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The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:
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* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
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* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
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* intestinal barrier;
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* body composition;
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* intestinal microbiota;
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* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. conditions: NAFLD conditions: Obesity conditions: IBS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.
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The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Mediterranean diet and moderate intensity physical exercise (outdoor walking). measure: The effect of intervention on CAP value measure: The effect of intervention on FLI value measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk measure: The effect of the intervention on the integrity of the intestinal barrier measure: The effect of the intervention on the Gastrointestinal Symptoms measure: The effect of the intervention on the Body Composition sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Irccs Saverio de Bellis city: Castellana Grotte state: Bari zip: 70013 country: Italy lat: 40.88643 lon: 17.16549 hasResults: False
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<|newrecord|> nctId: NCT06275893 id: ACM01 briefTitle: IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy overallStatus: RECRUITING date: 2024-03-29 date: 2025-02-01 date: 2025-08-01 date: 2024-02-23 date: 2024-04-02 name: Implicit Bioscience class: INDUSTRY briefSummary: The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.
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Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests. conditions: Arrhythmogenic Right Ventricular Dysplasia conditions: Arrhythmogenic Left Ventricular Cardiomyopathy conditions: Arrhythmogenic Right Ventricular Cardiomyopathy 1 conditions: Arrhythmogenic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured. primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: IC14 measure: Safety: Treatment-emergent adverse events and serious adverse events measure: Safety: Incidence of anti-drug antibodies measure: Inflammatory biomarker C-reactive protein measure: CCR2+ Myocardial Imaging (optional) measure: Ventricular tachycardia measure: Ventricular premature contractions measure: Sustained and non-sustained ventricular tachycardia measure: Treated ventricular tachycardia measure: Atrial premature contractions measure: New York Heart Association (NYHA) Functional Class measure: Implantable cardioverter/defibrillator (ICD) discharges measure: Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire measure: Disease biomarker Troponin I measure: Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP) measure: Inflammatory biomarker interleukin (IL)1-beta measure: Pharmacokinetics: Serum IC14 concentration versus time curve measure: Pharmacokinetics: Peak serum IC14 concentration measure: Pharmacokinetics: Half life measure: Pharmacodynamics: Receptor Occupancy measure: Pharmacodynamics: Effective Concentration 95% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Philip S. Cuculich, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
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<|newrecord|> nctId: NCT06275880 id: F-2023-3201-066 briefTitle: Intraarticular Collagen in Patients With Gonarthrosis overallStatus: COMPLETED date: 2023-04-01 date: 2023-07-30 date: 2024-01-10 date: 2024-02-23 date: 2024-02-23 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following:
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1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
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2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
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3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.
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Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks. conditions: Gonarthrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 130 type: ACTUAL name: Intra-articular infiltration of PVP Collagen name: Rehabilitation measure: Western Ontario and McMaster Universities Osteoarthritis Index - Pain measure: Western Ontario and McMaster Universities Osteoarthritis Index - stiffness measure: Western Ontario and McMaster Universities Osteoarthritis Index - functionality measure: Number Analog Scale for pain sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital General Regional No. 1 Lic. Ignacio García Téllez city: Mérida state: Yucatán zip: 97155 country: Mexico lat: 20.97537 lon: -89.61696 hasResults: False
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<|newrecord|> nctId: NCT06275867 id: SOPRIMA//T023635 briefTitle: Improved Access to Quality Care and Healthcare Use overallStatus: RECRUITING date: 2024-01-20 date: 2024-06-10 date: 2024-08-30 date: 2024-02-23 date: 2024-02-23 name: London School of Economics and Political Science class: OTHER name: University of Witwatersrand, South Africa briefSummary: This study is an individual-level randomised controlled trial which looks at the effect of providing free access to higher quality providers in urban South Africa. The study will recruit about 1,500 individuals with a child aged 5 or under. They will be randomly allocate to a control group (CONTROL) with the default free access to government facilities or one of the two treatment groups where they will have free access to private providers located either relatively close (CONVENIENT) by or relatively far (INCONVENIENT). The primary outcomes be overuse and underuse of healthcare services for children under 5 conditions: Health Care Utilization conditions: Health Knowledge, Attitudes, Practice conditions: Health, Subjective studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 1500 type: ESTIMATED name: Free high-quality care name: Close distance name: Far distance measure: Underuse measure: Overuse measure: Illness duration measure: Out-of-pocket expenditures measure: Health knowledge sex: ALL minimumAge: 2 Months maximumAge: 6 Years stdAges: CHILD facility: HDSS Soweto clusters status: RECRUITING city: Soweto state: Gauteng country: South Africa name: Nomalanga Boyce role: CONTACT email: [email protected] lat: -26.26781 lon: 27.85849 hasResults: False
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<|newrecord|> nctId: NCT06275854 id: 22265 briefTitle: YASU Research Registry: For Young Adults With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-05-01 date: 2030-05-01 date: 2024-02-23 date: 2024-02-23 name: Young Adult Survivors United class: OTHER name: Staunton Farm Foundation name: Elsie H. Hillman Foundation briefSummary: The goal of this observational research registry is to learn about health, wellbeing, and needs of survivors of young adult cancer (diagnosed between the ages of 18 and 39). The main question\[s\] it aims to understand are:
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* What are the levels of depression, anxiety, social support, and financial distress
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* Determine effectiveness of YASU programming by measuring changes over time
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With this registry, the investigators also plan to identify survivors who may be eligible for participation in future research studies pertaining to young adult cancer.
