bioihbjkbjnl/mcl2 huggingface dataset:
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate; FF/Vilanterol (VI; GW642444M); Placebo
Intervention description: FF; FF/VI; Placebo Inhaler
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: mild asthma; allergen challenge; early asthmatic response

Summary:

      We propose to use an inhaled allergen challenge model to explore the individual contributions
      of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS)
      combination product on protection from allergic triggers in asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).

          -  Females of non-child bearing potential.

          -  Documented history of bronchial asthma, first diagnosed at least 6 months prior to the
             screening visit and currently being treated only with intermittent short-acting beta
             -agonist therapy by inhalation

          -  Pre-bronchodilator FEV1 >70% of predicted at screening

          -  Subjects who are current non-smokers

          -  Methacholine challenge PC20 < 8 mg/mL at screening

          -  Screening allergen challenge demonstrates that the subject experiences an early
             asthmatic response

        Exclusion Criteria:

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Subject is hypertensive at screening

          -  Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the
             first dose of study medication.

          -  History of life-threatening asthma

          -  Symptomatic with hay fever at screening or predicted to have symptomatic hayfever

          -  Unable to abstain from short acting beta agonists

          -  Unable to abstain from antihistamines

          -  Unable to abstain from other medications including non-steroidal anti-inflammatory
             drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever
             medication

          -  The subject has participated in a study with a new molecular entity during the
             previous 3 months or has participated in 4 or more clinical studies in the previous 12
             months

          -  undergoing allergen desensitisation therapy
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: AGN-214868; AGN-214868 placebo
Intervention description: AGN-214868 injected into the bladder.; AGN-214868 placebo injected into the bladder.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic
      overactive bladder (IOAB) and urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, must be of nonreproductive potential

          -  If male, must agree to use acceptable contraception

          -  Symptoms of overactive bladder with urinary urgency incontinence

          -  Inadequate response or limiting side effects with anticholinergics for the treatment
             of OAB

        Exclusion Criteria:

          -  Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple
             sclerosis)

          -  History of bladder surgery

          -  Treatment with botulinum toxin therapy of any serotype for any non-urological
             condition within the prior 12 weeks

          -  Previous treatment with botulinum toxin therapy of any serotype for any urological
             condition
Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
Condition: Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: Melphalan hydrochloride
Intervention description: Drug administered intra-arterially (injection in the artery).
Standard dose:
2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (>3 years old)
Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
Dose not to exceed 0.5mg/kg, per treatment cycle.
Intervention MeSH terms: Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Retinoblastoma; intra-arterial chemotherapy; angiography

Summary:

      The purpose of this study is to show that chemotherapy delivered directly through the artery
      supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective
      treatment alternative to conventional systemic chemotherapy, external beam radiation, and
      surgical removal of the eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients newborn to 18 years old.

          -  Patients with intraocular retinoblastoma, unilateral or bilateral, who would be
             treated either by systemic chemotherapy, EBR, or enucleation would be considered for
             this study.

        Exclusion Criteria:

          -  Patients over the age of 18.

          -  Patients with small, localized intraocular Rb amenable to focal therapy (laser or
             cryotherapy).

          -  Patients with extraocular disease evident on MRI (extension into the optic nerve),
             massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside
             the globe evident on MRI or physical examination.

          -  Documented hypercoagulable disorders or vasculopathies.

          -  Laboratory exclusion criteria: GFR < 60 mL/min/1.73 m2
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
Condition: Hepatitis C; HIV Infections
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Intervention: telaprevir or matching placebo; telaprevir or matching placebo; peginterferon alfa-2a; ribavirin (fixed dose); ribavirin (weight-based dose)
Intervention description: Tablet, Oral, 750 mg, q8h, 12 weeks; Tablet, Oral, 750 mg or 1125 mg, q8h, 12 weeks; Subcutaneous injection, 180 μg, once weekly, 48 weeks; Tablet, Oral, 800 mg, b.i.d., 48 weeks; Tablet, Oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: VX-950; INCIVEK; INCIVO

