bioihbjkbjnl/mcl2 huggingface dataset:
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation
Condition: Medical Abortion
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48
      hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77
      days' compared to women 64-70 days' LMP.
    


Intervention name(s): Mifepristone followed by misoprostol 24-48 hours later
Intervention type(s): Drug
Intervention description(s): 200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)
Condition: Healthy; Hepatitis, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety data including serious
      and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms
      (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).
    

Detailed description: 
      Part 1: This is a first-in-human (FIH), double-blind (neither the researchers nor the
      participants know what treatment the participant is receiving), randomized (study medication
      assigned to participants by chance), placebo-controlled (an inactive substance; a pretend
      treatment [with no drug in it] that is compared in a clinical trial with a drug to test if
      the drug has a real effect) study. Part 1 includes healthy adult participants, divided into 3
      panels (Panel 1, 2 and 3) and in Part 2 adult Chronic Hepatitis B Participants will be
      included, in Sessions VIII to XI and Optional Sessions A-B-C (Panel 4). The study will
      consists of screening phase (part 1: [less than or equal to <=28 days before the first intake
      of study drug; part 2: [<=56 to greater than or equal to {>=} 20 days before the first intake
      of study drug), Treatment Phase (multiple dose phase in part 1: Day -1 up to 12 or 19 days;
      part 2: up to 4 weeks) and Follow up Phase (part 1: 30-35 days after last study drug intake
      or after dropout; part 2: up to week 8 after actual end of study drug treatment).
      Participants' safety will be evaluated throughout the study.
    

Intervention name(s): JNJ-56136379; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).; Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Intervention MeSH terms: JNJ-56136379
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Healthy; Hepatitis, Chronic; JNJ-56136379; Placebo
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
Condition: Helicobacter-associated Gastritis
MeSH terms: Gastritis
Study type: Observational

Summary: 
      Although endoscopic findings of H. pylori have been reported in the literature, there is
      still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic
      features alone. Most studies concluded that it is not possible to diagnose H. pylori-related
      gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has
      greatly improved in recent years and the exact examination of gastric mucosa was possible.
    

Detailed description: 
      Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern
      in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy
      for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4)
      validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent upper endoscopy in the Kyung Hee University Hospital
      
Biospecimen description: 
      Gastric mucosa for detecting Helicobacter pylori
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether SYL040012 is safe for the treatment of
      ocular hypertension and glaucoma.
    


Intervention name(s): SYL040012
Intervention type(s): Drug
Intervention description(s): Administration of single and multiple doses of SYL040012 in ophthalmic drops solution
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Ocular hypertension; Glaucoma; Beta-blocker
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Condition: Metastatic Castrate-resistant Prostate Cancer; mCRPC
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic
      radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky
      progressive disease, but also to provide antigen presentation and immune stimulation which is
      expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T
      and thereby significantly improve the treatment outcome for metastatic castrate resistant
      prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic
      cancer treatment
    


Intervention name(s): Sipuleucel-T; Stereotactic Ablative Body Radiation
Intervention type(s): Drug; Radiation
Other intervention name(s): Provenge; SABR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to evaluate dose-exposure and safety of nintedanib in
      children and adolescents with fibrosing Interstitial Lung Disease (ILD).
    


Intervention name(s): Nintedanib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Capsule
Other intervention name(s): Ofev®
Intervention MeSH terms: Nintedanib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
N-PhenoGENICS: Neurocognitive-Phenome, Genome, Epigenome and Nutriome In Childhood Leukemia Survivors
Condition: Childhood Leukemia Survivors
MeSH terms: Leukemia
Study type: Observational

Summary: 
      To find possible therapeutic targets to help prevent long-term brain and behavioural side
      effects in survivors of childhood leukemia that may have been caused by chemotherapy
      (Treatment-Related late Adverse Neuro-Cognitive Effects: TRANCE). The study hypothesis is
      that genetic variations of the elements in the folate-related cycles and methotrexate
      disposition networks are associated with the deficit phenotype (TRANCE) of childhood leukemia
      survivors.
    

Detailed description: 
      Hypothesis Genetic variants of the elements in the folate-related cycles and methotrexate
      disposition networks are associated with the TRANCE phenotype of childhood leukemia
      survivors.

