bioihbjkbjnl/mcl2 huggingface dataset:
Tiotropium In Exercise
Condition: Pulmonary Disease, Chronic Obstructive; Exercise
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium 18 mcg; Placebo
Intervention description: Oral inhalation once daily of 18mcg tiotropium via handihaler; Oral inhalation of once-daily placebo matching tiotropium via handihaler
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 519.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the effects on exercise duration of 96 weeks
      treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in
      patients with COPD.
    

Eligibility criteria:

        Inclusion criteria

          1. All patients must sign an informed consent

          2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)

          3. Age >= 40 years

          4. Medical Research Council Dyspnoea score >= 2

          5. Current or ex-smoker with a >= 10 pack-year smoking history

          6. Ability to exercise on treadmill

        Exclusion criteria

          1. Significant diseases other than COPD such as history of life-threatening pulmonary
             obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF,
             pulmonary thromboembolic disease, clinically evident bronchiectasis, active
             tuberculosis, or known moderate to severe renal impairment

          2. Clinical history of asthma

          3. Use of supplemental oxygen therapy

          4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or
             during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)

          5. Recent history (<= 12 months) of myocardial infarction

          6. Unstable or life-threatening cardiac arrhythmia

          7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years

          8. Pregnant or nursing women

          9. Known hypersensitivity to anticholinergic drugs or any component of the study
             medications

         10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1

         11. Estimated life expectancy < 2 years

         12. Symptomatic prostatic hyperplasia or bladder neck obstruction

         13. Known narrow-angle glaucoma

         14. Any condition that is contraindicated for exercise

         15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with
             regular participation in aerobic exercise or with exercise testing

         16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Carboplatin
Intervention description: Induction Therapy: 500 milligrams per square meter (mg/m^2) given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.
Maintenance Therapy: 500 mg/m^2 given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.; Dosage equal to area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Non-squamous

Summary:

      To investigate efficacy and safety of the combination with pemetrexed plus carboplatin,
      followed by pemetrexed in patients with advanced nonsquamous Non Small Cell Lung Cancer
      (NSCLC) who receive at least one dose of the induction therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-squamous cell Non Small Cell Lung Cancer (NSCLC) disease

          -  Clinical stage IIIB/IV or recurrent disease after surgery

          -  No prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy,
             including adjuvant therapy

          -  Prior radiation therapy is allowed to less than 25% of the bone marrow

          -  Measurable disease as defined by response evaluation criteria in solid tumors (RECIST)

          -  The Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate organ function

          -  Estimated life expectancy of at least 12 weeks

        Exclusion Criteria:

          -  Clinically significant third-space fluid collections

          -  Central nervous system disease other than stable and treated brain metastasis

          -  More than 3 weeks interval between the surgery and enrollment request date

          -  Unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs),
             for a 5 days period

          -  Unable or unwilling to take folic acid or vitamin B12 supplementation

          -  Unable to take corticosteroids.

          -  Serious concomitant disorder that, in the opinion of the investigator, would
             compromise the patient's ability to adhere to the protocol

          -  Currently have and historically had interstitial pneumonitis (interstitial pneumonia)
             or pulmonary fibrosis manifested as opacity on Chest x-ray or Computed tomography (CT)
Comparison of Clenpiq vs Golytely Bowel Preparation
Condition: Bowel Preparation Solutions
Intervention: Golytely; Clenpiq
Intervention description: bowel preparation; bowel preparation
Intervention MeSH terms: Picosulfate sodium; Magnesium Oxide; Polyethylene glycol 3350; Citric Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be receive either Golytely or Clenpiq bowel prep solutions. Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the colonoscopy procedure.
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Golytely, Clenpiq, bowel prep

Summary:

      This is a prospective randomized study which will be done at main campus Cleveland Clinic.
      The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale
      in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be
      randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a
      low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and
      anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the
      evening before or as split-dose on the evening before and on the day of the procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will
        be eligible to participate.

