bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; PF-06649751 low dose (1 mg QD); PF-06649751 middle dose 1 (3 mg QD); PF-06649751 middle dose 2 (7 mg QD); PF-06649751 high dose (15 mg QD)
Intervention description: Placebo; PF-06649751 low dose (1 mg QD); PF-06649751 lower middle dose 1 (3 mg QD); PF-06649751higher middle dose 2 (7 mg QD); PF-06649751 high dose (15 mg QD)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson Disease; Motor Fluctuation

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751
      in Parkinson's disease patients who experience motor-fluctuations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential and/or male subjects between the ages of 40 and
             85 years, inclusive.

          -  Clinical diagnosis of Parkinson's disease.

          -  Able to refrain from any Parkinson's disease medication not permitted by the protocol.

        Exclusion Criteria:

          -  Female of childbearing potential

          -  History or presence of atypical Parkinsonian syndrome.

          -  History of surgical intervention for Parkinson's disease.

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality.

          -  Any condition possibly affecting drug absorption.

          -  Participation in other studies involving investigational drug(s), or treatment with
             any investigational drug within 30 days.
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
Condition: Arthroplasty, Replacement, Knee; Venous Thrombosis
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Dabigatran etexilate; Dabigatran etexilate; Dabigatran Etexilate; placebo
Intervention description: Dabigatran etexilate 110 mg capsule, once a day, oral administration; Dabigatran etexilate 150 mg capsule, once a day, oral administration; Dabigatran etexilate 220 mg capsule, once a day, oral administration; matching placebo capsule, once a day, oral administration
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 512.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The goal of this study is to evaluate the comparative efficacy and safety of three different
      doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to
      placebo, in prevention of venous thromboembolism in patient with primary elective total knee
      replacement surgery, and to evaluate dose-response.
    

Eligibility criteria:

        Inclusion criteria Inclusion criteria

          1. Patients scheduled to undergo a primary, unilateral elective total knee replacement

          2. Male or Female 20 years of age or order

          3. Patients weighing at least 40 kg

          4. Written informed consent prior to the start of study participation

        Exclusion criteria Exclusion criteria

          1. History of bleeding diathesis

          2. Constitutional or acquired coagulation disorders that in the investigator's judgment
             puts the patient at excessive risk for bleeding

          3. Major surgery or trauma (e.g. hip fracture) within the last 3 months

          4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time
             of enrollment (investigator's judgment) or history of myocardial infarction within the
             last 3 months

          5. Any history of hemorrhagic stroke or any of the following intracranial pathologies:
             bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding
             history

          6. Condition requiring anti-coagulant therapy

          7. Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any
             history of clinically relevant liver disease

          8. Patients with a history of clinically significant renal diseases or with elevated
             creatinine values
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Intervention: PA-824
Intervention description: 200 mg, 600 mg, 100 mg, 1200 mg qd
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Early Bactericidal Activity; EBA; pulmonary tuberculosis; PA-824; Pretomanid; CL-007

Summary:

      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly
      diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard
      TB treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  informed consent

          -  M/F 18-64 yo

          -  newly diagnosed pulmonary TB

          -  sputum positive

          -  adequate contraception

        Exclusion Criteria:

          -  poor health

          -  rifampicin resistance

          -  treatment with other anti TB agents in last 3 mos.

          -  extrapulmonary TB

          -  COPD

          -  neuropathy

          -  ECG wih QRS prolongation ove 120 msec

          -  CV disorder

          -  diabetes requiring insulin

          -  Metabolic disease

          -  drug/alcohol abuse

          -  pregnancy

          -  use of substances that are strong inhibitors/inducers of CYP450

          -  use of ARV
Pharmacokinetics/Pharmacodynamics of Albiglutide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide (GSK716155); albiglutide (GSK716155)
Intervention description: subcutaneous injection administered once a week; subcutaneous injection administered once a week
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pharmacokinetics; pharmacodynamics; GSK716155; albiglutide

Summary:

      The first part of the study includes a single dose treatment period to evaluate the
      pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug
      substance compared with process 3 drug substance. The second part of the treatment period
      will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and
      tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug
      substance compared with process 3 drug substance. Subjects with type 2 diabetes whose
      glycemia is inadequately controlled on their current regimen of diet and exercise or stable
      dose of metformin will be recruited into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing
             inadequate glycemic control on their current regimen of diet and exercise or on a
             stable dose of metformin

          -  Body mass index ≥20 kg/m2 and ≤45 kg/m2

          -  Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)

          -  Thyroid-stimulating hormone level is normal or clinically euthyroid

          -  Female subjects of childbearing potential (i.e., not surgically sterile and/or not
             postmenopausal) must be practicing adequate contraception.