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Participants will be asked to complete electronic surveys every 6 to 12 months during participation in the registry. conditions: Cancer conditions: Leukemia conditions: Sarcoma conditions: Germ Cell Cancer conditions: Lymphoma conditions: Colorectal Cancer conditions: Melanoma conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED measure: Anxiety measure: Depressive symptoms measure: Social Support measure: Financial Toxicity measure: Needs Assessment measure: Name, address, email, phone number sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06275841 id: C4891035 briefTitle: A Study to Learn If the Study Medicine Esomeprazole Changes How the Body Processes the Other Study Medicine Vepdegestrant overallStatus: RECRUITING date: 2024-02-23 date: 2024-05-03 date: 2024-05-24 date: 2024-02-23 date: 2024-03-22 name: Pfizer class: INDUSTRY name: Arvinas Estrogen Receptor, Inc. briefSummary: The purpose of the study is to investigate the effect of multiple doses of a proton-pump inhibitor (PPI) esomeprazole on the PK of vepdegestrant under fed conditions in healthy adult participants.
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All participants in this study will receive one dose of vepdegestrant alone by mouth in Period 1. In Period 2, everyone will receive esomeprazole by mouth once a day for multiple days. Participants will also receive one dose of vepdegestrant by mouth. The levels of vepdegestrant in Period 1 will be compared to the levels of vepdegestrant in Period 2 to determine if the PPI affects how vepdegestrant is processed differently in healthy adults. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: vepdegestrant name: esomeprazole measure: Maximum observed plasma concentration (Cmax) of vepdegestrant when vepdegestrant is administered alone measure: Maxium observed plasma concentration of vepdegestrant when vepdegestrant is administered with esomeprazole measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered alone measure: Area under the curve from time zero to extrapolated infinite time (AUCinf) when vepdegestrant is administered with esomeprazole measure: number of participants with treatment-emergent adverse events (AEs) and serious adverse events (SAEs) measure: Number of participants with clinical laboratory abnormalities measure: Number of participants with electrocardiogram (ECG) abnormalities measure: Number of participans with clinically significant change from baseline in vital signs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pfizer Clinical Research Unit - New Haven status: RECRUITING city: New Haven state: Connecticut zip: 06511 country: United States lat: 41.30815 lon: -72.92816 hasResults: False
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<|newrecord|> nctId: NCT06275828 id: PoliceGeneralHospiral briefTitle: The Effect of Perioperative and Postoperative Music Reduces Pain Perception After Anterior Cruciate Ligament Reconstruction overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-15 date: 2023-07-31 date: 2024-02-20 date: 2024-02-23 date: 2024-02-23 name: Police General Hospital, Thailand class: OTHER briefSummary: study the effect of music therapy in pre-operative and post operative period and measure the out come by the visual analog scale (pain score) and analgesic drug use such as morphine and the anxiety score conditions: Anterior Cruciate Ligament Tear studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: slow beat mesic listening by headphone measure: visual analog scale measure: analgesic drug use measure: Amsterdam Preoperative Anxiety and Information Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Police General Hospital city: Bangkok state: Pathuwam zip: 10330 country: Thailand lat: 13.75398 lon: 100.50144 hasResults: False
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<|newrecord|> nctId: NCT06275815 id: R01DC020958 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020958 briefTitle: Promoting Caregiver Implementation of an Effective Early Learning Intervention overallStatus: RECRUITING date: 2024-04-10 date: 2028-07-31 date: 2028-07-31 date: 2024-02-23 date: 2024-04-12 name: Ohio State University class: OTHER name: Nationwide Children's Hospital briefSummary: The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:
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* how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
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* how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week.
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Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years.
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Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions. conditions: Developmental Language Disorder conditions: Reading; Difficult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 320 type: ESTIMATED name: Sit Together and Read (STAR) name: Monetary Reward name: Text Encouragement measure: Preschool Word and Print Awareness (PWPA) measure: Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing measure: The Reading House (THR) measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension sex: ALL minimumAge: 48 Months maximumAge: 66 Months stdAges: CHILD facility: Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy status: RECRUITING city: Columbus state: Ohio zip: 43201 country: United States name: Jennifer M Bostic, MA role: CONTACT phone: 614-292-5715 email: [email protected] name: Laura M Justice, PhD role: PRINCIPAL_INVESTIGATOR name: Rebecca Dore, PhD role: SUB_INVESTIGATOR name: Hui Jiang, PhD role: SUB_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Nationwide Children's Hospital status: RECRUITING city: Columbus state: Ohio zip: 43205 country: United States name: Jamie B Boster, PhD role: CONTACT phone: 614-722-8756 email: [email protected] name: Jamie B Boster, PhD, CCC-SLP role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06275802 id: 22-5.1T/2 briefTitle: The Effect of Nutrition Education Interventions for Adolescents overallStatus: RECRUITING date: 2022-06-06 date: 2023-12-30 date: 2024-06-30 date: 2024-02-23 date: 2024-02-23 name: Ege University class: OTHER briefSummary: The aim of this study is to determine the effect of nutrition education on nutritional literacy, nutritional status, eating habits and eating behavior in high school students. The research will be conducted in six high schools, three of which are intervention schools and three of which are control schools It is planned that a total of 1000 students will be included in the study from the intervention school and 1000 students from the control school. At the beginning of the study (June 2022), an introductory form (sociodemographic characteristics, body image (Stunkart scale), dietary habits, knowledge about weight status) was applied to all students. Adolescent Nutrition Literacy Scale (ANLS), Instrument of Nutrition Literacy, Mediterranean Diet Quality Index (KID-MED), Eating Attitudes Test 26 (EAT-26), International Physical Activity Questionnaire Short Form (IPAQ) were applied, anthropometric measurements and three-day food consumption records were taken. During the study, nutrition initiatives consisting of 8 modules will be made to the intervention schools. Control schools will not be interfered with during this period.At the end of the study, the procedures applied at the beginning will be repeated. conditions: Nutrition, Healthy