bioihbjkbjnl/mcl2 huggingface dataset:
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Condition: Hypercholesterolemia, Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Simvastatin; Placebo
Intervention description: 40 mg once daily for 2 weeks; Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
Intervention MeSH terms: Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: Male
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor

Summary:

      The purpose of this study was to provide human lipidomics standards with simvastatin
      treatment that were to be used for comparison with similar preclinical studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a Caucasian (including Hispanic) male

          -  Participant has a maximum waist size of 40 inches

          -  Participant does not currently use any lipid-altering medications

          -  Participant is in good health other than the diagnosis of dyslipidemia

        Exclusion Criteria:

          -  Participant has had stomach ulcers within the last 3 months

          -  Participant has had a heart attack in the last 6 months or has angina

          -  Participant has chronic heart failure

          -  Participant has a history of stroke, seizures, or major neurological disorder

          -  Participant has a history of cancer

          -  Participant has a gastrointestinal condition that affects bowel movements

          -  Participant has type 1 or 2 diabetes
Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Condition: Hepatic Impairment; Hepatic Insufficiency; Healthy Subjects
MeSH terms: Liver Diseases; Hepatic Insufficiency; Liver Failure
Intervention: acalabrutinib
Intervention description: A 50-mg single oral dose of acalabrutinib will be administered.
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatic; Acalabrutinib

Summary:

      This study is investigate the influence of severe hepatic impairment on the pharmacokinetics
      of acalabrutinib and its metabolite.
    

Eligibility criteria:

        Inclusion Criteria

          -  Women must be of non childbearing status

          -  Understands the study procedures in the ICF and be willing and able to comply with the
             protocol.

          -  Willingness and ability to swallow study drug capsule.

          -  Adult men or women, 18 to 75 years of age

        Hepatic-Impaired Subjects Only:

          -  Subject has a diagnosis of chronic, stable HI.

          -  Subject's score on the Child-Pugh scale must range from 10 to 15 at screening.

        Exclusion Criteria

          -  History or presence of clinically significant or unstable medical or psychiatric
             condition or disease in the opinion of the PI.

          -  Dosed in another clinical trial within 28 days before dosing of study drug and
             throughout the current study.

          -  History or presence of drug abuse within 2 years before screening.
Study of Cobimetinib in Participants With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: cobimetinib; dextromethorphan; midazolam
Intervention description: Repeating oral dose; In Stage III only: single dose of dextromethorphan; In Stage III only: single dose of midazolam
Intervention MeSH terms: Midazolam; Dextromethorphan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This non-randomized, open-label, study will determine the highest safe dose of cobimetinib,
      how often it should be taken, how well participants with cancer tolerate cobimetinib and will
      assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed solid tumor that is metastatic or unresectable, and for which
             standard curative or palliative measures do not exist or are no longer effective, and
             there are no known therapies to prolong survival

          -  Disease that is measurable according to Response Evaluation Criteria in Solid Tumors
             (RECIST)

          -  Adequate organ and marrow function

          -  Sexually active participants must use medically acceptable methods of contraception
             during the course of the study and at least 11 days after the last dose of study
             treatment

          -  Female participants of childbearing potential must have a negative serum pregnancy
             test at screening

          -  No other history of/or ongoing malignancy that would potentially interfere with the
             interpretation of the pharmacodynamic or efficacy assays

        Exclusion Criteria:

          -  Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within
             28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or
             kinase inhibitors) before the first dose of study drug

          -  The participant has not recovered to Grade </=1 from adverse events (AEs) or to within
             10% of baseline values due to investigational or other agents administered more than
             28 days prior to study enrollment

          -  The participant has received another investigational agent within 28 days of the first
             dose of study drug

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris,
             or cardiac arrhythmia

          -  The participant is pregnant or breastfeeding

          -  The participant is known to be positive for the human immunodeficiency virus (HIV)

