hackint0sh/New-Dataset huggingface dataset:
Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.
Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (RCT) with prospective longitudinal follow up primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments. whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: E-Based Physical Exercise Intervention measure: 6-meters' walk test measure: "no evidence of disease activity" (NEDA-3) score measure: Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA), measure: Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale measure: Neurofilament Light Chain (NfL) determination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern Denmark status: ENROLLING_BY_INVITATION city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: University of Southern Denmark status: RECRUITING city: Odense zip: 5230 country: Denmark name: Nasrin Asgari, Professor role: CONTACT phone: +4530700612 email: nasgari@health.sdu.dk name: Ulrik Dalgas, Professor role: CONTACT email: dalgas@ph.au.dk lat: 55.39594 lon: 10.38831 hasResults: False
nctId: NCT06298188 id: RisaKids briefTitle: Risankizumab in Children With Crohn's Disease (RisaKids) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-10 date: 2026-10 date: 2024-03-07 date: 2024-03-07 name: Shaare Zedek Medical Center class: OTHER briefSummary: The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Risankizumab measure: Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06298175 id: 2021-157 briefTitle: Self-Management Training With Online Intervention Process for Young Adults With Chronic Conditions overallStatus: COMPLETED date: 2021-04-15 date: 2021-04-15 date: 2021-08-15 date: 2024-03-07 date: 2024-03-07 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The study was conducted from 15th April 2021 to 15th August 2021. It employed a pretest-posttest design with control and training groups. In this study, a pretest-posttest design including control and training groups was used. Pre-assessments were taken from young adults who reported that they wanted to participate in the study via social media accounts and e-mail and who met the study criteria, and two groups were formed by the simple randomization method. The study group received 8 weeks of self-management training. The control group was informed about self-management for 1 week. Final evaluations were conducted for both groups after eight weeks. conditions: Chronic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-post test, randomized controlled study primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Self management training measure: Self-Control Self-Management Scale (SCMS) measure: Cognitive Emotion Regulation Questionnaire (CERQ) measure: The Occupational Balance Questionnaire (OBQ) sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Saglik Bilimleri Universitesi city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
nctId: NCT06298162 id: 2018-1279 briefTitle: Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass acronym: MRI pouch overallStatus: COMPLETED date: 2019-07-25 date: 2020-02-01 date: 2020-02-01 date: 2024-03-07 date: 2024-03-07 name: Rijnstate Hospital class: OTHER briefSummary: A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB). conditions: Bariatric Surgery Candidate conditions: Gastric Bypass conditions: Obesity, Morbid conditions: Pouch Emptying studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10 type: ACTUAL name: 2 years after RYGB, no intervention. MRI measurement. Observational. measure: Pouch emptying rate measured with MRI measure: subjective ratings of fullness measure: subjective ratings of wellbeing sex: FEMALE minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Yonta Burgh city: Arnhem zip: 6815 AD country: Netherlands lat: 51.98 lon: 5.91111 hasResults: False
nctId: NCT06298149 id: 2023-650-EXEMPT id: 1U54CA280812-01 type: NIH link: https://reporter.nih.gov/quickSearch/1U54CA280812-01 briefTitle: Reach Through Equitable Implementation of Turtle Island Tales overallStatus: ENROLLING_BY_INVITATION date: 2023-11-01 date: 2028-04-30 date: 2028-04-30 date: 2024-03-07 date: 2024-03-07 name: Montana State University class: OTHER name: National Institutes of Health (NIH) name: University of Utah name: National Cancer Institute (NCI) briefSummary: Reach Through Equitable Implementation of Turtle Island Tales is a family-level obesity prevention intervention that aims to reinforce AI cultural values of family interaction and holistic wellness. The long-term objective of this research program is to increase the reach of existing evidence-based interventions (EBIs) for cancer and obesity prevention among American Indian (AI) families who live in persistent poverty census tracts. conditions: Obesity, Childhood conditions: Obesity conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participating family will receive a monthly lesson targeting a healthy behavior (increase fruit/vegetable intake, decrease added sugar intake, increase physical activity, decrease sedentary/screen time, promote healthy sleep, and promote emotional regulation) over the course of one year. primaryPurpose: PREVENTION masking: NONE count: 200 type: ESTIMATED name: Turtle Island Tales measure: 20-item Family Nutrition and Physical Activity Survey measure: Food insecurity screener measure: Mental Health screening sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montana State University city: Bozeman state: Montana zip: 59717 country: United States lat: 45.67965 lon: -111.03856 hasResults: False
