hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06310005 id: 1466-0003 briefTitle: A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-18 date: 2024-10-18 date: 2024-03-13 date: 2024-04-09 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The trial is designed single-blind. The treatments administered (BI 3006337 or placebo) will be blinded to subjects but will be known to the investigators (outcome assessors). whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: BI 3006337 name: Placebo measure: SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator measure: SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf) measure: SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax) measure: MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6 measure: MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Clinical Research Hospital Tokyo status: RECRUITING city: Tokyo, Shinjuku-ku zip: 160-0004 country: Japan name: Boehringer Ingelheim role: CONTACT phone: 0120201230 email: nippon@bitrialsupport.com hasResults: False
nctId: NCT06309992 id: 1404-0056 id: 2023-505303-23-00 type: REGISTRY domain: CTIS id: U1111-1299-9925 type: REGISTRY domain: WHO registry briefTitle: A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight overallStatus: RECRUITING date: 2024-03-13 date: 2026-02-16 date: 2026-03-09 date: 2024-03-13 date: 2024-04-16 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults who are at least 18 years old and have
The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works. conditions: Obesity conditions: Non-Alcoholic SteatoHepatitis (NASH) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Survodutide name: Placebo measure: Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) measure: Relative change (%) in body weight from baseline to Week 48 measure: Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF measure: Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF measure: Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no) measure: Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels measure: Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels measure: Absolute change from baseline to Week 48 in waist circumference [cm] measure: Relative change from baseline to Week 48 in waist circumference [cm] measure: Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5) measure: Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) measure: Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE) measure: Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI measure: Relative change in liver volume [mL] from baseline to Week 48 measured using MRI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Panax Clinical Research status: RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 25.90871 lon: -80.30866 facility: Verus Clinical Research Corporation status: RECRUITING city: Miami state: Florida zip: 33135 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 25.77427 lon: -80.19366 facility: Louisiana Research Center, LLC status: RECRUITING city: Shreveport state: Louisiana zip: 71105 country: United States name: Boehringer Ingelheim role: CONTACT phone: 833-602-2368 email: unitedstates@bitrialsupport.com lat: 32.52515 lon: -93.75018 hasResults: False
nctId: NCT06309979 id: 111-903 briefTitle: A Study to Assess Growth in Children With Idiopathic Short Stature overallStatus: RECRUITING date: 2024-03-25 date: 2040-12-31 date: 2040-12-31 date: 2024-03-13 date: 2024-03-13 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest. conditions: Idiopathic Short Stature studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 600 type: ESTIMATED measure: Change in annualized growth velocity (AGV) measure: Change in Height Z-score measure: Change in Standing Height measure: Change in BMI measure: Change in BMI Z-score measure: Frequency of event rates of medical events of interest measure: Frequency of Serious Medical Events measure: Association between specific variants and growth velocity measure: Association between other health outcomes directly related to short stature sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: Children's National Health System status: RECRUITING city: Washington state: District of Columbia zip: 20010 country: United States lat: 38.89511 lon: -77.03637 hasResults: False
nctId: NCT06309953 id: 937 briefTitle: A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease overallStatus: RECRUITING date: 2024-02-28 date: 2024-06-28 date: 2024-06-28 date: 2024-03-13 date: 2024-03-15 name: Bausch & Lomb Incorporated class: INDUSTRY briefSummary: An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease conditions: Dry Eye studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Miebo measure: Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 205 status: NOT_YET_RECRUITING city: Petaluma state: California zip: 94954 country: United States lat: 38.23242 lon: -122.63665 facility: Site 203 status: RECRUITING city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Site 204 status: NOT_YET_RECRUITING city: Stillwater state: Minnesota zip: 55082 country: United States lat: 45.05636 lon: -92.80604 facility: Site 202 status: RECRUITING city: Kansas City state: Missouri zip: 64154 country: United States lat: 39.09973 lon: -94.57857 facility: Site 201 status: NOT_YET_RECRUITING city: Brecksville state: Ohio zip: 44141 country: United States lat: 41.31978 lon: -81.62679 hasResults: False
nctId: NCT06309940 id: Basal ganglionic haemorrhage briefTitle: Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-04 date: 2024-03-13 date: 2024-03-13 name: Assiut University class: OTHER briefSummary: The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate conditions: Basal Ganglionic Hemorrhage studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 25 type: ESTIMATED name: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage measure: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage sex: ALL minimumAge: 15 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False
nctId: NCT06309927 id: 0025-24-ASF briefTitle: Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-03-13 date: 2024-03-13 name: Assaf-Harofeh Medical Center class: OTHER_GOV briefSummary: Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.
