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<|newrecord|> nctId: NCT06348602 id: PI23-00201 briefTitle: Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-08 name: Hospital Universitario Dr. Jose E. Gonzalez class: OTHER briefSummary: Chronic GVHD (cGVHD) is a predominant cause of mortality and disability not related to relapse; it occurs in 30 to 70% of patients. The majority of patients with cGVHD present with ocular involvement with a reported incidence of 40-60%. Symptoms can range from mild dry eye syndrome to severe epithelial defects that can generate corneal perforation and loss of vision. The most accepted pharmacological modality is the topical application of cyclosporine A; on the other hand, tacrolimus has shown greater immunosuppressive power when used in ocular GVHD. However, this effectiveness is limited since by the time the manifestations appear, there is already permanent damage to the lacrimal gland due to the lymphocytic infiltration; so it is necessary to use a prevention strategy before these manifestations appear. Previously, the employment of ocular cyclosporine drops as ocular GVHD prophylaxis was assessed to evaluate safety and effectiveness, showing that it is well tolerated and can limit the appearance of severe dry eye manifestations in a small group of patients. The purpose of this work is to compare the two modalities currently accepted for the treatment of the disease, but in a prophylactic way; topical ciclosporin A against topical tacrolimus, to determine the safety and efficiency of each of them as a preventive measure to limit the risk of developing the appearance of ocular cGVHD and the permanent consequences that this generates. conditions: Ocular Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental, prospective, randomized, unblinded. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Cyclosporine ophthalmic solution 0.1% name: Tacrolimus ophthalmic ointment 0.03% measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Incidence of ocular graft-versus-host disease in patients undergoing allo-HSCT receiving topical prophylaxis with Cyclosporine A or Tacrolimus as assessed by the National Institutes of Health Consensus Development Projects on Chronic GVHD scoring system. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the International Consensus Criteria on chronic ocular graft-versus-host disease. measure: Prevalence of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Severity of ocular GVHD based on historical records in the hematology service of the University Hospital U.A.N.L. in patients without prophylactic treatment, as assessed by the National Institutes of Health Consensus on Chronic GVHD scoring system. measure: Number of participants requiring adjuvant treatment for ocular GVHD in patients receiving prophylactic tacrolimus or cyclosporine for ocular GVHD. measure: Prevalence of Dry Eye Disease prior to the HSCT. measure: Subtypes of Dry Eye Disease prior to the HSCT measure: Number of participants requiring adjuvant treatments for the Dry Eye Disease measure: Incidence of other manifestations of acute and chronic GVHD, local or systemic, in patients receiving prophylactic treatment for ocular GVHD. measure: Number of participants with topical tacrolimus related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Number of participants with topical cyclosporine related adverse events as assessed by a questionnaire for evaluation of adverse drug events measure: Incidence of ocular GVHD in patients receiving prophylactic treatment for ocular GVHD. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario de la U.A.N.L. status: RECRUITING city: Nuevo León state: Monterrey zip: 66640 country: Mexico name: Olga Graciela Cantú Rodriguez, MD role: CONTACT phone: 8186939257 email: [email protected] name: David Gómez Almaguer, MD role: CONTACT phone: 8186756718 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06348589 id: 2023-05959-01 briefTitle: Orthostatic Hypotension and Blood Pressure Variability in Persons Undergoing Hemodialysis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-04 date: 2024-04-04 name: Vrinnevi Hospital class: OTHER name: Linkoeping University briefSummary: High blood pressure is a risk factor for end-stage renal disease and is common in patients undergoing maintenance hemodialysis. Intradialytic hypotension is associated with an adverse prognosis. More knowledge is needed to identify patients at high risk for intradialytic hypotension and dialysis-associated hypotensive episodes. The aim of this observational single-center pilot study is to evaluate whether point-of-care ultrasound measurements may predict intradialytic hypotension and orthostatic blood pressure falls, in patients with chronic kidney disease who undergo maintenance hemodialysis. conditions: Chronic Kidney Disease Requiring Chronic Dialysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED measure: Intra-dialytic systolic blood pressure fall of 20 mmHg or larger measure: Post-dialytic orthostatic systolic blood pressure fall of 20 mmHg or larger sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06348576 id: AD-209P3 briefTitle: Phase III Study to Evaluate the Efficacy and Safety of AD-209 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-02 date: 2024-04-04 date: 2024-04-04 name: Addpharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-209 conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 280 type: ESTIMATED name: AD-209 name: AD-2091 name: AD-209 Placebo name: AD-2091 Placebo measure: Change rate of MSSBP sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Guro Hospital city: Seoul country: Korea, Republic of name: Chang Gyu Park, M.D., Ph.D role: CONTACT name: Chang Gyu Park, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06348563 id: 7437787981 briefTitle: AGED Diagnostics Liver Disease Assessment acronym: AGEDDX overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-09-15 date: 2024-04-04 date: 2024-04-04 name: Active Genomes Expressed Diagnostics, Corp class: INDUSTRY name: Arizona Clinical Trials name: Walter Reed National Military Medical Center briefSummary: Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts. conditions: NASH With Fibrosis conditions: NAFLD conditions: Healthy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 400 type: ESTIMATED name: AGED Multiple Target Assay in Healthy Controls name: AGED Multiple Target Assay in NAFLD Participants name: AGED Multiple Target Assay in Fibrosis Participants measure: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma measure: Biomarker Validation, Targeted Epigenetic Sequencing Assessment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AGED Diagnostics city: Bethesda state: Maryland zip: 20002 country: United States name: Rachel Zayas role: CONTACT phone: 617-777-7971 email: [email protected] lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06348550 id: BFMKP 01 briefTitle: Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. overallStatus: RECRUITING date: 2023-11-30 date: 2024-07 date: 2024-09 date: 2024-04-04 date: 2024-04-04 name: University of Pavia class: OTHER name: Foundation IRCCS San Matteo Hospital briefSummary: The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl. conditions: Dyslipidemias conditions: Dysglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Berberol® K name: Placebo measure: Variation of LDL cholesterol measure: Variation of lipid profile measure: Change in glycemic status sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico S. Matteo Foundation status: RECRUITING city: Pavia zip: 27100 country: Italy name: Giuseppe Derosa, MD, PhD role: CONTACT email: [email protected] name: Pamela Maffioli, MD role: CONTACT email: [email protected] name: Giuseppe Derosa, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Pamela Maffioli, MD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06348537 id: Polyphenol-Fibromyalgia briefTitle: Effects of Olive Polyphenols in Fibromyalgia Patients overallStatus: COMPLETED date: 2021-01-20 date: 2021-04-01 date: 2023-09-01 date: 2024-04-04 date: 2024-04-04 name: Universidad de Granada class: OTHER name: Solvitae Medical, S.L name: University of Jaén briefSummary: To study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with FM. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Olive Polyphenols name: Placebo measure: Plasma proteome measure: Lipid peroxidation measure: Aldolase measure: C-reactive protein (CRP) measure: Impact of fibromyalgia measure: Quality of Life measure: Red blood cells measure: Haemoglobin measure: Fibrinogen measure: Total cholesterol measure: Cholesterol ratio measure: LDL cholesterol measure: Cortisol sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Jaén city: Jaén zip: 23071 country: Spain lat: 37.76922 lon: -3.79028 hasResults: False