conditions: Nutrition Disorders in Adolescence conditions: Eating Habit conditions: Eating Behavior conditions: Body Image studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1000 type: ESTIMATED name: Nutrition Education name: nutritional status, eating habits measure: nutrition literacy measure: Mediterranean Diet Quality Index (KID-MED) measure: Eating Attitudes Test 26 (EAT-26) measure: weight and height measurement measure: waist circumference measurement measure: Food Consumption Record measure: International Physical Activity Questionnaire (IPAQ- Short Form) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Menemen District Directorate of National Education status: RECRUITING city: İzmir country: Turkey name: Sibel ÖZER role: CONTACT phone: (0232) 832 26 29 lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06275789 id: 2023-268 briefTitle: Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation? overallStatus: RECRUITING date: 2024-01-26 date: 2025-06 date: 2025-06 date: 2024-02-23 date: 2024-04-09 name: Nova Southeastern University class: OTHER name: Geistlich Pharma AG name: ZimVie briefSummary: The purpose of the study is to compare a new grafting material for alveolar ridge preservation to a commonly used and well studied material. Alveolar ridge dimensions as well as histology will be compared. conditions: Alveolar Ridge Preservation conditions: Dental Extraction conditions: Bone Graft studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alveolar ridge preservation measure: changes in horizontal dimensions of the alveolar ridge measure: changes in vertical dimensions of the alveolar ridge measure: vital bone percentage measure: thickness of the buccal plate in mm and its influence on the ridge dimension measure: the thickness of the lingual plate in mm and its influence on the ridge dimension measure: the thickness of the overlying buccal soft tissue in mm and its influence on the ridge dimension measure: the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension measure: # of cigarettes and its influence on the ridge dimension measure: oral hygiene using the plaque index and its influence on the ridge dimension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nova Southeastern University status: RECRUITING city: Fort Lauderdale state: Florida zip: 33328 country: United States name: Saynur Vardar-Sengul, DDS, PhD role: CONTACT phone: 954-262-1815 email: [email protected] lat: 26.12231 lon: -80.14338 hasResults: False
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<|newrecord|> nctId: NCT06275776 id: OC-2022-005 briefTitle: HIP-STITCH (Wound Recovery After THA) overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-03-01 date: 2028-05-01 date: 2024-02-23 date: 2024-03-05 name: Reinier Haga Orthopedisch Centrum class: OTHER briefSummary: This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.
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This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.
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The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.
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Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA. conditions: Wound Healing Disturbance of studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Test subjects are randomised into one of four study arms. Each study arm corresponds with one of the suturing techniques that are going to be used to close the superficial skin after Total Hip Arthroplasty. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: No one in this study can reasonably be blinded for the suturing technique during the duration of the study, since the suturing techniques differ substantially in shape, appearance and size. The only blinding in this study is the blinding of the outcome assessor to data of the test subjects. The assessor will only see the photographs of the wound/plaster, and the moment on which the photograph was taken. Additional information on the test subject, such as age, comorbidities, et cetera, will be withheld from the assessor. whoMasked: OUTCOMES_ASSESSOR count: 236 type: ESTIMATED name: Ethicon Monocryl Smooth Suture name: Ethicon Vicryl Rapide Braided Suture name: Flexifuze Indermil Topical Skin Adhesive name: Dermabond Prineo Skin Closure System name: Stryker Zip Skin Closure System measure: Number of Participants with Aberrant Wound Recovery measure: Number of Participants with Superficial or Deep Wound Infection measure: Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire) measure: Costs measure: Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire) measure: Patient reported outcome measure: Number of Participants with Other postoperative symptoms measure: Number and Type of Complications measure: Number of Visits to a Healthcare Professional sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Reinier Haga Orthopedisch Centrum city: Zoetermeer state: Zuid Holland zip: 2725NA country: Netherlands name: Brechtje Hesseling, Msc role: CONTACT phone: 003179-2065595 email: [email protected] name: Nina MC Mathijssen, Dr. role: CONTACT phone: 003179-2065595 email: [email protected] lat: 52.0575 lon: 4.49306 hasResults: False
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<|newrecord|> nctId: NCT06275763 id: 2020/ABM/01/00037 briefTitle: Optimal Medical Treatment of Difficult-to-treat Hypertension acronym: OPTIMAL-HT overallStatus: RECRUITING date: 2023-10-20 date: 2025-12-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: National Institute of Cardiology, Warsaw, Poland class: OTHER briefSummary: The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2500 type: ESTIMATED name: Phase C: Eplerenone name: Phase C: Spironolactone name: Phase C: Torasemide name: Phase B: Triplixam / Elestar HCT name: Phase A: Confirmation of uncontrolled hypertension measure: Patients with uncontrolled BP on ABPM measure: Patients with controlled BP after 12 weeks on triple SPC measure: Systolic BP reduction on 4th antihypertensive drug measure: Percentage of patients with BP controlled confirmed by HBPM measure: Consistency of the rate of uncontrolled BP measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Percentage of patients requiring an increase in the dose measure: Consistency of the rate of uncontrolled BP measure: The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks measure: The magnitude of changes in HBPM and ABPM derived indices after 12 weeks measure: Phase C measure: Changes of SBP on ABPM (24h mean) after 12 weeks of treatment measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Phase C continuation measure: Phase C continuation measure: Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups measure: Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks measure: Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups measure: Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups measure: Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiology status: RECRUITING city: Warsaw state: Mazowieckie zip: 04628 country: Poland name: Agata Skutnik role: CONTACT email: [email protected] lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06275750 id: CEI 175/23 briefTitle: Non-surgical Spinal Decompression in Patients With Chronic Low Back Pain overallStatus: COMPLETED date: 2023-08-21 date: 2023-11-29 date: 2024-01-11 date: 2024-02-23 date: 2024-02-23 name: Hospital Civil de Guadalajara class: OTHER briefSummary: The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.