6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies. conditions: Early Pregnancy Loss conditions: Intrauterine Adhesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Operative hysteroscopy (by tissue removal device) name: Suction curettage measure: Operative complications measure: Intrauterine adhesions measure: Subsequent fertility measure: Conversion from operative hysteroscopy to suction curettage sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shamir Medical Center city: Be'er Ya'aqov zip: 70200 country: Israel name: Noam Smorgick, MD role: CONTACT email: nsmorgik@shamir.gov.il lat: 31.93864 lon: 34.83749 hasResults: False
nctId: NCT06309914 id: Pro00074459 briefTitle: The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States overallStatus: RECRUITING date: 2024-02-21 date: 2024-03-15 date: 2024-05-06 date: 2024-03-13 date: 2024-03-13 name: Applied Science & Performance Institute class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups. conditions: Mental Processes conditions: Cognitive Change conditions: Mood Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Placebo name: Enovita Grape Seed Extract name: Mirtoselect Bilberry Extract name: Virtiva Plus Ginko Biloba Extract measure: Change in Visual Memory measure: Change in Verbal Memory measure: Change in Finger Tapping Test (FTT) Results measure: Change in Symbol Digit Coding (SDC) Test Results measure: Change in Stroop Test Results measure: Change in Shifting Attention Test Results measure: Change in Continuous Performance Test Results measure: Change in Abbreviated Profile of Mood States (POMS) Score sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: Applied Science and Performance Institute status: RECRUITING city: Tampa state: Florida zip: 33607 country: United States name: Jacob Wilson, PhD role: CONTACT phone: 813-673-8888 email: jwilson@theaspi.com name: Justine Davis, MS role: CONTACT phone: 813-673-8888 email: jdavis@theaspi.com lat: 27.94752 lon: -82.45843 hasResults: False
nctId: NCT06309901 id: ankaraYBU2019-199 briefTitle: Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques overallStatus: COMPLETED date: 2019-06-30 date: 2021-12-01 date: 2022-05-31 date: 2024-03-13 date: 2024-03-13 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair. conditions: Meniscus Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 33 type: ACTUAL name: Exercise name: Fascial Distortion Model name: Instrument Assisted Soft Tissue Mobilisation measure: Visual Analog Scale measure: environmental measurement measure: Power Track Manuel Muscle Tester measure: sit and reach test measure: Goniometric measurement measure: The Western Ontario Meniscal Evaluation Tool (WOMET ) measure: Lysholm Knee Score sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Yıldırım Beyazıt University Yenimahalle Training and Research Hospital city: Ankara zip: 06010 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
nctId: NCT06309888 id: 2023-18 briefTitle: Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury acronym: SCI_Cog overallStatus: RECRUITING date: 2024-02-01 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Swiss Paraplegic Research, Nottwil class: NETWORK briefSummary: In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.
Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up). conditions: Spinal Cord Injury studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Brain activity measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Behavioral performance measure: Brain morphometry measure: Level of life satisfaction measure: Level of anxiety measure: Level of pain measure: Quality of sleep measure: Level of attention and awareness measure: Motor symptom severity measure: Demographics sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Swiss Paraplegic Research status: RECRUITING city: Nottwil state: Lucerne zip: 6207 country: Switzerland name: Jothini Sritharan, MSc role: CONTACT phone: +41419396557 email: jothini.sritharan@paraplegie.ch name: Jothini Sritharan, MSc role: SUB_INVESTIGATOR lat: 47.13472 lon: 8.13772 hasResults: False
nctId: NCT06309875 id: ENF- 25-2018 briefTitle: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure acronym: PLANCUIDARTE overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-06-25 date: 2024-11-12 date: 2024-03-13 date: 2024-03-13 name: Universidad de la Sabana class: OTHER name: Universidad de Caldas briefSummary: According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.
Methodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons. conditions: Heart Failure conditions: Caregiver Burden conditions: Discharge Plan conditions: Care Transitions conditions: Nursing studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test.
The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later) primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 84 type: ESTIMATED name: PLAN CUIDARTE name: Conventional care measure: Care Competence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de Caldas city: Manizales state: Caldas zip: 170004. country: Colombia name: Claudia Marcela Vallejo, Mag role: CONTACT phone: +573163614224 email: marcela.vallejo@ucaldas.edu.co lat: 5.06889 lon: -75.51738 hasResults: False
nctId: NCT06309862 id: 5993 briefTitle: Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-09-30 date: 2025-12-31 date: 2024-03-13 date: 2024-03-13 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes. conditions: Cardio-Oncology conditions: Cardiomyopathy Due to Drug studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED measure: Define changes in CMR tissue and blood biomarkers during ICI treatment. measure: Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction. measure: Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06309849 id: Jerash University briefTitle: Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail". overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-20 date: 2024-06-01 date: 2024-03-13 date: 2024-04-08 name: South Valley University class: OTHER briefSummary: Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: includes 30 participants. whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique) measure: 1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer. measure: 3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10) sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
nctId: NCT06309836 id: SID03 briefTitle: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma acronym: REGISTRO-BCC overallStatus: RECRUITING date: 2021-06-23 date: 2024-06-23 date: 2024-06-23 date: 2024-03-13 date: 2024-03-13 name: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse class: OTHER briefSummary: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma. conditions: Basal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: clinical evolution, treatment and prognosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Fondazione Policlinico Gemelli status: RECRUITING city: Roma state: ITA zip: 00168 country: Italy name: peris MD Peris role: CONTACT phone: 0630154211 email: ketty.peris@unicatt.it lat: 41.89193 lon: 12.51133 hasResults: False