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<|newrecord|> nctId: NCT06348524 id: ferumoxytol_2015 briefTitle: Ferumoxytol-enhanced Magnetic Resonance Imaging overallStatus: NOT_YET_RECRUITING date: 2024-08-03 date: 2024-12-30 date: 2025-12-30 date: 2024-04-04 date: 2024-04-04 name: Transmed Solutions class: OTHER briefSummary: There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR \<30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Ferumoxytol injection measure: Detect the absence of ≥50% stenosis in the coronary artery tree measure: Detect stenosis in proximal and distal segments of the coronary artery tree measure: Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06348511 id: 0165-22-TLV briefTitle: XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders overallStatus: COMPLETED date: 2022-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-04 date: 2024-04-04 name: Tel-Aviv Sourasky Medical Center class: OTHER_GOV briefSummary: The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome. conditions: Tic Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group. whoMasked: INVESTIGATOR count: 35 type: ACTUAL name: XTics measure: The Tic Yale Global Tic Severity Scale (YGTSS) measure: The Parent Tic Questionnaire (PTQ) measure: Premonitory Urge for Tic Scale (PUTS) measure: The Subjective Units of Distress Scale (SUDS) measure: The "Urge Thermometer" measure: Rush Videotape Protocol measure: Tic-to-tic interval measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED) measure: The Children Depression Inventory (CDI) measure: The Conners' Parent Rating Scale-Revised Long Form (CRS:RL) measure: Obsessive Compulsive Inventory-Child Version (OCI-CV) measure: The Behavior Rating Inventory of Executive Function (BRIEF) measure: The Emotion Regulation Questionnaire (ERQ) measure: User Engagement Scale (UES) sex: ALL minimumAge: 7 Years maximumAge: 15 Years stdAges: CHILD facility: Sagol Brain Institute, Tel Aviv Sourasky Medical Center city: Tel Aviv country: Israel lat: 32.08088 lon: 34.78057 hasResults: False
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<|newrecord|> nctId: NCT06348498 id: TSL-TCM-JSP-Ⅰb briefTitle: Pharmacokinetic and Pharmacodynamic of Jia Shen Tablets in Chronic Heart Failure overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2026-06-30 date: 2026-06-30 date: 2024-04-04 date: 2024-04-04 name: Tasly Pharmaceutical Group Co., Ltd class: INDUSTRY briefSummary: Evaluate the pharmacokinetic and pharmacodynamic characteristics of Jia Shen Tablets in patients with Chronic Heart Failure. conditions: Heart Failure studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Jia Shen Tablet measure: Pharmacokinetic characteristic evaluation：Maximum observed plasma concentration (Cmax) measure: Plasma PK analysis: Time to reach peak or maximum observed concentration following drug administration (Tmax) measure: Plasma PK analysis: Area under curve at steady state (AUCss) measure: NT-proBNP measure: 6-Minutes-Walking-Test (6MWT) measure: Echocardiogram results measure: NYHA classification measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine city: Tianjin state: Tianjin country: China name: Yuhong Huang role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06348485 id: VGHTCCTC_NPCbleeding001 briefTitle: Massive Nasal Bleeding in Patients With NPC Received Curative RT overallStatus: COMPLETED date: 1994-12-01 date: 2019-04-30 date: 2024-02-29 date: 2024-04-04 date: 2024-04-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: To investigate the incidence, predictive markers, and survival impact of massive nasal bleeding in nasopharyngeal carcinoma (NPC) patients who received curative radiotherapy (RT) with/without chemotherapy. A total of 1327 patients with previously untreated, biopsy-proven NPC, and no distant metastasis were retrospective reviewed. Investigators analyzed the occurrence rates of massive nasal bleeding between different characteristics and tried to identify important predictive factors. Investigators compared overall survival between patients with and without massive nasal bleeding by Kaplan-Meier method. conditions: Nasopharyngeal Carcinoma Patients Treated With Curative Radiotherapy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1327 type: ACTUAL name: Patients without massive nasal bleeding name: Patients with massive nasal bleeding measure: Massive Nasal Bleeding Rate measure: Overall Survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital city: Taichung zip: 407 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06348472 id: 0004-24-SHA briefTitle: The Predictive Role of Immune-inflammatory Biomarkers and Their Interaction With the Oxytocin System in Trauma-related Psychotherapy Responsiveness overallStatus: RECRUITING date: 2024-03-14 date: 2028-03-01 date: 2028-03-01 date: 2024-04-04 date: 2024-04-04 name: Shalvata Mental Health Center class: OTHER briefSummary: Despite a range of treatments for posttraumatic stress disorder (PTSD), only a small proportion of patients reach full symptomatic remission. Recent developments in the field of neuroscience have been providing compelling evidence to suggest that neurobiological determinants might influence not only the emergence of PTSD, but also its resistance to treatment. Immune-inflammation regulatory processes were found to be active during recovery from PTSD, potentially through interactive relationship with the oxytocin secretion system. This innovative longitudinal study aims to examine the role of inflammatory biomarkers and their interactive effect with the oxytocin (OT) system on the development of PTSD and on treatment response among patients with PTSD symptoms undergoing psychotherapy treatment. Patients (N = 100) suffering from trauma-related distress will be recruited from the trauma clinic in Shalvata Mental Health Center. Participants will be followed for 12 weeks of once-a-week psychotherapy sessions. They will be measured for endogenous OT level and cytokines levels in saliva before and after sessions 1, 6, and 12, and will complete psychotherapy outcome self-report questionnaires following each of these sessions. conditions: Posttraumatic Stress Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Oxytocin Secretion measure: Inflammatory Response: IL-1β measure: Inflammatory Response: IL-6 measure: Inflammatory Response: TNF-α measure: Posttraumatic stress disorder symptoms measure: Depression severity measure: General anxiety symptoms measure: Psychological resilience measure: Working Alliance sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shalvata Mental health Center status: RECRUITING city: Hod HaSharon country: Israel name: Omer Sedoff, MA role: CONTACT email: [email protected] lat: 32.15934 lon: 34.8932 hasResults: False