          -  Allergy or hypersensitivity to components of the cobimetinib formulation
Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Intervention: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min; BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min; BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Intervention description: BIBF 1120 twice daily along with standard therapy of PLD + CBDCA; BIBF 1120 twice daily along with standard therapy of PLD + CBDCA; BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
Intervention MeSH terms: Carboplatin; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to
      treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in
      patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma
      or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with
      carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression
      is observed.
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients, age 20 years or older, with relapse of histologically (on initial
             diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary
             peritoneal cancer

          2. Up to 3 lines of prior chemo therapy, with treatment free interval of >6 months

          3. Platinum based chemotherapy in the immediately preceding line.

          4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1

          5. Written informed consent that is consistent with Good Clinical Practice (GCP)
             guidelines

        Exclusion criteria:

          1. Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or
             PLD.

          2. More than 2 lines of prior therapies that contained angiogenesis inhibitor.

          3. Patients for whom surgery is planned, e.g. interval debulking surgery.

          4. History of a cerebral vascular accident, transient ischemic attack or subarachnoid
             haemorrhage within the past 6 months.

          5. Serious infections in particular if requiring systemic antibiotic (antimicrobial,
             antifungal) or antiviral therapy.

          6. Laboratory values indicating an increased risk for adverse events.

          7. Significant cardiovascular diseases.
Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Intervention: Nutrition time control/placebo intervention; Computer-delivered, brief intervention on alcohol use
Intervention description: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.; A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: pregnancy; screening; motivation

Summary:

      The purpose of this study is to lay the ground work for a fully powered clinical trial of a
      computer-delivered screener and intervention for alcohol use during pregnancy. The pilot
      study will include:

        1. Evaluation of the usefulness of handheld devices and anonymous screening for self report
           of at-risk alcohol use among pregnant women.

        2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the
           detection of at-risk drinking in pregnant women.

        3. Evaluation of the efficacy of a computer-delivered brief intervention and use of
           tailored handouts to supplement the computer-based brief intervention focusing on
           alcohol use during pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  intention to carry pregnancy to term

          -  self-reported alcohol use

          -  willingness to be sent tailored messages

          -  gives consent to access medical records for collection of birth outcome data

        Exclusion Criteria:

          -  unable to communicate in English

          -  less than 4 months before delivery due date
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: Administered as specified in the treatment arm.
Intervention MeSH terms: Factor VIII
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc
      administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The
      secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK
      assessment for up to 6 months for a continued treatment period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have severe hemophilia A

          -  Previously treated subject, defined as having at least 150 documented prior exposure
             days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products
             (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh
             frozen plasma treatment must not be considered in the count for documented exposure
             days.

          -  No history of a positive inhibitor test or clinical signs of decreased response to
             FVIII administrations. Family history of inhibitors will not exclude subjects.

          -  No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at
             Screening.

          -  Platelet count ≥100,000 platelets/μL at screening

          -  CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening.

          -  Viral load of <400 copies/mL if known HIV antibody positive at screening.

        Key Exclusion Criteria:

          -  Subject is at high risk of bleeding during the 5-day period between the first and
             second injections for PK analyses, as per Investigator discretion.

          -  Previous treatment with rFVIIIFc as study drug or commercial product.

          -  Other coagulation disorder(s) in addition to hemophilia A.

          -  History of hypersensitivity or anaphylaxis associated with any FVIII or IV
             immunoglobulin administration.

          -  Currently taking (or likely to require during the study) acetylsalicylic acid (ASA),
             except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are
             permitted).

          -  Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to
             Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV),
             and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more
             than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled
             steroids.

        NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply
Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Bococizumab (PF-04950615; RN316); Bococizumab (PF-04950615; RN316); Bococizumab (PF-04950615; RN316)
Intervention description: Single 150 mg PF-04950615 dose administered SC to the abdomen; Single 150 mg PF-04950615 dose administered SC to the upper arm; Single 150 mg PF-04950615 dose administered SC to the thigh
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: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pharmacokinetics; bioavailability; PF-04950615

Summary:

      This study aims to characterize the single dose pharmacokinetics of PF-04950616 following
      subcutaneous injection to the abdomen, upper arm or the thigh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 18 to 65 years of age.