        Exclusion Criteria:

          -  Creatinine clearance less than 30 ml/min

          -  History of heart failure with current shortness of breath at rest causing limited
             physical activity, arrhythmia, unstable angina or acute myocardial infarction

          -  Small bowel obstruction, ileus or bowel perforation

          -  Dementia or cognitive dysfunction to an extent that they cannot perform the study
             related documentation or consent to participate in the study.

          -  Gastroparesis

          -  Toxic megacolon or undergoing colonoscopy for decompression

          -  Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin,
             chlorpromazine and penicillamine within 2 hours before or 6 hours after administration
             of Clenpiq or stimulant laxatives within 24 hours

          -  History of prior colorectal surgery

          -  Allergy to any of the ingredients in Clenpiq or golytely

          -  if the procedure is planned in the intensive care unit (ICU)
Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib
Condition: Chronic Phase Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: Dasatinib
Intervention description: tablets, oral, 100 mg, Once daily, Up to12 months on study,
Intervention MeSH terms: Dasatinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse
      Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from
      imatinib to dasatinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with CML-CP patients achieving an optimal response to imatinib treatment with
             Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or
             recurring at least 3 times in the preceding 12 months, despite best supportive care

          -  Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18

          -  Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2

          -  Patient willing and able to give informed consent

          -  Life expectancy > 6 months

          -  Adequate renal function

          -  Adequate hepatic function

        Exclusion Criteria:

          -  Patients who are pregnant or breast feeding

          -  Men whose partner is unwilling to avoid pregnancy.

          -  Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib

          -  Current grade 3 or 4 imatinib related adverse event

          -  Prior documented T315I mutation

          -  Prior diagnosis of accelerated phase or blast crisis CML

          -  Previous loss of complete hematologic response (CHR) or major cytogenetic response
             (MCyR) on imatinib

          -  Concurrent medical condition of uncontrolled infection, cardiovascular diseases of
             cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT
             interval, second or third degree heart block, uncontrolled angina, myocardial
             infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial
             hypertension, pleural or pericardial effusions, or history of bleeding disorder
Electrophysiologically Guided PAcing Site Selection Study
Condition: Sinus Arrhythmia; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Arrhythmia, Sinus
Intervention: IAS pacing - study group; IAS pacing control group; Pacing RAA study group; Pacing RAA control group
Intervention description: site of implant and permanent pacing; site of implant and permanent pacing; site of implant and permanent pacing; site of implant and permanent pacing
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; interatrial septum; atrial pacing; symptomatic sinus node dysfunction,; pacemaker indication class I

Summary:

      This study is a long-term, prospective, and controlled evaluation of the incidence of
      persistent atrial fibrillation (AF) in patients with severe intra-right atrial conduction
      delay paced with preventive algorithms at the interatrial septum (IAS) versus right atrial
      appendage (RAA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic sinus node dysfunction

          -  More than 18 years old

          -  Signed informed consent

        Exclusion Criteria:

          -  Less than 18 years old

          -  Pregnancy

          -  Anamnestic transient ischemic attack (TIA) or stroke

          -  Neoplastic or any other severe disease reducing life expectancy

          -  Heart surgery in the last 3 months

          -  Left atrial diameter > 55mm, determined in the parasternal long-axis view (during
             either sinus rhythm or atrial fibrillation)

          -  Participation in other studies
Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast
Intervention MeSH terms: Apremilast
Phase: Phase 4
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:

      Sixteen week open label study of apremilast in combination with topical steroids with a four
      week safety follow up visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be in general good health as judged by investigator

          -  Female of childbearing potential (FCBP) must have a negative pregnancy test at
             screening and Baseline.

          -  FCBP must use an approved method of contraception as outlined in the protocol.

          -  Male subjects who engage in activity in which conception is possible must use barrier
             contraception as defined in the protocol.

