hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06360445 id: HD1912BE202201 briefTitle: Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects overallStatus: COMPLETED date: 2022-05-26 date: 2022-08-21 date: 2022-08-21 date: 2024-04-11 date: 2024-04-11 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This Study is a Randomized, Open-Label, 2-formulation, Single-Dose, 2-Period Crossover Bioequivalence Study with a washout period of 7 days. During each session, the subjects were administered a single dose of 100 mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting conditions or 150mg Olaparib Tablets (Test formulation or reference formulation ) under Fasting and Fed conditions. Venous blood samples were collected at pre-dose (0 h), and up to 72 h post dose. This study was to evaluate the bioequivalence and safety of the test formulation and the reference formulation of Olaparib Tablets in healthy subjects. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2-period Crossover Assignment primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 102 type: ACTUAL name: Olaparib Tablet test formulation 100mg name: Olaparib Tablet reference formulation 100mg name: Olaparib Tablet test formulation 150mg name: Olaparib Tablet reference formulation 150mg measure: Cmax Description: Maximum observed plasma concentration measure: AUC0-∞ Description: Area under the plasma concentration time curve from time zero extrapolated to infinite time measure: AUC0-t Description: Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration measure: Time of maximum observed plasma concentration (Tmax) measure: Terminal elimination half-life (T1/2) measure: Apparent total body clearance (Cl/F) measure: Apparent volume of distribution (V/F) measure: Number of participants with Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Friendship Hospital, Capital Medical University city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06360432 id: HSEARS20240214001 briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-10-31 date: 2025-04-30 date: 2024-04-11 date: 2024-04-11 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.
Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0. conditions: Sarcopenic Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Dietary modification program name: Exercise training name: The EatWellLog App measure: Changes of muscle strength measure: Changes of muscle mass measure: Changes of body mass index measure: Changes of waist circumference measure: Changes of fat mass measure: The Short Physical Performance Battery (SPPB) scale measure: Mini Nutritional Assessment (MNA) Short-form measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale measure: Dietary Quality Index-International (DQI-I) measure: EuroQoL 5D (EQ-5D) measure: Diet Adherence measure: Exercise Adherence sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hong Kong country: Hong Kong name: Amy Cheung, MA role: CONTACT phone: +852 27664145 email: amy-ka-po.cheung@polyu.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False
nctId: NCT06360406 id: D1346R00009 briefTitle: Real-World Treatment Study of Koselugo (Selumetinib) overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2031-09-30 date: 2031-09-30 date: 2024-04-11 date: 2024-04-11 name: AstraZeneca class: INDUSTRY briefSummary: As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea.
This study will provide information on the Korean patient population that is treated with the study drug. conditions: Neurofibromatosis 1 conditions: Neurofibroma, Plexiform studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 150 type: ESTIMATED measure: Adverse events (AEs) rate measure: Physeal dysplasia occurance rate measure: Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06360393 id: 17384 briefTitle: Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics acronym: OUTERSPACE-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-02 date: 2026-05 date: 2024-04-11 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Trudell Medical International briefSummary: Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response.
The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals.
