bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.
Condition: Enoxaparin Sodium is Administered to Healthy Volunteers
Intervention: Enoxaparin Sodium; Enoxaparin Sodium
Intervention description: comparison of bioavailability of generic Enoxaparin Sodium and Clexane; comparison of bioavailability of generic Enoxaparin Sodium and Clexane
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      -  The primary objective of the trial is to assess the single-dose relative bioavailability
           of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by
           subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.

        -  The secondary objective of the trial is to assess safety and tolerability of Chemi
           Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection,
           under fasting conditions in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female volunteer between 18 and 55 years of age.

          -  Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / [Height (m)]2)

          -  Subject with no clinically significant abnormal serum biochemistry, haematology,
             coagulation factors and urine examination values within 14 days of the first dose.

          -  Subject with no clinically significant abnormalities in 12-lead electrocardiogram
             (ECG) and vital signs determined within 14 days of the first dose.

          -  Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface
             antigen (HbsAg) and hepatitis C virus antibody (HCV) results.

        Exclusion Criteria:

          -  Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low
             molecular weight heparins, and/or pork products.

          -  Subject with a relevant history or presence of significant cardiovascular, pulmonary,
             hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
             neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug
             abuse;

          -  Subject with clinically relevant abnormal physical findings or clinically relevant
             abnormal laboratory values indicative of physical illness;

          -  Female subject who is pregnant or lactating

          -  Female subject with weight < 45 kg or male subject with weight < 57 kg.
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 10 mg MK-0941 DFC (fasted); 10 mg MK-0941 OCT (after meal); 10 mg MK-0941 OCT (before meal); 10 mg MK-0941 OCT (fasted)
Intervention description: single dose of 10 mg MK-0941 dry filled capsules (DFC) administered in a fasted state; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered after consumption of a high-fat meal; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered before consumption of a standard breakfast; single dose of 10 mg MK-0941 oral compressed tablet (OCT) administered in a fasted state
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) & oral
      compressed tablet (OCT) formulations of MK-0941-009 & to assess the effect of food on the OCT
      formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females (of non-childbearing potential) between the ages of 18 to 70

          -  Participants have been diagnosed with Type 2 Diabetes

          -  Participants are nonsmokers for at least 6 months

        Exclusion Criteria:

          -  Participant should not be diagnosed with Type 1 diabetes

          -  Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior
             to study start

          -  Participant has a recent history of eye infection or other inflammatory eye condition
             within 2 weeks prior to study start

          -  Participant has been diagnosed with glaucoma or is blind

          -  Participant has had trauma to one or both eyes

          -  Participant has had major surgery, donated blood or participated in another clinical
             study in the past 4 weeks

          -  Participant is a regular user of illicit drugs or has a history of drug, including
             alcohol, abuse in the past 6 months
Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Intervention: Metronidazole + MMX Mesalazine/mesalamine placebo; Metronidazole + MMX Mesalazine/mesalamine
Intervention description: Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally; Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
Intervention MeSH terms: Metronidazole; Mesalamine
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: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered
      alone & in combination with MMX® Mesalazine/mesalamine
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent
             is defined as the beginning of the Screening Period.

          2. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is:

               -  Male, or

               -  Non-pregnant, non-lactating female

               -  Females must be at least 90 days post-partum or nulliparous.

        Exclusion Criteria

          1. A history of current or recurrent disease that could affect the colon. This includes
             gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac
             disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel
             Syndrome. Subjects who have a history of chronic constipation, which is physician
             diagnosed and treated, will also be excluded from the study (frequency of bowel
             movements >48 hours between samples).

          2. A history of current or relevant serious, severe, or unstable (acute or progressive)
             physical or psychiatric illness.

          3. A history of gastrointestinal surgery performed within the past 12 months prior to the
             first dose of investigational product, with the exception of an appendectomy.

          4. A history of or current clinically relevant moderate or severe renal or hepatic
             impairment.

          5. A history of asthma or bronchospasm associated with the use of 5-ASA or other
             non-steroidal anti-inflammatory drugs.

