hackint0sh/New-Dataset huggingface dataset:
The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Buprenorphine measure: Successful initiation of buprenorphine maintenance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06379971 id: 23-2327 briefTitle: Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-04 date: 2029-04 date: 2024-04-23 date: 2024-04-23 name: University of Colorado, Denver class: OTHER briefSummary: The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development. conditions: Child Development conditions: Cannabis Use studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phosphatidylcholine or placebo primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Placebo name: Choline measure: Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index measure: Auditory Sensory Gating (P50) measure: Child Behavior Checklist (CBCL) 1 1/2-5 measure: Maternal Plasma Choline Levels measure: Bayley Scales of Infant and Toddler Development sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UC Health city: Aurora state: Colorado zip: 80045 country: United States name: Sharon Hunter, PhD role: CONTACT phone: 303-724-6246 email: sharon.hunter@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False
nctId: NCT06379958 id: IST-05 briefTitle: Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-05-31 date: 2024-09-30 date: 2024-04-23 date: 2024-04-23 name: Modern Biosciences Ltd class: INDUSTRY briefSummary: A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: leramistat 40mg name: Itraconazole 200 mg name: Phenytoin 100 Mg Oral Capsule name: Simvastatin 40mg measure: leramistat: Area under the curve - AUC0 t measure: leramistat: Area under the curve - AUC0 24 measure: leramistat: Area under the curve - AUC0 inf measure: leramistat: Maximum observed concentration - Cmax measure: leramistat: Time of the maximum observed concentration - Tmax measure: leramistat:Elimination rate constant -Kel measure: leramistat: Half life - t½ measure: leramistat: Plasma Clearance -CL/F measure: leramistat: Volume of distribution - Vz/F measure: Incidence of adverse event. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Belfast country: United Kingdom name: Phase 1 Unit role: CONTACT name: Nadine Abdullah role: PRINCIPAL_INVESTIGATOR lat: 54.59682 lon: -5.92541 hasResults: False
nctId: NCT06379945 id: PI23/01103 id: PI2024 01 1484 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA) acronym: UMBRELLA-SUMMA overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-12-31 date: 2024-04-23 date: 2024-04-23 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.
More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients.
On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches. conditions: Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Structural variants and complex rearrangements in MDS measure: Mutations in MDS measure: Overall survival and leukemia-free survival in patients with MDS measure: ISCIII collections of viable samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Instituto de Investigación Germans Trias i Puyol status: RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Francesc Solé, PhD role: CONTACT phone: 935 57 28 06 phoneExt: 4040 email: fsole@carrerasresearch.org lat: 41.45004 lon: 2.24741 facility: Hospital Universitario Vall d´Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: David Valcárcel Ferreiras, PhD role: CONTACT phone: 934 89 30 00 email: dvalcarcel@vhio.net lat: 41.38879 lon: 2.15899 facility: Clínica Universitaria de Navarra status: RECRUITING city: Pamplona zip: 31008 country: Spain name: Felipe López Cardoso, PhD role: CONTACT phone: 848 42 87 00 email: fprosper@unav.es lat: 42.81687 lon: -1.64323 facility: Complejo Asistencial Universitario de Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: María Díez Campelo, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55418 email: mdiezcampelo@usal.es name: Sandra Muntión Olave, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55015 email: terapiacelular@usal.es lat: 40.96882 lon: -5.66388 hasResults: False
nctId: NCT06379932 id: APHP240433 briefTitle: Pain and Muscle Biopsy acronym: BIODOMU overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future. conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Surveys completion measure: To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale. measure: To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service measure: Gather patient feedback on procedures, facilities and reception to improve our service to patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06379919 id: C Acnes in TSA briefTitle: Wound Irrigation Comparative Effectiveness Study overallStatus: RECRUITING date: 2024-03-20 date: 2025-05-31 date: 2027-05-31 date: 2024-04-23 date: 2024-04-26 name: Orthopaedic Education and Research Institute (dba Hoag Orthopedics) class: OTHER name: Irrimax Corporation briefSummary: The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups. conditions: Cutibacterium Acnes Contamination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Irrisept Irrigation name: Saline Irrigation Solution Delivery measure: C Acnes Presence measure: American Shoulder and Elbow Surgeons Patient Reported Outcome Measure measure: Shoulder Range of Motion (ROM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Orthopedics status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Edward Quilligan, BS role: CONTACT phone: 949-526-1570 email: Edward.quilligan@hoagorthopedics.org name: Kalyn Smith, BS role: CONTACT phone: (949) 526-1570 email: kalyn.smith@hoagorthopedics.org lat: 33.78779 lon: -117.85311 hasResults: False
nctId: NCT06379906 id: DMD, UE and Balance briefTitle: Upper Extremity Muscle Strength, Balance and Functional Skills in DMD overallStatus: COMPLETED date: 2023-11-10 date: 2023-12-10 date: 2024-03-10 date: 2024-04-23 date: 2024-04-25 name: Halic University class: OTHER name: Biruni University name: Istanbul University briefSummary: This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 32 type: ACTUAL name: Assessment measure: Upper Extremity Muscle Strength Measurements measure: Trunk Control Measurement Scale measure: Functional Reach Test measure: Timed Up & Go Test measure: Pediatric Evaluation of Disability Inventory sex: MALE minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