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The main questions it aims to answer were:
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* Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?
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* Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?
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Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group. conditions: Low Back Pain conditions: Sciatica conditions: Lumbar Disc Herniation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) measure: Self-reported disability measure: Pain intensity sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Hospital Civil de Guadalajara Fray Antonio Alcalde city: Guadalajara state: Jalisco zip: 44280 country: Mexico lat: 20.66682 lon: -103.39182 hasResults: False
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<|newrecord|> nctId: NCT06275737 id: POP-UP G-128 briefTitle: POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer acronym: POP-UP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-02-23 date: 2024-02-23 name: GERCOR - Multidisciplinary Oncology Cooperative Group class: OTHER briefSummary: This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) . conditions: Pancreatic Ductal Adenocarcinoma conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Two-cohort, open-label, single-arm feasibility study primaryPurpose: OTHER masking: NONE count: 72 type: ESTIMATED name: Prehabilitation program measure: Rate of patients with successful completion of an 8-week trimodal prehabilitation program measure: Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately. measure: Health-related quality of life (HRQoL) assessment measure: Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions measure: Nutritional status assessment measure: Physical/functional test assessment measure: Number of patients with reduced chemotherapy tolerance measure: Number of patients with chemotherapy dose modification measure: Rate of patients who complete the strategy measure: Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia measure: Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption measure: Rate of surgical complications measure: Overall survival (OS) assessment measure: Disease-free survival (DFS) assessment measure: Adherence to Adapted Physical Activity (APA) program assessment measure: Physical activity behavior changes assessment measure: Nurse coordination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06275724 id: CKJX839A11401 briefTitle: Specified Drug-use Survey of Leqvio for s.c. Injection. overallStatus: RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2027-12-31 date: 2024-02-23 date: 2024-04-26 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice conditions: Familial Hypercholesterolaemia conditions: Hypercholesterolaemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 560 type: ESTIMATED name: inclisiran measure: Number of patients with adverse events measure: Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions measure: Number of patients with adverse events leading to discontinuation of treatment with the product measure: Percent change from baseline in LDL-C levels sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Handa state: Aichi zip: 475-0817 country: Japan lat: 34.88333 lon: 136.93333 facility: Novartis Investigative Site status: RECRUITING city: Ichinomiya state: Aichi zip: 491-8551 country: Japan lat: 35.3 lon: 136.8 facility: Novartis Investigative Site status: RECRUITING city: Komaki state: Aichi zip: 485-8520 country: Japan lat: 35.28333 lon: 136.91667 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 454-0933 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 461-0045 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Toyoake city state: Aichi zip: 470 1192 country: Japan lat: 35.038 lon: 136.99931 facility: Novartis Investigative Site status: RECRUITING city: Matsuyama state: Ehime zip: 791-8016 country: Japan lat: 33.83916 lon: 132.76574 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka-city state: Fukuoka zip: 811-0213 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Kitakyushu state: Fukuoka zip: 800-0031 country: Japan lat: 33.85181 lon: 130.85034 facility: Novartis Investigative Site status: RECRUITING city: Shirakawa state: Fukushima zip: 961-0005 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Kure-city state: Hiroshima zip: 737-0023 country: Japan lat: 34.23222 lon: 132.56658 facility: Novartis Investigative Site status: RECRUITING city: Asahikawa state: Hokkaido zip: 078-8214 country: Japan lat: 43.77063 lon: 142.36489 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 004-0052 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 065-0027 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Amagasaki state: Hyogo zip: 660-8511 country: Japan lat: 34.71667 lon: 135.41667 facility: Novartis Investigative Site status: RECRUITING city: Himeji state: Hyogo zip: 670-8560 country: Japan lat: 34.81667 lon: 134.7 facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 654-0026 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Takarazuka-city state: Hyogo zip: 665-0873 country: Japan lat: 34.79936 lon: 135.35697 facility: Novartis Investigative Site status: RECRUITING city: Moriya-city state: Ibaraki zip: 302-0102 country: Japan lat: 35.93333 lon: 140.0 facility: Novartis Investigative Site status: RECRUITING city: Kanazawa-city state: Ishikawa zip: 920-8641 country: Japan lat: 36.6 lon: 136.61667 facility: Novartis Investigative Site status: RECRUITING city: Fujisawa state: Kanagawa zip: 252-0802 country: Japan lat: 35.34926 lon: 139.47666 facility: Novartis Investigative Site status: RECRUITING city: Yokohama state: Kanagawa zip: 235-0016 country: Japan lat: 35.43333 lon: 139.65 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 238-8567 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 240-0101 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Kumamoto-city state: Kumamoto zip: 861-4193 country: Japan lat: 32.80589 lon: 130.69182 facility: Novartis Investigative Site status: RECRUITING city: Yatsushiro-city state: Kumamoto zip: 866-8533 country: Japan lat: 32.55723 lon: 130.65285 facility: Novartis Investigative Site status: RECRUITING city: Kyotanabe state: Kyoto zip: 610-0334 country: Japan lat: 34.8045 lon: 135.76681 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 602-8566 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 607-8062 