (GS). When this system is faulty, these accumulate, there is local inflammation, and progressive death of the cells. This occurs in neurological diseases including Parkinson's, or Alzheimer's. Inflammation and progressive death of the cells are also present in another neurological disorder, named Multiple Sclerosis (MS).
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Doctors think that GS dysfunction plays a role in MS too. In this research therefore, the aim is to study whether it drives inflammation, and disease progression in MS patients.
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The researchers have developed a new way to find signs of alteration of the GS using a scan named Magnetic Resonance Imaging (MRI) and will use it in a pilot study on patients with a condition named Clinically Isolated Syndrome (CIS), which often represents the very beginning of MS. It would therefore be demonstrated that the GS is a new mechanism of disease in CIS, which may associate with the symptoms, or the alterations in the levels of some substances in the blood suggestive of brain cells damage.
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Should this study be successful, this would provide preliminary evidence to perform a larger research study to assess if GS dysfunction drives the progression of MS. conditions: Clinically Isolated Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Magnetic Resonance Imaging measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by Structural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by microstructural MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by diffusion-weighted MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by perfusion-MRI measure: To determine that patients with CIS display alterations of the glymphatic system visible in vivo by ALS-MRI measure: To correlate in vivo measures of altered glymphatic system with MRI measures of structural integrity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of disease activity in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of enlarged Wirchow-Robin spaces in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of microstructural altertions in CIS measure: To correlate in vivo measures of altered glymphatic system with MRI measures of brain perfusion in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with clinical measures of disease severity measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of axonal injury in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of astrocytis integrity in CIS measure: To correlate in vivo measures of altered glymphatic system in CIS with fluid biomarkers of glymphatic activity in CIS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Exeter city: Exeter country: United Kingdom name: Edoardo R de Natale, MD role: CONTACT email: [email protected] lat: 50.7236 lon: -3.52751 hasResults: False
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<|newrecord|> nctId: NCT06274658 id: STUDY00006517 briefTitle: The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People With Spinal Cord Injury overallStatus: RECRUITING date: 2024-02-14 date: 2025-06-30 date: 2025-08-31 date: 2024-02-23 date: 2024-02-23 name: State University of New York at Buffalo class: OTHER briefSummary: The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls. conditions: Autonomic Nervous System Disease conditions: Spinal Cord Injuries conditions: Cognition studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: High-intensity interval exercise measure: Low frequency of systolic blood pressure variability measure: High frequency of heart rate variability measure: Blood pressure measure: Heart rate measure: Cerebral blood flow velocity measure: Symbol Digit Matched Test score measure: California Verbal Learning Test score measure: Color-Word Stroop Test score measure: Controlled Word Association Task score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University at Buffalo, South Campus status: RECRUITING city: Buffalo state: New York zip: 14214 country: United States name: Wenjie Ji role: CONTACT phone: 716-907-2508 phoneExt: 1 email: [email protected] lat: 42.88645 lon: -78.87837 hasResults: False
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<|newrecord|> nctId: NCT06274645 id: IVUS CHIP China Registry briefTitle: IVUS CHIP China Registry overallStatus: RECRUITING date: 2024-03-12 date: 2026-07 date: 2028-02 date: 2024-02-23 date: 2024-04-26 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI. conditions: Complex Higher Risk Indicated Patients Undergoing PCI studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2020 type: ESTIMATED name: The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific measure: Time-to-first-event analysis of these three event including cardiac death, target vessel myocardial infarction will be primarily used for clinical endpoints. measure: Time-to-first-event analysis will be primarily used for clinical endpoints. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan Zhongshan Hospital status: RECRUITING city: Shanghai country: China name: Chenguang Li, Doctor role: CONTACT email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06274632 id: 2023P001913 briefTitle: ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-02-28 date: 2027-02-28 date: 2024-02-23 date: 2024-04-03 name: Massachusetts General Hospital class: OTHER name: Baylor College of Medicine name: University of Miami briefSummary: The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ADELANTE measure: 12-month viral suppression measure: Number of Emergency department visits measure: Number of Hospitalizations measure: 6-month viral suppression measure: Retention in care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33146 country: United States name: Allan Rodriguez, MD role: CONTACT phone: 305-243-3711 email: [email protected] lat: 25.77427 lon: -80.19366 facility: Baylor College of Medicine city: Houston state: Texas zip: 77030 country: United States name: Thomas P Giordano, MD role: CONTACT phone: 713-798-8918 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06274619 id: 23HH8541 id: MISP 59717 type: OTHER_GRANT domain: MSD id: 57276 type: REGISTRY domain: CPMS id: 324970 type: OTHER domain: IRAS briefTitle: Novel Mucosal Correlates Of RSV Protection In Older Adults acronym: CHIRP01 overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-02 date: 2026-02 date: 2024-02-23 date: 2024-03-07 name: Imperial College London class: OTHER briefSummary: Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease.