          6. Known or suspected intolerance or hypersensitivity to the investigational product or
             metronidazole, closely related compounds, or any of the stated ingredients

          7. A history of, or current, pancreatitis.
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
Condition: Postmenopause
Intervention: Comparator: placebo; Comparator: Estrace
Intervention description: placebo capsule once daily for 7 days.; Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Biomarkers of estrogen receptor beta activation

Summary:

      This study will develop a model for the assessment of successful activation/engagement of
      estrogen receptor beta using salivary biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is healthy, postmenopausal woman at least 40 years of age with onset of
             menopause within 10 years of screening

          -  Subject has a normal mammogram at screening

          -  Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not
             had a Pap-smear in the last 3 years will have the option to have the test at screening

          -  Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva
             flow

          -  Subject is willing to avoid strenuous exercise during the study

          -  Subject is willing to avoid use of mouthwash or salt water rinses during the study

          -  Subject is willing to avoid use of teeth whitening products

          -  Subject is willing to avoid eating and/or drinking grapefruit products

          -  Subject is willing to limit alcohol consumption to 2 drinks a day

          -  Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent)
             per day

          -  Subject is a non-smoker

        Exclusion Criteria:

          -  Subject has a history of multiple and/or severe allergies to drugs or food

          -  Subject has a cold or viral infection within 2 weeks of Visit 2

          -  Subject is taking antibiotics within 2 weeks of Visit 2

          -  Subject needs dental work or procedures during the study

          -  Subject has used any estrogen or progesterone preparation or product containing
             phytoestrogens within 3 months of screening

          -  Subject is unable to discontinue anti-coagulants
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Metformin Single Tablet; Linagliptin/Metformin Combo; Linagliptin Single Tablet
Intervention description: Metformin medium doseTablet; Fixed dose combination; Linagliptin Single medium dose Tablet
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The data from this study will be used to compare the kinetic profile of metformin 500mg in
      linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference
      product administered concomitantly with linagliptin 2.5 mg tablet.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects.

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions.
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Condition: Healthy
Intervention: Ortho-Cyclen; AG200-15
Intervention description: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.; AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
Intervention MeSH terms: Moxifloxacin; Contraceptive Agents; Norgestimate, ethinyl estradiol drug combination; Contraceptives, Oral
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety

Summary:

      Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be
      evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, ages 18-45

          -  Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.

          -  Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have
             already undergone previous bilateral tubal ligation or hysterectomy

          -  Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until
             completion of each treatment period

        Exclusion Criteria:

          -  Known or suspected pregnancy;

          -  Lactating women

          -  Significant skin reaction to transdermal preparations or sensitivity to surgical /
             medical tape

          -  Any disease that may worsen under hormonal treatment (cardiovascular, liver,
             metabolic)

          -  Use of other contraceptive methods than study medication

          -  Smokers
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Condition: Sepsis
MeSH terms: Sepsis
Intervention: piperacillin-tazobactam
Intervention description: 6 doses intravenously at the following doses:
Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6
Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6
≥ 14 days PNA 100 mg/kg Q6
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Maximum age: 60 Days
Healthy volunteers: No
Keywords: presumed sepsis

Summary:

      This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety
      of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be
      four cohorts of 8 infants each:

        1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)

        2. < 32 weeks gestational age and >=14 days postnatal age

        3. >=32 weeks gestational age and < 14 days postnatal age

        4. >=32 weeks gestational age and >=14 days postnatal age. The study requires
           administration of 6 doses of study drug along with other antimicrobials per standard of
           care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at
           steady state. The risks are reasonable vs. the benefits and have been minimized
           appropriately. There may be benefit to the subjects (administration of broad spectrum
           empirical antimicrobial therapy), and information from the study may benefit a large
           number of other infants in whom the drug is currently being administered despite the
           lack of PK data in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written permission from parent or legal guardian