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<|newrecord|> nctId: NCT06348459 id: 18/010-E briefTitle: Registry of Catheter Intervention in Pulmonary Embolism acronym: RiTEP overallStatus: RECRUITING date: 2018-09-18 date: 2029-12-31 date: 2030-12-31 date: 2024-04-04 date: 2024-04-04 name: Hospital San Carlos, Madrid class: OTHER name: Asociación de Cardiología Intervencionista de la Sociedad Española de Cardiología briefSummary: Multicenter longitudinal observational ambispective (retrospective cases from 2014 and prospective from 2018 onwards) cohort study. The registry recruits a series of consecutive patients admitted for moderate-high risk or high-risk pulmonary embolism (according to 2019 European Society of Cardiology guidelines) treated invasively. This study aims to describe the acute management of the safety and effectiveness of different percutaneous interventions for acute pulmonary embolism. conditions: Pulmonary Embolism conditions: Pulmonary Embolism Acute Massive conditions: Pulmonary Embolism Acute conditions: Pulmonary Embolism and Thrombosis conditions: Pulmonary Thromboembolisms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: All cause-death measure: all cause-death measure: all cause-death measure: all cause-death measure: procedural success measure: in-hospital complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clinico San Carlos status: RECRUITING city: Madrid zip: 28040 country: Spain name: Pablo Salinas, MD, PhD role: CONTACT phone: +34913303000 email: [email protected] lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06348446 id: FY20-2963 briefTitle: Tacrolimus Exposure in Kidney Transplantation overallStatus: RECRUITING date: 2022-02-01 date: 2024-07-30 date: 2024-08-30 date: 2024-04-04 date: 2024-04-04 name: Seoul National University Hospital class: OTHER name: Astellas Pharma Inc briefSummary: Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation. conditions: Kidney Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 12000 type: ESTIMATED measure: relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes measure: relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Asan medical center, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Young Hoon Kim, MD role: CONTACT phone: 82-10-2705-6998 email: [email protected] lat: 37.566 lon: 126.9784 facility: Samsung medical center, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Jae Berm Park, MD role: CONTACT phone: 82-10-8971-1953 email: [email protected] lat: 37.566 lon: 126.9784 facility: Seoul St. Mary's hospital, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Sun Cheol Park, MD role: CONTACT phone: 82-10-6310-2847 email: [email protected] lat: 37.566 lon: 126.9784 facility: Severance hospital, Seoul, Korea status: RECRUITING city: Seoul country: Korea, Republic of name: kyuha Hur, MD role: CONTACT phone: 82-10-2043-9947 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06348433 id: QL000003 briefTitle: Efficacy Evaluation and Mechanism Study of Ketogenic Diet on Autism Spectrum Disorder in Children overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Qilu Hospital of Shandong University class: OTHER briefSummary: Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, which is characterized by social interaction and communication defects, rigid repetitive behaviors, and often accompanied by speech development retardation. According to the report released by the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC), according to the statistical data analysis in 2020, one out of every 36 8-year-old children (2.76%) was confirmed to have autism spectrum disorder (ASD). This ratio is higher than that published in December 2021, when the prevalence rate of 8-year-old children was 1/44 (2.3%) according to the statistics in 2018. Although ASD has a high incidence, there is still a lack of effective treatment measures for autism at present. Drug treatment can only partially alleviate some related symptoms, such as irritability and aggressiveness. Other interventions mainly focus on behavioral and educational interventions, which have limited help to patients. The high cost also leads to a huge burden on families and health care systems. Therefore, finding targeted treatment measures and treatment mechanisms for ASD as soon as possible has become an urgent problem for us to solve.Faced with limited treatment options, as many as a third of parents try various dietary pattern interventions to help their autistic children. In recent years, ketogenic diet, as a diet mode with extremely low carbohydrate, high fat, proper amount of protein and other nutrients, has attracted wide attention. In this mode, increased lipolysis puts the body in a ketosis state, thus ensuring energy supply.Although ketogenic diet (KD) has been proved to be effective in reducing the core symptoms in autistic patients and mouse models, the specific mechanism of KD in autism spectrum disorder (ASD) is still not completely clear.This study aims to evaluate the efficacy of ketogenic diet in improving core symptoms, sleep disorders and gastrointestinal symptoms of ASD children, explore the changes of excitation/inhibition (dorsolateral prefrontal cortex) in prefrontal cortex of ASD children before and after ketogenic diet intervention, and try to reveal the mechanism of ketogenic diet in treating ASD. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ketogenic diet measure: Autism Behavior Checklist（ABC） measure: Childhood Autism Rating Scale(CARS) measure: Gastrointestinal Symptom Scale（GSRS) measure: Children's Sleep Habits Questionnaire（CSHQ) measure: MRS sex: ALL minimumAge: 18 Months maximumAge: 10 Years stdAges: CHILD facility: Yu Wang city: Jinan state: Shandong zip: 274400 country: China lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06348420 id: 2023-QILU-LU 03 briefTitle: Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment acronym: ARMV overallStatus: NOT_YET_RECRUITING date: 2024-04-10 date: 2027-04-20 date: 2027-08-13 date: 2024-04-04 date: 2024-04-04 name: Qilu Hospital of Shandong University class: OTHER name: Shandong University briefSummary: The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs). conditions: Gastroesophageal Reflux Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: anti-reflux mucosal valvuloplasty (ARMV) measure: The total score of the GERD-HRQL questionnaire measure: Number of Participants with PPI usage measure: Appearance of the mucosal flap measure: Presence of reflux esophagitis measure: Safety evaluation indicators measure: Total score of GERD GerdQ questionnaire measure: DeMeester score sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06348407 id: 2024-BA-001 briefTitle: A Clinical Study of Omalizumab in the Treatment of Allergic Asthma(ESSENCE) acronym: ESSENCE overallStatus: RECRUITING date: 2023-12-01 date: 2024-11-30 date: 2024-11-30 date: 2024-04-04 date: 2024-04-04 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.Previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which Immunoglobulin E (IgE) plays a critical role.Omalizumab was approved as an anti-IgE humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.The drug was launched in mainland China in August 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.The aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment. conditions: Moderate to Severe Allergic Asthma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED name: IgE monoclonal antibody measure: Change in Asthma Control Test (ACT) measure: Global Evaluation of Treatment Effectiveness (GETE) measure: Forced