bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Exenatide (Bydureon®); Placebo
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The goal of the proposed pilot study is to determine whether glucose control can be improved
      with Bydureon treatment in patients with type I diabetes (T1D)
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female aged 18-65 years who meets the American Diabetes Association standard
             T1DM criteria.

          -  Diagnosis of T1DM at least 2 years from Visit 0

          -  Insulin Requirement of ≤ 0.90 units/kg

          -  Absence of ketoacidosis in the past 6 months

          -  HbA1c of ≥ 6.5% and ≤ 9.5%

          -  Menstruating women must have a negative pregnancy test and be willing to avoid
             pregnancy during the study period

          -  Signed informed consent

        Exclusion Criteria:

          -  Inability or unwillingness to give informed consent

          -  Current or prior use of immunomodulators or systemic steroids in the last 6 months
             that could potentially affect diabetes or immunologic status.

          -  Known hypersensitivity to Exenatide, Liraglutide or any product component.

          -  Participation in an investigational treatment trial within the last 6 weeks before
             enrollment.

          -  1 or more episodes of hypoglycemia (loss of consciousness or requiring the help of
             others) within the last 6 months.

          -  Another condition that would, in the view of the investigator, affect the safety of
             using Bydureon. This might include, among others a history of MEN 2, a history of
             medullary carcinoma of the thyroid or pancreatitis.

          -  Known severe renal impairment, end-stage renal disease or renal transplantation.

          -  Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis,
             thyroid nodules or malignancy with the exclusion of a history of localized basal cell
             carcinoma.

          -  Uncompensated heart failure, fluid overload, myocardial infarction or liver disease
             within the last 6 weeks before enrollment.

          -  Clinically active serious infection.

          -  Positive pregnancy test in menstruating women or lactating females.

          -  Concurrent use of Pramlinitide, other Incretin medications, or other anti-diabetes
             medications other than insulin.
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
Condition: Hypercholesterolemia and High Risk for Cardiovascular Events
MeSH terms: Hypercholesterolemia
Intervention: Evolocumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 310.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Japanese, hypercholesterolemia, high risk for cardiovascular events

Summary:

      The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every
      2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in
      low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in
      Japanese adults with hypercholesterolemia and high cardiovascular risk.
    

Eligibility criteria:

        Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable
        dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0
        mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion
        Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled
        hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left
        ventricular ejection fraction < 30%, myocardial infarction, unstable angina, percutaneous
        coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac
        surgery or revascularization within 6 months of randomization, uncontrolled cardiac
        arrhythmia.
A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Intervention: CPC-201
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 50 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple
      Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with
      Alzheimer's Disease Type Dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 50 - 79 years inclusive.

          -  Meeting the diagnosis of probable Alzheimer's Disease

          -  Of moderate severity (Mini-Mental Status Exam [MMSE] score 10 - 20 inclusive).

          -  Patients must be in generally good health as indicated by their medical history and
             physical examination, vital signs, electrocardiogram (ECG), and standard laboratory
             tests.

        Exclusion Criteria:

          -  Women of child bearing potential.

          -  History or presence of a seizure disorder.

          -  History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive
             pulmonary disease.

          -  History or presence of bladder outflow obstruction, gastrointestinal obstructive
             disorder or reduced GI motility, or narrow-angle glaucoma.

          -  History or presence of gastrointestinal, hepatic, or renal disease, or other condition
             known to interfere with the absorption, distribution, metabolism or excretion of
             drugs.

          -  History or presence of myasthenia.

          -  Known hypersensitivity to donepezil, solifenacin or related drugs.

          -  Any other clinically relevant acute or chronic diseases which could interfere with
             patients' safety during the trial, or expose them to undue risk, or which could
             interfere with study objectives.

          -  Patients who have participated in another clinical trial with an investigational drug
             within previous 30 days.
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Erlotinib; Placebo
Intervention description: Participants received erlotinib 150 mg tablet orally once daily.; Participants received placebo matching to erlotinib 150 mg tablet orally once daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to identify biomarkers which may predict improvement in progression
      free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who
      failed one prior regimen of standard chemotherapy or who are deemed unsuitable for
      chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient
      population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po
      daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study
      treatment is until disease progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  histologically or cytologically documented locally advanced-unresectable or metastatic
             pancreatic cancer;

          -  measurable disease according to RECIST;

          -  failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for
             chemotherapy;

          -  ECOG performance status of 0-2.

        Exclusion Criteria:

          -  local or locally advanced-resectable pancreatic cancer;

          -  any other malignancies within last 5 years, except for adequately treated cancer in
             situ of the cervix, or basal or squamous cell skin cancer;

          -  major surgery within 2 weeks prior to randomization.
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Venetoclax
Intervention description: Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Oncology; Chronic Lymphocytic Leukemia; Cancer of the blood and bone marrow

Summary:

      This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy
      and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic
      leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets
             2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer
             Institute-Working Group (IWCLL NCI-WG) criteria

          -  Participant has relapsed/refractory disease with an indication for treatment

          -  Participant has refractory disease or developed recurrence after therapy with a B-cell
             receptor pathway inhibitor (BCR PI)

          -  Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2

          -  Participant must have adequate bone marrow function at Screening

          -  Participant must have adequate coagulation profile, renal, and hepatic function, per
             laboratory reference range at Screening

        Exclusion Criteria:

          -  Participant has undergone an allogeneic stem cell transplant within the past year

          -  Participant has developed Richter's transformation confirmed by biopsy

          -  Participant has active and uncontrolled autoimmune cytopenia

          -  Participant has malabsorption syndrome or other condition that precludes enteral route
             of administration

          -  Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B
             or hepatitis C virus requiring treatment

          -  Participant has known contraindication or allergy to both xanthine oxidase inhibitors
             and rasburicase
Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Danicopan
Intervention description: Danicopan was administered as multiple oral doses over a period of at least 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal; Hemoglobinuria

Summary:

      The purpose of this study was to determine the safety and efficacy of ACH-0144471 (also known
      as danicopan and ALXN2040) in currently untreated participants with PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently untreated PNH participants with PNH Type III erythrocyte and/or granulocyte
             clone size ≥10% and anemia (hemoglobin <12 grams/deciliter) with adequate
             reticulocytosis (as determined by the Investigator).

          -  LDH ≥1.5 x the upper limit of normal.

          -  Platelets ≥50,000/microliter without the need for platelet transfusions.

          -  Documentation of vaccination for Neisseria meningitidis, Haemophilus influenza, and
             Streptococcus pneumoniae, or willingness to receive vaccinations during the screening
             period.

          -  Negative pregnancy test for females prior to dosing and throughout the study.

        Exclusion Criteria:

          -  History of a major organ transplant (for example, heart, lung, kidney, liver) or
             hematopoietic stem cell/marrow transplant.

          -  Participants who had received another investigational agent within 30 days or 5
             half-lives of the investigational agent prior to study entry, whichever is greater.

          -  Participants who had received eculizumab at any dose or interval within the past 75
             days before study entry.

          -  Participants with known or suspected complement deficiency.

          -  Participants with active bacterial infection or clinically significant active viral
             infection, a body temperature >38°Celsius, or other evidence of infection on Day 1, or
             with a history of febrile illness within 14 days prior to first study drug
             administration.

          -  History of meningococcal infection, or a first-degree relative or household contact
             with a history of meningococcal infection.

          -  Females who were pregnant, nursing, or planning to become pregnant during the study or
             within 90 days of study drug administration or participants with a female partner who
             was pregnant, nursing, or planning to become pregnant during the study or within 90
             days of study drug administration.
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Condition: Diabetes; Metabolic Syndrome; Insulin Resistance
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Insulin Resistance
Intervention: pegvisomant
Intervention description: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Growth hormone antagonism

Summary:

      Growth hormone is well known to cause changes in glucose regulation. People with Laron
      syndrome are born without the growth hormone receptor and are protected from diabetes. Mice
      who are engineered without the growth hormone receptor are similarly protected from diabetes.
      Conversely, people who have excessive amounts of growth hormone, such as patients with
      acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment
      with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the
      growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been
      explored as a possibility for the treatment of type 2 diabetes or insulin resistance in
      people without acromegaly. In this study, the investigators hope to study the metabolic
      effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is
      expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum
      free fatty acids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI between 18-35

          -  Homeostatic model assessment - insulin resistance (HOMA-IR) >2.77

          -  Able to administer daily subcutaneous injections of pegvisomant

        Exclusion Criteria:

          -  Pregnancy

          -  Breastfeeding in the last 6 months

          -  Liver function tests greater than 3x the upper limits of normal

          -  unstable diet over the last 3 months

          -  unstable weight over the last 6 months

          -  unstable lipid lowering regimen

          -  diabetes - type 1 or type 2

          -  History of major gastrointestinal surgery

          -  History of pancreatic, liver, biliary, or intestinal disease

          -  Fasting blood glucose >126

          -  Fasting triglycerides>500

          -  A1c>6.5
A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Placebo; AC-201; Febuxostat
Intervention description: Placebo twice daily from Day 1 to Week 12; AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12; Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR
      in an initial dosing period, followed by the addition of a ULT to test the efficacy and
      safety of the combination and prophylaxis of gout flares during ULT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 20 to 65 years, inclusive.

          2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for
             the classification of acute arthritis of primary gout (Appendix 2), OR have proven
             tophus or documented monosodium urate (MSU) crystals in the joint fluid.

          3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare
             within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at
             screening with or without prior gout flares.

        Exclusion Criteria:

          1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2
             weeks prior to screening.

          2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the
             screening period through baseline.

          3. Use of colchicine within 1 week prior to screening.

          4. Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.

          5. Allergy, contraindication, or intolerance to febuxostat.

          6. Severe renal impairment.

          7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration >2
             times the upper limit of laboratory normal range (>2x ULN) at screening.
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide 400 μg bid; Tiotropium 18 μg once-daily; Placebo
Intervention description: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.; Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.; Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Antimuscarinic

Summary:

      The main purpose of this study is to evaluate the efficacy, safety and tolerability of
      multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female patients aged 40 with stable moderate to severe COPD (GOLD
             guidelines).

          -  Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol
             FEV1/FVC < 70%.

          -  Current or ex smokers of 10 pack-years.

        Exclusion Criteria:

          -  Patients with no history or current diagnosis of asthma.

          -  No evidence of an exacerbation within 6 weeks prior to the screening visit.

          -  No evidence of clinically significant respiratory and/or cardiovascular conditions or
             laboratory abnormalities.

          -  No contraindication to use of anticholinergic drugs such as known symptomatic
             prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.