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Omura state: Nagasaki zip: 856-8562 country: Japan lat: 32.92139 lon: 129.95389 facility: Novartis Investigative Site status: RECRUITING city: Ikoma state: Nara zip: 636-0802 country: Japan lat: 34.68333 lon: 135.7 facility: Novartis Investigative Site status: RECRUITING city: Kashihara state: Nara zip: 634-0045 country: Japan lat: 34.50896 lon: 135.7929 facility: Novartis Investigative Site status: RECRUITING city: Nagaoka-city state: Niigata zip: 940-8621 country: Japan lat: 37.45 lon: 138.85 facility: Novartis Investigative Site status: RECRUITING city: Oita-city state: Oita zip: 870-0263 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Kurashiki state: Okayama zip: 713-8121 country: Japan lat: 34.58333 lon: 133.76667 facility: Novartis Investigative Site status: RECRUITING city: Okayama-city state: Okayama zip: 700-8558 country: Japan lat: 34.65 lon: 133.93333 facility: Novartis Investigative Site status: RECRUITING city: Urasoe state: Okinawa zip: 901-2102 country: Japan lat: 26.25902 lon: 127.73012 facility: Novartis Investigative Site status: RECRUITING city: Uruma state: Okinawa zip: 904-2293 country: Japan lat: 26.37609 lon: 127.85908 facility: Novartis Investigative Site status: RECRUITING city: Izumisano-city state: Osaka zip: 598-8577 country: Japan lat: 34.41663 lon: 135.31667 facility: Novartis Investigative Site status: RECRUITING city: Moriguchi state: Osaka zip: 570-8507 country: Japan lat: 34.73333 lon: 135.56667 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 540-0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-0035 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-8555 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-0852 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki state: Osaka zip: 569-1121 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Toyonaka state: Osaka zip: 560-0083 country: Japan lat: 34.78244 lon: 135.46932 facility: Novartis Investigative Site status: RECRUITING city: Asaka state: Saitama zip: 351-0021 country: Japan lat: 35.80472 lon: 139.60194 facility: Novartis Investigative Site status: RECRUITING city: Gyoda state: Saitama zip: 361-0056 country: Japan lat: 36.14074 lon: 139.46011 facility: Novartis Investigative Site status: RECRUITING city: Tokorozawa state: Saitama zip: 359-1142 country: Japan lat: 35.79916 lon: 139.46903 facility: Novartis Investigative Site status: RECRUITING city: Nagahama state: Shiga zip: 526-8580 country: Japan lat: 35.38333 lon: 136.26667 facility: Novartis Investigative Site status: RECRUITING city: Hachioji-city state: Tokyo zip: 192-0918 country: Japan lat: 35.65583 lon: 139.32389 facility: Novartis Investigative Site status: RECRUITING city: Machida state: Tokyo zip: 194-0021 country: Japan lat: 35.54028 lon: 139.45083 facility: Novartis Investigative Site status: RECRUITING city: Nerima-ku state: Tokyo zip: 176-8530 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Shinjuku state: Tokyo zip: 160-8488 country: Japan lat: 35.2946 lon: 139.57059 facility: Novartis Investigative Site status: RECRUITING city: Toshima-ku state: Tokyo zip: 171-0014 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Takaoka state: Toyama zip: 939-1104 country: Japan lat: 36.75 lon: 137.01667 facility: Novartis Investigative Site status: RECRUITING city: Hashimoto state: Wakayama zip: 648-0005 country: Japan lat: 34.31667 lon: 135.61667 facility: Novartis Investigative Site status: RECRUITING city: Sakata-city state: Yamagata zip: 998-8501 country: Japan lat: 38.91667 lon: 139.855 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka zip: 815-0082 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Gifu zip: 500-8384 country: Japan lat: 35.42291 lon: 136.76039 facility: Novartis Investigative Site status: RECRUITING city: Kagoshima zip: 892-0853 country: Japan lat: 31.56667 lon: 130.55 facility: Novartis Investigative Site status: RECRUITING city: Nagasaki zip: 852-8055 country: Japan lat: 32.75 lon: 129.88333 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 870-1133 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 879-7761 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 545-8586 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False
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<|newrecord|> nctId: NCT06275711 id: 223K003 briefTitle: The Effect of Therapeutic Communication Methods on the Psychological State of Children overallStatus: COMPLETED date: 2023-11-30 date: 2023-12-06 date: 2023-12-06 date: 2024-02-23 date: 2024-02-23 name: Gazi University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected.
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Due to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions.
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The aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake.
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Hypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease.
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H2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease.
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H3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease.
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H4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase. conditions: Psychological studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-test post-test quasi-experimental study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 65 type: ACTUAL name: Therapeutic communication methods measure: State Anxiety Scale on Children measure: Trait Anxiety Scale on Children measure: Me and My Feelings Scale on Children measure: Child and Youth Resilience Measure sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: K-1 Container City city: Adıyaman state: Altınsehir zip: 02040 country: Turkey lat: 37.76441 lon: 38.27629 hasResults: False
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<|newrecord|> nctId: NCT06275698 id: RD2023-14 HONEY-POT id: 323188 type: OTHER domain: IRAS id: 56974 type: OTHER_GRANT domain: CPMS briefTitle: HONEY for the Treatment of POst-Tonsillectomy Pain acronym: HONEY-POT overallStatus: RECRUITING date: 2023-09-04 date: 2025-09-04 date: 2025-09-04 date: 2024-02-23 date: 2024-02-23 name: East and North Hertfordshire NHS Trust class: OTHER_GOV name: Manuka Doctor UK Ltd name: National Institute for Health Research, United Kingdom briefSummary: Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.
