hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06335134 id: SCW0502-1016 briefTitle: A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin overallStatus: RECRUITING date: 2023-07-14 date: 2024-01-08 date: 2024-03-31 date: 2024-03-28 date: 2024-03-28 name: Hangzhou Sciwind Biosciences Co., Ltd. class: INDUSTRY briefSummary: This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: XW003 injection name: Metformin name: Warfarin name: Rosuvastatin name: Digoxin measure: Pharmacokinetics of metformin: AUC0-inf measure: Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf measure: Pharmacokinetics of rosuvastatin: AUC0-inf measure: Pharmacokinetics of digoxin: AUC0-inf sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second University Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Qin Yu role: CONTACT phone: 02885503960 lat: 30.66667 lon: 104.06667 hasResults: False
nctId: NCT06335121 id: 21120602 id: 1R01MH134264 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH134264 briefTitle: Implementation of PrEP Care Among Women in Family Planning Clinics overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-06 date: 2024-03-28 date: 2024-03-28 name: Rush University Medical Center class: OTHER name: National Institute of Mental Health (NIMH) name: University of Illinois at Chicago name: Planned Parenthood of Illinois briefSummary: This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers. conditions: PrEP Uptake conditions: HIV conditions: Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 250 type: ESTIMATED name: POWER Up strategies - measure: PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP. measure: Receipt of PrEP refills among Black women accessing FP services at 6 months. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
nctId: NCT06335108 id: SenoEx_TLA_Maligne briefTitle: Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 ) overallStatus: RECRUITING date: 2022-12-05 date: 2024-12-01 date: 2024-12-01 date: 2024-03-28 date: 2024-03-28 name: University Hospital Tuebingen class: OTHER briefSummary: The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery. conditions: Breast Carcinoma conditions: Breast Carcinoma in Situ studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: General Anaesthesia name: Local tumescent anaesthesia measure: Postoperative Pain measure: HRQoL/ Quality of life measure: Postoperative pain medication requirements measure: Complications measure: Length of hospital stay measure: Duration of surgery measure: Drainage delivery rate measure: Follow-up surgery for R1 situation measure: Preoperative fear of surgery and anaesthesia measure: Costs measure: Satisfaction of the surgeon with the course of the operation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Women's Hospital status: RECRUITING city: Tübingen zip: 72076 country: Germany name: Bettina Böer, Dr. role: CONTACT phone: +49 7071 29 82211 email: Bettina.Boeer@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False
nctId: NCT06335095 id: a319 briefTitle: Gait Analysis and Degenerative Spine overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-09 date: 2026-09 date: 2024-03-28 date: 2024-03-28 name: Universidade Nova de Lisboa class: OTHER briefSummary: The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:
* How they evolve with disease progression and treatment conditions: Spinal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Kinematic sensors measure: Change from baseline in gait parameter - speed (m/s) - at 3 months measure: Change from baseline in gait parameter - speed (m/s) - at 6 months measure: Change from baseline in gait parameter - speed (m/s) - at 12 months measure: Change from baseline in gait parameter - step length (m) - at 3 months measure: Change from baseline in gait parameter - step length (m) - at 6 months measure: Change from baseline in gait parameter - step length (m) - at 12 months measure: Change from baseline in gait parameter - step width (m) - at 3 months measure: Change from baseline in gait parameter - step width (m) - at 6 months measure: Change from baseline in gait parameter - step width (m) - at 12 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months measure: Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months measure: Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months measure: Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months measure: Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06335069 id: 2023-508066-15-00 briefTitle: 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-03-28 date: 2024-03-28 name: Maastricht University Medical Center class: OTHER briefSummary: The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients. conditions: Breast Cancer conditions: Breast Neoplasms conditions: Breast Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group, single-center pilot study primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI measure: To investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a radioactive PET tracer in patients with ER+ breast cancer. measure: To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center+ city: Maastricht zip: 5800 country: Netherlands name: Thiemo JA van Nijnatten, MD, PhD role: CONTACT email: thiemo.nijnatten@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False
nctId: NCT06335056 id: IRBAM-21-0702 id: 1R15HD108765-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R15HD108765-01A1 briefTitle: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools acronym: ProudMe overallStatus: ENROLLING_BY_INVITATION date: 2024-02-19 date: 2025-12 date: 2026-04 date: 2024-03-28 date: 2024-03-28 name: Louisiana State University and A&M College class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Pennington Biomedical Research Center name: Texas A&M University name: University of Nevada, Las Vegas briefSummary: This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost. conditions: Treatment (ProudMe) conditions: Waitlist Control studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions. primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: ProudMe name: Waitlist Control measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers measure: Screen time measure: Food environment measure: Body mass index z score measure: Waist circumference measure: Activity self-efficacy measure: Self-monitoring measure: Social support measure: School Wellness Policy measure: Cafeteria Nutrition sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: LSU Pedagogical Kinesiology Lab city: Baton Rouge state: Louisiana zip: 70803 country: United States lat: 30.45075 lon: -91.15455 hasResults: False
nctId: NCT06335043 id: 119245 briefTitle: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans acronym: PGx overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2027-04-01 date: 2024-03-28 date: 2024-03-28 name: Lawson Health Research Institute class: OTHER briefSummary: This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation. conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: Pharmacogenetics Testing measure: PHQ-9 - Patient Health Questionnaire 9 measure: GAD-7 - General Anxiety Disorder-7 measure: PCL-5 - Posttraumatic Stress Disorder Checklist - 5 measure: OQ-45 - Outcome Questionnaire 45 measure: Pharmacological Side Effect Measure measure: Electronic Medical Record Extraction Measure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06335030 id: 2.1_AUT-SP2_001_Tancredi briefTitle: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism overallStatus: RECRUITING date: 2021-03-29 date: 2024-01-30 date: 2024-11-30 date: 2024-03-28 date: 2024-03-28 name: IRCCS Fondazione Stella Maris class: OTHER name: Ospedale Borgo Trento - Verona name: Università degli Studi di Trento briefSummary: Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD) , both on an individual level, both on family and social ones .
Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Child Oral and Motor Proficiency Scale (ChOMPS) measure: Brief Autism Mealtime Behavior Inventory (BAMBI) measure: Sensory Profile 2 (SP2) measure: Child Behavior Checklist (CBCL) measure: Parenting Stress Index (PSI) measure: Observation of child meal-time measure: Food Diary measure: Gastrointestinal severity symptom index (GSSI) measure: Mac Arthur measure: Autism Quotient (AQ) measure: Autism Diagnostic Observation Schedule-2 (ADOS-2) measure: Vineland-II scales (VABS II) sex: ALL minimumAge: 2 Years maximumAge: 6 Years stdAges: CHILD facility: IRCCS Stella Maris status: RECRUITING city: Pisa state: PI zip: 56128 country: Italy name: Raffaella Tancredi role: CONTACT phone: +39050886292 email: raffaella.tancredi@fsm.unipi.it name: Roberta Nencioli role: CONTACT phone: +39050886347 email: roberta.nencioli@fsm.unipi.it lat: 43.70853 lon: 10.4036 facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione status: TERMINATED city: Rovereto zip: 38068 country: Italy lat: 45.8904 lon: 11.04053 facility: Azienda Ospedaliera Borgo Trento status: TERMINATED city: Verona zip: 37126 country: Italy lat: 45.4299 lon: 10.98444 hasResults: False
nctId: NCT06335017 id: 294-2024-HFH briefTitle: Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous overallStatus: RECRUITING date: 2024-04-10 date: 2024-12 date: 2024-12 date: 2024-03-28 date: 2024-04-12 name: Holy Family Hospital, Nazareth, Israel class: OTHER briefSummary: The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in multiparous women.
Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline.
In the control group, the catheter will be inserted into cervical canal without ingestion of castor oil. conditions: Induction of Labor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Induction of labor measure: time to delivery measure: balloon expulsion time measure: Bishop score at catheter expulsion measure: Number of women that will have non-vertex presentation after removal of the catheter measure: Duration of active phase measure: Duration of second stage measure: Mode of delivery measure: Indications for cesarean or vacuum deliveries measure: Number of patients that will have intrapartum fever ≥ 38 °C measure: Number of patients that will require use of intrapartum use of antibiotic treatment measure: Number of Participants with that will develop clinical signs of chorioamnionitis. measure: Number of Participants with that will develop 3rd and 4th degrees perineal lacerations. measure: Number of Participants with develop postpartum hemorrhage. measure: Number of Participants with need blood transfusion. measure: Number of women that will have side effects related to castor oil use measure: Oxytocin dosage measure: Number of participants with Umbilical Cord prolapse. measure: Number of neonates that will have Apgar score (range 0 to 10) <7. measure: number of women with cord artery pH <7.1 measure: Neonatal birthweight measure: Number of neonates with Neonatal fever ≥ 38 °C measure: The number of neonates that will develop neonatal sepsis. measure: The number of neonates that will require antibiotic treatment. measure: number of neonates with any neonatal complications measure: The number of neonates that will Admit to neonatal intensive care unit (NICU) measure: Length of stay in NICU. measure: Number of neonatal death measure: Maternal hemoglobin level after delivery. measure: Number of participants that will require postpartum hysterectomy. measure: Number of participants that will require postpartum laparotomy. measure: Number of women that will develop postpartum complications measure: The length of stay from birth to discharge home. measure: Maternal satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Holy Family hospital, Nazareth status: RECRUITING city: Nazareth country: Israel name: Wiaam Khatib, MD role: CONTACT phone: 0549192433 email: wiaam.khatib.95@gmail.com name: Raed Salim, MD role: CONTACT email: r.salim@hfhosp.org name: Wiaam Khatib, MD role: PRINCIPAL_INVESTIGATOR lat: 32.69925 lon: 35.30483 hasResults: False
nctId: NCT06335004 id: 926 briefTitle: Evaluation of Brain Waste Clearance Pathways Using Magnetic Resonance Imaging in Pediatric Patients With White Matter Diseases overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2024-12-31 date: 2025-02-28 date: 2024-03-28 date: 2024-03-28 name: IRCCS Eugenio Medea class: OTHER briefSummary: The dilation of perivascular spaces can be the result of various etiopathogenetic processes. White matter atrophy can cause enlargement of these perivascular spaces (PVS) but also obstruction of fluid drainage systems (interstitial fluid, ISF) and metabolites, as evidenced by some recent studies. Focal stagnation of liquids and deposition of toxic material induce tissue hypoxia and neuroglial dysfunction. Dilation of PVS can be associated with changes in white matter and microhemorrhages. We want to study these etiopathogenetic phenomena by implementing specific MRI methods. conditions: Glymphatic System conditions: White Matter Disease conditions: Pediatric Disorder conditions: Perivascular Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Magnetic resonance imaging measure: Extent of white matter lesions measure: Number of perivascular spaces measure: Volume of parasagittal dural space sex: ALL minimumAge: 9 Months maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy lat: 45.80075 lon: 9.29 hasResults: False