The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy. conditions: Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Smart spacer measure: Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12) measure: Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse measure: Assessing the association of smart spacer assessed adherence with annual exacerbation rate measure: Assessing the association of smart spacer assessed adherence with reliever inhaler use (e.g. SABA) measure: Assess the association of smart spacer assessed adherence with oral corticosteroids use measure: Assess the association of smart spacer assessed adherence with FeNO results measure: Assess the association of smart spacer assessed adherence with blood eosinophils measure: Assess the association of smart spacer assessed adherence with asthma control (ACQ-6) measure: Assess the association of smart spacer assessed adherence with spirometry results measure: Assess usability and patient satisfaction using the System Usability Scale measure: Assess usability and healthcare provider satisfaction using the System Usability Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medisch Centrum Leeuwarden city: Leeuwarden state: Friesland zip: 8934AD country: Netherlands name: Akke-Nynke van der Meer, MD, PhD role: CONTACT phone: +31 58 286 3875 email: a.n.van.der.meer@mcl.nl lat: 53.20139 lon: 5.80859 facility: Isala city: Zwolle state: Overijssel zip: 8025AB country: Netherlands name: Niels Patberg, MD role: CONTACT email: k.w.patberg@isala.nl lat: 52.5125 lon: 6.09444 facility: Stichting Sint Franciscus Vlietland Groep city: Rotterdam state: Zuid-Holland zip: 3118JH country: Netherlands name: Yasemin Türk, MD, PhD role: CONTACT phone: +31 10 461 6161 email: yasemin.turk@Franciscus.nl lat: 51.9225 lon: 4.47917 facility: University Medical Center Groningen city: Groningen zip: 9713GZ country: Netherlands name: Maarten van den Berge, MD, PhD role: CONTACT phone: +31 6 24450194 email: m.van.den.berge@umcg.nl name: Titia Klemmeier, RN role: SUB_INVESTIGATOR name: Huib Kerstjens, MD, PhD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Foundation Martini Hospital city: Groningen zip: 9728NT country: Netherlands name: Marjolein J van Es, MD, PhD role: CONTACT phone: +31 50 524 5245 email: m.vanes@mzh.nl lat: 53.21917 lon: 6.56667 hasResults: False
nctId: NCT06360380 id: AQP-CLP-004 briefTitle: Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System acronym: REFORM-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-03 date: 2024-11-03 date: 2024-12-29 date: 2024-04-11 date: 2024-04-11 name: AquaPass Medical Ltd. class: INDUSTRY briefSummary: The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Participants will select if to be treated at their home or in the outpatient clinic. conditions: Chronic Heart Failure conditions: CKD Stage 3 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective, multicenter, single-arm, within-patient-controlled, pivotal trial, enrolling patients with decompensated heart failure and/or CKD stage 2-3 inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥40 mg furosemide or equivalent. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: AquaPass System measure: AquaPass Performance Evaluation measure: AquaPass Safety Evaluation sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06360367 id: 2023-00060 briefTitle: mHealth to Improve Diet Quality Among Early Adolescents in SNAP-Ed in Hawaii overallStatus: RECRUITING date: 2024-04-23 date: 2024-10-22 date: 2024-10-22 date: 2024-04-11 date: 2024-04-12 name: University of Hawaii class: OTHER name: United States Department of Agriculture (USDA) name: Pennington Biomedical Research Center briefSummary: The goal of this 8-week clinical trial is to learn whether the PortionSize Ed mobile app helps to improve healthy eating habits among early adolescents in the Hawai'i-Food and Lifeskills for Youth (HI-FLY) program.
Participants in this study will be randomly assigned to either the HI-FLY only group (HI-FLY), where they will receive the standard HI-FLY program or to the HI-FLY + PortionSize Ed app (HI-FLY + PSEd) group where they will receive the standard HI-FLY program and a study iPhone with the PortionSize Ed app for the 8-week study. This will allow us to evaluate the effect of the PortionSize Ed app among early adolescents in HI-FLY. conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: HI-FLY Curriculum name: HI-FLY Curriculum + PortionSize Ed app measure: Feasibility- Study enrollment measure: Acceptability- User Satisfaction Survey (USS) scores and qualitative responses measure: Acceptability- Computer System Usability Questionnaire (CSUQ) scores measure: Acceptability- PortionSize Ed app usage data measure: Acceptability- Reason for study drop out measure: Efficacy- Change in total Healthy Eating Index-2020 (HEI-2020) total score measure: Efficacy- Change in HEI-2020 component scores measure: Efficacy- Change in healthy eating behavior scores from the Nutrition Education Survey measure: Feasibility- Study Attrition measure: Change in body weight sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: University of Hawaii at Manoa status: RECRUITING city: Honolulu state: Hawaii zip: 96822 country: United States name: Chloe P Lozano, PhD role: CONTACT phone: 808-956-7095 email: cpanizza@hawaii.edu lat: 21.30694 lon: -157.85833 hasResults: False