Expiratory Volume in 1 second（FEV1) measure: FEV1/predicted%. measure: Forced Vital Capacity （FVC） measure: FEV1/FVC. measure: Number of Acute Exacerbations（AE） measure: Oral glucocorticoid dosage measure: Good adherence measure: Poor adherence measure: Adverse events sex: ALL minimumAge: 14 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Linfu zhou status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Xuejun Zhang, Master role: CONTACT phone: 86+13704726254 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06348394 id: 023-318 briefTitle: Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion acronym: ICETEE overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-14 date: 2025-12-14 date: 2025-12-30 date: 2024-04-04 date: 2024-04-04 name: Baylor Research Institute class: OTHER briefSummary: This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach. conditions: Left Atrial Appendage Closure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, parallel controlled, open-label, single center study primaryPurpose: OTHER masking: NONE count: 444 type: ESTIMATED name: Intracardiac Echocardiography measure: Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. measure: Periprocedural complications measure: Procedural characteristics measure: Patient satisfaction measure: Periprocedural complications measure: Periprocedural complications measure: Procedural characteristics measure: Procedural characteristics measure: Procedural characteristics sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Baylor Scott and White Heart Hospital city: Plano state: Texas zip: 75093 country: United States lat: 33.01984 lon: -96.69889 hasResults: False
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<|newrecord|> nctId: NCT06348381 id: IS24030 briefTitle: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Shanghai Chest Hospital class: OTHER briefSummary: Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury. conditions: Esophageal Neoplasm conditions: Anastomotic Leak conditions: Recurrent Laryngeal Nerve Injuries conditions: Anastomotic Stenosis conditions: Endoscopic Evaluation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: No intervention measure: anastomotic leak measure: anastomotic stenosis measure: laryngeal nerve injury sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai zip: SH 21 country: China name: Zhigang Li, Doctor role: CONTACT phone: 86-18930619260 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06348368 id: Soh-Med-23-01-29 briefTitle: Refractive and Corneal Topographic Characteristics in Upper Egypt Children With High Cylinder overallStatus: COMPLETED date: 2023-01-01 date: 2024-01-30 date: 2024-02-01 date: 2024-04-04 date: 2024-04-09 name: Sohag University class: OTHER briefSummary: Refractive and Corneal Topographic Characteristics in upper Egypt children with high cylinder: A cross sectional study conditions: Corneal Ectasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 4000 type: ACTUAL name: Pentacam and autorefractometry measure: Values anterior and posterior corneal elevation values by pentacam. sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Elshimaa A.Mateen city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06348355 id: D5084C00016 id: 2023-508334-34-00 type: OTHER domain: EMA-CTIS briefTitle: A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-28 date: 2024-06-28 date: 2024-04-04 date: 2024-04-04 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers.
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This study will determine brain exposure of \[11C\]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma). conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 8 type: ESTIMATED name: [11C]savolitinib name: Savolitinib measure: Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain measure: The following endpoint: Cmax_brain SUV measure: The following endpoint: Tmax brain measure: The following endpoint: AUCbrain 0-90 measure: The following endpoint: AUCplasma 0-90 measure: The following endpoint: Kp measure: The following endpoint: Kp,uu measure: The following endpoint: VT measure: The following endpoint: Cmax_brain SUV measure: The following endpoint: Tmax brain measure: The following endpoints: AUCbrain 0-90 measure: The following endpoints: AUCplasma 0-90 measure: The following endpoints: Kp measure: The following endpoints: Kp,uu measure: The following endpoints: VT measure: Number of participants with safety findings, AEs sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Solna zip: 171 64 country: Sweden lat: 59.36004 lon: 18.00086 hasResults: False
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<|newrecord|> nctId: NCT06348342 id: TÜTF-GOBAEK 2023/24 briefTitle: Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women overallStatus: ENROLLING_BY_INVITATION date: 2023-10-15 date: 2024-04-20 date: 2024-06-30 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the \&#34;Pelvic Floor Distress Scale (PFDI)\&#34; and \&#34;Pelvic Floor Impact Questionnaire (PFIQ)\&#34; will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman\&#39;s correlation, and regression analyzes will be used in the analysis of research data. conditions: Menopause conditions: Stress Urinary Incontinence conditions: Kegel Exercises conditions: Core Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Before starting the research, four groups of mothers will be randomly formed. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumbergenerator.aspx). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 136 type: ESTIMATED name: Pelvic Floor Muscle Exercise name: Core Exercise measure: Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary) measure: Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire) measure: Urinary incontinence evaluated using the Stress Test measure: Urinary incontinence evaluated using the Uroflowmetry measure: Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement measure: Urinary incontinence evaluated using the Digital Palpation sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bartın University city: Bartin zip: 78100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False
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<|newrecord|> nctId: NCT06348329 id: TÜTF-GOBAEK 2023/41 briefTitle: Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy overallStatus: RECRUITING date: 2023-06-29 date: 2023-10-15 date: 2024-04-15 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.
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The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.
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Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx). conditions: Birth Order conditions: Parenting conditions: Self Efficacy conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 158 type: ESTIMATED name: Birth Preparation Training measure: Parenting behavior evaluated using the Postpartum Parenting Behavior Scale measure: Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale measure: Spouse support evaluated using the Spouse Support Scale measure: Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Trakya University status: RECRUITING city: Edirne zip: 22030 country: Turkey name: Burcu Küçükkaya role: CONTACT phone: 05422931357 email: [email protected] lat: 41.67719 lon: 26.55597 hasResults: False
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<|newrecord|> nctId: NCT06348316 id: TÜTF-GOBAEK 2023/45 briefTitle: Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies overallStatus: RECRUITING date: 2023-09-30 date: 2024-04-02 date: 2024-07-30 date: 2024-04-04 date: 2024-04-04 name: Trakya University class: OTHER briefSummary: Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression.