Summary:

      The purpose of this study is to determine whether the combination of telaprevir,
      peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus
      (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus
      (HIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic, genotype 1, hepatitis C with detectable HCV RNA

          -  HIV-1 infection for >6 months

          -  Documentation of a liver biopsy within 1 year before the screening visit showing
             evidence of hepatitis (demonstrated by inflammation and/or fibrosis)

        Exclusion Criteria:

          -  Previous treatment with any approved or investigational drug or drug regimen for the
             treatment of hepatitis C

          -  Previous treatment with interferon or ribavirin

          -  Evidence of hepatic decompensation in cirrhotic subjects

          -  Subjects who have participated in a clinical study involving administration of an
             investigational drug within 2 months

          -  Part A only: subjects who have been on a HAART regimen within 12 weeks before study
             start
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: vorinostat
Intervention description: All patients will receive vorinostat at the same dose and schedule as they received in the base protocol until disease progression or unacceptable toxicity.
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683)
      dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001,
      MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving
      this drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient participated in one of the five vorinostat base protocols, has not shown tumor
             progression on that study, and has tolerated the study drug

          -  Patient did not withdraw from the base protocol

          -  Patient agrees to practice effective birth control during the study

        Exclusion Criteria:

          -  Patient is receiving other standard and/or investigational anticancer therapy

          -  Patient has any condition or disease that would interfere with compliance or pose
             addition risk in administering the study drug
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Condition: Diabetic Macular Edema; Retina Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: GB-102
Intervention description: Intravitreal injection of GB-102
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-arm design
Masking: None (Open Label)
Masking description: Open-label study design
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Macular Edema

Summary:

      Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety,
      tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels
      of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥ 21 years of age

          -  Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein
             occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent
             (aflibercept, bevacizumab, or ranibizumab)

          -  Demonstrated response to prior anti-VEGF treatment since diagnosis

          -  BCVA of 31 letters or better

        Exclusion Criteria:

          -  History, within 6 months prior to screening, of any of the following: myocardial
             infarction, any cardiac event requiring hospitalization, treatment for acute
             congestive heart failure, transient ischemic attack, or stroke

          -  Uncontrolled hypertension, diabetes mellitus or IOP

          -  Chronic renal disease
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
Condition: Vitamin D Deficiency
MeSH terms: Cystic Fibrosis; Vitamin D Deficiency
Intervention: Treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 36 Months
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than
      or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to
      participate in this study. Upon consent, they will be given oral cholecalciferol
      supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed
      by measuring a serum calcium level within 1 week of supplementation. Efficacy will be
      assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be
      assessed with the previous two measures as well as a brief questionnaire administered via
      telephone within 1 week of supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with Cystic Fibrosis >36 months of age

          -  Serum/blood 25OHD level < 30 ng/dL

          -  Ability to provide valid informed consent to be a part of the study

        Exclusion Criteria:

          -  Any history of kidney disease, kidney stones or on dialysis

          -  Any history of hypercalcemia

          -  Any history of hypercalciuria

          -  Pregnancy at time of enrollment

          -  Any history of parathyroid disorders

          -  Inability to swallow pills by mouth
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas
Condition: Basal Cell Carcinoma (BCC); Skin Cancer
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: Itraconazole
Intervention description: Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months
Intervention MeSH terms: Itraconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1
      million people. There is no effective drug to prevent basal cell carcinomas of the skin.

      We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of
      proliferation and a biomarker (tumor signaling pathway) of BCC development.

      Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and
      has been used for the past 25 years with relatively few side effects. It has been shown in
      mice to reduce a BCC biomarker and to reduce growth of BCCs.

      Thus, it may reduce BCC growth in humans.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be
             biopsied and surgically removed.

          -  Had at least one liver function test [eg, aspartate aminotransferase (AST), alanine
             aminotransferase (ALT)] with normal results in the last year.

          -  Consent to research use of their BCC tissue.

