bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
Condition: Healthy
Intervention: Tirzepatide; EE/NGM
Intervention description: Administered SC; Combination oral contraceptive administered orally
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how the body processes the commonly prescribed birth
      control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and
      the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side
      effects that may occur will also be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 20 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy females as determined by medical history, physical examination, and
             other screening procedures

          -  Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared
             (kg/m²), at screening

          -  Are not intending to start a family within 2 months after the study

        Exclusion Criteria:

          -  Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or
             related compounds

          -  Have a medical condition or medical history that precludes the taking of combined oral
             contraceptives

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or
             gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder
             disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery,
             pyloric stenosis, with the exception of appendectomy) or could be aggravated by
             glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have used hormonal implants or received hormonal injections in the past 12 months

          -  Unwilling to comply with smoking restrictions during the study

          -  Is a known user of drugs of abuse
Nicotinic Receptors and Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Pharmacokinetic
Intervention description: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: receptors nicotinic

Summary:

      The study determines if a new preparation of a drug designed to treat schizophrenia is more
      slowly released into the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers: males and females who are incapable of pregnancy

        Exclusion Criteria:

          -  Medical illnesses requiring acute treatment

          -  History of seizures

          -  Substance abuse including nicotine
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Condition: Smoking Cessation
Intervention: Nicotine (2 mg); Nicotine (4 mg)
Intervention description: 2 mg nicotine gum in two formulations; 4 mg nicotine gum in two formulations
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine; nicotine replacement therapy; nicotine gum

Summary:

      The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess
      the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the
      reference nicotine gums (2 mg and 4 mg) in healthy smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI within the range of 19 to 30 kilograms/meters^2

          -  Current cigarette smokers who have smoked daily for at least a year, and smoke their
             first cigarette within 30 minutes of waking up

        Exclusion Criteria:

          -  Participants who have attempted to quit smoking in the last 12 months, are currently
             attempting to quit smoking or reduce the number of cigarettes they smoke, or are
             intending to quit smoking in the next 3 months, with or without use of smoking
             cessation aids

          -  Treatment with known hepatic enzyme altering agents
Interventions of Smoking Cessation During Pregnancy
Condition: Smoking Cessation
Intervention: Low intensity intervention; Higher intensity intervention
Intervention description: Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.; Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 92.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pregnancy; Smoking cessation; Cognitive-Behavioural interventions

Summary:

      The aim of this clinical trial is to test whether offering pregnant smokers a high intensity
      intervention for smoking cessation increases the rate of smoking cessation at the third
      trimester of pregnancy, compared to low intensity intervention for smoking cessation that is
      the usual care, control condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women

          -  current cigarette smoker (smoked >5 cigarettes in the past 7 days)

          -  18 years old or older

        Exclusion Criteria:

          -  More than 24 weeks' gestation at study entry

          -  No telephone access

          -  Not planning to live in Athens for 1 year

          -  Unable to read and speak Greek

          -  Alcoholics

          -  Use of drug substances

          -  Depression
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Condition: Healthy
Intervention: Inhaled Placebo; Inhaled Loxapine
Intervention description: Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Intervention MeSH terms: Loxapine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato
      Loxapine within a day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  nonsmoker subjects in good general health with normal spirometry at screening AND
             baseline

        Exclusion Criteria:

          -  history of asthma, COPD, or any other acute or chronic pulmonary disease or
             bronchodilator use
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model
Condition: Healthy
Intervention: PF-06282999; Placebo; LPS; PF-06282999; Placebo; LPS
Intervention description: Tablet, 125 mg, TID, 3 days, 1 of 2 periods; Tablet, 0 mg, TID, 3 days, 1 of 2 periods; IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods; Tablet, 500 mg, BID, 3 days, 1 of 2 periods; Tablet, 0 mg, BID, 3 days, 1 of 2 periods; IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Endotoxin challenge

Summary:

      An endotoxin challenge will be administered to healthy subjects to induce production of
      inflammatory markers. An investigational drug or placebo will be administered prior to the
      endotoxin challenge to assess the effect of the investigational drug on the markers of
      inflammation. Safety and tolerability will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women (non-childbearing potential) between the ages of 18-40 years.

          -  Body Mass Index (BMI) 18-30 kg/m2 and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  History or evidence of habitual use of tobacco- or nicotine-containing products within
             3 months of screening.

          -  History of frequent headaches or migraines (>3 per month), or headaches from an
             absence of caffeine.

          -  Caffeine consumption in excess of 3 cups per day.

          -  Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever)
             within 2 weeks of the first administration of study drug/placebo of each period.

          -  History of recurrent or chronic infections of any type such as tuberculosis,
             sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection,
             etc. Also excluded are subjects with recurrent oral or genital herpes, recurrent
             herpes zoster, or any infection otherwise judged by the investigator to have the
             potential for worsening if enrolled in this study.