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Design: The prospective, randomized controlled study conditions: Mothers conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 136 type: ESTIMATED name: Half swaddle name: Kangaroo care measure: Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI) measure: Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Trakya University status: RECRUITING city: Edirne zip: 22030 country: Turkey name: Burcu Küçükkaya role: CONTACT phone: 05422931357 email: [email protected] lat: 41.67719 lon: 26.55597 hasResults: False
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<|newrecord|> nctId: NCT06348303 id: PMMD-01 briefTitle: Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-04 date: 2024-04-26 name: Primus Pharmaceuticals class: INDUSTRY name: ClinOhio Research Services, LLC briefSummary: Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Single mask of participants. Participants will be prevented from knowing product dose. whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Metaxalone m640 mg oral tablet name: Metaxalone 800 mg oral tablet measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). measure: Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path measure: Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale measure: Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes measure: The number of product related adverse events experienced by participants from Visit 2 through Visit 4 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: ClinOhio Research Institute status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States name: J Sanders role: CONTACT phone: 614-683-4900 lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06348290 id: JY-JM1899-105 briefTitle: Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2024-09-15 date: 2024-04-04 date: 2024-04-04 name: Jemincare class: INDUSTRY briefSummary: This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 72 type: ESTIMATED name: JMKX001899 name: Itraconazole name: Midazolam name: Rifampin name: dextromethorphan name: Rosuvastatin name: digoxin measure: maximum concentrations (Cmax ) for plasma measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06348277 id: 121119 briefTitle: Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students overallStatus: COMPLETED date: 2018-01-02 date: 2020-04-07 date: 2020-06-17 date: 2024-04-04 date: 2024-04-04 name: Lawrence University class: OTHER briefSummary: The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone. conditions: Depression, Anxiety conditions: Self-Injurious Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 130 type: ACTUAL name: Mindfulness plus mood monitoring name: Mood monitoring measure: Depressive Symptoms measure: Anxiety Symptoms measure: Urges to Self-injure measure: Rumination measure: Worry measure: Depressive Symptoms measure: Depressive Symptoms measure: Anxiety Symptoms measure: Anxiety Symptoms measure: Urges to self-injure measure: Urges to self-injure measure: Rumination measure: Rumination measure: Worry measure: Worry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lawrence University city: Appleton state: Wisconsin zip: 54911 country: United States lat: 44.26193 lon: -88.41538 hasResults: False
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<|newrecord|> nctId: NCT06348264 id: SDC-1 briefTitle: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma overallStatus: RECRUITING date: 2024-03-30 date: 2029-03-30 date: 2031-03-30 date: 2024-04-04 date: 2024-04-04 name: Peking University First Hospital class: OTHER name: Jiangsu Hengrui Pharmaceutical Co., Ltd. name: Beijing Biote Pharmaceutical Co.,Ltd briefSummary: The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).
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The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years. conditions: Salivary Gland Neoplasm Duct studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Rezvilutamide name: Leuprolide Acetate measure: 3-year disease-free survival (DFS) measure: 3-year overall survival (OS) measure: 3-year disease-specific survival (DSS) measure: 3-year distant-metastatic free survival (DMFS) measure: Adverse events measure: 5-year disease-free survival (DFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Xueying Ren, MD role: CONTACT phone: +86 10 83572408 email: [email protected] lat: 39.9075 lon: 116.39723 facility: Peking University School and Hospital of Stomatology status: RECRUITING city: Beijing state: Beijing country: China name: Xiaofeng Shan, MD role: CONTACT phone: +86 10 82195390 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06348251 id: STU00219612 briefTitle: FoodSteps for Binge Eating & Food Insecurity overallStatus: RECRUITING date: 2024-03-26 date: 2024-11-30 date: 2024-11-30 date: 2024-04-04 date: 2024-04-04 name: Northwestern University class: OTHER briefSummary: The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity. conditions: Binge Eating conditions: Type 2 Diabetes conditions: Food Insecurity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FoodSteps measure: Recruitment and retention rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University Feinberg School of Medicine status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Andrea K Graham, PhD role: CONTACT phone: 312-503-5266 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06348238 id: 2074997 briefTitle: Strategies to Improve Well-Being and Diabetes Management overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-03-28 date: 2027-02-28 date: 2024-04-04 date: 2024-04-04 name: Elizabeth Scharnetzki class: OTHER name: MaineHealth Institute for Research briefSummary: This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:
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* Will self-affirmation reduce feelings of stigmatization?
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* Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.
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* Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.
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After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: Self-Affirmation measure: Social Identity Threat Concerns (SITC) Scale measure: Two-Factor Weight Bias Internalization Scale measure: Diabetes Stigma Assessment Scale measure: The Revised Diabetes Self-Management Questionnaire measure: Confidence in Diabetes Self-Care Scale measure: Blood glucose measure: Hemoglobin A1C measure: Patient-reported age measure: Patient Gender measure: Patient Race measure: Patient ethnicity measure: Patient's highest level of education completed measure: Household income measure: Zip code measure: Years since diagnosis measure: Diabetes Management Plan measure: Physical activity measure: Continuous glucose monitor use measure: Height measure: Weight measure: History of weight-based victimization (moderator/covariate) measure: Problem Areas in Diabetes Questionnaire (moderator/covariate) measure: Generalized Anxiety Disorder 7-item (moderator/covariate) measure: Patient Health Questionnaire (PHQ-9) (moderator/covariate) measure: Stigma Consciousness Questionnaire (moderator/covariate) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MaineHealth Institute for Research, Center for Interdisciplinary and Population Health Research city: Westbrook state: Maine zip: 04092 country: United States name: Elizabeth Scharnetzki role: CONTACT phone: 805-340-9716 email: [email protected] lat: 43.67703 lon: -70.37116 hasResults: False
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<|newrecord|> nctId: NCT06348225 id: FY24-10 briefTitle: Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure acronym: ExHT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: Providence College class: OTHER briefSummary: The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.
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. The main questions it aims to answer are:
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* Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.
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* If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.
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Participants will complete four different trials:
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* 30 minutes of walking with a 45-minute lukewarm leg bath after
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* 30 minutes of walking with a 45-minute hot leg bath after
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* 45 minutes of a hot leg bath with no exercise
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* A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone. conditions: Elevated Blood Pressure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A repeated-measures design will be used with all participants completing the three acute interventions (exercise, heat, or exercise + heat) as well as a control day. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: It is not possible to mask the participant to treatments (exercise/no exercise, water temperature, etc) or the PI who is monitoring them during treatment. However, all data (hourly blood pressure, heart rate variability, and flow-mediated dilation) will be analyzed by an individual blinded to the trial/intervention. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Exercise or heat treatment measure: Ambulatory blood pressure measure: Heart Rate Variability measure: Flow-mediated dilation sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-28 uploadDate: 2024-03-28T10:14 filename: Prot_SAP_000.pdf size: 198276 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-28 uploadDate: 2024-03-28T10:15 filename: ICF_001.pdf size: 162356 hasResults: False
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<|newrecord|> nctId: NCT06348212 id: 2022-11-008C briefTitle: Effect of Probiotic Strain Lactobacillus Paracasei PS23 on Brain Fog in People With Long COVID acronym: COVID-19 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: The goal of this clinical trial is to test whether the intervention of probiotics supplement can improve symptoms of long covid syndrome.
