bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
Condition: Healthy Subjects
Intervention: Exenatide; Moxifloxacin; Placebo comparator
Intervention description: IV Exenatide (therapeutic and supratherapeutic concentrations); Oral Moxifloxacin (400 mg); IV Placebo (matching volume of placebo)
Intervention MeSH terms: Exenatide; Moxifloxacin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes; exenatide; Amylin; Lilly; QT interval

Summary:

      Compare the effect of exenatide (therapeutic and supratherapeutic concentrations),
      moxifloxacin and placebo on the QT interval.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is overtly healthy, as determined by medical history and physical examination

          -  Has body mass index (BMI) between 25 and 35 kg/m2

          -  Has fasting serum glucose <110 mg/dL

          -  Has no clinically significant blood pressure or heart rate readings as judged by the
             investigator at study start

          -  Has electrocardiogram (ECG) results judged as not clinically significant by the
             investigator at study start

        Exclusion Criteria:

          -  Has a clinically significant medical condition that could potentially affect study
             participation and/or personal well-being

          -  Has an abnormality in the 12-lead ECG that, in the opinion of the investigator,
             increases the risk of participating in the study, such as a Bazett's corrected QT
             (QTcB) interval >450 ms.

          -  Family history of sudden death

          -  Personal history of unexplained syncope within last year, or family history of Long QT
             Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or
             transient ischemic attacks within the previous 6 months
Safety Study of PLX108-01 in Patients With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: PLX3397
Intervention description: Capsules administered once or twice daily, continuous dosing
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PVNS

Summary:

      PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary
      objective of this study is to evaluate the safety and pharmacokinetics of orally administered
      PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are
      linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic
      activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 and older

          -  Solid tumors refractory to standard therapy

          -  For the Extension cohorts, patients must have measurable disease by RECIST criteria
             and meet the following disease-specific criteria:

               -  For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland,
                  patients must not be candidates for curative surgery or radiotherapy.

               -  For pigmented villo-nodular synovitis (PVNS), patients must have a histologically
                  confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable
                  tumor requesting mutilating surgery, as well as demonstrated progressive disease
                  in the last 12 months.

               -  For gastrointestinal stromal tumors (GIST), patients must have failed previous
                  therapy with imatinib and sunitinib. Patients with known PDGFR mutations are
                  excluded, but mutation testing is not required for study entry.

               -  For anaplastic thyroid cancer (ATC), patients must have histologically or
                  cytologically diagnosed advanced ATC.

               -  For metastatic solid tumors with documented malignant pleural and/or peritoneal
                  effusions, patients must not be receiving specific therapy for the effusion or
                  have an indwelling drain.

          -  Eastern Cooperative Oncology Group performance status 0 or 1

          -  Life expectancy >= 3 months

          -  Adequate hepatic, renal, and bone marrow function

        Exclusion Criteria:

          -  Specific anti-cancer therapy within 3 weeks of study start

          -  Uncontrolled intercurrent illness

          -  Refractory nausea or vomiting, or malabsorption

          -  Mean corrected QT interval (QTc) >= 450 msec (for males) or QTc >= 470 msec (for
             females)
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: rizatriptan benzoate (5 mg); rizatriptan benzoate (10 mg); Rizatriptan 5 mg Placebo; Rizatriptan 10 mg Placebo
Intervention description: A single dose of rizatriptan 5 mg administered on Day 1.; A single dose of rizatriptan 10 mg administered on Day 1.; A single dose of rizatriptan 5 mg placebo administered on Day 1.; A single dose of rizatriptan 10 mg placebo administered on Day 1.
Intervention MeSH terms: Rizatriptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed
      drug in pediatric subjects with migraines.