        Exclusion Criteria:

          -  Current ongoing symptomatic biliary disease or history of pancreatitis

          -  History of significant GI surgery

          -  Recent clinically significant cardiovascular and/or cerebrovascular disease

          -  History of human immunodeficiency virus infection

          -  History of, or current hepatic disease

          -  History of alcohol or substance abuse

          -  Female subject is pregnant, lactating, or <6 weeks postpartum

          -  History of type 1 diabetes

          -  Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is
             longer, before Screening or a history of receipt of an investigational antidiabetic
             drug within the 3 months before randomization, or receipt of any GLP-1 agents
             including albiglutide

          -  History of, or family history of thyroid disease
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Tivozanib; Sunitinib
Intervention MeSH terms: Sunitinib; Tivozanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tivozanib hydrochloride; renal cell carcinoma; subject preference; quality of life

Summary:

      Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and
      sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for
      Renal Cell Carcinoma (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unresectable mRCC

          -  Histologically or cytologically confirmed RCC of any histology

          -  Subjects with or without prior nephrectomy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Any prior systemic therapy for treatment of mRCC (including investigational or
             licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of
             rapamycin [mTOR] inhibitors)

          -  Central nervous system malignancies or metastases

          -  Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or
             coagulation disorders

          -  Significant serum chemistry or urinalysis abnormalities

          -  Significant cardiovascular disease, including symptomatic left ventricular ejection
             fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled
             hypertension, myocardial infarction or severe angina within 6 months prior to
             administration of first dose of study drug, history of class III or IV congestive
             heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or
             coronary or peripheral bypass graft within 6 months of screening

          -  Corrected QT interval (QTc) of >480 msec using Bazett's formula

          -  Currently active second primary malignancy
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: 100 mg AMG 162; 60 mg AMG 162; 14 mg AMG 162; Placebo
Intervention description: 100 mg AMG 162 (denosumab) SC every 6 months; 60 mg AMG 162 (denosumab) SC every 6 months; 14 mg AMG 162 (denosumab) SC every 6 months; Placebo SC every 6 months
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 212.0
Sex: Female
Maximum age: 80 Years
Healthy volunteers: No
Keywords: RANKL; RANK; denosumab; AMG 162; osteoporosis; bone turnover; bone mineral density; Japanese

Summary:

      The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment
      on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60
      and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared
      with those treated with placebo over 12 months.
    

Eligibility criteria:

        Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must
        be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD
        values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and
        0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH
        derivatives use within the last 12 months and administration of any of anti-osteoporotic
        treatments within the last 3 months before initial administration of the investigational
        product. - History of hypocalcemia. - More than two moderate vertebral fractures or any
        severe vertebral fracture.
Broccoli Sprout Intervention in Qidong, P.R. China
Condition: Environmental Carcinogenesis
MeSH terms: Carcinogenesis
Intervention: Broccoli Sprout Extract Beverage; placebo beverage
Intervention description: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.; 100 mL of dilute pineapple and lime juice daily for 84 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 291.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: glucoraphanin; sulforaphane; pharmacokinetics; pharmacodynamics; broccoli sprout; carcinogens, environment

Summary:

      This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be
      conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships
      will be screened and three hundred eligible individuals will be enrolled in the study.
      Participants will be randomized into two treatment groups: one will receive a juice beverage
      containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice,
      lime juice, and water and the other will receive a placebo beverage containing pineapple
      juice, lime juice and water. Participants will drink their assigned beverage every evening
      and provide biweekly urine samples and monthly blood samples. The principal endpoints of this
      study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their
      metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of
      exposure biomarkers for dietary and air-borne toxins, which are known to be high in this
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 21-65 years

          -  in good general health with no history of chronic illness

          -  normal liver function tests: alanine aminotransferase (ALT), aspartate
             aminotransferase (AST), bilirubin)

          -  normal renal function tests (creatinine, blood urea nitrogen, urinalysis)