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However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments. conditions: Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: RSV A Memphis 37 measure: Number of solicited and unsolicited adverse events (AEs) measure: Infection rate measure: Nasal Viral Load measure: Antibody levels by serum neutralisation assay measure: Antibody levels by ELISA sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Imperial College London city: London zip: W12 0NN country: United Kingdom name: Polly Fox role: CONTACT email: [email protected] name: Christopher Chiu role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06274606 id: HSR230106 briefTitle: Exercise Training Study Before Bariatric Surgery acronym: BaSE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-01-01 date: 2025-03-15 date: 2024-02-23 date: 2024-02-23 name: University of Virginia class: OTHER briefSummary: The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
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Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.
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Researchers will compare the effects of walking before bariatric surgery on:
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* Insulin sensitivity (diabetes risk factor)
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* Health of blood vessels
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* Rate of complications after surgery
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* Weight
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* Body Fat
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* Fitness level conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team. count: 30 type: ESTIMATED name: Exercise Group measure: Insulin sensitivity measure: Surgical outcomes - readmission within 30 days of surgery measure: Surgical outcomes - IV treatment as an outpatient measure: Surgical outcomes - emergency department visits measure: Surgical outcomes - time of surgery measure: Surgical outcomes - length of stay after surgery completion measure: Flow-mediated dilation (FMD) measure: Pulse-wave analysis (PWA) measure: Pulse-wave velocity (PWV) measure: Body fat measure: Lean body mass measure: Bone mineral density measure: Visceral adiposity measure: Weight measure: Blood Lipids measure: Plasma glucose measure: Plasma insulin measure: Hemoglobin A1c measure: Cardiorespiratory fitness measure: Quality of life (SF-36) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22902 country: United States name: Damon L Swift, PhD role: CONTACT phone: 434-924-1436 email: [email protected] name: Emily E Grammer, MS role: CONTACT phone: 8508968401 email: [email protected] lat: 38.02931 lon: -78.47668 hasResults: False
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<|newrecord|> nctId: NCT06274593 id: AP_JBD_MJ_003 briefTitle: Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma acronym: OGA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-09 date: 2024-02-23 date: 2024-02-23 name: Nantes University Hospital class: OTHER briefSummary: Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.
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To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.