          2. < 61 days of age

          3. Likely to survive beyond the first 48 hours after enrollment

          4. Sufficient intravascular access (either peripheral or central) to receive study drug.

        AND ONE OF THE FOLLOWING

          1. Suspected systemic infection

          2. Receiving piperacillin-tazobactam as part of standard of care

        Exclusion Criteria:

          1. History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase
             inhibitors

          2. Urine output < 0.5 mL/hr/kg over the prior 24 hours

          3. Serum creatinine > 1.2 mg/dL

          4. Any condition which would make the subject or the caregiver, in the opinion of the
             investigator, unsuitable for the study
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: Daclatasvir; Darunavir; Ritonavir; Lopinavir/Ritonavir
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or
      lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Healthy male and female participants, aged 18 to 49, as determined by medical history,
             physical examination, 12 lead electrocardiogram, vital signs, and clinical laboratory
             evaluations

        Key Exclusion Criteria:

          -  Any significant acute or chronic medical illness; donation of blood to a blood bank or
             in a clinical study (except a screening visit) within 4 weeks of study drug
             administration (within 2 weeks for plasma only); or blood screen findings positive for
             hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibodies
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Tamiflu
Intervention description: oral repeating dose
Intervention MeSH terms: Oseltamivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir
      [Tamiflu] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours
      prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will
      receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10
      doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued
      study treatment for an additional 10 doses (5 days). The anticipated time on study treatment
      is 4 weeks, and the target sample size is 65-85 male and female infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants </=12 months of age

          -  laboratory confirmed diagnosis of influenza within 96 hours prior to first dose

          -  influenza symptoms for </=96 hours prior to first dose

        Exclusion Criteria:

          -  preterm infants less than 40 weeks (corrected for gestational age)

          -  weight less than 5th percentile for age (corrected for gestational age)

          -  concurrent gastrointestinal conditions that preclude enteric absorption of the drug

          -  bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of
             enrollment

          -  active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline

          -  symptomatic inborn errors of metabolism
Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: hypertonic saline (7%); isotonic saline
Intervention description: single treatment by inhalation; single treatment by inhalation
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects inhale isotonic saline on one imaging day and 7% hypertonic on the other. The order is randomized. There is a period of 5-24 days between imaging days.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cystic fibrosis; nuclear medicine; aerosol; nebulizer

Summary:

      Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung
      problems for people with cystic fibrosis (CF). Many researchers now believe that people with
      CF absorb too much water from the insides of their lungs, and that the mucus in their lungs
      becomes so thick and sticky because there is not enough water in it. The investigators are
      trying to develop ways to measure how fast water is absorbed from the breathing tubes in the
      lung so that the investigators can more quickly test new medications that are being developed
      to fix this problem for CF patients. The investigators have already done studies showing that
      people with CF absorb a particular radioactive drug (Indium-111 diethylenetriaminepentaacetic
      acid or In-DTPA) from their lungs more quickly than people without CF. Now the investigators
      are trying to prove that the absorption of this drug is related to the absorption of water.
      The investigators measure the absorption of In-DTPA by delivering it in an aerosol (inhaled
      mist) along with another radioactive drug (Technetium 99m sulfur colloid or Tc-SC). This
      other drug helps us measure how much material is cleared from the lungs in other ways (like
      coughing) without being absorbed. In this study, the investigators will measure how the
      absorption of In-DTPA is affected by inhaling isotonic saline and hypertonic saline (salt
      water), both of which the investigators know affect the absorption of water in the airways.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age ≥ 18 years

          -  diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical
             symptoms

          -  clinically stable as determined by the investigator (pulmonologist)

        Exclusion Criteria:

          -  intolerant to hypertonic saline.

          -  FEV1%p <40% of predicted

          -  nursing mother

          -  positive urine pregnancy test

          -  unwilling to stop hypertonic saline therapy for 72 hours prior to each test day

          -  cigarette smoker (regular smoking within 6 months of study)