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Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials. conditions: Post Surgical Pain conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.
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Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events.
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Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Manuka honey MGO 1000 name: Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring measure: VAS pain scores measure: Number and frequency of concurrent analgesia usage measure: Rate of readmission to hospital measure: Rate of secondary haemorrhage measure: Rate of infection requiring antibiotics treatment measure: Speed of return to work sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lister Hospital status: RECRUITING city: Stevenage zip: SG1 4AB country: United Kingdom name: Toral Odedra role: CONTACT phone: 07918 360 060 email: [email protected] lat: 51.90224 lon: -0.20256 hasResults: False
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<|newrecord|> nctId: NCT06275685 id: CIP-0001510 briefTitle: Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking acronym: Foresight overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-06 date: 2026-06 date: 2024-02-23 date: 2024-02-23 name: Empatica, Inc. class: INDUSTRY briefSummary: The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.
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The main questions it aims to answer are:
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* can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
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* does this tool improve the lives of people with epilepsy?
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Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life. conditions: Epilepsy; Seizure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 3000 type: ESTIMATED name: SeizureWise algorithm name: Multi-day Visualizations measure: Sensitivity of SeizureWise measure: Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P) measure: Qualitative assessment of multi-day visualizations measure: Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8) measure: Modifiable behavior change measure: Accuracy of SeizureWise low-likelihood forecast measure: Accuracy of SeizureWise high-likelihood forecast sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06275672 id: TREAT INTERACT briefTitle: Implementing an Education- and Health System Task-shifting Approach for Child Mental Health Promotion in Uganda acronym: TREAT overallStatus: RECRUITING date: 2023-08-01 date: 2025-05 date: 2025-12 date: 2024-02-23 date: 2024-02-23 name: Norwegian Center for Violence and Traumatic Stress Studies class: OTHER name: Makerere University name: University of Bergen name: Norwegian Institute of Public Health name: Norwegian University of Science and Technology briefSummary: This study will adapt a school version (mhGAP-IGs) of the World Health Organization´s (WHO) "Mental Health Gap Action Programme Intervention Guide" (mhGAP). Both teachers and health workers will receive training in mhGAP, and systems for collaboration between the school and health sector as well as other relevant stakeholders will be developed and integrated. The project is conducted in close collaboration with key stakeholders from the Ministry, the health and education sector, the police, and religious leaders. The aim is to increase mental health literacy among school staff, facilitate a healthy school environment, and increase detection of mental health needs among primary school aged children. conditions: Mental Health Issue conditions: Stigma, Social conditions: Child Development conditions: Child Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Stepped-wedge cluster randomized trial to randomize 18 schools into six cohorts of three schools incrementally. primaryPurpose: PREVENTION masking: NONE count: 180 type: ESTIMATED name: Adapted version of the mhGAP-IG measure: Reach questionnaire, developed by the project group measure: The Program Sustainability tool (Finch et al., 2013) measure: Service measure on access to mental health care, developed by the project group measure: Attitudes about Child Mental Health (Perceived Discrimination-Devaluation (Link et al., 1987) questionnaire measure: The dimensions of discipline inventory, school (DDI; Strauss & Faucher, 2007) measure: Treatment at home, developed by the project group, by inspiration from our siste project "TREAT C-AUD") measure: The Implementation Quality Questionnaire (Bogen, 2020) measure: Fidelity Scale, developed by the project group measure: General Health Questionnaire (GHQ; Goldberg, 1970) measure: Attitudes on Gender Norms (Waszak et al., 2000) questionnaire measure: Help-seeking behaviour, developed by the project group after inspiration from Yifeng et al., 2022 measure: Pediatric Symptom Checklist (PSC-17; Jellinek et al., 1998) measure: Teacher Support Scale (TSS; Metheny, McWhirter, & O'Neil, 2008) measure: Teacher violence scale (Piskin et al, 2014) measure: The dimensions of discipline inventory, home (DDI; Strauss & Faucher, 2007) measure: The Implementation Leadership Scale (Aarons, Ehrhart, et al., 2014) measure: Organizational Readiness for Implementing Change (Shea et al., 2014) measure: Teacher concerns about child mental health, developed by the project group, after inspiration from Yifeng et al., 2022 measure: Provider Report of Sustainment Scale (PRESS) (Moullin et al., 2021) (PRESS): development and validation (PRESS; Moullin et al., 2021) measure: Mental health knowledge (Evans-Lacko et al., measure: AUDIT scale (WHO) measure: Child alcohol use, developed by the project group measure: Child mental health - Pediatric symptoms (Jelinek et al.) measure: Perceived teacher support and its influence on adolescent career development (Metheny et al., 2008) measure: Sexual violence, developed by the project group measure: Dimensions of discipline inventory (DDI; Straus and Fauchier, 2007) sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Nowegian Center for Violence and Traumatic Stress Studies status: RECRUITING city: Oslo zip: 0655 country: Norway name: Ane-Marthe Skar, PhD role: CONTACT phone: 97661591 email: [email protected] lat: 59.91273 lon: 10.74609 hasResults: False
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<|newrecord|> nctId: NCT06275659 id: CT-100-D-003 briefTitle: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-04 date: 2024-02-23 date: 2024-03-18 date: 2024-02-23 date: 2024-03-08 name: Click Therapeutics, Inc. class: INDUSTRY briefSummary: CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.
