bioihbjkbjnl/mcl2 huggingface dataset:
General Anesthesia Emergence Induced by Methylphenidate
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Intervention: Methylphenidate HCl; Placebo
Intervention description: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL); 20 mg of placebo (PO) will be given 2 hours prior to surgery
Intervention MeSH terms: Methylphenidate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess whether methylphenidate affects time of emergence from
      isoflurane general anesthesia. Time to emergence was defined as the time from termination of
      isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths
      spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated
      and the time will be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 65 years of age

          -  ASA I or II

          -  Capable and willing to consent

          -  Participants literate in English language

        Exclusion Criteria:

          -  ADHD with current use of methylphenidate

          -  Hypersensitivity to methylphenidate

          -  ASA III, IV or V

          -  Patients with severe visual or auditory disorder

          -  Illiteracy

          -  Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition
             such as bipolar disorder, uncontrolled major depression, schizophrenia

          -  Tics or Tourette's syndrome

          -  Glaucoma

          -  Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter),
             myocardial infarction

          -  Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI
             (Selegiline)

          -  Subjects who have participated or are currently participating in a clinical trial of
             an investigational drug within 30 days prior to surgery

          -  Any condition, which in the opinion of the investigator would make subject ineligible
             for participation in the study such as history of unstable cardiovascular, pulmonary,
             renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality
             (hyperthyroidism, unstable Diabetes type I/II)
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Glial growth factor 2/ Neuregulin 1β3; Placebo
Intervention MeSH terms: Mitogens
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single
      intravenous administrations of GGF2 in patients with heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Left ventricular ejection fraction (LVEF) between 10% and 40%.

          2. Male or female, aged 18 to 75 years, inclusive.

        Exclusion Criteria:

          1. Received any investigational agent or participation in any clinical study of an
             investigational agent or investigational therapy up to 30 days prior to the screening
             visit.

          2. Use of any new prescription medication up to 14 days prior to receiving
             investigational drug.

          3. Patients with known specific hepatic disease; bilirubin >2 mg/dL, SGOT > 100 IU.

          4. Patients with a history of hepatic impairment (hepatitis B and C).

          5. Serum creatinine >2.5 mg/dL.

          6. Documented stroke or transient ischemic attack (TIA) within 60 days of study
             enrollment.
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-1006; Placebo
Intervention description: MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.; Matching placebo to MK-1006 in a single oral dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      A single rising dose study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM).
      The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe
      and well tolerated, based on the assessment of clinical and laboratory evaluations and
      adverse experiences, in Japanese participants with T2DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female between 20 to 64 years of age

          -  Diagnosis of type 2 diabetes

          -  Patient is being treated with diet and exercise alone or single oral
             anti-hyperglycemic agent

        Exclusion Criteria:

          -  Subject has a history of type 1 diabetes mellitus

          -  Subject has a clinical diagnosis of glaucoma

          -  Subject has donated blood or participated in another clinical study in the past 12
             weeks

          -  Subject is a regular user of any illicit drugs or has a history of drug, including
             alcohol, abuse in the past 6 months
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: BI 201335; BI 201335
Intervention description: BI 201335 for 9 days; BI 201335 for 9 days
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
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Otherwise healthy subjects who are currently bein maintained on either methadone or
      buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at
      least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs
      between BI 201335 and either methadone or buprenorphine/naloxone.
    

Eligibility criteria:

        Inclusion criteria:

          1. stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid
             maintenance therapy.

          2. Male and female volunteers with a body mass index (BMI) = 18.5 and < 32 with a minimum
             weight of 50kg.

        Exclusion criteria:

          1. any other significant medical illness of clinical significance.

          2. history of rash or photosensitivity

          3. chronic or acute infections including HIV, hepatitis B and hepatitis C.

          4. history of allergy considered significant for this study

          5. intake of any other medications except for methadone or buprenorphine/naloxone.

          6. QTc on electrocardiogram (ECG) > 470.

          7. use of any other investigational drug within 30 days of the study.

          8. drug or alcohol abuse (other than the defined opioid maintenance therapy with either
             methadone or buprenorphine/naloxone)

          9. blood donation of more than 100mL within four weeks of the trial.

         10. excessive physical activities one week prior to and during the trial.

         11. any clinically relevant laboratory value.

         12. concomitant use of any food product known to alter P450 or P-gp activity such as
             grapefruit juice, seville oranges and St. John's Wort.

         13. inadequate venous access

             For women of childbearing potential:

         14. pregnancy or planning to become pregnant within 3 months of the trial

         15. positive pregnancy test at screening visit

         16. no proof of sterilization or unwilling or unable to use a double barrier method of
             birth control during the study and up to 3 months after the study.

         17. lactation with active breastfeeding from screening up to 30 days after last study
             visit.
Pharmacokinetics and Safety Study of BI 695502 in Healthy Subjects
Condition: Healthy
Intervention: BI 695502; bevacizumab; bevacizumab
Intervention description: BI 695502 single i.v. infusion; bevacizumab single i.v. infusion; bevacizumab single i.v. infusion
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 91.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish
      pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males.