          -  18 years of age or older

          -  Understand and voluntarily sign the Informed Consent

          -  Able to adhere to study visit schedule

          -  Moderate plaque type psoriasis as define by a a PGA of 3

          -  BSA 0f 5-10% or a DLQI score of 7 or more

          -  History of uncontrolled plaque psoriasis after either stable dose of high potency
             topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6
             months

        Exclusion Criteria:

          -  Any clinically significant disease as determined by the investigator or major disease
             that is currently uncontrolled

          -  Any condition, including the presence of laboratory abnormalities, which would place
             the subject at unacceptable risk

          -  Prior history of suicide attempt at any time in the subject's lifetime prior to
             screening or randomization, or major psychiatric illness requiring hospitalization
             within the last 3 years

          -  Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control
             methods.

          -  Active substance abuse or a history of substance abuse within 6 months prior to
             screening.

          -  Malignancy or history of malignancy except fo treated (cured) basal cell or or
             squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial
             neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the
             previous 5 years

          -  Has not completed the prescribed washout for restricted treatments

          -  Known or suspected allergy to investigational product

          -  Other types of psoriasis

          -  Prior history of depression

          -  Prior use of apremilast
Treatment for Post-Stroke Depression
Condition: Stroke; Depression
MeSH terms: Stroke; Depression; Depressive Disorder
Intervention: case management
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Single (Outcomes Assessor)
Enrollment: 188.0
Sex: All
Healthy volunteers: No
Keywords: stroke; depression

Summary:

      The purpose of this study is to evaluate a program of education, medicine, and monitoring for
      the treatment of depression after a stroke.
    

Eligibility criteria:

        -  No severe language or cognitive deficits,

          -  life expectancy of at least 9 months, and

          -  willingness to participate.
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained-release 50 mg/day; desvenlafaxine succinate sustained-release 100 mg/day; placebo
Intervention description: 50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper; 100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day; 50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 924.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of
      desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with
      major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients aged 18 years or older who are fluent in written and spoken
             English.

          -  A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical
             Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode,
             without psychotic features.

          -  A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no
             more than a 4-point improvement from screening to baseline.

        Exclusion Criteria:

          -  Significant risk of suicide based on clinical judgment.

          -  Current (within 12 months before baseline) psychoactive substance abuse or dependence
             (including alcohol), manic episode, posttraumatic stress disorder, obsessive
             compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.

          -  Current generalized anxiety disorder, panic disorder, or social anxiety disorder.

          -  History or current evidence of gastrointestinal disease known to interfere with the
             absorption or excretion of drugs or a history of surgery known to interfere with the
             absorption or excretion of drugs.

          -  Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or
             other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation or
             investigational product administration or may interfere with the interpretation of
             study results.
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Placebo
Intervention description: Indacaterol 150µg capsules for inhalation daily; Matching placebo indacaterol capsules for inhalation daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, FEV1, indacaterol

Summary:

      This study compared the efficacy of indacaterol versus placebo in COPD patients classified as
      GOLD 2014 Patient Group B.

      This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient
      Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1
      to receive prn salbutamol plus:

        1. Indacaterol 150ug or

        2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough
           FEV1) was assessed after 12 weeks.
    

Eligibility criteria:

        Inclusion criteria

          1. Male or female adults aged ≥40 years, who have provided their consent and signed an
             Informed Consent Form. Written informed consent must be obtained before any assessment
             is performed.

          2. Patients diagnosed with COPD at 40 years of age or older.

          3. Patients with smoking history of at least 10 pack years, both current and ex-smokers
             are eligible. (Ten pack years is defined as 20 cigarettes a day for 10 years, or 10
             cigarettes a day for 20 years, etc)

          4. Patients with stable COPD in Patient Group B according to GOLD 2014.

        Exclusion criteria

          1. Use of other investigational drugs within 5 half-lives of enrollment, or [within 30
             days /until the expected PD effect has returned to baseline], whichever is longer.

          2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes.

          3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.

          4. Patients who have had 2 or more COPD exacerbations that required treatment with
             antibiotics, systemic steroids (oral or intravenous) or 1 or more exacerbation
             resulting in hospitalization in the 12 months prior to Visit 1.

          5. Patients who have COPD exacerbation or infection 6 weeks prior to Visit 1.

          6. Patients who develop a moderate or severe COPD exacerbation during the period between
             Visit 1 and Visit 2.

          7. Patients with a history of asthma.