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The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl). conditions: Glaucoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: OCT measure: Compare the progression of vascular density (VD) in advanced glaucoma patients. measure: Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients. measure: Compare the progression of visual field in advanced glaucoma patients. measure: CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jean-Baptiste Ducloyer city: Nantes zip: 44093 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT email: [email protected] lat: 47.21725 lon: -1.55336 hasResults: False
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<|newrecord|> nctId: NCT06274580 id: 5916 briefTitle: Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Ospedale Policlinico San Martino class: OTHER briefSummary: Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1. conditions: Subdural Hematoma, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: embolization of the middle meningeal artery measure: Rate of incomplete hematoma resolution or surgical rescue measure: treatment complication measure: treatment successful sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274567 id: 2024P000348 briefTitle: Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-08-31 date: 2029-03-31 date: 2024-02-23 date: 2024-02-23 name: Massachusetts General Hospital class: OTHER name: University of Pennsylvania briefSummary: The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized allocation primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: We will use an active/placebo TMS coil. TMS operator and participant will be blinded to active versus sham. Investigator will be blinded to participant condition assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 136 type: ESTIMATED name: Transcranial Magnetic Stimulation (TMS) name: Sham (placebo) TMS measure: Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity) measure: Affective Multisource Interference Task measure: Balloon Analogue Risk Task sex: ALL minimumAge: 24 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martinos Center for Biomedical Imaging city: Charlestown state: Massachusetts zip: 02129 country: United States lat: 42.37787 lon: -71.062 hasResults: False
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<|newrecord|> nctId: NCT06274554 id: 23-11026746 briefTitle: Testing the Role for Anti-fungal Therapy in Improving the Response to Medicine for Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-12 date: 2029-12 date: 2024-02-23 date: 2024-02-23 name: Weill Medical College of Cornell University class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to or are undergoing standard of care treatment with an IL-23 therapy for their Crohn's disease.
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The main question it aims to assess is will patient response to IL-23 therapies improve when simultaneously treated with fluconazole. conditions: Crohn's Disease conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double-blinded study whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Fluconazole name: Placebo name: IL-23 Therapy measure: Proportion of subjects achieving clinical response measure: Proportion of subjects achieving clinical remission measure: Proportion of patients achieving endoscopic response or remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Weill Cornell Medicine city: New York state: New York zip: 10065 country: United States name: Grace Xiang, BS role: CONTACT phone: 646-697-0985 email: [email protected] name: Randy Longman, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Dana Lukin, MD, PhD role: SUB_INVESTIGATOR name: Ellen Scherl, MD role: SUB_INVESTIGATOR name: Iliyan Iliev, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06274541 id: CTRIAL-IE 18-01 briefTitle: Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-22 date: 2025-11 date: 2025-11 date: 2024-02-23 date: 2024-02-23 name: Cancer Trials Ireland class: NETWORK briefSummary: A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics. conditions: Serous Ovarian Tumor conditions: Endometrioid Carcinoma Ovary conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Somatic and Germline BRCA1/2 Testing measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience. measure: The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials). measure: The impact on patient management by use of clinical genetics counselling sessions. measure: The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model) measure: The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland measure: Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials measure: Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Misericordiae University Hospital / Mater Private Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: St James's Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: Bon Secours city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: Cork University Hospital city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False
