bioihbjkbjnl/mcl2 huggingface dataset:
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Condition: Coronary Disease
MeSH terms: Acute Coronary Syndrome; Coronary Disease
Intervention: placebo; dabigatran etexilate; dabigatran etexilate; dabigatran etexilate; dabigatran etexilate
Intervention description: matched placebo; capsules, twice daily, 26 weeks treatment; capsules, twice daily, 26 weeks treatment; capsules, twice daily, 26 weeks treatment; capsules, twice daily, 26 weeks treatment
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1878.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4
      doses of orally administered dabigatran etexilate, administered twice daily, compared to
      placebo when given in addition to dual antiplatelet treatment in patients with an index event
      (MI) at high risk for new ischaemic cardiovascular events.
    

Eligibility criteria:

        Inclusion criteria Patients with acute coronary syndromes with at least one additional risk
        factor for cardiovascular complications.

        Exclusion criteria

          1. Long term treatment with any other oral anticoagulant

          2. Severe/disabling stroke within last 6 months

          3. Conditions associated with increased bleeding risk

          4. Anaemia or thrombocytopenia

          5. Severe renal impairment

          6. Liver disease

          7. Positive pregnancy test
Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: enzastaurin; pemetrexed; cisplatin; placebo
Intervention description: 1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression; 500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle; 75 mg/m², IV, every 21 days, for each 21-day cycle; po, QD
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is intended for participants with advanced, not amenable to surgery, or metastatic
      lung cancer who have not received any prior chemotherapy. The study will be conducted in 2
      parts:

        -  Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin
           combination chemotherapy

        -  Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin +
           enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part
           2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling
             in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of
             nonsquamous histology.

          -  no prior systemic therapies [chemotherapy, et cetera (etc.)] or pleurodesis with
             chemotherapy for this disease

          -  prior radiotherapy is allowed but must be completed at least 2 weeks before study
             enrollment and participant must be recovered from the acute toxic effects

          -  have a good performance status

          -  participant must sign an informed consent document

        Exclusion Criteria:

          -  participant had myocardial infarction occurring less than 6 months before inclusion,
             uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not
             controlled by medications

          -  participant is unable to swallow tablets

          -  participant is taking a certain medicine to control seizure activity, called "enzyme
             inducing antiepileptic drugs" and is not able to stop taking the medicine prior to
             enrolling in the study

          -  participant is unable to interrupt aspirin and/or other anti-inflammatory agents

          -  participant is unwilling or unable to take vitamin supplementation (folic acid and
             vitamin B12) or medications to prevent side effects
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; PF-03715455
Intervention description: 680 micrograms BID, Orally inhaled placebo for 12 weeks; 680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; Staged withdrawal of background therapy

Summary:

      The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe
      asthma when added to standard of care and during staged withdrawal of background therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a physician documented history or diagnosis of persistent asthma
             (according to GINA, 2014 definition of asthma),

          -  Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.

          -  Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol
             combination therapy, or budesonide/formoterol combination therapy or
             mometasone/formoterol combination therapy.

          -  Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control
             Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than
             or equal to 3.0)

        Exclusion Criteria:

          -  Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic
             pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis,
             Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis,
             tuberculosis).

          -  Subjects who are current smokers.
Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: vandetanib; Placebo
Intervention description: 300 mg orally, once daily for up to 18 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; hormone treatment

Summary:

      The purpose of this study is to determine whether treatment with Zactima for up to 18 months
      will prolong the off-treatment interval in patients who are undergoing intermittent androgen
      deprivation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of prostate cancer

          -  Prostate specific antigen (PSA) greater than or equal to 5 ng/mL

          -  Recent completion of first hormone treatment [intermittent androgen deprivation with a
             Luteinising hormone releasing hormone (LHRH) analogue]

          -  Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

        Exclusion Criteria:

          -  Bone or soft tissue metastases

          -  Significant cardiovascular disease including hypertension not controlled by medical
             therapy or history of irregular heart beats or recent heart attack
Ranolazine Among Unrevascularized Chronic Stable Angina Patients
Condition: Angina
MeSH terms: Angina Pectoris
Intervention: Ranolazine; Sugar pill
Intervention description: Ranolazine 500mg tablet
500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks; 500mg tablet two times per day for 7 days then,
500mg tablet (1000mg) two times per day for 15 weeks
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: deferred percutaneous coronary intervention; fractional flow reserve

