bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Famotidine FCT; Famotidine CT
Intervention description: Famotidine 20 mg oral film-coated tablet taken once daily; Famotidine 20 mg oral chewable tablet taken once daily
Intervention MeSH terms: Famotidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine whether the CT formulation of famotidine taken with and without
      water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under
      the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single
      dose of famotidine 20 mg CT without water are equivalent to a single dose of famotidine 20 mg
      FCT with water.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participant is not pregnant or lactating

          -  Female of childbearing potential must use reliable means of contraception during the
             course of the study

          -  Is in good health

          -  Is able to abstain from smoking during the 24-hour periods before and during each
             treatment day

        Exclusion Criteria:

          -  Has any major systemic disorders

          -  Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery

          -  Has or has a history of any illness or condition that might interfere with optimal
             participation in the study

          -  Has a history of asthma or severe allergies to drugs or foods

          -  Currently uses prescribed or non-prescribed drugs on a regular basis

          -  Has a recent history of drug/alcohol abuse

          -  Consumes more than 6 cups of coffee per day

          -  Has unconventional or extreme dietary habits

          -  Has donated blood or has been in a clinical trial in which they received an
             investigational drug during the past 30 days

          -  Has a history of allergy or intolerance to antacids

          -  Is known to be pregnant or is not using reliable means of contraception
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
Condition: Inflammation; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Bromfenac
Intervention description: Drug: Bromfenac Other names: PRO-155
Intervention MeSH terms: Bromfenac
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PRO-155; Ocular NSAIDs; Safety and tolerability; Ocular Inflammation; Ocular Paint

Summary:

      Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in
      healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female.

          -  Age ≥ 18 years old at screening visit

        Exclusion Criteria:

          -  Any ocular or systemic condition.

          -  Patient with one blind eye.

          -  Visual acuity of 20/40 in any eye.

          -  Use of ocular or systemic medications.

          -  Contraindications or sensitivity to any component of the study treatments.

          -  Contact lens users.

          -  Ocular surgery within the past 3 months..

          -  Women who were not using an effective means of contraception or who were pregnant or
             nursing.

          -  Participation in any studies of investigational drugs within 90 days previous to the
             inclusion.
Utilization of Confocal Microscopy During Cardiac Surgery
Condition: Atrial Septal Defect
MeSH terms: Heart Septal Defects, Atrial
Intervention: Fluorescite; Cellvizio 100 Series System with Confocal Miniprobes
Intervention description: Dilute fluorescite will be applied to cardiac tissue prior to imaging; Microscopy system will image cardiac tissue.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 30 Days
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The investigators propose to translate confocal microscopy for use during open heart surgery.
      This tool will help discriminate between various types of tissues in the heart during
      surgery. One of the most feared complication after heart surgery is heart block. This
      flexible fiberoptic confocal microscope will help discriminate between the various types of
      tissues in the heart and thus help avoid injury to the conduction tissue during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 30 days and 21 years old

          -  Undergoing elective surgery for closure of atrial septal defect

          -  Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or
             an adult participant (age 18-21) may provide consent for him/herself

        Exclusion Criteria:

          -  Prior history of adverse reaction to fluorescein sodium

          -  Prior history of renal failure or abnormal renal function

          -  Baseline PR interval > 220 msec or 98% for age

          -  Baseline HR > 87% for age

          -  Underlying genetic syndrome associated with progressive AV block of sinus node
             dysfunction (e.g. Holt-Oram or NKX2.5)
To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Condition: Solid Tumours
Intervention: Selumetinib; Moxifloxacin; selumetinib placebo
Intervention description: Volunteers will receive 75 mg selumetinib oral dose (Treatment A); Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B); Volunteers will receive selumetinib placebo oral dose (Treatment C)
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase I, healthy, pharmacokinetics

Summary:

      Study to assess the effect of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc
      interval in healthy male volunteers.
    