      After completion of a portion of the study (Panels A and B), a regulatory agency issued an
      amended request that the 12-17 year old age group studied should include a similar number of
      male and female subjects. Therefore, the study was amended to add an additional panel of
      subjects (Panel C) to ensure gender balance specifically in this age group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of
             migraines

          -  Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines

          -  Subject has a history of migraine headaches, and is not experiencing a migraine on the
             day of study drug administration

        Exclusion Criteria:

          -  Subject has no history of migraine headaches

          -  Taking medications that are monoamine oxidase inhibitors (MAOI) and selective
             serotonin reuptake inhibitors (SSRI)

          -  Subject has a condition which, in the opinion of the investigator, may interfere with
             optimal participation in the study
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention description: SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.; Placebo Capsule(s) for oral use taken once daily for 30 days
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      This is a multiple ascending dose study; the purpose of this study is to examine the safety,
      tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic
      Patients who are currently maintained on a stable dose of an antipsychotic medication.
    

Eligibility criteria:

        Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not
        have any cardiac risk factors
Afatinib and Vinorelbine in Tumours Known to Overexpress EGFR and/or HER2
Condition: Neoplasms
Intervention: BIBW 2992 low (20mg) dosage; BIBW 2992 medium (40mg) dosage; BIBW 2992 high (50mg) dosage; Vinorelbine per os 60 mg/m²; Vinorelbine per os 80 mg/m²; Vinorelbine i.v. 25 mg/m²
Intervention description: Patients will receive 20mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.; Patients will receive 40mg dosage per day of BIBW 2992 plus standard dosage of vinorelbine.; Patients will receive 50mg dosage of BIBW 2992 plus standard dosage of vinorelbine.; Patients will receive 60 mg/m² Vinorelbine per os at J1 J8 and J15; Patients will receive 80 mg/m² Vinorelbine per os at J22; Patients will receive 25 mg/m² of Vinorelbine i.v.
Intervention MeSH terms: Vinorelbine; Afatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of
      oral BIBW 2992 in combination with intravenous or oral vinorelbine
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically or cytologically confirmed diagnosis of malignancy that is now
             advanced, non resectable and/or metastatic

          -  Tumours historically known to overexpress EGFR and/or HER2

        Exclusion criteria:

          -  Prior treatment with HER2 inhibiting drugs within the past 4 weeks before the start of
             therapy or concomitantly with this trial.

          -  Prior treatment with EGFR inhibiting drugs within the past two weeks before the start
             of therapy or concomitantly with this trial.
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
Condition: Dupuytren's Contracture
MeSH terms: Dupuytren Contracture; Contracture
Intervention: collagenase clostridium histolyticum
Intervention description: Single dose of AA4500 0.58 mg into the cord
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Assessment of AUX I and/or AUX II in human plasma

Summary:

      A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's
      contracture conducted at one site in the United States. All subjects received a single dose
      of AA4500 0.58 mg, which was injected directly into the cord affecting either the
      metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood
      samples were collected before dosing, at predetermined time points through the 24 hours after
      dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after
      the AA4500 0.58 injection.

      This study was designed to be part of the larger clinical program, for adult patients with
      Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
      Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7
      non-pivotal studies were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity
             of at least one finger, other than the thumb, that had a contracture at least 20°, but
             not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.

          -  Had a positive "table top test," defined as the inability to simultaneously place the
             affected finger(s) and palm flat against a table top.

          -  Were naive to AA4500 treatment.

          -  Were judged to be in good health.

        Exclusion Criteria:

          -  Had a chronic muscular, neurological, or neuromuscular disorder that affected the
             hands.

          -  Had received treatment for Dupuytren's contracture within 90 days of the AA4500
             injection to the MP or PIP selected, including surgery (fasciectomy or surgical
             fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or
             interferon on the selected primary joint within 90 days before the first dose of study
             drug.

