bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)
Condition: Fungal Infections
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Intervention: Posaconazole 200 mg; Posaconazole 300 mg
Intervention MeSH terms: Posaconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to collect pharmacokinetic (PK) information related to how well
      posaconazole tablet is distributed in the body and to determine the safety of this new
      formulation. The study consists of a Phase 1B study that includes participants with
      neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia
      (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML
      or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant
      (HSCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight >34 kg (75 lb) and of any race/ethnicity

          -  Able to swallow oral tablets whole

          -  Anticipated (likely to develop within 3-5 days) or documented neutropenia due to
             chemotherapy, chemotherapy for a new diagnosis of acute myelogenous leukemia (AML), or
             AML in first relapse; myelodysplastic syndromes (MDS) in transformation to AML;
             allogeneic hematopoietic stem cell transplant (HSCT) participants in the
             pre-engraftment period or in the post-engraftment period if they are receiving
             immunosuppressive therapy for graft versus host disease

        Exclusion Criteria:

        - Female must not be pregnant, must not intend to become pregnant

        during the study, and must not be nursing

          -  History of hypersensitivity to azoles

          -  Moderate or severe liver dysfunction defined as aspartate aminotransferase (AST) or
             alanine aminotransferase (ALT) levels greater than three times the upper limit of
             normal (ULN), AND a total bilirubin level greater than two times the ULN

          -  Electrocardiogram (ECG) with corrected QTc interval greater than 500 msec

          -  Posaconazole within 10 days before study enrollment

          -  Receipt of systemic antifungal therapy within 30 days of study enrollment for reasons
             other than antifungal prophylaxis

          -  Evidence of known or suspected invasive or systemic fungal infection at baseline

          -  Known or suspected history of Gilbert's disease

          -  Creatinine clearance levels below 30 mL/min
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: RO7049665; Placebo
Intervention description: Multiple ascending doses of RO7049665 will be administered SC.; Matching placebo will be administered SC.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in
      participants with active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with UC for at least 12 weeks prior to screening

          -  Screening colonoscopy for colorectal cancer conducted within the prior two years if a
             history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis
             and disease duration ≥12 years

          -  Evidence of disease activity at time of screening

          -  Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease or indeterminate colitis

          -  History of infection with hepatitis B, human immunodeficiency virus (HIV), active
             hepatitis C virus (HCV) infection, or other chronic infection

          -  Active infections requiring systemic therapy with antibiotic, antiviral or antifungal
             or febrile illness within 7 days before Day -1

          -  History of primary or acquired immunodeficiency

          -  Abnormal hematologic values

          -  Abnormal hepatic enzyme or hepatic function values
Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Omadacycline
Intervention description: Omadacycline: PO Tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing
      regimen in the treatment of adults with CABP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, age 18 or older who have signed the informed consent form

          -  Must have a qualifying community-acquired bacterial pneumonia

          -  Has disease severity such that oral antibiotics therapy is appropriate

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

          -  Must be able to swallow tablets and comply with all of the requirements of the study

        Exclusion Criteria:

          -  Has received more than 24 hours of a potentially effective systemic antibacterial
             therapy within the 72 hours prior to the first dose of test article

          -  Known or suspected infection caused by a pathogen that may be resistant to test
             article

          -  Participants who reside in a long-term care or nursing home

          -  Evidence of empyema

          -  Evidence of significant immunological disease

          -  Evidence of liver impairment or disease

          -  Evidence of unstable cardiac disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing

          -  Unable or unwilling to comply with the protocol requirements
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
Condition: Healthy Volunteers
Intervention: Myrin P Forte; Single drug references
Intervention description: Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose; containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Volunteers

Summary:

      This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against
      reference drug in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, male or female, 21 to 55 years of age, body weight no less than 55 kg, Body
             mass index (BMI) of 17.5 to 30.5 kg/m2. Healthy is defined as no clinically relevant
             abnormalities identified by a detailed medical history, full physical examination,
             including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG)
             or clinical laboratory tests.