nctId: NCT06360354 id: 20230223 briefTitle: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion overallStatus: RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2028-06-29 date: 2024-04-11 date: 2024-04-22 name: Amgen class: INDUSTRY briefSummary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers. conditions: Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 282 type: ESTIMATED name: AMG 193 name: Gemcitabine name: Nab-paclitaxel name: Cisplatin name: Pembrolizumab name: Modified FOLFIRINOX measure: Number of Participants Experiencing Dose Limiting Toxicities (DLT) measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) measure: Number of Participants Experiencing Serious Adverse Events (SAE) measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) measure: Disease Control (DC) per RECIST v1.1 measure: Duration of Response (DOR) per RECIST v1.1 measure: Time to Response (TTR) per RECIST v1.1 measure: Overall Survival (OS) per RECIST v1.1 measure: Progression-free Survival (PFS) per RECIST v1.1 measure: Maximum Plasma Concentration (Cmax) of AMG193 measure: Time to Maximum Plasma Concentration (tmax) of AMG193 measure: Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope National Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States lat: 34.13945 lon: -117.97729 hasResults: False
nctId: NCT06360341 id: 202301946 briefTitle: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-01-01 date: 2024-04-11 date: 2024-04-11 name: University of Florida class: OTHER briefSummary: The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes. conditions: Low Back Pain, Mechanical conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC. primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants. count: 30 type: ESTIMATED name: Emergency Department Digital Pain Self-Management Intervention (EDPSI) name: Routine Discharge Care measure: Improving Self-Management Health Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health Shand's Adult Emergency Department city: Gainesville state: Florida zip: 32608 country: United States name: Alexandria A Carey, MSN, MBA-HC role: CONTACT phone: 661-607-1702 email: alexandria.carey@ufl.edu name: Angela R Starkweather, PhD role: CONTACT phone: (352) 273-6323 email: a.starkweather@ufl.edu lat: 29.65163 lon: -82.32483 hasResults: False
nctId: NCT06360315 id: 202201265 briefTitle: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-02 date: 2024-04 date: 2024-06 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure. conditions: Chronic Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12000 type: ESTIMATED name: Incentive letter for pneumococcal vaccination to the patient and to the GP measure: 1-year Pneumococcus vaccination rate measure: 1-year all-cause hospital admission rate measure: 1-year specific hospital admission rate measure: 1-year all-cause mortality rate sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montpellier University Hospital city: Montpellier zip: 34090 country: France lat: 43.61092 lon: 3.87723 hasResults: False
nctId: NCT06360302 id: RECHMPL22_0505 briefTitle: Plasma Biomarkers of Muscle Metabolism During Exercise to the Assessment of Insulin Resistance in CKD Dialysis Patients acronym: KREBSome-IRC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-11 date: 2024-04-11 name: University Hospital, Montpellier class: OTHER briefSummary: This prospective, multicenter, cross-sectional, repeated-measures comparative study compared functional and biochemical response profiles to exercise between 2 groups of chronically ill patients (chronic renal failure dialysis patients and patients with metabolic syndrome) and a group of healthy subjects.
* The combination of exercise energy metabolism intermediates reflecting insulin resistance among Krebs cycle cofactors/substrates, ß-oxidation cofactors/substrates, amino acids conditions: Metabolic Syndrome conditions: Dialysis; Complications studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cross-sectional comparative study with repeated measures primaryPurpose: BASIC_SCIENCE masking: NONE count: 42 type: ESTIMATED name: Exercise test name: Blood sample name: Impedancemetry measure: Compare V'O2-adjusted plasma lactate profile at rest and during exercise (metabolic stress test), between chronic renal failure patients, patients with metabolic syndrome and healthy subjects. measure: Compare between the 3 groups their metabolic profile (Krebs cycle cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (ß-oxidation cofactors/substrates) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (amino acids) adjusted to V'O2 at rest and during exercise. measure: Compare between the 3 groups their metabolic profile (acyl-carnitine profiles) adjusted to V'O2 at rest and during exercise. measure: Anthropometry Comparison between the 3 groups sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIDER Santé Fondation Charles Mion Montpellier, site Lapeyronie city: Montpellier zip: 34295 country: France name: Jean-Paul CRISTOL, Prof role: CONTACT phone: +33(0)4 67 33 83 15 email: jp-cristol@chu-montpellier.fr lat: 43.61092 lon: 3.87723 facility: Montpellier University Hospital city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False