      Objectives

        1. To identify TRANCE phenotypes of the childhood leukemia survivors.

        2. To characterize the folate and vitamin B12 levels of these children

        3. To identify DNA methylation patterns associated with TRANCE trait in the leukemia
           survivors

        4. To identify SNPs associated with the TRANCE trait in the leukemia survivors.

        5. To identify the "deficit genotype" associated only with the TRANCE leukemia survivors,
           but not with general population children who show developmental phenotypes similar to
           TRANCE: TRANCE-unique deficit variant

        6. To replicate the association between the TRANCE-unique deficit variants and the TRANCE
           trait in a population of childhood leukemia survivors.

        7. To evaluate the importance of rare genetic variants in the TRANCE trait in the leukemia
           survivors.

      Study design: A case-control study of leukemia survivors

      Analyses

        1. Leukemia survivors will be characterized by their status of neurocognitive function, and
           categorized into the Deficit case and the non-deficit Control case.

        2. They will be also characterized by the following attributes

             1. Pathway-based genetic variant status (folate and PK-related genes)

             2. Folate and vitamin B12 status

             3. Epigenetic markers

        3. Comparative analyses between neuro-cognitiive deficit phenotype (TRANCE) and Control on
           those parameters
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Childhood leukemia survivors
      
Biospecimen description: 
      DNA samples obtained via blood, saliva and buccal sample collection.
    
Keywords: Childhood leukemia survivors; Acute lymphoblastic leukemia; Leukemia; Late effects; Folate; Blood folate; Neurotoxicity; Methotrexate; Pharmacogenetics; Cognitive; Cognitive late effects; N-PhenoGENICS
A Bioequivalence Study to Compare the Pharmacokinetics of Two Formulations of Siklos® in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, open-label, single-centre, randomised, two-period, single-dose
      crossover study to compare and assess the bioequivalence, safety, tolerability and
      pharmacokinetics of hydroxycarbamide dispersible tablets (20 x 50 mg) (test IMP) and Siklos®
      film-coated tablet (1000 mg) (reference IMP) following single-dose administration. Thirty
      (30) healthy male and female participants, between 18 and 50 years of age are planned to
      participate in the study.

      Study participants will be randomised to one of the 2 possible combination sequences. After
      each treatment administration, blood samples will be collected at specific time points to
      assess the Pharmacokinetics (PK) parameters.
    


Intervention name(s): Hydroxycarbamide dispersible tablets; Hydroxycarbamide film-coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): Hydroxycarbamide dispersible tablets (20 x 50 mg); Hydroxycarbamide film-coated tablet (1000 mg)
Intervention MeSH terms: Hydroxyurea
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hydroxycarbamide; Hydroxyurea
Eradication of Malignant Carcinoma in the Breast Tissue
Condition: Breast Cancer
MeSH terms: Carcinoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to confirm the findings of an early study and expand our
      knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP
      (Adenosine-5'-Triphosphate) Inhibitor.
    


Intervention name(s): Acetogenins; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acetogenins BID for 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Condition: Delayed Graft Function; Acute Graft Rejection
MeSH terms: Delayed Graft Function
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and effectiveness of two different
      anti-rejection drug regimens.
    

Detailed description: 
      This multicenter prospective, randomized controlled clinical trial compared the open label
      use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen.
      Eligible patients were identified during a 90-day screening period immediately after
      transplantation and randomized via a computer-generated scheme. Patient randomization was
      stratified according to center and rejection status in the first 90 days after
      transplantation. All patients received IL-2 receptor antagonist induction therapy,
      tacrolimus, azathioprine, and corticosteroids until 90 days after transplantation. At 90 days
      after transplantation, patients were randomized at a 1:1 ratio to either continue
      azathioprine or change from azathioprine to sirolimus.

      The dosing and levels of immunosuppressive medications were standardized for all patients
      included in this study. Tacrolimus was dosed at 0.04 mg/kg twice daily with target trough
      levels between 5 and 15 ng/ml, azathioprine was administered at 2 mg/kg daily with dose
      adjustments for leukopenia, sirolimus was initially dosed at 2 mg/day with target trough
      levels between 5 and 15 ng/ml, and prednisone was tapered to not more than 10 mg/day by 3
      months after transplantation. All patients received induction therapy with either daclizumab
      or basiliximab as per the product package insert.

      In addition, prophylactic antimicrobials were standardized among the participating sites. All
      patients with either donor and/or recipient cytomegalovirus (CMV)-positive serostatus
      received either intravenous ganciclovir or oral valganciclovir for a total of 90 days. Lung
      transplant recipients who were negative for both donor and recipient CMV serostatus received
      valacyclovir for 90 days. Antifungal prophylaxis was determined by each site. Pneumocystis
      jiroveci prophylaxis was continued throughout the study. Lipid-lowering medications were
      recommended according to the National Cholesterol Education Program guidelines.
    