          -  An informed consent document signed and dated by the subject.

          -  Subjects who are 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
             Human Immunodeficiency Virus (HIV) serology results.

          -  pregnant or nursing female,

          -  alcohol, drug, smoke user,

          -  sensitive to any study medication or related component,

          -  History or active gout,

          -  History or active tuberculosis,

          -  Known optic neuritis or other ophthalmological conditions.
Probiotic Use in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Hematopoietic Organs; Disorder
Intervention: Lactobacillus plantarum strains 299 and 299v
Intervention description: Patients will receive a daily dose of Lactobacillus plantarum: 1 x10^8 CFU/kg/day. This supplement will be supplied in sachets of powder and will be mixed in water (certain water-based liquid) that is no warmer that 37o C.
Colony forming units (CFU)
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Probiotics; Hematopoietic Stem Cell Transplantation; Pediatrics

Summary:

      Primary Objective:

      1. To evaluate the safety of orally administered Lactobacillus plantarum strains 299 and
      299v, a probiotic, in patients undergoing allogeneic myeloablative HSCT, as measured by
      incidence of Lactobacillus plantarum bacteremia.

      Secondary Objectives:

        1. To investigate the feasibility of administering Lactobacillus plantarum 299 and 299v to
           children and adolescents undergoing HSCT.

        2. To describe the overall incidence of bacteremia in HSCT patients who have been
           administered Lactobacillus plantarum.

        3. To describe the overall incidence of acute graft versus host disease (GVHD) in HSCT
           patients who have been administered Lactobacillus plantarum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing myeloablative allogeneic HSCT will be eligible. The source of
             stem cells can be from bone marrow, umbilical cord blood or cytokine mobilized
             peripheral blood. Donor can be human leukocyte antigen (HLA) matched sibling or
             parent, a related donor mismatched for a single HLA locus (class I or II), unrelated
             marrow or peripheral blood stem cell donor, or unrelated cord blood at least 4/6
             antigen match (Class 1 or II).

          -  Patients of either gender and between 2 and 17.99 years of age

          -  Patients receiving any type of GVHD prophylaxis are eligible.

        Exclusion Criteria:

          -  Patients who have self-prescribed probiotics within 3 months of starting the
             conditioning regimen for stem cell transplant (consumption of yogurt products is
             allowed).

          -  Patients with known allergy to oats.

          -  Patients who have had any type of gut damage within the past three months; such as,
             previous bowel perforations; previous episode of Grade 4 neutropenic colitis or
             typhlitis.

          -  Patients with inflammatory bowel syndrome, short small bowel syndrome, Crohns Disease,
             Ulcerative Colitis, and patients with a history of bowel resections.

          -  Patients who have undergone a previous allogeneic HSCT.
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; metformin hydrochloride; Comparator: placebo sitagliptin; Comparator: placebo metformin
Intervention description: Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.; Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.; Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.; Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will assess the effects of sitagliptin and metformin alone and after
      co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects must have a negative pregnancy test

          -  Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA
             agent, has not received such treatment for 3 months prior to study, and/or has not
             received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months
             prior to the study

          -  Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months

        Exclusion Criteria:

          -  Subject has a history of stroke, seizures, or major neurological disorders

          -  Female subject is breastfeeding

          -  Subject cannot refrain from use of any prescription or non-prescription drugs
             beginning 2 weeks prior to first dose of study drug

          -  Subject consumes more than 3 alcoholic beverages per day

          -  Subject consumes more than 6 caffeinated beverages per day

          -  Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks
             of screening

          -  Subject has a history of cancer, except certain skin or cervical cancer or other
             cancers treated more than 10 years prior to screening

