bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Condition: Glucocorticoids Toxicity; Glucose Intolerance
MeSH terms: Glucose Intolerance
Intervention: Prednisone
Intervention description: Prednisone 60 mg tablet once
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: glucocorticoids; efficacy; metabolic toxicity

Summary:

      This study evaluates the effect of acute administration of oral prednisone in white blood
      cells counts and glucose tolerance and the relationship of these measures with changes in
      gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene
      expression will be study before and after prednisone administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 45 years old (to exclude the effect of age on glucose tolerance);

          -  BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired
             insulin response);

          -  Normal fasting glucose;

          -  Stable weight for three months before participation

        Exclusion Criteria:

          -  BMI >25kg/m2;

          -  Fasting glucose ≥126 mg/dl

          -  Shift work or disordered sleep (to exclude individuals with alterations in the
             hypothalamus-adrenergic axis);

          -  Any diseases;

          -  Use of any medication regularly (including over-the-counter);

          -  Previous exposure to glucocorticoids (within the last year);

          -  Pregnancy
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Semaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This is a study for participants with type 2 diabetes mellitus. The main purpose of this
      study is to learn more about how tirzepatide, semaglutide and placebo affect the body's
      ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks,
      including a 28-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM for at least 6 months

          -  Treated with diet and exercise and stable dose(s) of metformin, with or without 1
             additional stable dose of oral antihyperglycemia medication other than metformin, 3
             months prior to study entry

          -  Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin
             only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia
             medications other than metformin

          -  Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² )
             inclusive, at screening; are of stable weight (±5%) >3 months prior to screening

        Exclusion Criteria:

          -  Have a history of proliferative retinopathy or maculopathy as determined by the
             investigator based on a recent (<1.5 years) ophthalmologic examination

          -  Impaired renal estimated glomerular filtration rate (eGFR) <45 milliliters per minute
             per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease
             Epidemiology Collaboration (CKD-EPI)

          -  Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine,
             hematological or neurological disorders capable of significantly altering the
             absorption, metabolism or elimination of drugs; of constituting a risk when taking the
             study drug; or of interfering with the interpretation of data
A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: Olaratumab; Doxorubicin; External Beam Radiotherapy
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Doxorubicin; Olaratumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate potential biomarkers and method of action, efficacy
      and safety of olaratumab in participants with soft tissue sarcoma (STS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin
             would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are
             eligible if there is histological or radiographic evidence of evolution to more
             aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal
             tumors (GIST) will be excluded. Participants must have potentially resectable disease
             (as assessed by the study investigator) and have a primary tumor lesion deemed
             amenable to serial biopsy.

          -  For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of
             the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy
             would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid
             liposarcoma will be excluded.

          -  Have consented to undergo mandatory serial peripheral whole blood and tumor tissue
             sampling.

        Exclusion Criteria:

          -  Have active central nervous system (CNS) or leptomeningeal metastasis (brain
             metastasis) at the time of enrollment. Participants with a history of a CNS metastasis
             previously treated with curative intent (for example, stereotactic radiation or
             surgery) that have not progressed on follow-up imaging, have been asymptomatic for at
             least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants,
             are eligible. Participants with signs or symptoms of neurological compromise should
             have appropriate radiographic imaging performed before enrollment to rule out brain
             metastasis.

          -  Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other
             anthracyclines or anthracenediones; the participant has received treatment with
             olaratumab or has participated in a prior olaratumab trial.

          -  For radiotherapy addendum only: Have received previous radiotherapy in the primary
             tumor lesion and/or prior treatment with olaratumab or has participated in a prior
             olaratumab trial.
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lu AF35700
Intervention description: 5 mg tablets for oral administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral
      dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient is a man aged between ≤18 and ≥60 years

          2. BMI of ≥19 kg/m2 to ≤ 37 kg/m2

          3. The patient has a primary diagnosis of schizophrenia according to DSM-5™ (code 295.90)

          4. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤ 4
             (moderately ill) at screening and safety baseline

          5. The patient is currently under oral therapy with one or more of the antipsychotic
             medications listed in Appendix II.

          6. The patient has a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80

          7. The patient has a score of ≤ 4 (moderate) on the following PANSS items at screening
             and at safety baseline: P7 (hostility), G8 (uncooperativeness)

        Exclusion Criteria:

          1. The patient experienced an acute exacerbation requiring hospitalization within the
             last 3 months.

          2. The patient experienced an acute exacerbation requiring change in antipsychotic
             medication (with reference to drug or dose) within the last 4 weeks.

          3. The patient has a diagnosis or history of substance use disorder (except nicotine)
             according to DSM-5-TR® criteria ≤3 months prior to screening

          4. The patient is at significant risk of harming himself or others according to the
             investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5
             on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit within
             the last six months on the lifetime version of C-SSRS.

          5. Based on investigators judgment the patient has a medical or neurological disorder or
             treatment for such disorder that could interfere with the study treatment or impair
             treatment compliance.

          6. The patient has had past episodes of extrapyramidal symptoms (EPS) under current
             medication within the last 3 month

          7. The patient takes other medication than those listed as allowed concomitant medication
             in Appendix III

          8. The patient is occupationally exposed to significant levels of ionizing radiation.

        Other protocol-defined inclusion and exclusion criteria may apply
Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib
Condition: Healthy
Intervention: Tepotinib TF2; Tepotinib TF3
Intervention description: Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.; Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tepotinib; Pharmacokinetics; Bioequivalence

Summary:

      The main purpose of the study was to demonstrate bioequivalence between the new tablet
      formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2,
      reference treatment) and to investigate effect of food on pharmacokinetics (PK) of tepotinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body weight between 50 to 100 kilogram (kg)

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior
             to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Condition: Healthy Participants
Intervention: TAK-906 Maleate; Itraconazole
Intervention description: TAK-906 capsule; Itraconazole solution
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4
      inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at
             the Screening Visit.

