bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Condition: Venous Thromboembolism; Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis; Arthroplasty, Replacement, Hip
MeSH terms: Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis
Intervention: DU-176b 15mg; DU-176b 30mg; Enoxaparin sodium 20 mg (=2000IU)
Intervention description: DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.; DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.; Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 20 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: prevention; venous thromboembolism; edoxaban; anticoagulants

Summary:

      The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b
      15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after
      elective total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing unilateral total hip arthroplasty

          2. Patients who are 20-84 years olds

        Exclusion Criteria:

          1. Subjects with risks of hemorrhage

          2. Subjects with thromboembolic risks

          3. Subjects who weigh less than 40 kg

          4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become
             pregnant
Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Eteplirsen
Intervention description: Eteplirsen solution for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: DMD; exon 51; dystrophin; dystrophy; eteplirsen; Duchenne

Summary:

      The primary objective of this study is to explore safety and tolerability of eteplirsen in
      participants with advanced stage Duchenne muscular dystrophy (DMD) who are amenable to exon
      51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 7 - 21 years of age

          -  Diagnosis of DMD with a mutation that is amenable to exon 51 skipping, confirmed by a
             genetic report

          -  Stable dose of oral corticosteroids for at least 24 weeks or has not received
             corticosteroids for at least 24 weeks

          -  Non-ambulatory, or incapable of walking ≥300 meters on the 6-Minute Walk Test (6MWT).

          -  Score of ≤4 on the Brooke Score for Arms and Shoulders.

          -  Stable cardiac and pulmonary function

          -  Use of contraceptives for sexually active males throughout the study

          -  Willing to provide consent and comply with the study

        Exclusion Criteria:

          -  Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that
             may have an effect on muscle strength or function (e.g., growth hormone, anabolic
             steroids).

          -  Previous treatment with SMT C1100/BMN 195 at any time.

          -  Previous treatment with drisapersen (PRO051) within the last 6 months.

          -  Participation in any other DMD interventional clinical study within 12 weeks

          -  Major change in physiotherapy regimen within the past 3 months

          -  Major surgery within 3 months

          -  Presence of other clinically significant illness

          -  Use of an aminoglycoside antibiotic within 12 weeks or the need for this antibiotic or
             statin during study

          -  Forced vital capacity % predicted [FVC % predicted] <40%, or requiring daytime
             ventilation.

          -  Require antiarrhythmic and/or antidiuretic therapy for heart failure.

          -  Have a left ventricular ejection fraction (LVEF) of <40%.

          -  Prior or ongoing medical condition that could adversely affect the safety of the
             patient, make it unlikely that the course of treatment would be completed, or impair
             the assessment of study results.
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
Condition: Pharmacokinetics
Intervention: Voriconazole
Intervention description: Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.
Intervention MeSH terms: Voriconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents

Summary:

      This study is designed to collect additional pharmacokinetic and safety data of voriconazole
      in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help
      establish voriconazole dosing recommendations for adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are expected to develop neutropenia following chemotherapy.

          -  Subjects who require treatment for the prevention of systemic fungal infection.

        Exclusion Criteria:

          -  Subjects with a history of severe intolerance of azole antifungal agents.

          -  Subjects with documented bacterial or viral infection at the time of study entry who
             are not responding to appropriate treatment against the infection.
Coronary MDCTA With Iopamidol Injection 370
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Isovue 370, 70 mL; Isovue 370, 80 mL; Isovue 370, 90 mL
Intervention description: 70 mL of iopamidol injection 370 injected at a rate of >=4 mL/second; 80 mL of iopamidol injection 370 injected at a rate of >=4 mL/second; 90 mL of iopamidol injection 370 injected at a rate of >=4 mL/second
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      Determine the validity and compare the visualization of arterial segments obtained with 3
      doses of iopamidol to determine dose for further investigation in future trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide informed consent

          -  At least 30 years of age

          -  Weight less than 250 lbs

          -  Known or suspected coronary artery disease and suspected to have significant coronary
             artery stenosis

          -  Undergo MDCTA scan

          -  Undergo coronary angiography within 2 weeks of MDCTA scan

        Exclusion Criteria:

          -  Hx of hypersensitivity to iodinated contrast agents

          -  Known or suspected hyperthyroidism or pheochromocytoma

          -  Renal impairment

          -  History of coronary artery stent placement or bypass grafts

          -  Unstable

          -  Pregnant or lactating
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab
Intervention description: Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Intervention MeSH terms: Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 248.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ipilimumab; previously treated

Summary:

      The purpose of this study was to evaluate the continued use of ipilimumab in patients who had
      reinduction at the time of disease progression or to continue maintenance treatment. In
      addition, this study will continue to follow patients who have taken ipilimumab, but who are
      not eligible for maintenance or reinduction therapy.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria

          -  Diagnosis of advanced melanoma

          -  Prior treatment in a prespecified prior/parent ipilimumab study

          -  Men and women 18 years of age and older

        First Reinduction:

          -  No unacceptable toxicity (except select reversible immune-related adverse events)
             requiring ipilimumab discontinuation

          -  Had experienced documented progressive disease after expanded clinical benefit

        Extended Maintenance

          -  Received ipilimumab at any dose in a parent study

          -  Achieved expanded clinical benefit at the time of entry to current study

        Follow-up:

          -  Received ipilimumab at any dose in a closing parent study

          -  Deemed ineligible for reinduction or extended maintenance treatment or refused
             treatment as reinduction or extended maintenance at the time of screening in the
             current study, but consented to follow-up

        Key Exclusion Criteria

          -  Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor
             or agonist, other than ipilimumab

          -  Primary ocular or mucosal melanoma
Telemedicine To Provide Inflammatory Bowel Disease Outpatient Care
Condition: Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Collaborative Imaging
Intervention description: Hardware and software communication tools to provide clinical care from a distance.
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: telemedicine; remote consultation; telehealth; ehealth; image archiving; inflammatory bowel disease

Summary:

      The investigators hypothesize that outpatient clinical care of Inflammatory Bowel Disease
      patients may be provided using a new computerized system over standard network - called
      Collaborative Imaging - with similar patient experience compared to a conventional clinic
      visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (> 18 years old) outpatient IBD patients in the Veterans Affairs medical system

        Exclusion Criteria:

          -  VA patients without IBD

          -  Hospitalized IBD patients
A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
Condition: Asthma
MeSH terms: Asthma
Intervention: arformoterol; levalbuterol
Intervention description: Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).; Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).
Intervention MeSH terms: Albuterol; Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Respiratory Tract Diseases

Summary:

      To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female

          -  Between Age 2 and 11, inclusive, at the time of consent

          -  Weight equal to or greater than 15 Kg

          -  History of physician-diagnosed asthma of at least 2 years duration for children age 6
             and older, and at least 1 year duration for children 5 and younger.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  Subject who has a history of hospitalization for asthma within one year, or who is
             scheduled for in-patient hospitalization, including elective surgery during the course
             of the trial.

          -  Subject with any history of life-threatening asthma defined as a history of asthma
             episodes requiring intubation, associated with hypercapnia, respiratory arrest, or
             hypoxic seizures.

          -  Subject with a history of cancer.

          -  Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure
             disorders.

          -  Subject with a history of cigarette smoking or use of any tobacco products.
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: bortezomib
Intervention MeSH terms: Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; Velcade; bortezomib

Summary:

      Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple
      myeloma in patients who have received at least two prior therapies and have demonstrated
      disease progression on the last therapy. This study will determine if Velcade is effective in
      treating patients with multiple myeloma that have had no prior treatment for the disease. We
      will also use whole-genome scanning to identify drug response biomarkers in bone marrow
      samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and
      after treatment with Velcade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma based upon standard criteria

          -  Measurable disease, defined as a monoclonal immunoglobulin spike on serum
             electrophoresis of > 1 g/dl and/or urine monoclonal immunoglobulin spike of > 200mg/24
             hours.