          -  Treatment with LPS in the past 12 months and/or a history of an allergic type reaction
             or known hypersensitivity to endotoxin at any time.
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Condition: Deep Vein Thrombosis; Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Edoxaban low dose; Edoxaban high dose
Intervention description: Edoxaban low dose; Edoxaban high dose
Intervention MeSH terms: Edoxaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 0 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Pediatric; Pharmacokinetics (PK); Pharmacodynamics (PDy); Anticoagulant; Safety

Summary:

      This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a
      single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy
      to see what the body does to the drug (pharmacokinetics) and what the drug does to the body
      (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a pediatric subject requiring anticoagulant therapy

          -  Will abstain from the use of nonsteroidal anti-inflammatory drugs (such as ibuprofen),
             and other antiplatelet and anticoagulant agents (except for aspirin) from 24 hours
             prior to edoxaban dose until after the last PK sample is collected

          -  Will follow food and concomitant medication restrictions

        Exclusion Criteria:

          -  Any major or clinically relevant unexplained bleeding during prior anticoagulant
             therapy

          -  History of abnormal bleeding or coagulation within last 6 months prior to study drug
             administration

          -  Renal function with glomerular filtration rate (GFR) less than 50% of normal for age
             and size

          -  Malabsorption disorders (e.g., cystic fibrosis or short bowel syndrome)

          -  Hepatic disease associated with coagulopathy leading to a clinically relevant bleeding
             risk, alanine transaminase (ALT) > 5 times the upper limit of normal (ULN) or total
             bilirubin > 2 times the ULN with direct bilirubin > 20% of the total
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
Condition: HIV Infections; Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: efavirenz containing antiretroviral regimen; efavirenz containing antiretroviral regimen; efavirenz containing antiretroviral regimen; efavirenz containing antiretroviral regimen
Intervention description: Capsule or Tablet, Oral, once daily for 2 days; Capsule or Tablet, Oral, once daily for 2 days; Capsule or Tablet, Oral, once daily for 2 days; Capsule or Tablet, Oral, once daily for 2 days
Intervention MeSH terms: Efavirenz; Anti-Retroviral Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz
      (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable
      antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or
      normal hepatic function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection with or without Hepatitis B or C infection

          -  Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse
             transcriptase inhibitors (NRTI) for at least 1 month

          -  Mild, moderate or severe hepatic impairment with hepatic cirrhosis

        Exclusion Criteria:

          -  Acute flare of hepatitis

          -  Positive pregnancy test for a female

          -  Significant acute medical illness in past 2 months

          -  Use of agents known to significantly affect liver metabolism

          -  Change in medications to treat a chronic disease in the past 2 months
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
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Condition: Healthy
Intervention: Placebo; BI 655064
Intervention description: Solution for subcutaneous (s.c.) injection.; Solution for subcutaneous (s.c.) injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising
      doses in healthy Asian male volunteers.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy males based upon a complete medical history, including the physical
             examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

          -  Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese:
             born in Japan, have lived outside of Japan <10 years, and have parents and
             grandparents who were all born in Japan. Chinese: ethnic Chinese, born in China or
             ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese
             grandparents who were all born in China

          -  Age within the range of 20 to 45 years inclusive

          -  Body mass index within the range of 18.5 and 25 kg/m2 inclusive

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and the local legislation.

        Exclusion criteria:

          -  Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance

          -  Any disease or clinically relevant abnormality in laboratory parameters which,
             according to the investigator, might compromise the safety of the subject or interfere
             with the subjects participation in the trial or compromise the trial objectives

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          -  History of relevant orthostatic hypotension, fainting spells or blackouts.

          -  Chronic or relevant acute infections
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Condition: Pharmacokinetics
Intervention: Norethindrone/Ethinyl Estradiol; Colchicine; Placebo (for Colchicine)
Intervention description: one tablet daily - 1 mg norethindrone/0.035 mg ethinyl estradiol on Days 1 to 21; inert ingredients on Days 22 to 28; 0.6mg tablet every 12 hours on Days 8 to 21; placebo tablet every 12 hours on Days 8 to 21
Intervention MeSH terms: Colchicine; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; pharmacokinetics; drug-interaction

Summary:

      This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at
      steady state on the steady state pharmacokinetic profile of ethinyl estradiol and
      norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state
      ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will
      assess the safety and tolerability of concurrent use of colchicine and an
      estrogen/progesterone-containing oral contraceptive.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, non-smoking female volunteers of childbearing potential aged 18 to 45 years
             weighing at least 55 kg and within 15% of ideal body weight who are taking oral
             contraceptives on the advice of their personal health care provider and willing to
             switch to Ortho-Novum 1/35

          -  Subjects should be either sexually inactive or using a double barrier method of
             contraception for 14 days before the first dose of study drug and throughout the study

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C antibody (HCV)

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
             or psychiatric disease

          -  Hemoglobin < 12 g/dL

          -  Use of any drugs or substances known to inhibit or induce cytochrome (CYP) P450
             enzymes and/or P-gp within 30 days prior to the first dose of Ortho-Novum® 1/35 or
             expected to require such use