Eligibility criteria:

        Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at
        least 50 kg and no more than 100 kg (inclusive). 2. Must have not smoked in the last 30
        days prior to screening for this study. 3. Have a calculated creatinine clearance (CrCL)
        greater than 50 mL/min using the Cockcroft-Gault formula.

        Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Subjects
        where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese
        Asian (e.g. China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian
        Indians are acceptable. 3. Past history of central serous retinopathy or retinal vein
        thrombosis,intraocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any
        clinically relevant abnormal findings in physical examination, hematology, clinical
        chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
        5. History or presence of any clinically significant disease or disorder in the opinion of
        the investigator.
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
Condition: HIV
MeSH terms: Renal Insufficiency
Intervention: Bictegravir
Intervention description: 75 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1; Renally Impaired

Summary:

      The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral
      bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched,
      healthy controls with normal renal function. Each participant in the renal impairment groups
      will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40
      kg/m^2)] with a participant in the control group.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All Individuals:

               -  Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

          -  Individuals with impaired renal function

               -  Chronic stable renal impairment without recent clinical change

                    -  Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min

                    -  Moderate: CrCl = 30 - 59 mL/min

                    -  Severe: CrCl = 15 - 29 mL/min

          -  Healthy individuals

               -  CrCl ≥ 90 mL/min

        Key Exclusion Criteria:

          -  All Individuals:

               -  Pregnant or lactating females

               -  HIV positive or chronic hepatitis B infected

          -  Individuals with impaired renal function

               -  Chronic liver disease

               -  Dialysis or anticipated use of dialysis

               -  Renal transplant

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
Condition: Oncology
MeSH terms: Neoplasms
Intervention: Entospletinib
Intervention description: Entospletinib 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics of entospletinib
      (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function
      (stratified by smoking status, as appropriate) relative to matched, healthy controls.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Calculated body mass index from 18 to 40 kg/m^2

          -  Not pregnant

          -  Normal electrocardiogram

          -  Participants with impaired liver function must be sufficiently healthy based upon
             medical history and physical examination, vital signs, and screening laboratory
             evaluations.

        Key Exclusion Criteria:

          -  Participation in another clinical study (current or within last 30 days)

          -  HIV, hepatitis B virus, or active hepatitis C virus infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Condition: Chronic Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: Preladenant
Intervention description: After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
Intervention MeSH terms: Adenosine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson disease

Summary:

      The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after
      administration of a single 5 mg oral dose of preladenant in participants with hepatic
      impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with
      participants with mild hepatic impairment. Part 2 compares healthy volunteers with
      participants with moderate hepatic impairment. Healthy volunteers in each part of this study
      are to be matched with participants with hepatic impairment by race, age, gender, and body
      mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI,
      the area under the concentration-time curve from time 0 extrapolated to time of the last
      quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched
      healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within
      the interval [0.50, 2.00].
    

Eligibility criteria:

        Key Inclusion Criteria for Healthy Participants Groups:

          -  Must be healthy with normal hepatic function and be free of any clinically significant
             disease or condition that requires a physician's care and/or would interfere with
             study evaluations or procedures.

        Key Inclusion Criteria for Hepatic Impaired Groups:

          -  Must have mild or moderate hepatic impairment.

          -  Must have a diagnosis of chronic liver disease for >6 months.

          -  Clinical laboratory tests, physical examination, and electrocardiographs must be
             clinically acceptable to the investigator and sponsor.

          -  Must be free, other than chronic liver disease, of significant medical conditions
             unrelated to their hepatic disorder except for conditions that in the opinion of the
             investigator may not interfere with the study evaluations, procedures or
             participation.

        Key Exclusion Criteria

          -  Must not be on any prohibited medications for entry into the trial.
Dose Escalation Trial of Intra-Tumoral Injection of NIS Measles Virus in Combination With Atezolizumab
Condition: Recurrent Non-Small Cell Lung Cancer
MeSH terms: Measles; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MV-NIS; Atezolizumab
Intervention description: This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC; Atezolizumab will be administered every 3 weeks
Intervention MeSH terms: Atezolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer Measles Nivolumab Opdivo

Summary:

      This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of
      attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and
      metastatic NSCLC.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC
             histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.

