bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Leptin Administration During Fasting
Condition: Energy Deficiency Due to Short-term Fasting
Intervention: r-metHuLeptin
Intervention description: r-metreleptin was given in 3 different dose in fed and fasting states
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: leptin; fasting; pharmacokinetics

Summary:

      The purpose of this study will be to determine the correct dose of leptin, a natural hormone
      secreted by the fat cells, to give to people when they are fasting and also to determine
      whether giving leptin to a person when he or she is fasting will reverse the changes in
      hormone levels that occur with fasting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy men with body mass indices (BMI) <25 kg/m2)

          -  overweight otherwise healthy men with BMI > 27 kg/m2

          -  healthy lean women with BMI<25 kg/m2

          -  overweight otherwise healthy women with BMI > 27 kg/m2

        Exclusion Criteria:

          -  history of any illness that may affect the concentrations of the hormones that will be
             studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes
             mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or
             hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)

          -  on medications known to affect the hormones to be measured in this study (such as
             glucocorticoids, anti-seizure medications or thyroid hormones)

          -  known history of anaphylaxis or anaphylactoid-like reactions or who have a known
             hypersensitivity to E. Coli derived proteins

          -  women who are breast feeding, pregnant, or wanting to become pregnant during the next
             6 months
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
Condition: Healthy
Intervention: Dabigatran; BI 655075; Placebo
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 157.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
      655075 following intravenous administration of single rising doses of BI 655075 when
      administered alone and after administration of dabigatran.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Condition: Healthy
Intervention: 5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin; 12.5 mg empagliflozin; 850 mg metformin; 5 mg empagliflozin; 5 mg empagliflozin; 850 mg metformin; 12.5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin/500 mg metformin FDC; 5 mg empagliflozin/500 mg metformin FDC; 500 mg metformin; 500 mg metformin
Intervention description: 5 mg empagliflozin/850 mg metformin FDC; 10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet; 10mg empagliflozin tablet and 2.5 mg empagliflozin tablet; 850mg metformin tablet; 5 mg empagliflozin; 5 mg empagliflozin; 850 mg metformin; 12.5 mg empagliflozin/850 mg metformin FDC; 12.5 mg empagliflozin/500 mg metformin FDC; 5 mg empagliflozin/500 mg metformin FDC; 500 mg metformin; 500 mg metformin
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the trial is to assess the relative bioavailability of fixed dose combination
      tablets of Empagliflozin and metformin compared to the administration of single tablets
      (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose
      combination tablet is expected to significantly enhance patient's compliance with
      antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic
      patients.
    

Eligibility criteria:

        Inclusion criteria:

        Healthy male and female subjects

        Exclusion criteria:

        Any relevant deviation from healthy conditions
Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: Excel Cryo Cooling System
Intervention description: An Excel Cryo Cooling System collar will be place around the neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level, and pressure both in the head and in the blood.
2 hour neck cooling period
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if cooling the neck of patients with ICH decreases
      brain temperature. In addition, the investigators will determine if the device improves the
      delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers
      intracranial pressure (which is often times high in patients after ICH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with brain injury in the Neurological ICU.

          2. Consent from the patient or surrogate decision maker.

          3. Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.

        Exclusion Criteria:

          1. Cerebellar hemorrhages.

          2. Moribund state where the physician team doesn't believe the patient will survive.

          3. Patients who are being cared for with the intent of making them comfortable. DNR-CC
             (by Ohio law).

          4. Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could
             affect inflammation.

          5. Known significant carotid artery stenosis (known >50% stenosis by history or
             incidental hospital imaging). This will not be specifically tested. Patients found to
             have significant stenosis later in the hospital stay will have their data interpreted
             separately as well as in the total group.
Ropinirole 0.25 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Ropinirole HCl 0.25 mg Tablets; Requip® 0.25 mg Tablets
Intervention description: 1 x 0.25 mg; 1 x 0.25 mg
Intervention MeSH terms: Ropinirole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study was to compare the relative bioavailability of the test
      formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of
      Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under
      fasting conditions in healthy, non-smoking, adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males
             and/or females who were between 18 and 45 years old

        Exclusion Criteria:

          -  If female, pregnant, lactating or likely to become pregnant during this study.

          -  History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g.
             Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug
             hypersensitivity of intolerance which, in the opinion of the Investigator, would
             compromise the safety of the subject or the study.

          -  History of dizziness, lightheadedness or fainting upon standing.

          -  Significant history or current evidence of chronic infectious disease, system
             disorders, organ dysfunction, hyper/hypotension, arrythmia, tachycardia, seizure
             disorder or glaucoma.

          -  Presence of gastrointestinal disease or history of malabsorption within the last year.

          -  History of psychiatric disorders occuring within the last two years that required
             hospitalization or medication.

          -  Presence of a medical condition requiring regular treatment with prescription drugs.

          -  Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing
             enzymes within 30 days prior to dosing.

          -  Receipt of any drug as part of a research study within 30 days prior to dosing.

          -  Drug or alcohol addiction requiring treatment in the past 12 months.

          -  Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma
             within the past 14 days prior to dosing.

          -  Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.

          -  Positive test results for drugs of abuse at screening.

          -  Tobacco user within 90 days of the first study date.

          -  Unable, or unwilling to tolerate multiple venipunctures.

          -  Difficulty fasting or eating the standard meals that will be provided.
Mild, Moderate and Severe Renal Impairment Study
Condition: Gout
MeSH terms: Renal Insufficiency
Intervention: RDEA3170
Intervention MeSH terms: Verinurad
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD)
      study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40
             kg/m2.