Intervention name(s): azathioprine; sirolimus
Intervention type(s): Drug; Drug
Intervention description(s): azathioprine 2mg/kg; sirolimus 2-4mg daily
Intervention MeSH terms: Sirolimus; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rejection in lung transplant
Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China.
      The methods to treat SCI patients in sequela stage update are poor. Though traditional
      rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve
      the neurological disorders of these patients, such as sensory disturbance, dyskinesia,
      autologous adjustment of blood pressure, dysfunction of urination, defecation and
      perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is
      unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint
      stiffness. However, it can not repair the damaged nerve function. Studies show that
      mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI
      in animals without any severe side effect.

      In this study, 300 patients will be divided into three groups and the investigators will use
      mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also
      follow up 100 patients who only receive rehabilitation and another 100 patients who accept
      neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare
      the efficacy of these two treatments.
    

Detailed description: 
      Patients enrolled in this study need to finish our whole follow-up survey, which is carried
      out by clinical doctors and epidemiologist.
    

Intervention name(s): cell therapy; rehabilitation
Intervention type(s): Biological; Other
Intervention description(s): Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.; Patients only receive rehabilitation of limb function.
Other intervention name(s): physical exercise rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: cell therapy or rehabitation treatment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injury; cell transplantation; rehabilitation
Early Cancer Detection Test - Lung Cancer Scotland
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      HYPOTHESIS In a high risk population the EarlyCDT-Lung test reduces the incidence of late
      stage tumours;3 / 4 / Unclassified (U) at diagnosis compared to normal clinical practice.
    

Detailed description: 
      AIMS To assess the effectiveness of EarlyCDT-Lung test in increasing early stage lung cancer
      detection, thereby reducing the rate of late stage (3 / 4 / U) presentation, compared to
      normal clinical practice; to assess the cost-effectiveness of EarlyCDT-Lung test compared to
      normal clinical practice; to assess the effectiveness of EarlyCDT-Lung test in reducing
      adverse outcomes including potential psychological and behavioural consequences.
    

Intervention name(s): Early CDT Lung blood test
Intervention type(s): Biological
Intervention description(s): The EarlyCDT-Lung Test is an early detection test designed to assist in lung cancer risk assessment and detection in the earliest stages of the disease.
Other intervention name(s): EarlyCDT-Lung test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake
Condition: Obesity Prevention; Diabetes Prevention
Study type: Interventional

Summary: 
      The investigators hypothesize that different types of starch vary in their effects on
      appetite, blood sugar and food intake. In this study, subjects consumed five soups containing
      50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added
      starch at one week intervals. The investigators measured food intake at 30 minutes, appetite
      and blood sugar.
    


Intervention name(s): soup with or without starch
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: starch; carbohydrates; blood glucose; food intake; satiety; appetite
Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout
Condition: Burnout, Professional; Burnout Syndrome
MeSH terms: Occupational Stress; Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      This study seeks to evaluate the prevalence and characterize predictors of physician burnout
      in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to
      evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e.,
      less individual stress given the same workload).
    

Detailed description: 
      A cross-sectional evaluation of burnout, perceived stress, average sleep propensity, and
      social support and coping mechanisms will be assessed from four years of Vanderbilt
      University Medical Center (VUMC) Anesthesia residents. Burnout will be assessed using the
      Maslach Burnout Inventory (MBI-HSS).

      Participating interns, Anesthesia Residency Class 1 (CA-1), and Anesthesia Residency Class 2
      (CA-2) classes will be randomized to 8 weeks of an exercise intervention (15 min of activity
      at 70% of max heart rate or higher, 5 days a week) to meet the activity recommendations of
      the Office of Disease Prevention and Health Promotion or 8 weeks of continuing their baseline
      activity level prior to the study.
    

Intervention name(s): Prescribed Exercise Program; Usual Exercise Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief cardiovascular exercise training (>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.
The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.
Examples of possible 15-minute exercise regimens to be used include:
Walking quickly or running up and down stairs
Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc
Walking up an incline on a treadmill
Jogging or running on a treadmill or elliptical
Stationary cycling or rowing; Usual exercise activity for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: balanced order-randomized, 16-week within-subject crossover study
Masking: None (Open Label)
Primary purpose: Prevention