bioihbjkbjnl/mcl2 huggingface dataset:
Melatonin and the Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Melatonin; Placebo
Intervention description: 8 mg dose of Melatonin; Placebo
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 30 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Blood Pressure; Glucose levels; HDL levels; Triglyceride levels; Waist Circumference

Summary:

      This trial seeks to compare the effects of melatonin supplementation versus placebo in
      subjects with the metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 30-79 years.

          2. Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.

          3. Availability for six months after enrolling in the study.

        Exclusion Criteria:

          1. Inability to understand informed consent and to cooperate with study procedures.

          2. Supplemental intake of melatonin.

          3. Current smoking.

          4. Current use of calcium channel blockers.

          5. Current, planned, or recent (12 months) participation in another clinical trial.

          6. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt
             conception over the next 6 months.

          7. Presence of any of the following diagnosed health conditions:

               -  Active malignancy other than nonmelanoma skin cancer (current therapy for this
                  malignancy,diagnosis within five years of enrollment, recurrence within five
                  years of enrollment, or metastasis)

               -  Uncontrolled hypothyroidism or hyperthyroidism

               -  Recent (< 1 year ago) history of heart attack, bypass surgery, angioplasty, or
                  stroke

               -  Heart failure (New York Heart Association functional class 3 or 4)

               -  On renal dialysis

               -  Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate,
                  cyclophosphamide,

               -  etc.) or an immunodeficiency syndrome

               -  Narcotic or alcohol dependence

               -  Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or
                  without use of nasal CPAP), or by a score of 0.80 or higher on the MAP
                  (Multivariate Apnea Prediction), a validated screening algorithm with high
                  positive and negative predictive value for identifying OSA.

          8. Shift-workers.
A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Condition: Non-infectious Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: NS2; Prednisolone acetate ophthalmic suspension (1%)
Intervention description: NS2 ophthalmic drops (0.5%)
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: uveitis; acute uveitis; anterior uveitis; NS2; Aldeyra; prednisolone acetate

Summary:

      This is a randomized, multi-center, investigator masked, comparator controlled study. The
      purpose of this study is to determine the efficacy and safety of NS2 in patients with
      non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple
      doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.

      Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a
      small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-infectious anterior uveitis

          -  Grade 1 - Grade 3 anterior chamber cell count

          -  Subjects must have Intraocular pressure <25 mmHg at baseline and may only administer a
             maximum of 1 topical medication to control Intraocular pressure in the study eye.

          -  Visual acuity ≥ 20/200 in the study eye

        Exclusion Criteria:

          -  Severe/serious ocular pathology

          -  Active intermediate or posterior uveitis.

          -  Previous anterior uveitis episode in the study eye within 4 weeks of Visit 1

          -  Oral corticosteroids within 14 days of Visit 1

          -  Intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6
             months.
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
Condition: Carcinoma，Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib 150 mg oral doses will be administered daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm, multi-center study will evaluate the progression-free survival
      in participants with histologically documented, advanced and/or metastatic chemotherapy
      naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)
      positive mutations and receiving erlotinib treatment. The anticipated time on study treatment
      is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic -
             Stage IV or recurrent non-squamous NSCLC

          -  Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Life expectancy greater than or equal to (≥) 12 weeks

          -  Evidence of disease with at least one measurable disease evaluation on Response
             Evaluation Criteria in Solid Tumors (RECIST)

          -  Adequate hematological , liver and renal function

        Exclusion Criteria:

          -  Known hypersensitivity to erlotinib or any of its excipients

          -  Squamous non-small cell or small cell tumors or absence of histological report

          -  Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment

          -  Prior exposure to inhibitors of EGFR

          -  Prior chemotherapy or treatment with another systemic anti-cancer agent for the
             treatment of the participant's current stage of disease

          -  Any significant ophthalmologic abnormality, especially severe dry eye syndrome,
             keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other
             disorder likely to increase the risk of corneal epithelial lesions

          -  Radical radiotherapy with curative intent within 28 days prior to enrollment

          -  Any active non-controlled systemic disease
Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Kogenate FS, Advate, or Humate-P, Recombinate, Helixate FS
Intervention description: Starting at the 4-month visit, subjects will receive 250 units per day (if their weight is < 50 kg.) or 500 units per day (weight ≥ 50 kg.) of their usual preparation of factor VIII.
Intervention MeSH terms: Factor VIII
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 12 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Hemophilia; Prophylaxis; Youth; Young Adults; Feasibility

Summary:

      The primary objective of this study is to test the feasibility of a large-scale clinical
      trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy
      outcomes so that we can better plan a large-scale study; we will estimate the effect size and
      variability of effect and resource utilization of once-daily prophylaxis to allow us to set a
      sample size for a definitive trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe hemophilia A (<1% factor VIII)

          -  Age 12 to 24 years inclusive

          -  Male

          -  No current factor VIII inhibitor (an inhibitor will be defined as ≥ 0.6 Bethesda
             Units) within the past year

          -  Able to participate in a home infusion program with adequate peripheral venous access
             as assessed ny the treating investigator

        Exclusion Criteria:

          -  Important co-morbidities (Acquired Immunodeficiency Syndrome or symptomatic HIV
             infection, symptomatic hepatitis B or C infection)

          -  Other concomitant acquired or congenital bleeding disorder (e.g. von Willebrand's
             Disease)