          -  Karnofsky performance status of > 60

          -  Hemoglobin > 8.0 g/dL

          -  AST (SGOT) < 3 x ULN

          -  ALT < 3 x ULN

          -  Total bilirubin < 2 x ULN

          -  Is infertile or is practicing an adequate form of contraception

          -  18 years of age or older

        Exclusion Criteria:

          -  Prior treatment with systemic chemotherapy

          -  Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal
             protein and skin changes

          -  Plasma cell leukemia

          -  Calculated or measured creatinine clearance < 30 mL/minute within 14 days of
             enrollment

          -  Grade 2 or greater peripheral neuropathy

          -  Hypersensitivity to bortezomib, boron or mannitol

          -  Severe hypercalcemia

          -  HIV positive

          -  Known active hepatitis B or C

          -  New York Hospital Association Class III or IV heart failure

          -  Second malignancy requiring concurrent treatment

          -  Other serious medical or psychiatric illness

          -  Pregnant women

          -  Dialysis dependent patients
Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: HKI-272
Intervention description: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; HKI-272; Neratinib; Nerlynx

Summary:

      The purpose of this study is to learn whether HKI-272 is safe and effective in treating
      non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of NSCLC and current stage IIIB (with pleural effusion) or IV,
             not curable with conventional therapy. For Arm C, less than or equal to 20 pack-years
             smoking history and current non smoker. A pack year = number of packs of cigarettes
             smoked per day x years smoked.

          -  Progression following at least 12 weeks of treatment with Tarceva or Iressa. (Arms A
             and B only)

          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 (not
             declining within past 2 weeks).

          -  Tumor sample available and adequate for analysis.

          -  At least one measurable target lesion.

          -  Adequate cardiac, kidney, and liver function

          -  Adequate blood counts

        Exclusion Criteria:

          -  More than 3 prior cytotoxic chemotherapy treatments for relapsed or metastatic
             disease.

          -  Significant cardiac disease or dysfunction.

          -  Prior treatment with anthracyclines with cumulative dose of >400 mg/m^2.

          -  Active central nervous system metastases, as indicated by clinical symptoms and/or
             progressive growth.

          -  Use of Tarceva or Iressa within 14 days of treatment day 1 (Arms A and B only).

          -  Major surgery, chemotherapy, radiotherapy, investigational drugs, or other cancer
             therapy within 3 weeks of treatment day 1.

          -  Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major
             symptom.

          -  Inability or unwillingness to swallow HKI-272 capsules.

          -  Pregnant or breastfeeding women.
A Study of Enzastaurin in Participants With Follicular Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Enzastaurin
Intervention description: Administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the antitumor activity, as measured by tumor response rate, of enzastaurin in
      participants with Follicular Lymphoma (FL).
    

Eligibility criteria:

        Inclusion Criteria:

        All participants must:

          1. Have had a histologically confirmed diagnosis of Grade 1 or 2 FL, according to World
             Health Organization classification (Harris et al. 1999), at the original time of
             diagnosis. Pathology must be confirmed locally prior to enrollment at the
             investigational site.

          2. Have Ann Arbor Stage III or IV disease.

          3. Must be chemo-naive OR have relapsed disease after receiving only one prior
             chemotherapy regimen. The chemotherapy must have been completed at least 6 months
             prior to first dose of study treatment. Relapse after one prior course of single-agent
             rituximab treatment (in the chemo-naive setting) is also allowed if completed at least
             6 months prior to first dose of study treatment.

          4. Participants must not require cytoreductive therapy for at least 3 months from first
             dose of study treatment, in the opinion of the investigator.

          5. Previous radiation therapy is allowed, but should have been limited and must not have
             included whole pelvis radiation. Participants must have recovered from the toxic
             effects of the treatment prior to study enrollment (except for alopecia). Prior
             radiotherapy must be completed 30 days before study entry. Lesions that have been
             irradiated cannot be included as sites of measurable disease unless clear tumor
             progression has been documented in these lesions since the end of radiation therapy.

        Exclusion Criteria:

        Participants will be excluded from the study if they meet any of the following criteria:

          1. Are unable to swallow tablets.

          2. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.

          3. Are receiving concurrent administration of any other antitumor therapy.

          4. Are pregnant or breastfeeding.

          5. Have a serious concomitant systemic disorder (including active bacterial, fungal, or
             viral infection) that, in the opinion of the investigator, would compromise the
             participant's ability to adhere to the protocol.