Summary:

      This is a prospective, double-blind, placebo-controlled, randomized, single-center (North
      Florida- South Georgia VA Medical Center) study. The study objective is to determine if
      ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary
      artery disease patients who have demonstrable myocardial ischemia, but who do not undergo
      revascularization
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >= 18 years of age referred for cardiac catheterization for evaluation
             of cardiac symptoms ( angina, fatigue, or shortness of breath)

          -  At least 1 indeterminate stenosis (20-80%),

          -  Fractional flow reserve (FFR) <=0.8 and PCI deferred

        Exclusion Criteria:

          -  Coronary revascularization (percutaneous coronary intervention or coronary artery
             bypass grafting) during the index procedure or anticipated within the next month

          -  acute coronary syndrome or cardiogenic shock

          -  QTc > 500 milliseconds

          -  use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole,
             clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)

          -  use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital,
             phenytoin, carbamazepine, and St. John's wort)

          -  liver cirrhosis

          -  sever renal insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
Long-Term Assessment of Remyelinating Therapy
Condition: Acute Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Placebo; BIIB033 100mg/Kg
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: This was a follow-up study with no investigational product; however, the allocation method in RENEW Study (NCT01721161) was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or participants until the end of this study.
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FF-VEP; mfVEP; Human anti-LINGO-1; BIIB033; AON

Summary:

      The primary objective of the study is to assess full-field visual evoked potential (FF-VEP)
      latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after
      the last study visit. The secondary objective is to assess clinical progression and severity
      of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study
      NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was
      administered in the previous study. The participants, investigator and outcome assessors
      remain blinded in this follow-up study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or
             placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2
             years from Week 32 or projected Week 32 visit, if the subject did not complete all
             visits in Study NCT01721161).

        Key Exclusion Criteria:

          -  Not previously enrolled in Study NCT01721161

          -  Subjects with recent kidney function, such as serum creatinine above upper limit of
             normal range, will not be allowed to receive administration of Gd but will otherwise
             be allowed to participate in the study, including magnetic resonance imaging (MRI)
             assessments not requiring the use of Gd.

          -  Female subjects must have had a recent pregnancy test and must not be breastfeeding
             prior to MRI assessments with Gd.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: DAR-901; Sterile saline placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 625.0
Sex: All
Minimum age: 13 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine

Summary:

      DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed
      with BCG to determine if immunization reduces the risk of TB infection
    

Eligibility criteria:

        Inclusion Criteria: Negative IGRA at baseline -

        Exclusion Criteria: Pregnancy, serious underlying disease

        -
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: THN102 Dosage A; THN102 Dosage B; THN102 Dosage C
Intervention description: THN102 Dosages A: placebo; THN102 Dosage B : 200mg/2mg; THN102 Dosage C: 200mg/18mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Complete 3 way-Crossover
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose
      levels of THN102 to placebo in patients suffering from Parkinson's disease associated with
      excessive daytime sleepiness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement
             Disorders Society (MDS).

          -  Subjects with Hoehn and Yahr scale score ≤ 4.

          -  Body mass index > 18 kg/m2 and < 35 kg/m2.

          -  Subjects should have a complaint of daytime sleepiness impacting their quality of life
             and/or daytime functioning (e.g. falling asleep while reading or watching television,
             while eating or talking with other people).

          -  Epworth Sleepiness Scale (ESS) score ≥ 14.

        Exclusion Criteria:

          -  Subjects with known or with a suspected sleep apnea syndrome or who have any other
             cause of excessive daytime sleepiness, such as shift work sleep disorder.

          -  Psychiatric and neurological disorders (other than Parkinson's disease),

          -  Cardiovascular disorders such as - but not limited to

          -  Uncontrolled moderate to severe hypertension

          -  History or current diagnosis of electrocardiogram (ECG) abnormalities indicating
             significant risk of safety for patients participating in the study

          -  Recent myocardial infarction

          -  Stable or unstable angina pectoris

          -  Cardiac insufficiency or history of heart failure

          -  Previous history of cardiac valvular surgery

          -  Subjects with current impulse control disorder.

          -  Subjects showing dementia or with MoCA < 23.