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Participants will be given probiotics or placebo capsules for two month. Symptom questionnaires, cognitive function, eeg and fecal sample are recorded/collected before and after the supplement.
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Researchers will compare the probiotic group and the placebo to see if probiotic supplement really make differences. conditions: Long COVID conditions: Brain Fog conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization were performed by the provider of probiotic and placebo. The participant will never know their group. The study Investigator and Outcome assessor will not know the groups of participants until they finish recruiting and data processing. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Lactobacillus paracasei PS23 name: microcrystalline cellulose measure: Long covid related symptoms measure: Hospital Anxiety and Depression Scale measure: The Pittsburgh sleep quality index measure: Fatigue Severity Scale measure: GI symptoms measure: Cognitive function-Digit symbol substitution test measure: Cognitive function-The Montreal Cognitive Assessment(MoCA) measure: Cognitive function-Color Trails making Test measure: Cognitive function-Cogstate Brief Battery (CBB) measure: EEG measure: Gut microbiota measure: Fecal metabolite sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06348199 id: SB27-3004 briefTitle: A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-03-12 date: 2025-09 date: 2027-03 date: 2024-04-04 date: 2024-04-19 name: Samsung Bioepis Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:
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• How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.
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Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda. conditions: Non-small Cell Lung Cancer Stage IV studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 616 type: ESTIMATED name: SB27 name: Keytruda measure: Objective response rate (ORR) at Week 24 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Investigative Site status: RECRUITING city: Batumi country: Georgia lat: 41.64228 lon: 41.63392 facility: SB Investigative Site status: RECRUITING city: Tbilisi country: Georgia lat: 41.69411 lon: 44.83368 facility: SB Investigative Site status: RECRUITING city: Jaipur country: India lat: 26.91962 lon: 75.78781 facility: SB Investigative Site status: RECRUITING city: Surat country: India lat: 21.19594 lon: 72.83023 facility: SB Investigative Site status: RECRUITING city: Cluj-Napoca country: Romania lat: 46.76667 lon: 23.6 facility: SB Investigative Site status: RECRUITING city: Craiova country: Romania lat: 44.31667 lon: 23.8 facility: SB Investigative Site status: RECRUITING city: Sibiu country: Romania lat: 45.8 lon: 24.15 facility: SB Investigative Site status: RECRUITING city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06348186 id: Fascial Tissue Response briefTitle: Fascial Tissue Response To Manual Therapy: Implications In Long Covid Rehabilitation overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-01 date: 2024-07-31 date: 2024-04-04 date: 2024-04-04 name: University of the State of Santa Catarina class: OTHER name: Larissa Sinhorim briefSummary: According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Guidebook name: Guidebook and Myofascial Reorganization® (RMF). measure: Functioning and disability measure: Biomechanical and tissue viscoelastic properties measure: Work capacity measure: Quality of life measure: Upper limb dysfunctions measure: Balance sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Santa Catarina State University status: RECRUITING city: Florianópolis state: Santa Catarina zip: 88.035-001 country: Brazil name: Larissa Sinhorim role: CONTACT lat: -27.59667 lon: -48.54917 hasResults: False
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<|newrecord|> nctId: NCT06348173 id: 2021-2190 briefTitle: Response and Remission to Treatment With Anti-IL5/IL5R Antagonists overallStatus: COMPLETED date: 2023-06-01 date: 2023-11-30 date: 2023-11-30 date: 2024-04-04 date: 2024-04-04 name: Université de Montréal class: OTHER name: GlaxoSmithKline briefSummary: The aim of this retrospective observational study is to compare the response and remission rate after treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials.
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This study will be performed using the charts of the patients. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 109 type: ACTUAL name: Mepolizumab measure: Response to IL5/IL5R antagonists one year after cohort entry among subjects fulfilling and not fulfilling the original RCT inclusion criteria measure: Remission rate with IL5/IL5R antagonists one year after cohort entry in subjects fulfilling and not fulfilling the original RCT inclusion criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital du Sacré-Coeur de Montréal city: Montréal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
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<|newrecord|> nctId: NCT06348160 id: STUDY20230187 briefTitle: iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-04 date: 2024-04-04 name: Julia Blanchette class: OTHER name: The Leona M. and Harry B. Helmsley Charitable Trust briefSummary: This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 192 type: ESTIMATED name: iHERO Toolkit Resource measure: Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW) measure: Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM) measure: Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30. measure: Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale measure: Change in HbA1c levels as measured by self-collect capillary HbA1c sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Children's Hospital Los Angeles city: Los Angeles state: California zip: 90027 country: United States name: Jaquelin Flores Garcia, MPH role: CONTACT name: Jennifer Raymond, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of Florida Diabetes Institute city: Gainesville state: Florida zip: 32610 country: United States name: Michael Haller, MD role: CONTACT name: Michael Haller, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 facility: University Hospitals city: Cleveland state: Ohio zip: 44106 country: United States name: Dionne Williams, PhD role: CONTACT phone: 216-238-6100 email: [email protected] lat: 41.4995 lon: -81.69541 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Steven Willi, MD role: CONTACT name: Steven Willi, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06348147 id: LCCC2323 briefTitle: Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-05 date: 2028-08 date: 2024-04-04 date: 2024-04-10 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
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This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing. conditions: Newly Diagnosed Multiple Myeloma conditions: Multiple Myeloma conditions: Autologous Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Daratumumab name: Lenalidomide name: Bortezomib name: Dexamethasone measure: The rate of achievement of bone marrow minimal residual disease (MRD) negativity measure: Progression Free Survival (PFS ) measure: Stringent complete response (sCR) measure: Overall Survival (OS) measure: Therapeutic discontinuation measure: Time to first response measure: Time to best response measure: Maximum depth of response (from PR to CR, including sCR) measure: Overall response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Ralph L Dessieu role: CONTACT email: [email protected] name: Samuel M Rubinstein, MD, MSCI role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