          -  Body Mass Index (BMI) ≤ 33 kg/m2, and total body weight of 60 kg to 90 kg (132 lbs to
             198 lbs).

          -  Fasting LDL-C must be > 130 mg/dL (borderline high per NCEP ATP III criteria) at two
             qualifying visits: initial screening (Days -28 to -14) and Day -7.

        Exclusion Criteria:

          -  Poorly controlled type 1 or type 2 diabetes mellitus (HbA1c > 9.0%).

          -  History of a cardiovascular or cerebrovascular event (eg, MI, stroke, TIA) or related
             procedure (eg, angioplasty) during the past year.

          -  Subjects who meet the New York Heart Association (NYHA) criteria for congestive heart
             failure (CHF) classes III or IV.
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Condition: Healthy
Intervention: SPD503; Concerta; SPD503 + Concerta
Intervention description: SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets; CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.; SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).
Intervention MeSH terms: Methylphenidate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      This is a drug-drug interaction study; the purpose of this study is to examine the
      pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and
      Concerta (methylphenidate HCl) when given alone, and in combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be normal healthy adult volunteers with no significant abnormalities in
             medical history, physical exam, vital signs or lab evaluations at the screening visit
A Study of LY2409021 in Healthy Participants
Condition: Healthy Participants
Intervention: LY2409021
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to
      determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of
      the drug after the dose. This study will last approximately 28 days, not including screening.
      Screening can occur within 30 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or females as determined by medical history

          -  Satisfactory clinical laboratory and physical examination tests

          -  Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m^2)

        Exclusion Criteria:

        - Abnormal electrocardiograms (ECGs)
Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Metformin; Cisplatin; Radiation Therapy
Intervention description: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.; Dosed at 100mg/m2 on days 1, 22, and 43; 70 Gy in 2 Gy once daily fractions of 35 fractions
Intervention MeSH terms: Metformin; Cisplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety of adding metformin to standard of
      care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments
      and radiation for 7 weeks.

      Metformin is a medication that is currently used to treat diabetes. Increasing amounts of
      metformin will be given to groups of patients already receiving normal treatment for their
      cancer to see if metformin causes any good effects by killing your cancer or bad effects
      (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced squamous cell cancer of the head and neck, stage III or IV disease
             (T1-2, N2a-3 or T3-4).

          -  Measurable disease

          -  No prior chemotherapy or radiation for head and neck squamous cell cancer

          -  Life expectancy of greater than 3 months.

          -  Adequate labs

        Exclusion Criteria:

          -  Known metastatic disease.

          -  Nasopharyngeal carcinoma

          -  History of allergic reactions attributed to metformin or other agents used in study.

          -  Known diagnosis of diabetes requiring insulin for control.

          -  Administration of metformin within last 4 weeks.
Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Comparator: MK7009; Comparator: Placebo
Intervention description: Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.; MK7009 Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effectiveness, safety, and tolerability of
      MK7009 in patients infected with Hepatitis C
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a man or a woman aged 18 to 55 years of age.

          -  Subject has chronic Hepatitis C

          -  Subject is willing to not use alcohol for 2 weeks prior to therapy and through the
             study follow-up period

        Exclusion Criteria:

          -  Patient has evidence of advanced liver disease.

          -  Patient has human immunodeficiency virus (HIV)

          -  Patient has Hepatitis B
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
Condition: Healthy
Intervention: Evacetrapib; Omeprazole
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Omeprazole; Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect of increased stomach pH on how much
      evacetrapib is found in the blood stream and how long the body takes to get rid of it when
      given to healthy participants. Information about any side effects that may occur will also be
      collected.

      There are two parts to the study. Participation in both parts will be required.

      The study will last approximately 30 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy participants, as determined by medical history and physical
             examination

          -  Females must be of non-child-bearing potential

          -  Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Have known allergies to evacetrapib, omeprazole, related compounds, or any components
             of the evacetrapib or omeprazole formulations