hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06337734 id: 2 briefTitle: An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension overallStatus: COMPLETED date: 2021-11-01 date: 2023-08-01 date: 2023-08-01 date: 2024-03-29 date: 2024-04-01 name: University of California, San Diego class: OTHER briefSummary: This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 141 type: ACTUAL name: AI-Driven Lifestyle Coaching Program measure: Average change in systolic blood pressure (SBP) from baseline to 12 weeks measure: Average change in diastolic blood pressure (DBP) from baseline to 12 weeks measure: Average change in SBP from baseline to 24 weeks measure: Average change in DBP from baseline to 24 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks measure: Average weekly percentage of active participants measuring their BP measure: Average weekly percentage of active participants syncing their wearable measure: Average weekly percentage of active participants answering the mobile app questionnaire measure: Number of manual clinician outreaches based on the escalation rules set for the study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego city: La Jolla state: California zip: 92093 country: United States lat: 32.84727 lon: -117.2742 hasResults: False
nctId: NCT06337721 id: R01AA030786 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA030786 briefTitle: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2028-05 date: 2028-08 date: 2024-03-29 date: 2024-03-29 name: University of California, Riverside class: OTHER briefSummary: This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT). conditions: Alcohol Use Disorder conditions: Alcohol; Harmful Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group. primaryPurpose: PREVENTION masking: NONE count: 240 type: ESTIMATED name: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction) measure: Heavy Episodic Drinking (HED) Days measure: Alcohol Consumption sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: UC Riverside city: Riverside state: California zip: 91784 country: United States lat: 33.95335 lon: -117.39616 hasResults: False
nctId: NCT06337695 id: HREBA.CC-23-0271 briefTitle: VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-11-01 date: 2026-12-01 date: 2024-03-29 date: 2024-04-02 name: University of Calgary class: OTHER briefSummary: The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy conditions: Cancer conditions: Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized, Double-Blinded, Placebo Controlled Trial primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 298 type: ESTIMATED name: Vedolizumab name: Placebo measure: Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months measure: Proportion of patients with histologically confirmed colitis-free survival at 6 months measure: Proportion of patients with severe diarrhea or colitis at 6 months measure: Hazard Ratio of patients with diarrhea or colitis after 6 months measure: Total average dose of checkpoint inhibitor therapy received within 6 and 12 months measure: Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs) measure: Proportion of participants who require permanent ICI discontinuation due to irAEs measure: Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis measure: Total average prednisone equivalent dose of rescue corticosteroids required measure: Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365 measure: Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365 measure: Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline measure: Overall survival (measured as death) at +180 and Day +365 compared to baseline measure: Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176 measure: Proportion of participants experiencing any adverse events (AEs) measure: Proportion of participants experiencing serious AEs measure: Proportion of participants experiencing other irAEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06337682 id: CB_CY_P09_23_11 briefTitle: Blood Pressure Management in the Care Home Population acronym: BPITCH overallStatus: ACTIVE_NOT_RECRUITING date: 2016-01 date: 2020-01 date: 2024-06 date: 2024-03-29 date: 2024-03-29 name: University of Leeds class: OTHER name: Bradford Teaching Hospitals NHS Foundation Trust briefSummary: The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents. conditions: Aging conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Frequency of blood pressure measurements measure: change in antihypertensive medication measure: Injurious falls measure: Prevalence of hypertension measure: Antihypertensive medication measure: Blood pressure treatment measure: change in systolic pressure following care home admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Academic Unit for Ageing and Stroke Research city: Bradford state: West Yorkshire zip: BD9 6RJ country: United Kingdom lat: 53.79391 lon: -1.75206 hasResults: False
nctId: NCT06337669 id: OSRSCP-GUP21006 briefTitle: Characterization of DupEx2 Duchenne Muscular Dystrophy acronym: DMDDup2 overallStatus: RECRUITING date: 2022-01-31 date: 2025-01-31 date: 2025-01-31 date: 2024-03-29 date: 2024-03-29 name: IRCCS San Raffaele class: OTHER briefSummary: To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.
Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.
