bioihbjkbjnl/mcl2 huggingface dataset:
Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)
Condition: Liver Fibrosis; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: MRE
Intervention description: Part 1: Participants will have a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit will consist of two liver MRE scans.
Part 2: Participants will have a screening visit, followed ~1
month later by one imaging visit. The imaging visit will consist
of two liver MRE scans.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staging of liver fibrosis prior to clinical trials for treatment of Hepatitis C Virus

Summary:

      This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both
      healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the
      groundwork for the validation of MRE as an alternative to liver biopsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and at least 18 years of age

          -  Generally good health

          -  Willing to fast for 8 hours prior to each study visit

        Hepatitis C Virus (HCV) Inclusion Criteria:

          -  Positive serology for HCV and detectable HCV ribonucleic acid (RNA) in blood within 12
             weeks of screening;

        For Part I, known fibrosis stage of at least =F2 (METAVIR) or =F3 (Ishak) from biopsy
        performed within 3 months of screening; For Part 2, known fibrosis stage of F1-F4 (METAVIR)
        or F1-F6 (Ishak)

          -  Never been treated for HCV

        Healthy Participant Inclusion Criteria:

          -  Documented absence of hepatitis B virus, HCV, acute hepatitis A virus, and human
             immunodeficiency virus (HIV) within 12 weeks of screening

        Exclusion Criteria:

          -  History of stroke, seizures, or neurological disorders

          -  Consumption of excessive amounts of alcohol

          -  Use of products containing nicotine

          -  Unable to hold a breath for 20 seconds

          -  Claustrophobia

          -  Use of illicit drugs or history of drug or alcohol abuse

        HCV-Positive Exclusion Criteria:

          -  Evidence or history of chronic hepatitis not caused by HCV

          -  HIV
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
Condition: Healthy Participants
Intervention: ritlecitinib; ritlecitinib; ritlecitinib
Intervention description: 30 mg intact adult capsule; 10 mg pediatric capsule; 30 mg spray congealed beads
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult
      ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate
      for approximately 2.5 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are healthy as determined by medical evaluation
             including a detailed medical history, complete (full) physical examination, which
             includes BP and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
             dermatological, or allergic disease (including drug allergies, but excluding
             untreated, asymptomatic, seasonal allergies at the time of dosing).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

          -  Known immunodeficiency disorder, including positive serology for HIV at screening, or
             a first degree relative with a hereditary immunodeficiency

          -  Infection with hepatitis B or hepatitis C viruses.

          -  History of any lymphoproliferative disorder

          -  Known present or a history of malignancy other than a successfully treated or excised
             nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
             situ
Interaction of BI 691751 With Itraconazole
Condition: Healthy
Intervention: itraconazole; BI 691751; BI 691751
Intervention description: multiple doses of itraconazole given as capsules; single dose BI 691751 given as tablet; single dose BI 691751 given as tablet
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of the relative bioavailability of a single dose of BI 691751 when given alone
      and together with itraconazole; safety and tolerability
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy male subjects

          2. body mass index (BMI) of 18.5 to 29.9 kg/m2

          3. Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

          1. Any finding in the medical examination (including blood pressure (BP), pulse rate
             (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant
             by the investigator.

          2. Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to
             140 mmHg or diastolic BP outside 50 to 90 mmHg.

          3. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          4. Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or
             gammaglutamyltransferase (GGT) value outside the reference range at the screening
             examination

          5. Any evidence of a concomitant disease judged clinically relevant by the investigator

          6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological, or hormonal disorders

          7. Any history of relevant liver diseases such as disturbance of liver function,
             jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver
             tumors
A Study of LY3113593 in Participants With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: LY3113593; Placebo
Intervention description: Administered by slow intravenous (IV) infusion.; Administered by slow intravenous (IV) infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: single-blind participant only
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is not intended to treat anemia of chronic kidney disease but to determine the
      safety of the study drug, LY3113593.

      The study will also evaluate how much of the study drug gets into the blood stream, how long
      it takes the body to remove the study drug, and what effect the study drug has on the body.