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DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health. conditions: Psoriasis conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 120 type: ACTUAL name: CT-100-004-A name: CT-100-004-B measure: Change in Peak Pruritus Numerical Rating Scale measure: Change in Dermatology Life Quality Index measure: Change in Quality of Life symptoms measure: Time in App measure: Experience with Study App measure: Improved global rating of change measure: Frequency of Adverse Events measure: Severity of Adverse Events measure: Frequency of Serious Adverse Events measure: Severity of Serious Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Click Therapeutics city: New York state: New York zip: 10013 country: United States lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06275646 id: Adeel2 briefTitle: Comparison Of Outcome Of Different Layers in Hypospadias Surgery overallStatus: COMPLETED date: 2022-01-01 date: 2022-12-31 date: 2023-04-01 date: 2024-02-23 date: 2024-02-23 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied conditions: Hypospadias studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: NONE count: 220 type: ACTUAL name: PRP layer name: dartos flap measure: wound infectiom measure: frequency of glans dehiscence measure: frequency of meatal stenosis sex: MALE minimumAge: 6 Months maximumAge: 12 Years stdAges: CHILD facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False
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<|newrecord|> nctId: NCT06275633 id: H-18055648 briefTitle: Behavioural Profiling of Disease-related Cognitive and Motor Impairment in PD overallStatus: COMPLETED date: 2019-03-19 date: 2021-12-03 date: 2023-07-30 date: 2024-02-23 date: 2024-02-23 name: University Hospital Bispebjerg and Frederiksberg class: OTHER briefSummary: In this project, patients with Parkinson's Disease (PD) will be characterized by measuring cognitive and motor function and relation to effect of Levodopa.
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Participants will be patients with Parkinson's Disease and healthy controls. It will be investigated if there is a difference between patients with a good measured Levodopa response and with a poor measured response. conditions: Parkinson Disease conditions: Medication conditions: UPDRS conditions: Motor Function conditions: Cognitive Impairment conditions: Depression conditions: Impulsive conditions: Levodopa studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective patient with Parkinson's Disease cohort. After acute levodopa challenge test patients with Parkinson's Disease are divided due to measured levodopa response and their self-rated medicine effect. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: There will be a blinded assessment of videos of participants with Parkinson's Disease ON and OFF medication count: 68 type: ACTUAL name: Levodopa measure: Motor improvement measure: Cognitive function measure: Cognitive function measure: Depressive symptoms measure: Impulsivity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Bispebjerg and Frederiksberg city: Copenhagen state: Region Hovedstaden zip: 2400 country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False
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<|newrecord|> nctId: NCT06275620 id: AGTC-RPGR-001 DAWN briefTitle: A Study Comparing Two Doses of AGTC-501 in Male Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (DAWN) overallStatus: ENROLLING_BY_INVITATION date: 2023-11-14 date: 2025-07 date: 2029-08 date: 2024-02-23 date: 2024-03-21 name: Beacon Therapeutics class: INDUSTRY briefSummary: This Phase 2 study is a non-randomized, open-label, study of the safety of AGTC-501 in participants with XLRP who have previously been treated with a full-length AAV vector-based gene therapy targeting RPGR protein. conditions: X-Linked Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AGTC-501 (high dose and standard corticosteroid regimen) name: AGTC-501 (low dose and standard corticosteroid regimen) name: AGTC-501 (high dose and modified corticosteroid regimen) measure: The primary safety outcome is the number and proportion of participants experiencing Grade 3 or higher local (ocular) or non-ocular treatment-emergent adverse events, including treatment-emergent serious adverse events (SAEs). measure: Change from baseline in mean sensitivity across the whole grid, as measured by MAIA microperimetry measure: Response, as measured by MAIA microperimetry, where response is defined as a greater than or equal to 7 dB visual sensitivity improvement from baseline in at least 7 loci. measure: Change from baseline in BCVA using Early-Treatment Diabetic Retinopathy Study (ETDRS) visual acuity measure: Change from baseline in LLVA using ETDRS visual acuity measure: Change from baseline in Ora-VNC mobility test score sex: MALE minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florida city: Jacksonville state: Florida zip: 32209 country: United States lat: 30.33218 lon: -81.65565 facility: Bascom Palmer Eye Institute city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Cincinnati Eye Institute city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Casey Eye Institute city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Retina Foundation of the Southwest city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06275607 id: FY23-24-93 briefTitle: Maladaptive Anger Treatment overallStatus: RECRUITING date: 2024-02-07 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: The University of Texas at San Antonio class: OTHER briefSummary: From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample. conditions: Anger conditions: Intermittent Explosive Disorder conditions: Emotional Distress conditions: Aggression conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Cognitive Behavioral Affective Therapy name: Emotional Discussion measure: Anger Parameters Scale (APS) measure: Anger Parameters Scale (APS) measure: Anger Parameters Scale (APS) measure: Anger Expressions Scale (AES) measure: Anger Expressions Scale (AES) measure: Anger Expressions Scale (AES) measure: Self-Monitored Anger (Anger Log) measure: Self-Monitored Anger (Anger Log) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas at San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78249 country: United States name: Ephrem Fernandez, Ph.D. role: CONTACT email: [email protected] name: Brandon S Perez, M.S. role: CONTACT email: [email protected] name: Ephrem Fernandez, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Brandon S Perez, M.S. role: SUB_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06275594 id: YUMC2023-12-017 briefTitle: Trial Evaluating the Efficacy of Remimazolam in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration acronym: REST overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-02-01 date: 2025-02-01 date: 2024-02-23 date: 2024-02-23 name: Yeungnam University Hospital class: OTHER briefSummary: Study to evaluate the efficacy and safety of remimazolam in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration
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Primary Outcome Evaluate and compare the success of the procedure in patients undergoing EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) when administered with remimazolam in the experimental group, versus Real world midazolam (Control Group 1), and On label midazolam (Control Group 2).