          -  Subject with renal impairment, as determined at Screening, with creatinine clearance
             as calculated by the Cockcroft-Gault formula of 60 to < 90 mL/min (mild impairment),
             30 to < 60 mL/min (moderate impairment), or 15 to < 30 mL/min (severe impairment), or
             a matched control subject (by age and body mass index) with a creatinine clearance of
             ≥ 90 mL/min.

          -  Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL

        Exclusion Criteria:

          -  Subject has a history or clinical manifestations of significant metabolic,
             hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic,
             renal, urological, or psychiatric disorders.

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has a history of asthma.

          -  Subject has undergone major surgery within 3 months prior to Day 1.

          -  Subject has donated blood or experienced significant blood loss (> 450 mL) within 12
             weeks prior to Day 1 or gave a plasma donation
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: Placement of the PVSS Implant
Intervention description: Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor
      Ventricular Support System when used to treat patients with heart failure. The implant, which
      is loaded onto the delivery system, is placed over the epicardial surface of the right and
      left ventricles.

      No formal hypothesis testing will be performed; descriptive statistics will be used to
      summarize patient outcomes. The results of the study will be used to guide the design and
      sample size estimation of future studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NYHA functional class II or III

          -  Best medical therapy

          -  Ejection fraction <= 35%

        Exclusion Criteria:

          -  Heart measurements too large or small for implant sizes

          -  Intra-cardiac thrombus

          -  Restrictive cardiomyopathy

          -  Not a candidate for sternotomy

          -  Expected adhesions

          -  Previous coronary artery bypass graft (CABG)

          -  Active infection

          -  Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months

          -  Myocardial infarction (MI) within 1 month
Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: vorinostat; bortezomib
Intervention description: Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).; Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Intervention MeSH terms: Bortezomib; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are:

        -  To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and
           bortezomib in participants with advanced multiple myeloma

        -  To assess the safety and tolerability of this regimen and to document the participant's
           clinical status (by anti-tumor activity) for this combination, as determined per
           standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with refractory or relapsed multiple myeloma

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to
             determine participant's ability to perform daily activities)

          -  Adequate bone marrow reserve

          -  Adequate hepatic and renal function

          -  Ability to swallow capsules

          -  3 weeks or more since prior chemotherapy and have recovered from prior toxicities

        Exclusion Criteria:

          -  Participants who plan to have a bone marrow transplant within 4 weeks of start of
             treatment

          -  Participants with prior treatment with other investigational agents with a similar
             anti-tumor mechanism

          -  Participants with other active/uncontrolled clinically significant illness

          -  Pregnant or nursing female participants

          -  Participants who received bortezomib within 3 months of start of this trial
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
Condition: Chronic Asthma
MeSH terms: Asthma
Intervention: Comparator: montelukast; Comparator: placebo
Intervention description: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Intervention MeSH terms: Montelukast
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic asthma

Summary:

      This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast)
      compared to placebo on improved lung function in patients with chronic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A person is 15 to 65 years of age. A person has had chronic asthma for at least one
             year

        Exclusion Criteria:

          -  A person is a smoker or has smoked more that a pack a day for more than 10 years
             before stopping

          -  A person has other lung disorders such as COPD (chronic obstructive pulmonary
             disorder)
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
Condition: Neoplasms
Intervention: afatinib 20mg; afatinib 40mg; vinorelbine IV 25 or 20mg/m2
Intervention description: patient to receive afatinib low dose po daily in combination with vinorelbine iv; patient to receive afatinib high dose po daily in combination with vinorelbine iv; patient to receive standard dose vinorelbine once a week for four times per cycle
Intervention MeSH terms: Vinorelbine; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      -  To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine
           i.v. by assessment of Dose Limiting Toxicities (DLT);

        -  To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics
           of afatinib and vinorelbine i.v.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed diagnosis of malignancy that is advanced and for which
             standard therapies do not exist or are no longer effective.

          -  Life expectancy at least 12 weeks

          -  Eastern Cooperative Oncology Group Performance Status 0 or 1

          -  Adequate hepatic, renal, haematologic and other organ function

          -  Written informed consent

        Exclusion criteria:

          -  Chemotherapy, immunotherapy, surgery and radiotherapy within the past 4 weeks

          -  Prior treatment with afatinib and or vinorelbine

          -  Clinically significant active infectious disease
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Extended Release Metadoxine
Intervention description: one oral 1400mg dose (2 tablets)
Intervention MeSH terms: Pyridoxine; Metadoxine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: ADHD; ADD; TOVA; METADOXINE

Summary:

      This clinical study is designed to evaluate the safety and tolerability of a single oral
      administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD.
      Study also assess cognitive effects of such drug administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-45

          -  diagnosed as ADHD

        Exclusion Criteria:

          -  PDD patients

          -  head injured patients

          -  patients suffering from heart, lung, liver, kidney, intestinal, endocrine an
             neurological diseases and patients who are sensitive to vitamin B
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316); PF-04950615 (RN316)
Intervention description: Dose A - single-dose intravenous infusion; Dose B - single-dose subcutaneous injection; Dose C - single-dose subcutaneous injection; Dose D - single-dose subcutaneous injection
Intervention MeSH terms: Bococizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PF-04950615; RN316

Summary:

      This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615
      (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits.

          -  Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to
             150 kg (330 lbs)

        Exclusion Criteria:

          -  Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional
             supplements.

          -  Poorly controlled type 1 or type 2 diabetes.

          -  History of a cardiovascular or cerebrovascular event or related procedure during the
             past year.

          -  Poorly controlled hypertension.