      The study consists of up to three parts. Participants may only enroll in one part.
      Participants will receive up to four injections of LY3113593 or placebo into a vein. The
      study will last up to about 26 weeks including screening and follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving hemodialysis regularly (at least 3 times per week) for at least 4 months

          -  Have a hemoglobin value (taken prior to dialysis, if taken on a dialysis day) greater
             than or equal to 9.5 grams per deciliter (g/dL) and less than or equal to 11.0 g/dL at
             screening

          -  Have been receiving erythropoiesis stimulating agent (ESA) injections for at least 4
             weeks and are willing to stop the injections for approximately 8 weeks

        Exclusion Criteria:

          -  Have another health condition that may put the participant at risk or that the study
             doctor feels would make the participant unsuitable for the study

          -  Currently taking part in another study

          -  Have recently (within 30 days) completed a study or have previously taken part in this
             study
Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: MRI; Pathology; Blood Samples; Blood Samples
Intervention description: Participants undergo volumetric & diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.; Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.; Blood is collected from participants during screening Visit 1 - 24.5 ml. During Visit 3, blood samples totaling 22 ml, are collected at least 6-18 hours post-resection, and every other day up to a week until discharge. At follow up Visit 4, 5.5 ml of blood is collected.; Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatocellular carcinoma; MRI; pharmacogenomics; beta-catenin

Summary:

      The purpose of this study is to characterize the baseline variability of a panel of tissue
      (tumor and adjacent) and blood-based biomarkers obtained from participants with
      hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80%
      Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one
      core needle biopsy (CNB) equivalent is =< 0.65.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with HCC.

          -  Candidate for surgical resection or has no contraindications to MRI procedures.

        Exclusion Criteria:

          -  Prior loco-regional treatment of tumor, unless there is untreated tumor present
             representing a distinct untreated nodule.

          -  Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or
             metastatic tumor.

          -  Had a liver transplant.
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Condition: Healthy
Intervention: Placebo to dose; Idarucizumab; Placebo to Idarucizumab; dabigatran; Idarucizumab
Intervention description: placebo; short infusion; Placebo to Idarucizumab; 2 capsules dabigatran; short infusion
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 80.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
      655075 following intravenous administration of single rising doses of BI 655075 when
      administered alone and after administration of dabigatran.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy Japanese male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Trial In Patients With Advanced Cancer And Leukemia
Condition: Neoplasms by Histologic Type
MeSH terms: Leukemia; Neoplasms by Histologic Type
Intervention: PF-03084014
Intervention description: 10 mg, 50 mg or 100 mg tablets. Patients dosed from 20 mg - 500 mg, twice daily
Intervention MeSH terms: Gamma Secretase Inhibitors and Modulators; Nirogacestat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Phase 1 dose escalation study in advanced solid tumor malignancy and leukemia

Summary:

      This is a phase 1, dose escalating study to determine the safety of PF-03084014 in patients
      with advanced cancer and leukemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with advanced cancer that is resistant to standard therapy or for which no
             standard therapy is available

          -  Patients with acute T cell leukemia/lymphoblastic lymphoma that is resistant to
             standard therapy or for which no standard therapy is available

          -  Men and women >16 years old

        Exclusion Criteria:

          -  Prior treatment with a gamma secretase inhibitor for treatment of cancer

          -  Patients taking Tamoxifen

          -  Patients with active graft versus host disease

          -  Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
             related illness

          -  Patients who are pregnant or breast feeding

          -  Patients with clinical evidence of central nervous system disease
Dosing Study of Cranberry Capsules for the Prevention of Bacteriuria in Nursing Home Residents
Condition: Bacteriuria
MeSH terms: Bacteriuria
Intervention: Placebo; Cranberry Capsule
Intervention description: 36 milligram (mg) placebo capsule taken before quiet hours of sleep (qhs).; 36 milligram (mg) cranberry capsule, taken before quiet hours of sleep (qhs).
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate whether there is a particular dose of cranberry capsules that is
      effective in preventing the occurrence of urinary tract infections in females at least 65
      years of age or older who live in a nursing home and who have a history of urinary tract
      infections. The Yale research team will be enrolling 80 subjects in total over several
      nursing home locations within Connecticut.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female nursing home residents 65 years of age or older with history of urinary tract
             infection within the past year.