          -  Receiving factor VIII replacement through central venous catheter
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol
Condition: Persistent Asthma
MeSH terms: Asthma
Intervention: Indacaterol; Placebo to Indacaterol
Intervention description: Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.; Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Indacaterol; Asthma; Bronchodilation; Beta-agonist

Summary:

      This study assessed the bronchodilator efficacy of three different regimens of indacaterol in
      patients with asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of asthma and:

          -  Receiving daily treatment with inhaled corticosteroid in a regimen that has been
             stable for at least a month prior to screening

          -  FEV1 ≥50% and ≤90% of predicted normal at screening

          -  An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes
             after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

        Exclusion Criteria:

          -  Smoking history of ≥ 10 years

          -  Patients with a diagnosis of COPD

          -  Patients who have been previously intubated for a severe asthma exacerbation/ attack

          -  Patients who have experienced a severe asthma attack/exacerbation requiring
             hospitalization in the 6 months prior to screening

          -  Patients who have had an emergency room visit for an asthma attack/exacerbation within
             6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with seasonal allergy whose asthma is likely to deteriorate during the study
             period

          -  Patients with Type I or uncontrolled Type II diabetes mellitus

        Other protocol-defined inclusion/exclusion criteria may apply
Reduced Intensity Double Umbilical Cord Blood Transplantation
Condition: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Fludarabine; Melphalan; Total Body Radiation; Cord Blood
Intervention description: 30 mg/m2/day IV x 6 days; 100 mg/m2/day IV x 1 day; 200 cGy on Day 0; 2 cord blood units IV
Intervention MeSH terms: Fludarabine; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: NHL; lymphoma; leukemia; myelodysplastic disorder; aplastic anemia

Summary:

      This trial will use two cord blood units for transplantation using a reduced intensity
      regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood
      units (double cord blood) are being used, as the numbers of blood cells in one unit are too
      few to allow successful growth of these cells.

      Because the risk of infection, particularly virus infection, is high after double cord blood
      transplant, this study seeks to reduce the rise of virus infection by using a reduced
      intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior
      cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and
      fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The
      number of patients with virus infections in this study will be compared to our prior
      experience using the ATG.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hematologic malignancy for whom allogeneic stem cell transplantation is deemed
             clinically appropriate

          -  Appropriate candidate for reduced intensity regimen, according to the treating
             physician

          -  Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or
             unrelated donor not available with a time frame necessary to perform a potentially
             curative stem cell transplant

          -  Able to comply with the requirements for care after allogeneic stem cell
             transplantation

        Exclusion Criteria:

          -  Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular
             dysfunction

          -  Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic
             restrictive lung disease

          -  Renal disease

          -  Hepatic disease

          -  Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other
             neuropsychiatric abnormalities believed to preclude transplantation

          -  HIV-positive

          -  Uncontrolled infection

          -  Pregnant or breast-feeding
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
Condition: Bipolar Disorder; Schizoaffective Disorder; Manic Disorder; Mania; Manic State
MeSH terms: Mania; Bipolar Disorder; Psychotic Disorders
Intervention: Pentazocine; Lorazepam
Intervention description: see arms description; see arms description
Intervention MeSH terms: Pentazocine; Lorazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bipolar disorder; bipolar mania; schizoaffective disorder; schizoaffective mania; mania; kappa opiates; opiates

Summary:

      Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals.
      To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind
      study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases
      manic symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bipolar or schizoaffective disorder

          -  currently manic

          -  no acute medical issues

          -  no substance withdrawal

        Exclusion Criteria:

          -  unable to give informed consent

          -  using opiates for pain management

          -  history of head injury, dementia, or mental retardation

          -  seizure disorder

          -  glaucoma

          -  unstable cardiac condition or arrhythmia

          -  moderate-severe pulmonary disease

          -  pregnancy
Study Of Sunitinib With FOLFIRI In Colorectal Cancer
Condition: Unresectable or Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil); Sunitinib
Intervention description: FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.; 37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Sunitinib; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan,
      5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with
             unresectable or metastatic disease documented on diagnostic imaging studies.

          -  Patient must have at least one RECIST-defined measurable lesion that has not been
             treated with prior local therapy.

        Exclusion Criteria:

          -  History of another primary malignancy within 3 years prior to study entry, with the
             exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.

          -  Current, recent, or planned participation in an experimental treatment drug study
             other than this protocol.
Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Intervention: tetomilast; placebo
Intervention description: Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.; Placebo for 104 weeks (2 years)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the
      pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 40-75 yrs old,inclusive.

          -  Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema
             severity by HRCT.

          -  FEV1: FVC greater than 70% predicted.

          -  At least 1 documented COPD exacerbation within the past year but not within 8 weeks of
             randomization.

          -  Current or former smokers with a cigarette smoking history of at least 20 pack-years
             (or equivalent) and whose smoking status has not changed 60 days prior to screening.

        Exclusion Criteria:

          -  Patients with asthma, active tuberculosis or bronchiectasis.

          -  A respiratory tract infection within 30 days prior to the screening visit.

          -  Any malignancy within the last 5 years with the exception of non-melanomatous skin
             cancer.

          -  Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.

          -  Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period
             prior to randomization.

          -  Systemic use of corticosteroids or other immunosuppressive agents within 30 days of
             the screening visit.

          -  Subjects taking anticoagulants.