bioihbjkbjnl/mcl2 huggingface dataset:
A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)
Condition: Advanced Cancer Relapsed; Advanced Cancer Refractory
MeSH terms: Neoplasms
Intervention: vorinostat; Comparator: placebo (unspecified)
Intervention description: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.; A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval
      in patients with relapsed or refractory advanced cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a histologically-confirmed metastatic or locally advanced solid tumor that
             has failed to respond to standard therapy, progressed despite standard therapy or for
             which standard therapy does not exist

          -  Patient has life expectancy of greater than 3 months

          -  Patient is able to swallow capsules

        Exclusion Criteria:

          -  Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to
             taking study drug

          -  Patient is currently participating or has participated in a study with an
             investigational compound or device within 30 days of signing informed consent

          -  Patient has active CNS metastases and/or carcinomatous meningitis

          -  Patient has primary central nervous system tumor

          -  Patient has a history of drug or alcohol abuse

          -  Patient has Hepatitis B or C

          -  Patient is HIV positive

          -  Patient has active infection or has received intravenous antibiotics, antiviral or
             antifungal agents 2 weeks before taking study drug
Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds
Condition: Normal Female Volunteers
Intervention: HP802-247
Intervention description: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal for this study is to examine the persistence of growth
      arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product
      HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured
      using Y-STR for detection of Y-chromosome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent.

          -  Female, 18 years of age or older.

          -  Any race or skin type, provided that there are no tattoos within 5 cm of the wound
             target, and the gentian violet surgical marker produces a clearly visible mark on the
             skin.

          -  Willing to make all required study visits and, in the opinion of the Investigator,
             able to follow instructions.

          -  Willing to undergo the repeated biopsy procedures.

          -  Willing to undergo verification of sex chromosome status.

        Exclusion Criteria:

          -  Males, or phenotypic females bearing Y-chromosome genetic material [e.g., 46,X,(r)Y;
             46,X,der(X)t(X;Y); sex reassignment surgery].

          -  Contraindications or hypersensitivity to the use of the study medications or their
             components (e.g., history of anaphylaxis, serum sickness, or erythema multiforme
             reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin,
             streptomycin, or amphotericin B).

          -  History of keloid formation or hypertrophic scarring.

          -  Participation in any interventional clinical trial within 30 days prior to screening.

          -  History of prolonged bleeding, bleeding into joints, easy bruising following minor
             trauma, clotting factor deficiency, or current use of anticoagulants or platelet
             inhibitors.

          -  Any medical condition which, in the opinion of the Co-Investigator, may interfere with
             normal wound repair.

          -  Current therapy with drugs or biologics intended to function as immuno-suppressants,
             chronic (> 10 days) oral corticosteroids, or any concomitant medication which, in the
             opinion of the Co-Investigator, may interfere with normal wound repair.
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin; Dapagliflozin
Intervention description: Tablet, Oral, 2.5 mg, Single-dose; Tablet, Oral, 5 mg, Single-dose; Tablet, Oral, 10 mg, Single-dose
Intervention MeSH terms: Dapagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin
      in pediatric subjects with type 2 diabetes mellitus (T2DM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of T2DM

          -  Male and female subjects ages 10-17

          -  Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%

          -  Body weight ≥30 kg

        Exclusion Criteria:

          -  Fasting plasma glucose (FPG) >240 mg/dL at screening

          -  Abnormal renal function

          -  Active liver disease and/or significant abnormal liver function
A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
Condition: Neoplasm
Intervention: PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210; PF-00337210
Intervention description: 0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous; 1mg Capsule Once Daily (Dose Escalation) Continuous; 2mg Capsule Once Daily (Dose Escalation) Continuous; 4mg Capsule Once Daily (Dose Escalation) Continuous; 6mg Capsule Once Daily (Dose Escalation) Continuous; 9mg Capsule Once Daily (Dose Escalation) Continuous; 8mg Capsule Once Daily (Dose Escalation) Continuous; 4mg Capsule Twice Daily (Dose Escalation) Continuous; 6mg Capsule Twice Daily (Dose Escalation) Continuous; 6mg Capsule Twice Daily (Dose Expansion) Continuous
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: VGEF inhibitor; Anti angiogenesis; Advanced Solid Tumors

Summary:

      This study will test a new cancer medication to determine if this medication will block blood
      supply to a tumor and decrease growth of a tumor. This study will also define the safety
      profile and define the safest dose of this new medication for people who have cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced solid tumors un-responsive to
             currently available therapies or for which there is no standard therapy.

          -  At least 1 measurable disease site as defined by Response Evaluation Criterion in
             Solid Tumors [RECIST].

          -  Adequate bone marrow, liver function and renal function as defined by protocol.

          -  Blood pressure Requirements During dose escalation - no evidence of pre-existing
             hypertension and no antihypertensive medications at baseline.

        During dose expansion - patient's whose hypertension is controlled by antihypertensive
        therapy.

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study
             entry

          -  Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.

          -  Patients with carcinomatous meningitis or un-treated brain metastases.

          -  Any acute cardiovascular incident within the past 12 months.