          -  Subject has a history of multiple and/or severe allergies or intolerance to drugs or
             food
TL011 in Severe, Active Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: TL011, anti CD20, for the treatment of rheumatoid arthritis; MabThera infusions
Intervention description: TL011 administered by 2 infusions, 2 weeks apart; MabThera, administered by 2 infusions, 2 weeks apart
Intervention MeSH terms: Rituximab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and pharmacology of TL011 in patients
      with severe rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects

          -  Rheumatoid arthritis as defined by the 1987 ACR Classification

          -  Severe active seropositive disease

          -  Inadequate response or intolerance to other DMARDs

          -  Treatment with MTX

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA

          -  Active infection

          -  Known immunodeficiency syndrome

          -  Positive Hepatitis B surface antigen or antibodies to Hepatitis C

          -  History of cancer
Study to Evaluate Potential Food Effects
Condition: Healthy
Intervention: PG-760564; PG-760564
Intervention description: 200 mg capsule, single dose,fasted when dosed, duration is 4 days; 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics study

Summary:

      Half the group will be given a high fat diet and the other half will fast. They will then be
      crossed over.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and surgically sterile or post-menopausal (last menstrual period > 1
             year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at
             screening;

          -  Who have not used tobacco or nicotine-containing products within the past 3 months;

          -  Willing to abstain from caffeine or xanthine-containing beverages, including coffee
             and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours
             before admission and for the duration of the study;

          -  Who have a body mass index (BMI) between 18 and 32 kg/m2, inclusive.

        Exclusion Criteria:

          -  History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;

          -  History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;

          -  History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and
             cholecystectomy are allowed), or GI bleeding;

          -  History of autoimmune disease;

          -  History of immunodeficiency or of unusual susceptibility to infectious diseases;

          -  History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with
             human immunodeficiency virus (HIV);

          -  Any history of hypersensitivity or clinically significant allergy to any drug;

          -  Personal or family history of prolonged QT syndrome or any cardiac conduction
             abnormality;

          -  Family history of sudden death;

          -  History of uveitis or inflammatory ocular disease;

          -  History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and
             cholecystectomy are allowed), or GI bleeding;

          -  History of autoimmune disease;

          -  History of immunodeficiency or of unusual susceptibility to infectious diseases;

          -  History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with
             human immunodeficiency virus (HIV);

          -  Any history of hypersensitivity or clinically significant allergy to any drug;

          -  Personal or family history of prolonged QT syndrome or any cardiac conduction
             abnormality;

          -  Family history of sudden death;

          -  History of uveitis or inflammatory ocular disease.
Pharmacokinetic Study With Colchicine in Healthy Volunteers
Condition: Pharmacokinetics
Intervention: colchicine tablets; colchicine tablets
Intervention description: 0.6mg colchicine tablet; 0.6mg q12 hours for 10 days
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; pharmacokinetics

Summary:

      This open label, single group, sequential dose study will compare the single dose
      pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10
      days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the screening process within 28 days prior to Period I dosing

          -  Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18
             to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2

          -  Women must be postmenopausal, surgically sterile, commit to abstinence from
             heterosexual sexual contact or use two methods of contraception.

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Use of any investigational drug within 28 days prior to Period I dosing.

          -  Presence or history of a clinically significant disorder involving the cardiovascular,
             respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or
             neurologic system(s) or psychiatric disease as determined by the clinical
             investigator(s)

          -  Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen
             (HbsAg), or hepatitis C virus (HCV)

          -  Clinical laboratory test values outside the accepted reference range and when
             confirmed on re-examination.

          -  Any clinically significant illness during the 4 weeks prior to Period I dosing (as
             determined by the clinical investigators)

          -  Use of any systemic prescription medication in the 14 days prior to Period I dosing

          -  History of any allergy(s) including allergy to colchicine or related drugs.

          -  History of drug or alcohol addiction or abuse within the past year or a positive drug
             abuse screen

          -  Currently or recent (within 6 months) use of tobacco products prior to dose
             administration

          -  Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior
             to period I dosing