          -  Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and
             surgical removal of BCC

        EXCLUSION CRITERIA

          -  History or current hepatitis or other liver disease.

          -  Currently taking systemic medications that would affect BCC tumors (oral retinoids) or
             metabolism of itraconazole (anti-convulsants, corticosteroids)

          -  History or current evidence of malabsorption or liver disease within the one year
             prior to enrollment.

          -  History or current evidence of hyperthyroidism increasing metabolism of itraconazole

          -  Unable to attend to 2nd study visit at Stanford for Mohs surgical excision

          -  Current immunosuppression disease (cancer, autoimmune disease)

          -  Receiving immunosuppressive drugs

          -  Pregnant

          -  Lactating

          -  Any female actively trying to become pregnant
Study of Efficacy and Safety of INC424 in Regularly Transfused Patients With Thalassemia.
Condition: Thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia
Intervention: ruxolitinib
Intervention description: Ruxolitinib was taken at a starting dose of 10 mg twice daily with dose adjustments within the range of 5 to 25 mg twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: thalassemia; thalassemia major; spleen enlargement; INC424; ruxolitinib

Summary:

      Patients with severe thalassemia (thalassemia major) present with severe anemia that required
      life-long transfusion therapy, spleen enlargement that led to increased transfusion
      requirement, and other serious complications as early death, growth retardation, bone
      deformations and iron overload due to blood transfusions. Splenectomy can significantly
      reduce transfusion requirement in thalassemia patients, but it is associated with an
      increased risk of serious complications such as sepsis and thrombosis. Preliminary
      preclinical and clinical data suggested that JAK2 inhibition, by reducing spleen size, could
      improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing
      transfusion requirement and related iron overload.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with thalassemia on a regular and stable transfusion regimen (at least 2 RBC
             units within every 4-week interval for 24 weeks prior to Screening) and anticipated to
             receive the same transfusion regimen during the study.

          -  Patients with spleen enlargement at Screening, defined as spleen palpable below the
             costal margin and spleen volume of ≥ 450 cm3 as confirmed by MRI (or CT scan in
             applicable patients).

          -  Patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at
             least four weeks prior to Screening

        Exclusion Criteria:

          -  Splenectomy prior to or planned during the study

          -  Active serious bacterial, mycobacterial, fungal, parasitic or viral infection which
             requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster)

          -  Hemoglobin <65 g/L (<4.0 mmol/L) at Screening

          -  Platelet count <75×109/L, absolute neutrophils count < 1.5×109/L at Screening.

          -  Estimated MDRD < 30 mL/min/1.73 m2 at Screening.

          -  ALT (SGPT) levels >5 times ULN at Screening.

          -  Hepatocellular disease such as hepatitis B (presence of HBs antigen), hepatitis C
             (presence of HCV RNA), liver cirrhosis.

          -  HIV positivity
2 Arm Study of Clofarabine IV in MDS Patients
Condition: Myelodysplastic Syndrome; Leukemia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Clofarabine
Intervention description: Group A: 15 mg/m^2 IV over 1 hour daily for 5 days
Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
Intervention MeSH terms: Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Leukemia; Clofarabine; MDS

Summary:

      The goal of this clinical research study is to compare the effectiveness of 2 different doses
      of the drug clofarabine that can be given on a weekly schedule for the treatment of
      Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.

      Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.

      Secondary Objective: Compare response durations, survivals and side effects of the two
      schedules.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS)
             risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).

          2. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).

          3. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.

          4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and
             recovered from the toxic effects of that therapy, unless there is evidence of rapidly
             progressive disease.

          5. Hydroxyurea is permitted for control of counts prior to treatment.

          6. Procrit, GCSF are allowed before therapy.

          7. Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function
             including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal
             function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN).
             Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV
             excluded).

          8. Signed informed consent.

        Exclusion Criteria:

          1. Nursing and pregnant females. Patients of childbearing potential should practice
             effective methods of contraception. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          2. Active and uncontrolled infections.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          4. Prior clofarabine treatment.