nctId: NCT06298136 id: 15610923 briefTitle: The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder acronym: MindADHD overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-07 date: 2024-03-07 name: The Hong Kong Polytechnic University class: OTHER briefSummary: This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will investigate the effects of an online mindfulness-based intervention (MBI) on outcomes in children with ADHD. The effects of the MBI (arm 1) will be investigated in comparison with the effects of psychoeducation (arm 2). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participants will be informed that an intervention (program A or program B) will be assigned to them randomly. For research team who will be in contact with participants for outcome assessment, whether the participants have been allocated to arm 1 or arm 2 will be blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 208 type: ESTIMATED name: mindfulness-based intervention name: child behavior management measure: Child ADHD symptoms measure: Parent depressive symptoms measure: Parent anxiety symptoms measure: Parent sleep quality measure: Parent well-being measure: Child executive functioning measure: Parental Stress measure: Expressed emotion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Herman Hay Ming Lo status: RECRUITING city: Hong Kong country: Hong Kong name: Christine Wing Tung Yeung, MSsc role: CONTACT phone: +85266279904 email: wing-tung.yeung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
nctId: NCT06298123 id: adjuvant-03 briefTitle: Postoperative Adjuvant Immunotherapy for Hepatocellular Carcinoma: Risk Factor Analysis and Prognostic Modelling overallStatus: COMPLETED date: 2019-02-01 date: 2023-02-01 date: 2023-02-01 date: 2024-03-07 date: 2024-03-07 name: Chen Xiaoping class: OTHER briefSummary: The aim of this study was to analyse the independent risk factors for hepatocellular carcinoma (HCC) patients undergoing adjuvant immunotherapy after liver resection surgery, and to develop a prognostic model based on these factors. conditions: Hepatocellular Carcinoma conditions: Adjuvant Immunotherapy conditions: Checkpoint Inhibitor studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 304 type: ACTUAL name: Anti-PD-1 monoclonal antibody measure: Recurrence-Free Survival (RFS) measure: Overall Survival (OS) measure: Imaging data (enhanced CT and MRI） and histopathology data, if available. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False
nctId: NCT06298110 id: PRP in Abdominal hysterectomy briefTitle: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-08-25 date: 2024-09-25 date: 2024-03-07 date: 2024-03-08 name: Helwan University class: OTHER briefSummary: To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy. conditions: Wound Heal conditions: Abdominal Wound conditions: PRP studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Platelets Rich plasma of the same patient measure: changes in wound healing measure: Vancouver scar scale changes measure: Visual Analog Scale changes measure: Hospital readmission measure: Infection sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06298084 id: 2023-505925-15-00 id: 2023/3668 type: OTHER domain: CSET number briefTitle: Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd acronym: ICARUSBREAST02 overallStatus: RECRUITING date: 2024-03-21 date: 2027-09 date: 2029-06 date: 2024-03-07 date: 2024-03-29 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: Daiichi Sankyo briefSummary: ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months. conditions: Breast Cancer Metastatic conditions: HER2-positive Metastatic Breast Cancer conditions: HER2 Low Breast Carcinoma conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 152 type: ESTIMATED name: Patritumab deruxtecan name: Olaparib measure: DLTs (dose-limiting toxicity) for part 1a and 1b measure: Frequency of safety event for part 1a and 1b measure: Severity of safety event for part 1a and 1b measure: Proportion of treatment modification due to AEs for part 1a and 1b measure: frequency of laboratory abnormalities for part 1a and 1b measure: Severity of laboratory abnormalities for part 1a and 1b measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 1a and 1b measure: ORR for part 2 measure: DOR for part 2 measure: PFS for part 2 measure: CBR for part 2 measure: ORR for part 1 measure: DOR for part 1 measure: PFS for part 1 measure: CBR for part 1 measure: PK analysis for part 1 measure: ADA analysis for part 1 measure: DLTs for part 2 measure: Frequency of safety event for part 2 measure: Severity of safety event for part 2 measure: proportion of treatment modification event for part 2 measure: frequency of laboratory abnormalities for part 2 measure: Severity of laboratory abnormalities for part 2 measure: radiographic changes potentially consistent with ILD/pneumonitis or any other pulmonary signs/symptoms for part 2 measure: PK analysis for part 2 measure: ADA analysis for part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy Institut status: RECRUITING city: Villejuif zip: 94805 country: France name: Barbara Pistilli role: CONTACT phone: +33 (0)1 42 11 61 62 email: barbara.pistilli@gustaveroussy.fr name: Fernanda Mosele role: CONTACT phone: +33 (0)1 42 11 61 43 email: Mariafernanda.MOSELE@gustaveroussy.fr lat: 48.7939 lon: 2.35992 hasResults: False
nctId: NCT06298071 id: SIBP-R002-Ib briefTitle: A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout. overallStatus: RECRUITING date: 2023-03-03 date: 2024-12-30 date: 2025-12-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: First Affiliated Hospital Bengbu Medical College name: The First Affiliated Hospital of Henan University of Science and Technology name: Chengdu Fifth People's Hospital briefSummary: To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials. conditions: Gout studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: According to the sequence from low-dose group to high-dose group, there are 12 participants in each group, totaling 36 participants. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SIBP-R002 name: SIBP-R002 name: SIBP-R002 name: Methotrexate measure: AE(Adverse Events) measure: SAE(Serious Adverse Events) measure: AUC(Area Under The Plasma Concentration Versus Time Curve) measure: Cmax(Peak Plasma Concentration) measure: Tmax(Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ADA (Anti-uricase Antibody, Anti-PEG Antibody, Anti-PEG-uricase Antibody) measure: NAb (Anti-PEG-uricase Neutralizing Antibody) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Bengbu Medical College status: RECRUITING city: Bengbu state: Anhui country: China name: Huan Zhou, Master role: CONTACT phone: 86-13665527160 email: zhouhuanbest@hotmail.com lat: 32.94083 lon: 117.36083 hasResults: False
nctId: NCT06298058 id: SIBP-A13-I briefTitle: A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. overallStatus: NOT_YET_RECRUITING date: 2024-03-12 date: 2026-04-30 date: 2026-06-30 date: 2024-03-07 date: 2024-03-07 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shanghai Pulmonary Hospital, Shanghai, China briefSummary: To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D). conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is an open, multi-dose increasing single and multiple dose study. primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: SIBP-A13 formulation for injection measure: AE (Adverse Events) measure: SAE (Serious Adverse Events) measure: AUC (Area Under The Plasma Concentration Versus Time Curve) measure: Cmax (Peak Plasma Concentration) measure: Tmax (Peak Time) measure: T ½ (Terminal elimination half-life) measure: CL (Clearance Rate) measure: ORR (Objective Response Rate) measure: DCR (Disease control rate) measure: PFS (Progression-free survival) measure: OS (overall survival) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06298045 id: DIM-06790-002 briefTitle: Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy overallStatus: RECRUITING date: 2023-07-15 date: 2025-03-31 date: 2025-03-31 date: 2024-03-07 date: 2024-03-07 name: Servier Affaires Médicales class: INDUSTRY briefSummary: The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only. conditions: Stable Angina studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Assessment of angina symptoms via the summary score of SAQ-7 measure: CCS angina grading post-inclusion measure: Tolerance ( Adverse Events) measure: Tolerance ( Serious Adverse Events) measure: Adherence to the antianginal treatment combination under evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thera Card Srl status: RECRUITING city: Braşov zip: 500091 country: Romania name: Zara Cornelia, Dr role: CONTACT phone: +40723733774 email: cornelia.zara@theracardia.ro lat: 45.64861 lon: 25.60613 hasResults: False
nctId: NCT06298019 id: 73464 briefTitle: Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2039-04 date: 2024-03-07 date: 2024-03-07 name: Stanford University class: OTHER briefSummary: The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.