          -  Subjects with current suicidal risk

          -  Current or recent (within one year) history of substance abuse or dependence disorder

          -  Other active clinically significant illness

          -  Subjects with hepatic or renal impairment
Rituximab and Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) for Burkitt's and Burkitt's -Like Leukemia/Lymphoma
Condition: Burkitt's Lymphoma; Burkitt'S-like Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia
Intervention: Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Dexamethasone; G-CSF; Cytarabine; Methotrexate
Intervention description: 375 mg/m2 IV days 1 +/- 2 days and 11 +/- 2 days for the odd courses of therapy, and days 1 +/- 2 days and 8 +/- 2 days for the even courses of therapy, first 4 courses.; 300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) starting after rituximab completed (odd courses).; 50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).; 2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days (odd courses); 40mg IV or by mouth (P.O.) daily days 1-4 +/- 2 days and days 11-14 +/- 2 days (odd courses); 10 mcg/kg; 100 mg intrathecal day 7 +/- 2 days (odd courses); 3 gm/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).; 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 after the completion of Rituximab.
Intervention MeSH terms: Cytarabine; Dexamethasone; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Healthy volunteers: No
Keywords: Burkitt's Lymphoma; Burkitt's Like Lymphoma; Leukemia; Hyper-CVAD; Rituximab; Methotrexate; Cytarabine

Summary:

      The goal of this clinical research study is to learn if intensive chemotherapy given over 6
      months can help to control or cure Burkitt's leukemia, Burkitt's lymphoma, or small
      non-cleaved cell B-cell leukemia or lymphoma. Another goal is to see how well this treatment
      works when given with Rituximab. The safety of the combined treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Burkitt's or Burkitt-like leukemia and/or lymphoma, either previously untreated,
             previously treated (may be in CR or with active disease after 1-2 courses of
             chemotherapy), or HIV-related.

          2. All ages are eligible.

          3. Zubrod performance status < 3 (ECOG Scale, Appendix A).

          4. Adequate liver function (bilirubin < 3.0 mg/dL, unless considered due to tumor), and
             renal function (creatinine < 3.0 mg/dL, unless considered due to tumor).

          5. Signed informed consent.

        Exclusion Criteria:

        1) N/A
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Condition: Lung Injury, Acute; Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome; Acute Lung Injury
Intervention: Etanercept
Intervention description: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
Intervention MeSH terms: Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Enbrel; Stem Cell Transplantation; Lung Injury

Summary:

      The purpose of this study is to determine the effectiveness of etanercept in the treatment of
      patients with sub-acute lung injury following a bone marrow transplant. This study will also
      examine the toxicity of treatment with etanercept as well as whether there is an improved
      quality of life in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell
             transplants are eligible

          -  Age >6 years and able to complete pulmonary function testing

          -  Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)

          -  Recipients of sub-ablative transplant regimens are eligible

          -  Recipients of donor leukocyte infusions (DLI) post-transplant are eligible

          -  Patients must be > 100 days post transplant

        Exclusion Criteria:

          -  Patients with hypotension requiring inotropic agents other than dopamine < 5mcg/ kg/
             minute for blood pressure support.

          -  Patients with a positive quantitative bacterial culture from the BAL fluid (≥ 104 CFU/
             ml is considered positive)

          -  Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic
             nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR
             analysis

          -  Patients who are enrolled on a phase I or phase II trial for the prophylaxis or
             treatment of GVHD (acute or chronic) within 7 days of study entry.

          -  Patients with known hypersensitivity to etanercept.

          -  Patients who are pregnant.

          -  Patients with CMV seropositivity at the time of study entry. Testing may include
             wither CMV PCR analysis or CMV pp65 testing.

          -  Evidence for multi-system organ failure.
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OTX-DED; OTX-DED; OTX-DED
Intervention description: 0.2mg dexamethasone ophthalmic insert; 0.3mg dexamethasone ophthalmic insert; Hydrogel vehicle ophthalmic insert
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dexamethasone ophthalmic insert

Summary:

      To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and
      symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dry Eye Disease diagnosis

          -  VAS eye dryness severity score ≥ 40.

        Exclusion Criteria:

          -  Are unwilling to discontinue use of contact lenses

          -  Are unwilling to withhold use of artificial tears.