Anticipated output We expect that Dup2 patients present a milder DMD phenotype , which might be predicted by genomic studies. conditions: Muscular Dystrophy, Duchenne studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 26 type: ESTIMATED measure: Age at loss of ambulation measure: Time test for motor function measure: Respiratory function sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Dept. of Neurology, IRCCS Ospedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Stefano C Previtali, MD role: CONTACT phone: 00390226433036 email: neuromuscolare@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06337656 id: VITAL_0 briefTitle: Vibration Training Approach in Liver Cirrhosis acronym: VITAL overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-10-01 date: 2026-04-01 date: 2024-03-29 date: 2024-04-01 name: University Hospital of Cologne class: OTHER briefSummary: * Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia
* Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Galileo WBV measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle strength measure: Evaluation of the Effectiveness on muscle mass measure: Evaluation of the Effectiveness on muscle thickness measure: Evaluation of the Effectiveness on mobility, in particular the risk of falling measure: Evaluation of the Effectiveness on physical function measure: Evaluation of Safety of the Training Method measure: Health-Related Quality of Life measure: Health-Related Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06337643 id: MVX01-01 briefTitle: A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-07 date: 2024-04-16 date: 2024-04-16 date: 2024-03-29 date: 2024-03-29 name: Matrivax Research and Development Corporation class: INDUSTRY briefSummary: The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels. conditions: Pneumococcal Vaccine studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: Cohort 1 is open-label. Cohorts 2-5 include two open-label sentinel participants each and the remainder of the participants are randomized and double-blind to either MVX01 or MVX01 Placebo (Participant \& Site). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 75 type: ESTIMATED name: MVX01 name: MVX01 Placebo measure: Incidence of immediate reactogenicity adverse events measure: Incidence of solicited reactogenicity events measure: Incidence of adverse events (AEs) measure: Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI) measure: Changes in safety laboratory results compared to baseline measure: Changes in vital signs compared to baseline measure: Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity (Meridian) Clinical Research city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Alliance for Multispecialty Research (AMR) city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 hasResults: False
nctId: NCT06337630 id: IC 2022-10 briefTitle: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors acronym: POP-ART overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-06-15 date: 2029-02-15 date: 2024-03-29 date: 2024-03-29 name: Institut Curie class: OTHER name: ProLynx LLC name: Merck Sharp & Dohme LLC briefSummary: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types. primaryPurpose: TREATMENT masking: NONE count: 92 type: ESTIMATED name: PLX038 + Tuvusertib measure: Dose escalation step : Dose limiting toxicities (DLTs) measure: Expansion cohorts : Best tumor response measure: Expansion cohorts : Serious Adverse Events (SAEs) measure: Expansion cohorts : Adverse Events (AEs) measure: Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Dose escalation step : objective response rate (ORR) measure: Dose escalation step : Time to response (TTR) measure: Dose escalation step : Duration of Response (DoR) measure: Dose escalation step : Progression free survival (PFS) measure: Expansion cohorts : Time to response (TTR) measure: Expansion cohorts : Duration of Response (DoR) measure: Expansion cohorts : Progression free survival (PFS) measure: Expansion cohorts : Overall Survival (OS) measure: Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups measure: Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib measure: Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib measure: Exploratory endpoints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Curie city: Paris zip: 75005 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Institut Curie city: Saint-Cloud zip: 92210 country: France name: François-Clément BIDARD role: CONTACT email: francois-clement.bidard@curie.fr name: François-Clément BIDARD role: PRINCIPAL_INVESTIGATOR lat: 48.84598 lon: 2.20289 hasResults: False
nctId: NCT06337604 id: TNP-2092-04 briefTitle: The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets overallStatus: COMPLETED date: 2017-10-10 date: 2017-11-23 date: 2017-11-23 date: 2024-03-29 date: 2024-04-01 name: TenNor Therapeutics Inc. class: INDUSTRY briefSummary: A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: TNP-2092 capsules name: TNP-2092 capsules placebo name: Rabeprazole sodium enteric-coated tablets measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t) measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092 measure: Percentage of Participants With Adverse Events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Hospital of Jilin University city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 hasResults: False
nctId: NCT06337591 id: INRCA_003_2024 briefTitle: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location acronym: VI-RADS overallStatus: COMPLETED date: 2022-10-15 date: 2024-03-10 date: 2024-03-10 date: 2024-03-29 date: 2024-03-29 name: Istituto Nazionale di Ricovero e Cura per Anziani class: OTHER briefSummary: VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ACTUAL name: VI-RADS measure: Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: IRCCS INRCA Hospital city: Ancona country: Italy lat: 43.5942 lon: 13.50337 facility: Carlo Urbani Hospital city: Jesi country: Italy lat: 43.52142 lon: 13.24368 hasResults: False
nctId: NCT06337578 id: 23C308 briefTitle: Advances in Telephone-based Cognitive Screening Procedures acronym: TBCS overallStatus: RECRUITING date: 2023-10-25 date: 2026-10-25 date: 2026-10-25 date: 2024-03-29 date: 2024-03-29 name: Istituto Auxologico Italiano class: OTHER briefSummary: 1. Background
Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture).
The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.
The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.