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<|newrecord|> nctId: NCT06274528 id: 202301150 briefTitle: DORA and LP in Alzheimer's Disease Biomarkers overallStatus: RECRUITING date: 2024-03-11 date: 2029-03-11 date: 2029-03-11 date: 2024-02-23 date: 2024-03-29 name: Washington University School of Medicine class: OTHER briefSummary: The purpose of this study is to see if the sleep aid, lemborexant, can decrease the amount of amyloid-beta and tau in the fluid around the brain known as cerebrospinal fluid (CSF). Amyloid-beta and tau are proteins involved in the disease process leading to Alzheimer's disease. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Pharmacist whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 201 type: ESTIMATED name: Lemborexant 10 mg name: Lemborexant 20mg name: Placebo measure: Changes CSF pT181/T181 ratio of lemborexant 10 and 20 mg compared to Placebo measure: Number of participants with treatment-related adverse events measure: Measure the blood concentration of lemborexant 10 mg and 20 mg and determine the dose-response relationship with CSF pT181/T181 measure: Measure changes on blood plasma amyloid-beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of CSF amyloid beta isoforms (Aβ38, Aβ40, Aβ42) measure: Measure changes of blood plasma p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal fluid p-tau/tau forms (T181, pT181, S202, pS202, pS202/S202, T217, pT217, pT217/T217). measure: Measure changes of cerebrospinal TREM2 (exploratory) measure: Measure changes of cerebrospinal NPTX2 (exploratory) measure: Measure changes of cerebrospinal NfL (exploratory) measure: Measure changes of blood plasma NfL (exploratory) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Washington University in St. Louis, School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Cristina Toedebusch, BS role: CONTACT phone: 314-747-0646 email: [email protected] name: Chloe Meehan, BS, MA role: CONTACT phone: 314-273-0878 email: [email protected] name: Brendan P. Lucey, M.D. role: PRINCIPAL_INVESTIGATOR name: J. Philip Miller, Ph.D. role: SUB_INVESTIGATOR name: Jason Hassenstab, Ph.D. role: SUB_INVESTIGATOR name: David Carr, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
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<|newrecord|> nctId: NCT06274515 id: WO44977 briefTitle: A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies acronym: REMERGE overallStatus: RECRUITING date: 2024-04-02 date: 2027-01-28 date: 2027-01-28 date: 2024-02-23 date: 2024-04-08 name: Hoffmann-La Roche class: INDUSTRY briefSummary: This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 320 type: ESTIMATED name: Tumor Tissue and Blood Draw measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) measure: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3) measure: Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1) measure: Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1) measure: Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KEM/Evang. Kliniken Essen Mitte gGmbH; Klinik für Internistische Onkologie / Hämatologie status: RECRUITING city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: I.R.S.T Srl IRCCS; Oncologia Medica status: RECRUITING city: Meldola state: Emilia-Romagna zip: 47014 country: Italy lat: 44.12775 lon: 12.0626 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06274502 id: deep learning briefTitle: Automated Detection and Diagnosis of Pathological DRGs in PHN Patients Using Deep Learning and Magnetic Resonance overallStatus: COMPLETED date: 2023-10-01 date: 2024-01-31 date: 2024-01-31 date: 2024-02-23 date: 2024-03-06 name: Huazhong University of Science and Technology class: OTHER briefSummary: Here, this study aimed to develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning. This study retrospectively analyzed the DRG images of all patients with postherpetic neuralgia who underwent magnetic resonance neuroimaging examinations in our radiology department from January 2021 to February 2022. After image post-processing, the You Only Look Once (YOLO) version 8 was selected as the target algorithm model. Model performance was evaluated using metrics such as precision, recall, Average Precision, mean average precision and F1 score. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 41 type: ACTUAL name: YOLOv8 measure: Develop an automated system for detecting and diagnosing lesion DRGs in PHN patients based on deep learning sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan country: China lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06274489 id: GSN000500 briefTitle: A Study to Evaluate Setanaxib in Patients With Alport Syndrome overallStatus: RECRUITING date: 2023-11-27 date: 2025-01-27 date: 2025-01-27 date: 2024-02-23 date: 2024-04-05 name: Calliditas Therapeutics AB class: INDUSTRY briefSummary: The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.
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Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.