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<|newrecord|> nctId: NCT06348134 id: IRB23-0502 briefTitle: Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2034-07-01 date: 2036-07-01 date: 2024-04-04 date: 2024-04-04 name: University of Chicago class: OTHER briefSummary: Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: HER2-positive Breast Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Trastuzumab emtansine name: Pertuzumab Injection name: Docetaxel name: Tamoxifen name: Letrozole name: Goserelin measure: Pathological Complete Response measure: Reported Adverse Events and clinical/medical records of participants measure: Percentage of participants who are suitable for breast-conserving surgery measure: Event-free survival duration reported among participants measure: Quality of life reported among study participants measure: Genetic and epigenetic factors associated with breast cancer in Nigeria sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60615 country: United States name: Olufunmilayo Olufunmilayo role: CONTACT phone: 773-702-1632 email: [email protected] lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06348121 id: WK2024003 briefTitle: Impact of Probiotics on Children With ADHD overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-08-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy and safety of probiotic product WecProB as food supplements for the treatment of clinical symptoms in children with ADHD, in comparison with placebo. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Probiotic measure: Clinical symptoms of ADHD sex: MALE minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06348108 id: 232514 id: NCI-2024-01992 type: REGISTRY domain: NCI Clinical Trials Reporting Program briefTitle: Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2028-06-30 date: 2024-04-04 date: 2024-04-04 name: Thomas Martin, MD class: OTHER name: Bristol-Myers Squibb name: Janssen Research & Development, LLC briefSummary: This phase I trial tests the safety, side effects, and best dose of talquetamab in combination with iberdomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). There is currently a significant unmet need for patients with relapsed or refractory multiple myeloma (RRMM) who are triple class refractory and have been exposed to B-cell maturation antibody (BCMA) targeted therapy. These patients currently have limited treatment options and poor survival. Talquetamab is approved for use by the Food and Drug Administration (FDA) to treat RRMM when given alone. Talquetamab can bring T-cells to the myeloma cell, resulting in myeloma cell death. Iberdomide is an investigational drug. Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive. Dexamethasone is a corticosteroid, is similar to a natural hormone produced by the adrenal glands. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain types of cancer including myeloma. Giving talquetamab in combination with iberdomide and dexamethasone may be safe, tolerable and effective in treating patients with RRMM conditions: Multiple Myeloma conditions: Refractory Multiple Myeloma conditions: Relapsed Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Talquetamab name: Iberdomide name: Dexamethasone name: Bone Marrow Biopsy measure: Proportion of participants reporting treatment-emergent adverse events (AEs) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Escalation Cohorts) measure: Recommended phase 2 dose (RP2D) (Dose Escalation Cohorts) measure: Proportion of participants experiencing Dose-Limiting Toxicity (DLTs) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Expansion Cohort) measure: Objective response rate (ORR) (Dose Escalation Cohorts) measure: Number of participants achieving VGPR or CR and MRD (negative (-)) response measure: Proportion of participants with treatment-related adverse events measure: Changes in scores on the European Organization for Research and Treatment of Cancer - Quality of Life questionnaire (EORTC-QLQ-C30) over time measure: Changes in scores on the EORTC QLQ- Multiple Myeloma Questionnaire (EORTC-QLQ-M20) over time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calfornia, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Kenya Gomez role: CONTACT email: [email protected] role: CONTACT phone: 877-827-3222 email: [email protected] lat: 37.77493 lon: -122.41942 hasResults: False
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<|newrecord|> nctId: NCT06348095 id: WK2024004 briefTitle: Effect of Probiotics on Viral Pneumonia overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-10-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with viral pneumonia, in comparison with placebo. conditions: Viral Pneumonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Probiotic name: Placebo measure: Respiratory syncytial virus (RSV) viral load sex: ALL minimumAge: 6 Months maximumAge: 3 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06348082 id: 2000036068 id: 1R18HS029812-01 type: AHRQ link: https://reporter.nih.gov/quickSearch/1R18HS029812-01 briefTitle: Project Women's Insomnia Sleep Health Equity Study (WISHES) acronym: Project WISHES overallStatus: NOT_YET_RECRUITING date: 2025-09 date: 2028-07 date: 2028-07 date: 2024-04-04 date: 2024-04-05 name: Yale University class: OTHER name: Department of Health and Human Services briefSummary: The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women. conditions: Insomnia conditions: Sleep Health conditions: Cardiometabolic Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Hybrid Type 1 effectiveness/implementation study using a pragmatic randomized controlled trial (RCT) with MBTI and a waitlist control. Participants will be randomly assigned by a computer-generated sequence to either the MBTI or waitlist control in a 1:1 ratio using permuted blocks stratified by age (2 strata: ≤50 or postmenopausal age \>51) with random block sizes of 2 or 4 to reduce predictability. primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: Mindfulness-based therapy for insomnia (MBTI) measure: Change in Insomnia Severity measure: Change in Perceived Stress measure: Acceptability of Intervention (AIM) measure: Feasibility of Intervention (FIM) measure: Treatment Fidelity sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale School of Nursing Biobehavioral Lab city: West Haven state: Connecticut zip: 06516 country: United States lat: 41.27065 lon: -72.94705 hasResults: False
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<|newrecord|> nctId: NCT06348069 id: 2022-11-15783 briefTitle: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe acronym: TOPAZ overallStatus: RECRUITING date: 2024-03-25 date: 2025-03-11 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of California, Berkeley class: OTHER name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe) name: University of California, San Francisco name: Liverpool School of Tropical Medicine briefSummary: Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP. conditions: Adherence, Medication conditions: HIV Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 200 type: ESTIMATED name: Pharmacy-based PrEP refill and gift voucher name: Control (Standard of care) measure: PrEP retention at 6 months measure: PrEP retention at 6 months among FSW who are 18-24 years of age measure: : PrEP retention at 6 months among participants who have remained active in sex work measure: FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies measure: HIV tests measure: HIV care referrals sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CESHHAR Zimbabwe status: RECRUITING city: Harare zip: 0000 country: Zimbabwe name: Oppah Kuguyo role: CONTACT email: [email protected] lat: -17.82772 lon: 31.05337 hasResults: False
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<|newrecord|> nctId: NCT06348056 id: 2022-07-15499 briefTitle: A Comparison of the Metabolic Effects of Zinc-Amino Acid (ZnAA) Versus Zinc Gluconate overallStatus: RECRUITING date: 2024-01-22 date: 2024-08-30 date: 2024-12-31 date: 2024-04-04 date: 2024-04-08 name: University of California, Berkeley class: OTHER briefSummary: Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate.
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The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state.