          -  Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

          -  Ability to provide informed consent.

          -  Adequate hematological, liver and kidney function.

          -  Must be willing to implement contraception throughout study and for the 8 weeks
             following last study drug administration.

        Key Exclusion Criteria:

          -  Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration.
             Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to
             registration

          -  Other concurrent investigational therapy (utilized for a non-FDA-approved indication
             and in the context of a research investigation).

          -  Pregnant women.

          -  Nursing women.

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception during treatment and 8 weeks following the completion of study drug
             treatment.

          -  Allergy to measles vaccine or history of severe reaction to prior measles vaccination.

          -  History of organ transplantation.
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: sildenafil citrate 100 mg CT; sildenafil citrate 100 mg CT; Viagra®
Intervention description: sildenafil citrate 100 mg CT, single dose without water; sildenafil citrate 100 mg CT, single dose with water; sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sildenafil; Bio-equivalence

Summary:

      The purpose of this study is to perform a relative bioavailability study between two
      formulations of sildenafil citrate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index higher or equal to 18,5 and lower or equal than 29,9 kg/m2.

          -  Good health conditions or without significant disease, at medical discretion,
             according to the rules defined in the Protocol, and evaluations undergone: clinical
             history, pulse and blood pressure measurements, physical and psychological
             examination, ECG and complementary laboratory examination.

          -  Able to understand the study nature and objective, including the risks and adverse
             effects and willing to cooperate with the investigator and act according to all the
             trial requirements, which is confirmed by signing the Informed Consent Form.

        Exclusion Criteria:

          -  Hypersensitivity to the study drug or to the chemically related compounds; history of
             serious adverse reactions or hypersensitivity to any drug.

          -  History or presence of hepatic or gastrointestinal diseases, or other condition that
             affects the drug absorption, distribution, excretion or metabolism

          -  History of hepatic, renal, lung, gastrointestinal, epileptic, hematological or
             psychiatric disease; hypo or hypertension of whatever etiology which demands treatment
             with drugs; history or occurrence of myocardial infarction, angina and/or cardiac
             failure;
Relative Bioavailability of Olodaterol and Fluconazole
Condition: Healthy; Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744; Fluconazole
Intervention description: 10 mcg solution for oral inhalation; 400 mg capsule
Intervention MeSH terms: Fluconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor
      fluconazole on the bioavailability of olodaterol
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male and female volunteers
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Drug cocktail; RO5185426
Intervention description: Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20; 960 mg orally twice daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single-arm study will evaluate the effect of RO5185426 [RG7204; PLEXXIKON:
      PLX4032] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K,
      omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with
      metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1,
      patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426
      twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21
      to 25, patients will receive RO5185426. Assessments will be made at regular intervals during
      the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426)
      until the development of progressive disease or unacceptable toxicity. Target sample size
      <50.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient >/= 18 years of age

          -  Malignant melanoma (Stage IV, AJCC)

          -  Patients who are treatment-naive or have received prior systemic treatments for
             metastatic melanoma. Time elapsed between previous treatment for metastatic disease
             and first administration of study drug must be at least 28 days

          -  Positive tested for BRAF mutation

          -  Patients must not be poor metabolizers of CYP450 enzymes 2C9, 2C19, or 2D6 as
             determined by genotyping

          -  Measurable disease by RECIST criteria

          -  Negative pregnancy test; for fertile men and women, effective contraception during
             treatment and for 6 months after completion

        Exclusion Criteria:

          -  Active CNS lesions on CT/MRI within 28 days prior to enrollment

          -  History of known spinal cord compression, or carcinomatous meningitis

          -  Severe cardiovascular disease within 6 months prior to study