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The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period. conditions: Alport Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 18 type: ESTIMATED name: Setanaxib name: Placebo measure: Percentage of patients with Serious Adverse Events (SAEs) measure: Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs) measure: The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample measure: Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss) measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss) measure: Percentage of patients with clinically significant changes in heart rate measure: Percentage of patients with clinically significant changes blood pressure measure: Percentage of patients with clinically significant changes in 12-lead electrocardiogram (ECG) measure: Percentage of patients with clinically significant changes in physical examination measure: Percentage of patients with clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function measure: Percentage of patients with clinically significant changes in hearing audiometric testing (bone- and air-conduction) sex: ALL minimumAge: 12 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Fakultni Nemocnice Hradec Kralove status: RECRUITING city: Hradec Králové country: Czechia name: Roman Safranek role: CONTACT lat: 50.20923 lon: 15.83277 facility: Fakultni Nemocnice Olomouc status: RECRUITING city: Olomouc country: Czechia name: Karel Krejci role: CONTACT lat: 49.59552 lon: 17.25175 facility: Institut Klinicke a Experimentalni Mediciny status: RECRUITING city: Praha country: Czechia name: Ondrej Viklicky role: CONTACT lat: 50.08804 lon: 14.42076 facility: Vseobecna Fakultni Nemocnice v Praze status: RECRUITING city: Praha country: Czechia name: Vladimir Tesar role: CONTACT lat: 50.08804 lon: 14.42076 facility: Hospital Clinic Barcelona status: RECRUITING city: Barcelona state: L'eixample zip: 08036 country: Spain name: Marc Xipell Font role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario 12 de Octubre status: RECRUITING city: Madrid state: Usera zip: 28041 country: Spain name: Enrique Morales role: CONTACT lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Vall d'Hebron status: RECRUITING city: Barcelona country: Spain name: Irene Agraz Pamplona role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Reina Sofia status: RECRUITING city: Córdoba zip: 14004 country: Spain name: Cristina Rabasco role: CONTACT lat: 37.89155 lon: -4.77275 facility: Hospital Universitario Virgen de las Nieves status: RECRUITING city: Granada zip: 18014 country: Spain name: Rafael Jose Esteban de la Rosa role: CONTACT lat: 37.18817 lon: -3.60667 facility: Royal Free London NHS Foundation Trust status: RECRUITING city: London zip: NW3 2QG country: United Kingdom name: Daniel Gale role: CONTACT lat: 51.50853 lon: -0.12574 facility: Great Ormond Street Hospital for Children status: NOT_YET_RECRUITING city: London zip: WC1N 3JH country: United Kingdom name: Zainab Arslan role: CONTACT lat: 51.50853 lon: -0.12574 facility: Royal Manchester Children's Hospital status: RECRUITING city: Manchester zip: M13 9WL country: United Kingdom name: Rachel Lennon role: CONTACT lat: 53.48095 lon: -2.23743 facility: Nottingham City Hospital status: RECRUITING city: Nottingham country: United Kingdom name: Matthew Hall role: CONTACT lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06274476 id: 2020/9/9 briefTitle: Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement acronym: implant overallStatus: COMPLETED date: 2018-09-09 date: 2019-12-09 date: 2020-01-01 date: 2024-02-23 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically. conditions: Atrophic Maxillary Ridge and Mandibular Ridge studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: maxillary and mandibular atrophic ridge primaryPurpose: OTHER masking: DOUBLE maskingDescription: double whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 21 type: ACTUAL name: implant placement measure: implant success sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Mohamed yahia Sharaf city: Zagazig state: Sharkia zip: 44715 country: Egypt lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06274463 id: 2023-11-035 briefTitle: A Personalized Trunk Stability Exercise Program Study With Brain Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-02-21 date: 2024-12-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Bundang CHA Hospital class: OTHER briefSummary: To investigate the effect on improving trunk stability and satisfaction with the program when a customized trunk stabilization exercise program personalized to the subject's functional level is applied to patients with brain disease. conditions: Brain Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Exercise therapy including a trunk stabilization exercise program measure: Trunk Impairment Scale measure: Berg Balance Scale measure: Joint angle measure: Joint moment measure: Joint power sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06274450 id: C2202112 briefTitle: A Clinical Study on the Improvement of Skin and Living Conditions After Drinking Rosa Roxburghii and Pomegranate Drinks overallStatus: COMPLETED date: 2022-07-06 date: 2022-09-02 date: 2022-09-02 date: 2024-02-23 date: 2024-02-23 name: Botanee Group Co., Ltd. class: INDUSTRY briefSummary: The main objective of the study is to observe changes in the subjects' skin condition and life status after 8 weeks of drinking rosa roxburghii and pomegranate drinks.