          -  serum alpha-fetoprotein negative

        Exclusion Criteria:

          -  personal history of cancer except for non-melanoma skin cancer

          -  use of prescribed medications

          -  hepatomegaly by clinical exam

          -  for women, a positive pregnancy test
A Long-Term Extension Study of AT2101 (Afegostat Tartrate) in Type 1 Gaucher Patients
Condition: Gaucher Disease; Type 1 Gaucher Disease; Gaucher Disease, Type 1
MeSH terms: Gaucher Disease
Intervention: afegostat tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; AT2101; afegostat tartrate; isofagomine tartrate

Summary:

      This study evaluated the long-term safety and efficacy of afegostat tartrate in participants
      with Gaucher disease who were enrolled in a previous Phase 2 study of afegostat tartrate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants, 18 years of age or older

          -  Completed study GAU-CL-202 with no significant protocol violations or safety concerns

          -  Clinically stable

          -  Had not received enzyme replacement therapy (ERT) or substrate reduction therapy (SRT)
             in the past 12 months and was willing not to initiate ERT or SRT during study
             participation

          -  Agreed to practice an acceptable method of contraception

          -  Provided written informed consent to participate in the study

        Exclusion Criteria:

          -  During the screening period, had any clinically significant findings which would
             compromise the safety of the participant, or preclude the participant from completing
             the study as deemed by the investigator

          -  Had a clinically significant disease, severe complications from Gaucher disease, or
             serious intercurrent illness that may preclude participation in the study, in the
             opinion of the Investigator

          -  Had a history of allergy or sensitivity to the study drug or any excipients, including
             any prior serious allergic reaction to iminosugars (for example, miglustat)

          -  Had a pacemaker or other contraindication for magnetic resonance imaging scanning

          -  Was pregnant or breast-feeding

          -  Had current gastrointestinal, liver, or kidney disease, sequelae of these diseases, or
             other conditions known to interfere with the absorption, distribution, metabolism, or
             excretion of drugs

          -  Participant was otherwise unsuitable for the study in the opinion of the Investigator
Effect of Verb Network Strengthening Treatment (VNeST) on Lexical Retrieval in Aphasia
Condition: Aphasia
MeSH terms: Aphasia
Intervention: Verb Network Strengthening Treatment
Intervention description: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aphasia; therapy; treatment; verbs; sentences

Summary:

      The purpose of this study is to evaluate the effect of Verb Network Strengthening Treatment
      (VNeST) on the ability to produce sentences and connected speech in persons with aphasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans with a diagnosis of aphasia

          -  primary language is English

          -  aphasia due to stroke

        Exclusion Criteria:

          -  Functionally bilingual
Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Tivozanib Hydrochloride; paclitaxel; Placebo
Intervention MeSH terms: Paclitaxel; Tivozanib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tivozanib hydrochloride; triple negative breast cancer; paclitaxel; pharmacokinetics; biomarkers; metastatic breast cancer; mBC; TNBC

Summary:

      This is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study
      for subjects with locally recurrent or metastatic triple negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally recurrent or metastatic TNBC, defined as ER/PR <1%, HER2 0-1+, or 2+ with
             negative FISH

          -  Measurable disease per RECIST version 1.1

          -  ECOG performance status of 0 or 1

          -  Confirmed available archival tumor tissue.

        Exclusion Criteria:

          -  More than 1 prior systemic chemotherapy for treatment of locally recurrent or
             metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the
             subject did not progress within 12 months of taxane based therapy

          -  Prior treatment with VEGF pathway targeted agent

          -  Major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first
             dose of study drug

          -  Known history of central nervous system metastasis (subjects with previously treated
             (radiotherapy or surgery) brain metastasis that have been stable off steroids or
             enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment
             may be enrolled)

          -  Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or
             coagulation disorders

          -  Significant serum chemistry or urinalysis abnormalities

          -  Significant cardiovascular disease, including: uncontrolled hypertension; myocardial
             infarction or unstable angina within 6 months prior to administration of first dose of
             study drug; and symptomatic left ventricular dysfunction or baseline left ventricular
             ejection fraction (LVEF) by multigated acquisition scan (MUGA) or ECHO.

          -  Severe peripheral neuropathy ≥ Grade 2

          -  Currently active second primary malignancy