          2. Complete medical history, including physical examination, vital signs, 12-lead
             electrocardiogram (ECG), and clinical laboratory tests.

          3. Aged 21 to 50 years.

          4. Body mass index below or equal to 30.

          5. Body weight 65 to 95 kg, inclusive.

        Exclusion criteria:

          1. Any finding of the medical examination (including blood pressure, pulse rate and ECG)
             deviating from normal and of clinical relevance.

          2. Any evidence of a clinically relevant concomitant disease, as judged by the
             investigator.

          3. History of relevant orthostatic hypotension, fainting spells, or blackouts.

          4. Chronic or relevant acute infections.

          5. History of relevant allergy/hypersensitivity (including allergy to the study
             medications or its excipients).

          6. Intake of prescribed or over-the-counter drugs within less than 6 half-lives of the
             respective drug prior to study drug administration or during the trial.

          7. Participation in another trial with a study medication within two months prior to
             administration or during the trial (six half-lives).

          8. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day).

          9. Inability to refrain from smoking during days of confinement at the study center.

         10. Current alcohol abuse as judged by the investigator.

         11. Current drug abuse, as judged by the investigator.
A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: CVX-241; CVX-241; CVX-241; CVX-241; CVX-241; CVX-241; CVX-241; CVX-241
Intervention description: 0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.; 25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy

Summary:

      The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when
      given as weekly infusions to adult patients with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed solid tumors unresponsive to current therapy or for which there is no
             standard therapy.

          -  Stage 2 only: Histologically or cytologically documented EOC or PPC with < or equal to
             3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.

          -  Adequate coagulation, liver, and renal function.

          -  Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging [DCE-MRI]
             evaluation

          -  Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

        Exclusion Criteria:

          -  History of clinically significant toxicity to Vascular Endothelial Growth Factor
             [VEGF] inhibition.

          -  Evidence of bleeding problems.

          -  Uncontrolled hypertension.

          -  Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell
             histology
Effect of, OAT3, on the Renal Secretion of Cefotaxime
Condition: Focus Groups
Intervention: Cefotaxime
Intervention description: Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
Intervention MeSH terms: Cefotaxime; Cefoxitin
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers willing to be dosed with cefotaxime

Summary:

      In the proposed study, we plan to use a genotype to phenotype strategy to study the role of
      the organic anion transporter, OAT3, in drug response. More specifically we will examine the
      contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying
      individuals with a non-functional (or poorly-functional) variant of OAT3.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous participation in the "SOPHIE" study;

          2. Has a specific genotype for OAT3

        Exclusion Criteria:

          1. Under 18 years old or over 45 years old;

          2. Pregnant (pregnancy status in female subjects will be determined by a urine pregnancy
             test before study drug administration);

          3. They report a prior history of any allergic reaction to cephalosporin antibiotic, or
             severe hypersensitivity to penicillin;

          4. Has a prior history of renal or hepatic dysfunction (renal and hepatic function will
             also be determined for each subject with prescreening blood tests);

          5. Taking a medication that could confound study results (such as known substrates or
             inhibitors of OATs);

          6. They do not consent to participate in the study.
Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors
Condition: Sarcoma, Ewing's
MeSH terms: Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Intervention: CP-751,871
Intervention description: Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently
      enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET
      and Askin's).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Ewing's sarcoma family tumors

        Exclusion Criteria:

          -  Concurrent treatment with any other anti tumor agents
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
Condition: Healthy
Intervention: PF-04958242; Placebo
Intervention description: Administered as specified in treatment arm; Administered as specified in treatment arm
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Single ascending doses; pharmacokinetics; safety; tolerability; healthy volunteers; cognitive impairment associated with schizophrenia (CIAS)

Summary:

      This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a
      number of single ascending doses in healthy volunteers
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy female subjects of non-childbearing potential and/or male subjects between the
             ages of 18 and 55 years, inclusive (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 ECG and clinical
             laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >55 kg

        Key Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Condition: Atherosclerotic Vascular Disease
MeSH terms: Vascular Diseases; Atherosclerosis
Intervention: atorvastatin; placebo
Intervention description: Participants will be asked to self-administer one atorvastatin 10 mg or 80 mg tablet at approximately the same time each day.; Participants will be asked to self-administer one tablet of placebo to atorvastatin 10 mg or 80 mg at approximately the same time each day.
Intervention MeSH terms: Atorvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose
      Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female ages 30 to 80

          -  Participant is on a low dose statin for at least 6 weeks prior to screening or is
             statin-naive at screening

        Exclusion Criteria:

          -  Participant has human immunodeficiency virus (HIV), Hepatitis B or C

          -  Participant uses illegal drugs

          -  Participant has Type I diabetes

          -  Participant has a history of claustrophobia