        Exclusion Criteria:

          -  residents that are not expected to be in the nursing home for at least one month
             (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1
             month]);

          -  residents who are on chronic suppressive antibiotic or anti-infective (i.e.,
             mandelamine) therapy for recurrent UTI;

          -  residents with end stage renal disease on dialysis (they do not regularly produce
             urine);

          -  residents unable to produce a baseline clean catch urine specimen for collection;

          -  residents on warfarin therapy because of a potential interaction of warfarin and
             cranberry juice;

          -  residents with a history of nephrolithiasis because cranberry may increase the risk of
             nephrolithiasis.
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: 300 IR grass pollen allergen extract tablet; Placebo tablet
Intervention description: 300 IR grass pollen allergen extract tablet once daily during four months; Placebo tablet once daily during four months
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Sublingual immunotherapy; Rhinitis; Conjunctivitis; Allergen challenge; Allergen exposition chamber; Grass pollen tablet; Allergic rhinoconjunctivitis

Summary:

      The objective of this study is to assess the effect of grass pollen extract SLIT tablets on
      the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in
      response to grass pollen challenge after one week, one, two and four months of treatment in
      patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 18-50 years old

          -  grass pollen rhinoconjunctivitis of at least 2 years.

          -  positive specific skin prick test and a specific IgE dosage level of at least 0.70
             kU/L at screening.

          -  written consent

          -  a positive response to the baseline challenge test (RTSS reaches 7 at one time-point
             at least during baseline challenge)

        Exclusion Criteria:

          -  Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly
             change the symptoms of the subject throughout the study

          -  Asthma requiring treatment other than short-acting beta-2 inhaled agonists.

          -  Desensitisation treatment for grass pollen in the previous five years and current
             immunotherapy with another allergen.
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
Condition: Healthy Volunteers
Intervention: RIN 150; reference drugs
Intervention description: Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.; Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; RIN 150; Healthy volunteers

Summary:

      This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual
      reference drugs in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a
             signed and dated informed consent document and is willing and able to comply with all
             scheduled visits, treatment plan, laboratory tests and other study procedures.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV
             serology results;

          -  Pregnant or nursing female;

          -  History or active tuberculosis;

          -  Participated in investigational drug studies within 3 months;

          -  Used prescription or nonprescription drugs within 7 days or 5 half-lives.
Nicotine Lozenge Bioequivalence Study
Condition: Smoking Cessation
Intervention: Nicotine (2 mg); Nicotine (4 mg)
Intervention description: 2 mg nicotine lozenge in two formulations; 4 mg nicotine lozenge in two formulations
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine lozenge; nicotine; nicotine replacement therapy

Summary:

      To compare the bio equivalence of new nicotine lozenge formulation with the reference
      nicotine lozenge so as to deliver the same nicotine blood profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be healthy smokers who usually smoked their first cigarette within
             30 minutes of waking.

          -  Body Mass Index within the range 19-27 kilograms/meters^2

        Exclusion Criteria:

          -  Participants who used chewing tobacco or tobacco products other than cigarettes within
             21 days of screening visit
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Blosozumab
Intervention description: Administered subcutaneously
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose(s) of this study is to measure how much of the study drug gets into the blood
      stream and how long it takes the body to get rid of it when given in multiple doses,
      subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower
      abdominal area), to postmenopausal (PMP) female participants. Information about any side
      effects that may occur will also be collected.

      This study will also be looking for special markers called "biomarkers" that can be used to
      study osteoporosis and/or the effects of the study drug.

      There will be 2 parts to this study. The first part will last approximately 6 weeks and the
      second part will last approximately 7 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: Overtly healthy PMP females

          -  Part B: PMP women who are currently taking oral bisphosphonates

          -  Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter
             (kg/m^2)

        Exclusion Criteria:

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen

          -  Have known allergies to blosozumab, its constituents, or related compounds

          -  Have an abnormality in the 12-lead electrocardiogram (ECG)