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This is a single-center, randomized, single-blind, controlled, 8-week (56-day) clinical study conducted in Chinese healthy women aged 25-45 years old who were offered a rosa roxburghii and pomegranate drink. conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: skin care product name: Drinks with active ingredients Rosa Roxburghii and Pomegranate measure: Changes in the skin hydration measure: Changes in the skin glossiness measure: Changes in the skin firmness measure: Changes in the skin elasticity measure: Changes in the individual type angle measure: Changes in the melanin content measure: Changes in the proportion of crow's feet area measure: Changes in the proportion of fine lines under the eye measure: Changes in the CIE RGB of skin tone measure: Changes in the grade of Pigmentation measure: Skin condition Assessment after 4-week application measure: Skin condition Assessment after 8-week application measure: Changes in the satisfaction with the quality of life sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai China-norm Quality Technical Service Co ，Ltd city: Shanghai state: Shanghai zip: 200072 country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06274437 id: BND-35-001 briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-11 date: 2024-02-23 date: 2024-02-23 name: Biond Biologics class: INDUSTRY briefSummary: This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BND-35 name: Nivolumab name: Cetuximab measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT) measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 2: Incidence of TEAEs and SAEs measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 1: Maximum observed plasma concentration (Cmax) measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 1: Time of maximum observed serum concentration (Tmax) measure: Part 1: Terminal elimination half-life (T1/2) measure: Part 1: Area under the plasma concentration-time curve (AUC) measure: Part 1: Incidence of anti-drug antibodies (ADA) measure: Part 2: Progression Free Survival (PFS) measure: Part 2: PFS rate measure: Part 2: Duration of Response measure: Part 2: Maximum observed plasma concentration (Cmax) measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 2: Time of maximum observed serum concentration (Tmax) measure: Part 2: Terminal elimination half-life (T1/2) measure: Part 2: Area under the plasma concentration-time curve (AUC) measure: Part 2: Incidence of anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 3109601 country: Israel name: Ruth Perets role: CONTACT role: CONTACT phone: +97247776234 email: [email protected] lat: 32.81841 lon: 34.9885 facility: Hadassah University Medical Center city: Jerusalem zip: 91120 country: Israel name: Jonathan Cohen role: CONTACT role: CONTACT phone: +97226776781 email: [email protected] lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah Tikva zip: 49100 country: Israel name: Solomon Shtemer role: CONTACT role: CONTACT phone: +97239378110 email: [email protected] lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan zip: 52621 country: Israel name: Gal Strauss role: CONTACT phone: +97235304498 email: [email protected] lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center city: Tel Aviv zip: 6423906 country: Israel name: Ravit Geva role: CONTACT phone: +97236973193 email: [email protected] lat: 32.08088 lon: 34.78057 hasResults: False
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<|newrecord|> nctId: NCT06274424 id: HUS/211/2016 and HUS/2699/2018 briefTitle: Hair Cortisol and Symptoms in Children With Psychopathology During CBT overallStatus: COMPLETED date: 2016-07-01 date: 2019-10-01 date: 2019-10-01 date: 2024-02-23 date: 2024-02-29 name: Helsinki University Central Hospital class: OTHER briefSummary: This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study. conditions: Child Behavior Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: The Friends Program measure: Hair Cortisol Concentration measure: Parent- and teacher rated internalizing and externalizing symptoms measure: Child-rated internalizing symptoms measure: Parent-rated sleep disturbance symptoms sex: ALL minimumAge: 6 Years maximumAge: 13 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06274411 id: KS2024014 briefTitle: Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention acronym: ESCORT overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2026-03-01 date: 2024-02-23 date: 2024-02-23 name: Beijing Anzhen Hospital class: OTHER briefSummary: The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :
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• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI conditions: ECMO conditions: High-risk PCI studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Standby cannulated ECMO name: Prophylactic ECMO measure: Composite rate of 8 major adverse events measure: Platelet drop measure: Duration of ECMO support measure: Length of hospital stay measure: Hemoglobin drop measure: Serum interleukin-6 concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital status: RECRUITING city: Beijing state: Beijing zip: 100029 country: China name: Liangshan Wang, MD role: CONTACT phone: 86-13811363372 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06274398 id: RITE Study briefTitle: Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study acronym: RITE PrEP overallStatus: RECRUITING date: 2024-01-16 date: 2024-10-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: Eastern Virginia Medical School class: OTHER name: CONRAD name: Emory University name: Centers for Disease Control and Prevention briefSummary: This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days. conditions: Safety Issues studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Placebo-controlled, Double-blind primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TAF/EVG rectal insert name: Matching placebo rectal insert measure: Frequency and intensity of Adverse Events measure: Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood measure: PK (Cmax) in rectal secretions measure: PK (Cmax) in rectal mucosal tissue measure: PK (Cmax) in cervicovaginal secretions measure: PK (Cmax) in cerviocovaginal mucosal tissues measure: Cytokine Profiles measure: Microbiome Profiles sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Emory Clinic status: RECRUITING city: Atlanta state: Georgia zip: 30322 country: United States name: Cassie Grimsley Ackerley, MD, MSc role: CONTACT email: [email protected] lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06274385 id: 2311010178 briefTitle: The Effects of an Acute Dose of a Betalain-rich Concentrate on Repeated-sprint Cycling Performance and Recovery. acronym: BET_RSE overallStatus: RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-23 date: 2024-02-23 name: Drexel University class: OTHER briefSummary: Betalains have well-known antioxidant and anti-inflammatory properties. Recent investigations examining the effects of a betalain-rich concentrate (BRC) on exercise and recovery performance show promise of BRC as an ergogenic aid. To date, no study has examined the effects of a single dose of a BRC on supramaximal performance and recovery. Therefore, the purpose of this study is to examine the effects of an acute dose of BRC on repeated-sprint cycling performance and recovery. conditions: Nutraceuticals studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Betalain-rich concentrate (AltRed) name: Placebo measure: Repeated Sprint Performance measure: Neuromuscular Fatigue sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Drexel University - Health Sciences Building status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19102 country: United States name: Arun Ramakrishnan, PhD role: CONTACT phone: 215-553-7018 email: [email protected] lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06274372 id: FCV,V-2202 briefTitle: The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-07 date: 2024-08-06 date: 2024-08-06 date: 2024-02-23 date: 2024-03-06 name: Derince Training and Research Hospital class: OTHER briefSummary: It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations. conditions: Laparoscopic Surgeries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: flow controlled ventilation name: volume controlled ventilation measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effects of flow controlled ventilation on heamodynamic parameters measure: effectcs of flow controlled ventiletion on respiratory parameters measure: respiratory related complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kocaeli Derince Training and Research Hospital city: Derince state: Kocaeli zip: 41900 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06274359 id: 21-3985 briefTitle: Digital Storytelling to Reduce Pediatric Influenza Vaccination Disparities overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2027-08-31 date: 2024-02-23 date: 2024-02-23 name: Denver Health and Hospital Authority class: OTHER briefSummary: While the COVID-19 pandemic has highlighted health disparities, Black children have unduly suffered and died from seasonal influenza for decades. Through sustained partnership with Black community stakeholders, novel community-engaged research methods, and an innovative intervention approach, this proposal will explore, develop, and test a Digital Storytelling intervention to reduce influenza vaccination disparities in Black children aged 6 months to 5 years. This project will advance our understanding of engagement methods and interventions that improve health equity and serve as a model for future work to address vaccination disparities, ensuring all individuals have the chance to fulfill their potential free of preventable diseases. conditions: Influenza studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Caregivers will be assigned randomly to receive a series of digital stories by text message or to receive usual care. primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Digital storytelling measure: Child influenza vaccination status at influenza season's end (defined as March 31, 2025 for season 1 and March 31, 2026 for season 2 if a 2nd season of recruitment is necessary) measure: Intervention Feasibility measure: Intervention Acceptability measure: Intervention Appropriateness sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Denver Health Eastside Clinic city: Denver state: Colorado zip: 80205 country: United States lat: 39.73915 lon: -104.9847 facility: Denver Health Park Hill Clinic city: Denver state: Colorado zip: 80207 country: United States lat: 39.73915 lon: -104.9847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-26 uploadDate: 2024-01-30T11:52 filename: ICF_000.pdf size: 298169 hasResults: False
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