nctId: NCT06379893 id: 300128 id: 2024-510839-22-00 type: CTIS briefTitle: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-23 date: 2024-04-23 name: HALEON class: INDUSTRY briefSummary: The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA. conditions: Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 195 type: ESTIMATED name: Voltaren Gel 1% (diclofenac sodium) (US only) name: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) name: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) measure: Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 measure: Change from Baseline in the Average Minutes of MVPA at Week 2 measure: Change from Baseline in the Average Minutes of MVPA at Week 3 measure: Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21 measure: Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21 measure: Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21 measure: Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21 measure: Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21 measure: Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21 measure: MVPA on Each Day of the Study measure: WOMAC Physical Function Subscale Score on Days 7,14, and 21 measure: Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness measure: Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21 measure: Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21 sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06379867 id: HSK3486-112 briefTitle: A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects overallStatus: RECRUITING date: 2024-04-07 date: 2024-05-30 date: 2024-08-30 date: 2024-04-23 date: 2024-04-26 name: Haisco Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects. conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: HSK3486 name: Placebo name: Moxifloxacin measure: ΔQTcI measure: ΔHR, ΔQTcF, ΔPR, and ΔQRS measure: Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals measure: AE and SAE measure: Cmax measure: AUClast measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing GoBroad Boren Hospital status: RECRUITING city: Beijing country: China name: Jie Hou role: CONTACT phone: 18611422958 email: jie.hou@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06379854 id: RCRAHS-ISB/REC/MS-PT/01814 briefTitle: Trunk Rotation And Lateral Flexion Exercises In Stroke Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-06 date: 2024-06 date: 2024-04-23 date: 2024-04-23 name: Riphah International University class: OTHER briefSummary: In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: chest physiotherapy name: trunk rotation exercises,deep diaphragmatic also chest physiotherapy measure: Trunk Impairment Scale: measure: Peak Flow Meter measure: Chest Expansion: sex: ALL maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Shahida Khaliq Health Centre status: RECRUITING city: Islamabad zip: 44080 country: Pakistan name: Sara Jahan, MSPT role: CONTACT phone: +923415182331 email: saira.jahan@riphah.edu.pk lat: 33.72148 lon: 73.04329 hasResults: False
nctId: NCT06379841 id: STUDY00007357 briefTitle: Green Hysteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-23 date: 2024-04-23 name: Emory University class: OTHER briefSummary: The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.
Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time conditions: Hysteroscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 100 type: ESTIMATED name: Green Draping Procedure name: Full Draping Procedure measure: Difference in operative times measure: Infection Rate measure: Post Operative complication Rate measure: Peri operative Complication Rate measure: Number of cases of Fluid deficits measure: Operative room turnover time in Full Draping sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Hospital city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Emory Dunwoody Clinic city: Atlanta state: Georgia zip: 30338 country: United States lat: 33.749 lon: -84.38798 facility: Emory Saint Joseph's Hospital city: Atlanta state: Georgia zip: 30342 country: United States lat: 33.749 lon: -84.38798 hasResults: False
nctId: NCT06379828 id: 2024-0140 briefTitle: Self-assessment Tool for Implementing the ESCNH overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-10-01 date: 2026-09-01 date: 2024-04-23 date: 2024-04-25 name: European Foundation for the Care of Newborn Infants class: OTHER briefSummary: This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability. conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health conditions: Testing of the Developed Self-assessment Tool in European Hospitals conditions: Self-Assessment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Please note that this is an observational study; not applicable measure: Online self-assessment tool (including statements and questions) measure: Response rates measure: Demographics and characteristics measure: User-friendliness score of the self-assessment tool measure: Applicability score of the formulation of the questions measure: Qualitative feedback on illustration of output measure: Appraisal on the utilisation of the self-assessment tool measure: Scalability of the self-assessment tool and dissemination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Foundation for the Care of Newborn Infants (EFCNI) city: Munich state: Bavaria zip: 81379 country: Germany name: Isabel Geiger, Dr. role: CONTACT phone: 0049 89 89 0 83 26-0 email: isabel.geiger@efcni.org name: Julia Hoffmann, Dr. role: CONTACT email: julia.hoffmann@efcni.org name: Luc Zimmermann, Prof. role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-17T07:49 filename: Prot_SAP_000.pdf size: 200372 hasResults: False
nctId: NCT06379815 id: EMRL-23-03 briefTitle: Effect of Oral Lactate Ingestion on Appetite Regulation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08 date: 2024-08 date: 2024-04-23 date: 2024-04-23 name: Wilfrid Laurier University class: OTHER name: Natural Sciences and Engineering Research Council, Canada briefSummary: The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session. conditions: Appetitive Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: The allocation of lactate and placebo will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation. This will be completed in a counter-balanced order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Sodium Lactate name: Sodium Chloride measure: Blood Lactate measure: Acylated ghrelin measure: Total ghrelin measure: Subjective appetite perception measure: Free-living energy intake sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False