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The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex. conditions: Response of Fatty Acid Desaturation to Zinc Intake studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will take the first zinc supplement for two weeks, followed by a two-week washout period, and then take the second zinc supplement for two weeks. The order of whether the first supplement is the zinc amino acid complex, or zinc gluconate, will be randomized. primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE maskingDescription: The two zinc supplements will have the same appearance, and will be in coded bottles, such that the participant, care provider, investigator, and outcomes assessor may be kept unaware of the order of the supplements for each participant until the data analysis is complete. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: 30 mg Zn Amino Acid daily for 13 days name: 30 mg Zn Gluconate daily for 13 days measure: FADS1 activity index measure: Fasted plasma zinc concentration sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, Berkeley status: RECRUITING city: Berkeley state: California zip: 94720 country: United States name: Yasaman Massih, MPH role: CONTACT phone: 415-279-2171 email: [email protected] lat: 37.87159 lon: -122.27275 hasResults: False
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<|newrecord|> nctId: NCT06348043 id: SU_PumpKIN id: 1UG3HL163311-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG3HL163311-01A1 briefTitle: Pumps for Kids, Infants and Neonates (PumpKIN): The Jarvik 2015 Pivotal Trial acronym: PumpKIN overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-12 date: 2029-12 date: 2024-04-04 date: 2024-04-04 name: Stanford University class: OTHER name: University of Texas name: Carelon Research name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is a 22-subject prospective, multicenter, single-arm clinical trial to evaluate the safety and effectiveness of the Jarvik 2015 left ventricular assist device (LVAD) as a bridge to heart transplant in children weighing 8 to 30 kilograms. Data generated from the study will be used to support FDA review and potential approval of the device under the Humanitarian Device Exemption (HDE) regulation, the FDA approval pathway for devices intended to treat rare and orphan diseases. conditions: Heart Failure With Reduced Ejection Fraction conditions: Pediatric HD, Stage IV conditions: LVAD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Jarvik 2015 LVAD measure: Survival to heart transplant, recovery or 180 days of support in the absence of severe stroke. measure: Freedom from symptomatic stroke measure: Incidence rate of all protocol-defined SAE's through 180 days of support definitely or probably related to the device measure: Distribution of Pediatric Stroke Outcomes Measures measure: The KOSCHI score measure: Overall survival on Jarvik 2015 support to 180 days sex: ALL minimumAge: 6 Months maximumAge: 16 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06348030 id: 17401 briefTitle: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-03 date: 2024-04-04 date: 2024-04-08 name: St. Joseph's Healthcare Hamilton class: OTHER briefSummary: Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ESTIMATED name: Medtronic Signia Stapler name: Vessel Sealer Extend Energy Device and SureForm Stapler measure: Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection measure: Operating Room Time measure: Length of Stay in Hospital measure: Duration of Chest Tube measure: Intraoperative Complications and Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Joseph's Healthcare Hamilton city: Hamilton state: Ontario zip: L8N 4A6 country: Canada name: Yogita S Patel, BSc role: CONTACT phone: 905-522-1155 phoneExt: 35096 email: [email protected] name: Waël C Hanna, MDCM, MBA, FRCSC role: PRINCIPAL_INVESTIGATOR lat: 43.25011 lon: -79.84963 hasResults: False
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<|newrecord|> nctId: NCT06348017 id: Yozgat City Hospital briefTitle: Frequency of Neuropathic Pain in Patients With Plantar Fasciitis overallStatus: COMPLETED date: 2023-10-19 date: 2024-03-01 date: 2024-03-15 date: 2024-04-04 date: 2024-04-09 name: Yozgat City Hospital class: OTHER briefSummary: Study Design This prospective cross-sectional study was undertaken between November 2023 and March 2024. Written and verbal informed consent was obtained from all patients. The study protocol was approved by University Human Research Ethics Committee (AEŞH-EK 1-2023-612).
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Patients While 106 patients who applied to the City Hospital Physical Medicine and Rehabilitation outpatient clinic with heel pain that had been present for at least six months, received foot radiography and were diagnosed with PF were included in the study as a patient group; 100 patients who did not have foot pain and had musculoskeletal pain for at least 6 months were included in the study as a control group, between November 2023 and March 2024. All the participants were aged 18 to 65 years. Patients with a history of diabetes, hypothyroidism and CKD, a history of malignancy, with vasculitis, neurological diseases that may cause neuropathic pain, lumbar discopathy, those with a previous history of fracture or surgery in the heel area, received injections or ESWT treatment due to heel pain in the last 3 months, rheumatic diseases that may affect pain such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia, and severe circulatory disorders on the side with pain, were excluded from the study. The study was commenced after obtaining the approval of the local ethics committee and informed consent of the participants.
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All patients' personal information (age, gender, occupation, education information), general health information (smoking and alcohol use information, known chronic disease history, body mass index), severity of heel pain and when it started were recorded. While the Foot Function Index (FFI) scale, which evaluates the functionality of the foot, was applied to the patient group; the Visual Analog Scale (VAS), which evaluates pain intensity, the Pain-DETECT scale, which evaluates neuropathic pain, and the Central Sensitization Scale (CSI), which evaluates central sensitization, were applied to the patient and control groups. The details of the implementation of the instruments are as follows: conditions: Chronic Plantar Fasciitis conditions: Control Group studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 206 type: ACTUAL measure: Pain-DETECT measure: Foot Function Index measure: Central Sensitization Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yozgat City Hospital city: Yozgat zip: 66100 country: Turkey lat: 39.82 lon: 34.80444 hasResults: False
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<|newrecord|> nctId: NCT06348004 id: 2024IIT-0125 briefTitle: The Association Between Albumin Administration and Short-term Rebleeding Risk in Cirrhosis Patients With Acute Variceal Hemorrhage and Stable Hemodynamics overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-04 date: 2024-04 date: 2024-04-04 date: 2024-04-04 name: Zhejiang University class: OTHER briefSummary: The impact of albumin administration in cirrhotics with acute variceal hemorrhage (AVH) is controversial. We aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with AVH with stable hemodynamics. This retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from January 2021 to October 2023. Propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. According to the outcome, patients will be divided into rebleeding group and non-rebleeding group. To investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. The primary outcome is the rebleeding risk within 30 days after discharge. conditions: Cirrhosis conditions: Acute Variceal Haemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: The rebleeding risk within 30 days after discharge. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06347991 id: Pro00140155 briefTitle: Alberta Chiropractic SelfBack Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of Alberta class: OTHER name: Chiropractic Association of Alberta briefSummary: Recurrent and persistent low back pain (LBP) is a massive problem in Canada that causes a substantial pain, disability, cost, and even premature death.
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The good news is that treatments for recurrent and persistent LBP are available. Many guidelines now recommend education and exercise as the best intervention for chronic LBP. Unfortunately, education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs.
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As a result, the 50% of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians. Physicians, in turn, have little choice but to reach for what they have available, including opioids, x-rays and referrals to specialists. Not only are these interventions unhelpful for chronic LBP, they are often harmful, sometimes deadly, and disproportionately affect lower socio-economic status households.
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