          2. Has a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to
             (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50
             kilogram (kg) at the Screening Visit.

          3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the initial dose of
             trial drug/invasive procedure.

        Exclusion Criteria:

          1. Has a positive alcohol or drug screen.

          2. Has had a major surgery, donated or lost 1 unit of blood (approximately 500 milliliter
             [mL]) within 8 weeks of the first dose of study drug.

          3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces],
             or distilled spirits [29.5 mL/1 ounce] per day).

          4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          5. Has a substance abuse disorder.
Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: Famotidine; N-Acetyl cysteine
Intervention description: Oral Famotidine; Oral N-Acetyl Cysteine
Intervention MeSH terms: Acetylcysteine; Famotidine; N-monoacetylcystine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: outpatient; famotidine; n-acetyl cysteine

Summary:

      The purpose of this trial is to assess the safety and toxicity profile of the combination of
      famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18

          -  performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to
             proceed to treatment phase of the trial

        Exclusion Criteria:

          -  All patients under 18

          -  Known allergy to N-Acetyl Cysteine

          -  Known allergy to famotidine or other H2-receptor antagonists

          -  Pregnant or Nursing Mothers

          -  Laboratory Evidence or History of Renal Impairment (eGFR < 30 mL/min/1.73 m2)

          -  Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.

          -  Patient has been admitted to the hospital prior to study enrollment
Auditory Training and Hearing Aid Satisfaction
Condition: Hearing Impairment, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Intervention: Auditory Brian Training Games/Activities
Intervention description: Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Masking: Single (Participant)
Masking description: Participants are unaware if they are in the late or early intervention group.
Enrollment: 30.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Auditory Training

Summary:

      Although hearing aids are the most common treatment for hearing loss, and have the potential
      to help seniors stay active and productive, almost 50% of them who receive hearing aids
      rarely if ever use them, a state of affairs sometimes referred to as "the hearing aid in the
      drawer" syndrome. clEAR's customized auditory brain training has been shown to be effective
      in improving adults' abilities to recognize speech, in reducing their perceptual effort
      associated with listening with a hearing loss, and in increasing their confidence to engage
      in everyday conversations. In the proposed research, we will determine whether older adults
      who receive hearing aids for the first time report higher satisfaction with their new hearing
      aids and have longer daily use time as a result of having completed clEAR's auditory brain
      training program for new hearing aid users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a native English speaker

          -  Must have a mild to severe bilateral sensorineural hearing loss

          -  Must be a candidate for new hearing aid(s) (have never used hearing aids)

        Exclusion Criteria:

          -  Cognitive impairment or any factors that would prohibit a participant from completing
             questionnaires

          -  Cognitive or speech production factors that would prohibit a participant from
             repeating words during a speech perception test.
Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects
Condition: Healthy
Intervention: adalimumab; BI695501; adalimumab
Intervention description: 40mg adalimumab single s.c. injection; BI 695501 single s.c injection; 40mg adalimumab single s.c. injection
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 193.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to
      establish pharmacokinetic equivalence of BI 695501 to adalimumab.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males

          2. Body mass index (BMI) =18.5 to =29.9 kg/m2

        Exclusion criteria:

          1. Any clinically relevant abnormal finding of the medical examination (including blood
             pressure, pulse rate and electrocardiogram) deviating from normal and of clinical
             relevance

          2. Any evidence of a clinically relevant previous or concomitant disease as judged by the
             investigator.

          3. Chronic or relevant acute infections. A negative result for Human Immunodeficiency
             Virus, Hepatitis B and Hepatitis C testing is required for participation.

          4. History of relevant allergy/hypersensitivity (including allergy to drug or its
             excipients)

          5. Intake of prescribed or over-the-counter drugs with a long half-life (>24 hours)
             within at least one month or less than 5 half-lives of the respective drug prior to
             administration or during the trial

          6. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)

          7. Inability to refrain from smoking during days of confinement at the study center

          8. Alcohol abuse (average more than 30 g/day)

          9. Current drug abuse
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Condition: Healthy Adult Male
Intervention: (14C)-OPC-61815
Intervention description: On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Male
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  To determine the mass balance of totalradioactivity following a single IV infusionof
           (14C)-OPC-61815.

        -  To determine routes and rates of elimination of total radioactivity following a single
           IV infusion of (14C)-OPC-61815

        -  To assess the PK of total radioactivity in plasma and whole blood following a single IV
           infusion of (14C)-OPC-61815

        -  To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV
           infusion of (14C)-OPC-61815
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese
             passport and be first generation Japanese, defined as the subject, the subject's
             biological parent, and all of the subject's biological grandparents being of exclusive
             Japanese descent, have been born in Japan, and not lived outside of Japan for more
             than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a
             total body weight between 50 and 100 kg, inclusive; in good health, determined by no
             clinically significant findings from medical history, physical examination, 12-lead
             electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
             at Screening and Check in as assessed by the investigator (or designee); and have a
             history of a minimum of 1 bowel movement per day.

        Exclusion Criteria:

          -  History of stomach or intestinal surgery or resection that would potentially alter
             absorption and/or excretion; poor peripheral venous access; participation in a
             clinical trial involving administration of an investigational drug in the past 90 days
             prior to dosing; subjects with exposure to significant diagnostic or therapeutic
             radiation or current employment in a job requiring radiation exposure monitoring
             within 12 months prior to Check-in; subjects who have participated in any clinical
             trial involving a radiolabeled investigational drug within 12 months prior to
             Check-in.