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Secondary Outcome In patients undergoing EBUS-TBNA, compare the following aspects when administered with remimazolam in the experimental group versus Real world midazolam (Control Group 1) and On label midazolam (Control Group 2): Procedure start time, Time taken to achieve full alertness, Need for flumazenil administration, Total dose of fentanyl used, Scale of coughing/discomfort/convenience, Changes in vital signs, Complications related to the procedure. conditions: Midazolam conditions: Remimazolam studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 330 type: ESTIMATED name: Byfavo name: Midazolam measure: Procedural success during EBUS-TBNA (composite outcome) measure: Time to start of procedure after administration of the first dose of study medication measure: Time taken to achieve full alertness after the procedure measure: Requirement for flumazenil dosage during the procedure measure: Total fentanyl dose measure: Scale of coughing/discomfort/inconvenience measure: Changes in blood pressure measure: Changes of heart rate measure: Changes in respiration rate measure: Complications related to the procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yeungnam University Hospital city: Daegu state: Namgu zip: 42415 country: Korea, Republic of name: June Hong Ahn, M.D. PhD role: CONTACT phone: 821028562008 email: [email protected] lat: 35.87028 lon: 128.59111 hasResults: False
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<|newrecord|> nctId: NCT06275581 id: CR15_15 (EM-11-050055) briefTitle: Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population overallStatus: TERMINATED date: 2017-06-14 date: 2021-03-24 date: 2021-10-01 date: 2024-02-23 date: 2024-02-23 name: Universidad Europea de Madrid class: OTHER name: 3M briefSummary: STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment.
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STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTS
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Primary Endpoint:
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1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.)
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Secondary Endpoints:
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1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)
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2. Evaluation of restoration wear based on comparison of digital impressions
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Safety Endpoint:
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1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers
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* regarding overall survival
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* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)
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* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.
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Treatment:
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After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.
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Evaluation periods:
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All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)
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* at baseline at day of restoration placement or up to 1 month after restoration placement
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* after 6 months (± 1 months)
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* after 1 year (± 1 months)
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* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.
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In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline. conditions: Tooth Wear conditions: Glass Ionomer Cements studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinded evaluation whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group) name: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) measure: Restoration survival over time based on the glass ionomer restoration criteria measure: Evaluation of restoration quality based on the glass ionomer restoration criteria measure: Evaluation of restoration wear based on comparison of digital impressions measure: Safety Endpoint: The safety endpoint is the incidence of Adverse Events. sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics city: Madrid zip: 28045 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06275568 id: HSC-SPH-23-0655 briefTitle: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-15 date: 2024-11-15 date: 2024-02-23 date: 2024-02-23 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant). conditions: Nutrition in High-Risk Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 620 type: ESTIMATED name: Usual Care Fresh Connect cardholder engagement name: Enhanced engagement communication measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Number of participants diagnosed with pregnancy-induced hypertension measure: Number of participants diagnosed with gestational diabetes measure: Number of participants with pre-term birth (<37 weeks) measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Shreela Sharma, PhD role: CONTACT phone: 713-500-9344 email: [email protected] name: Naomi Tice, MPH role: CONTACT phone: (713) 500-9000 email: [email protected] lat: 29.76328 lon: -95.36327 hasResults: False
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<|newrecord|> nctId: NCT06275555 id: 2023-101 briefTitle: Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-26 name: Xiaotong Hou class: OTHER briefSummary: The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin. conditions: Extracorporeal Membrane Oxygenation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 154 type: ESTIMATED name: bivalirudin name: unfractionated heparin measure: thrombotic complications measure: bleeding complications measure: Hospitalization mortality measure: Loop replacement measure: Infusion volume of blood products measure: Acute renal failure measure: Heparin-induced thrombocytopenia measure: the time of reaching the target anticoagulant level for the first time measure: Percentage of time during ECMO within the target anticoagulant level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06275542 id: USurabaya briefTitle: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2026-01-01 date: 2024-02-23 date: 2024-02-23 name: University of Surabaya class: OTHER name: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada name: Sardjito General Hospital, Yogyakarta briefSummary: Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring. conditions: Anesthesia Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted through a randomized clinical trial with blinding of observers. Two parallel groups were selected to compare the incidence of paralysis in the recovery room. The research samples were collected using non-probability sampling method through consecutive enrollment over a specific period. This study consisted of 3 comparisons distinguished based on the type of volatile anesthetic gas maintenance and neuromuscular blockade agent, namely:
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* Comparison 1: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was rocuronium.
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* Comparison 2: The volatile anesthetic gas used was isoflurane and the muscular blockade agent used was rocuronium.
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* Comparison 3: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was atracurium. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Train of four monitoring device intraoperative name: Neostigmine name: Air chalenge prior to extubation name: Train of Four monitoring device in recovery room measure: Residual paralysis in recovery room measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06275529 id: 27.12.2023.685 briefTitle: Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-08-15 date: 2024-02-23 date: 2024-02-23 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.
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The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification. conditions: Radiculopathy Lumbar conditions: Low Back Pain conditions: Disc Herniation conditions: Injections, Epidural studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Transforaminal Epidural Steroid Injection measure: Change of the pain severity score measure: Change of the disability score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06275516 id: 2024-208 briefTitle: Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients. overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-09-20 date: 2024-02-23 date: 2024-02-23 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: multi-sensory stimulation immersive VR+ treadmill training name: treadmill training measure: Fugl-Meyer scale measure: Berg balance scale measure: three-dimensional gait detection measure: Fall incidents measure: Dizzy incidents sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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