          -  Patients with active gastrointestinal bleeding or significant gastrointestinal
             abnormalities as defined by protocol

          -  Patients with no evidence of the following for 5 years: malignancy or metastatic
             disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or
             T1C prostate cancer.
A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects
Condition: Healthy Volunteers
Intervention: Entrectinib Form A; Entrectinib Form C
Intervention description: Participants will receive a single oral dose of entrectinib form A under fasted conditions.; Participants will receive a single oral dose of entrectinib form C under fasted conditions.
Intervention MeSH terms: Entrectinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to demonstrate similarities between two different forms of entrectinib (A and
      C) when administered under fasted conditions in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy in the opinion of the investigator. Healthy is defined by the absence of
             evidence of any active disease or clinically significant medical condition based on a
             detailed medical history and examination

          -  Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus
             (HIV)

          -  Females must not be pregnant or breastfeeding, and females of childbearing potential
             will agree to use highly-effective contraception. Females of childbearing potential
             must also agree to refrain from donating eggs during the treatment period and for 6
             weeks after the final dose of study drug

          -  Males must agree to use contraception and to refrain from sperm donation from check-in
             (Day -1 of Period 1) to 90 days after the final dose of study drug

        Exclusion Criteria:

          -  History of gastrointestinal surgery or other gastrointestinal disorder that might
             affect absorption of medicines from the gastrointestinal tract

          -  Presence of a clinically significant disease, illness, medical condition or disorder,
             or any other medical history determined by the investigator to be clinically
             significant and relevant. Ongoing chronic disorders which are not considered
             clinically significant are permissible providing they are stable

          -  Clinically significant change in health status, as judged by the investigator, or any
             major illness within the 4 weeks before screening, or clinically significant acute
             infection or febrile illness within the 14 days before screening

          -  Participation in any other clinical study involving an investigational medicinal
             product (IMP) or device within 30 days or 5 half-lives (if known), whichever is
             longer, before screening
CP-690,550 Thorough QTc Study
Condition: Healthy
Intervention: CP-690,550; Placebo; Moxifloxacin
Intervention description: Single dose 100 mg (5 x 20 mg tablets); Single dose placebo tablets (5 tablets); Single dose Avelox 400 mg tablet
Intervention MeSH terms: Moxifloxacin; Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TQT study; CP-690; 550

Summary:

      ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine
      whether intensive monitoring of QT interval in target patient populations is required during
      later stages of development. The current study is designed to ascertain whether CP-690,550 is
      associated with QTc prolongation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.

          -  Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
             (110 lbs).

        Exclusion Criteria:

          -  Use of tobacco- or nicotine-containing products in excess of equivalent of 5
             cigarettes per day.

          -  12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities
             at Screening.

          -  History of risk factors for QT prolongation or torsades de pointes.

          -  Pregnant or nursing women; women of childbearing potential unwilling or unable to use
             an acceptable method of nonhormonal contraception from at least 14 days prior to first
             dose until completion of follow-up.

          -  Use of prescription or nonprescription drugs, vitamins and dietary supplements within
             7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.

          -  Any clinically significant infections within past 3 months or evidence of infection in
             past 7 days.
Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-04937319 IR MST; PF-04937319 MR 1; PF-04937319 MR 2; PF-04937319 MR 3
Intervention description: Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch; Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST; Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST; Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 1; bioavailability; type 2 diabetes mellitus; PF-04937319

Summary:

      Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three
      modified release formulations of PF-04937319 compared with the immediate release
      material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with type 2 diabetes, on stable background metformin therapy either alone or in
             combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones
             (TZDs)

        Exclusion Criteria:

          -  Patients with cardiovascular event within 6 months of screening

          -  Patients with diabetic complications

          -  Female subjects who are pregnant or planning to become pregnant

          -  Subjects with unstable medical conditions (eg, hypertension)
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Pitolisant
Intervention description: Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the safety, tolerability and
      pharmacodynamics of pitolisant in patients with Type 1 Diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria: Diagnosis of diabetes => 4yrs, On Insulin => 4yrs, HbA1c<= 10%, At
             least one episode of severe hypoglycemia in past 12 months, fasting c-peptide <0.7
             ng/ml

        Exclusion Criteria:

          -  Hypoglycemia unawareness, DKA within 3 months prior to randomization, Reduced renal
             function, Anxiety and depression
Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Condition: Glucocorticoids Toxicity; Glucose Intolerance
MeSH terms: Glucose Intolerance
Intervention: Prednisone
Intervention description: Prednisone 60 mg tablet once
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: glucocorticoids; efficacy; metabolic toxicity

Summary:

      This study evaluates the effect of acute administration of oral prednisone in white blood
      cells counts and glucose tolerance and the relationship of these measures with changes in
      gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene
      expression will be study before and after prednisone administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 45 years old (to exclude the effect of age on glucose tolerance);

          -  BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired
             insulin response);

          -  Normal fasting glucose;

          -  Stable weight for three months before participation

        Exclusion Criteria:

          -  BMI >25kg/m2;

          -  Fasting glucose ≥126 mg/dl

          -  Shift work or disordered sleep (to exclude individuals with alterations in the
             hypothalamus-adrenergic axis);

          -  Any diseases;

          -  Use of any medication regularly (including over-the-counter);

          -  Previous exposure to glucocorticoids (within the last year);

          -  Pregnancy
Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers
Condition: Healthy Volunteer
Intervention: PF-02341066
Intervention description: oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of [14C]PF 02341066
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: radiolabeled; healthy volunteers

Summary:

      The rationale for this study is to investigate the absorption, metabolism and excretion of
      [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any
      metabolites, if possible, of [14C]PF 02341066 in humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 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/m^2; and a total body weight >50 kg (110
             lbs).

        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).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy).

          -  A positive urine drug screen.