          -  Had a known recent history of stroke, bleeding, a disease process that affected the
             hands, or other medical condition, which in the investigator's opinion, would make the
             subject unsuitable for enrollment in the study.
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets
Condition: Healthy
Intervention: 1 tablet Empagliflozin/2 tablets Metformin XR; 10 mg Empagliflozin/1000 mg Metformin XR; 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR; 2 tablets 5 mg Empagliflozin/750 Metformin XR; 1 tablet Empagliflozin/2 tablets Metformin XR; 10 mg Empagliflozin/1000 mg Metformin XR
Intervention description: Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet; Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets; Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets; Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets; Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
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: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single
      tablets of empagliflozin and metformin XR when administered singularly
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males or females

          2. Age 18-50 years (incl.)

          3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

          4. Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

        Any deviation from healthy condition
Effect of Footwear on the Clinical, Functional, and Biomechanical Aspects in Elderly Women With Knee Osteoarthritis (OA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Flexible footwear
Intervention description: The patients of the Intervention Group (IG) will be use over 6 month a flexible and non-heeled footwear (Moleca; Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a women's flexible flat walking shoe, without heels, with an anti-slip rubber sole, 5-mm thin, with a 3 mm internal wedge of ethylene vinyl acetate, made out of dubbed canvas. It had a mean weight of 172 ± 19.6 g, ranging from 142 to 193 g depending upon the size.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 56.0
Sex: Female
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Knee osteoarthritis; Shoes; Gait; Biomechanics

Summary:

      The purpose of this study is to determine whether inexpensive, flexible and non-heeled
      footwear is effective in improving of clinical, functional and gait biomechanics in elderly
      women with knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kellgren and Lawrence grade 2 or 3

          -  Being able to walk independently for at least 6 hours per day without the aid of canes
             or attendant to perform their activities of daily living

          -  Knee pain between 3 and 8 on the visual analogue scale

        Exclusion Criteria:

          -  Previous history of surgery on knees, ankles and hips in the last 2 years

          -  Neurological disease

          -  BMI > 35 kg/m2

          -  Difference in lower limb length > 1 cm

          -  Prostheses and / or lower limb orthoses

          -  Having received steroid injections and hyaluronic acid intra-articular knee in
             previous periods of three and six months respectively

          -  Present at the knee joint instability (positive test results in the medial collateral
             ligament, lateral, anterior and posterior drawer)

          -  OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine

          -  Inflammatory arthritis (eg. rheumatoid arthritis)

          -  Asymptomatic OA of one or both knees

          -  Dementia or inability to provide consistent information

          -  Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks
             before inclusion or change of dosage of the same after the inclusion

          -  Being under physiotherapy or acupuncture treatment

          -  Patients with an indication of prosthesis or orthosis

          -  Patients who are already using a flexible and non-heeled shoes for more than 25 hours
             per week (3 ½ hours per day) over the past 6 months
A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet
Condition: Healthy
Intervention: BI 730357; BI 730357 mixed with [C-14] BI 730357 BS
Intervention description: Oral dose; Intravenous dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared
      with [C-14]BI 730357 BS administered as intravenous microtracer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, as based on a
             complete medical history including a physical examination, vital signs (Blood Pressure
             (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 65 years (inclusive)

          -  Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
             or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg,
             diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the
             range of 40 to 100 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease assessed as clinically relevant by the
             investigator

          -  Clinically significant gastrointestinal (including known or suspected inflammatory
             bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological
             or hormonal disorders

          -  Further exclusion criteria apply
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Condition: Healthy
Intervention: PF-06463922; rifampin
Intervention description: 100 mg oral dose on day 1 in period 1 and on day 8 in period 2; 600 mg QD from day 1 to day 12 in period 2.
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rifampin; pharmacokinetics; PF-06463922; drug interaction

Summary:

      The purpose of this study is to estimate the effect of rifampin on the single dose PK of
      PF-06463922.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non-childbearing potential and/or male subjects who, at the
             time of screening, are between the ages of 18 and 55 years, inclusive

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; 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

          -  Any condition possibly affecting drug absorption

          -  Positive urine drug screen

          -  History of HIV, Hep B or Hep C

          -  History of regular alcohol consumption

          -  History of cardiac arrhythmia, history of AV block, history of symptomatic
             bradycardia, history of QTc prolongation

          -  History of pancreatitis or hyperlipidemia, elevated lipase