bioihbjkbjnl/mcl2 huggingface dataset:
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Condition: Renal Artery Stenosis
MeSH terms: Renal Artery Obstruction
Intervention: Gadoterate meglumine (Dotarem); Time of Flight Magnetic Resonance Angiography
Intervention description: Each subject will receive one injection of Dotarem 0.2 ml/kg; Each subject will undergo a TOF MRA
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal artery stenosis; Contrast agent; MRA

Summary:

      The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA
      in patients suffering from renal arterial disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged more than 18 years,

          -  Strongly suspected of having renal arterial disease,

          -  Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography
             examination,

        Exclusion Criteria:

          -  Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²),

          -  Contraindication to MRI,

          -  Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA
             examination,
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Intervention: 100,000 IU cholecalciferol; Placebo
Intervention description: active drug; comparator drug
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vitamin D; surgery; acute stress

Summary:

      A growing body of evidence suggests that robust postoperative immune function is associated
      with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is
      increasingly recognized as a key regulator of the innate and adaptive immune systems. The
      investigators elected to conduct the current study in patients who will undergo colorectal
      surgery since these patients are historically at higher risk of developing SSIs and therefore
      would be ideal for future investigations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women;

          -  18 years or older;

          -  Scheduled for elective (non-emergent) colorectal surgery;

          -  Cleared for anesthesia; and

          -  Expected to stay overnight following surgery

        Exclusion Criteria:

          -  Scheduled for a purely laparoscopic procedure;

          -  Diagnosis of a terminal illness and/or in hospice care;

          -  Inability to sign informed consent;

          -  Inability to comply with study protocol;

          -  Intending to start vitamin D supplementation within 30 days of surgery;

          -  Intending to leave the Boston area during the follow-up period;

          -  History of renal stones or hypercalcemia;

          -  Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis,
             myeloma primary hyperparathyroidism)

          -  History of hypercalcemia

          -  History of severe anemia (Hematocrit <25%)

          -  Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis
             medication); and

          -  Already enrolled or planning to enroll in a research study that would conflict with
             full participation in the current study or confound the observation or interpretation
             of the study findings
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: AzaSite; Tobramycin
Intervention description: AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.; Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 743.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Bacterial Conjunctivitis; Pink Eye; Conjunctivitis; Eye Infection

Summary:

      The purpose of this study is to evaluate the clinical and microbial efficacy and safety of
      AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of
      age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will
      be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required
      for the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject, of any race, who is at least 1 year of age.

          -  Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
             mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular
             and yellow discharge) and redness in at least one eye.

          -  The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72
             hours) or less.

          -  Must be willing to discontinue contact lens wear for the duration of the study.

        Exclusion Criteria:

          -  Any uncontrolled systemic disease or debilitating disease.

          -  Use of topical ophthalmic solutions including tear substitutes within 2 hours before
             and during the study.

          -  Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and
             during study.

          -  Any active upper respiratory tract infection.

          -  Pregnant or nursing females.

          -  Use of any antibiotic (topical or systemic) within 72 hours of enrollment.
An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Dimebon tablet for oral administration
Intervention description: 10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Delirium; Dementia; Amnestic; Cognitive Disorders; Mental Disorders; Nervous System Diseases; Central Nervous System Diseases

Summary:

      The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in
      subjects with moderate-to-severe Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon
             study

        Exclusion Criteria:

          -  Any major medical illness or unstable medical condition that may increase the risk
             associated with study participation or investigational product administration or may
             interfere with the ability to interpret study safety data
Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis
Condition: Coronary Artery Bypass
MeSH terms: Thrombosis
Intervention: Prasugrel; Placebo
Intervention description: one 10 mg tablet by mouth daily; placebo similar in appearance to prasugrel
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Coronary Artery Bypass; thrombosis; prasugrel

Summary:

      This is a randomized-controlled clinical trial that will randomize 120 patients undergoing
      clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg
      daily or matching placebo for 12 months, starting at the time of hospital dismissal from
      surgery. The primary goal of the study is to determine whether prasugrel administration will
      prevent thrombus (clot) formation within a saphenous vein graft at 12 months, as examined by
      optical coherence tomography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or greater

          -  Willing and able to give informed consent. The patients must be able to comply with
             study procedures and follow-up.

          -  Undergoing clinically-indicated coronary artery bypass graft surgery

        Exclusion Criteria:

          -  Known allergy to aspirin or prasugrel

          -  Need for concomitant cardiac procedure, such as valve repair or replacement

          -  Increased risk of bleeding, including need for warfarin or dabigatran administration

          -  Positive pregnancy test or breast-feeding

          -  Coexisting conditions that limit life expectancy to less than 12 months or that could
             affect a patient's compliance with the protocol

          -  Serum creatinine > 2.5 mg/dL

          -  Severe peripheral arterial disease limiting vascular access

          -  Prior stroke or transient ischemic attack

          -  Weight <60 kg or age >75 years

          -  Multiple distal SVG anastomoses

          -  Postoperative complications prolonging hospitalization
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Sumatriptan; Placebo
Intervention description: Sumatriptan 20mg; Matching placebo
Intervention MeSH terms: Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Sumatriptan

Summary:

      The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through
      the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated
      with migraine headaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women, between the ages of 18 to 65 years

          -  Diagnosis of migraine, with or without aura

          -  Experiences between 1 and 8 migraine attacks per month for the past 12 months

        Exclusion Criteria:

          -  Inability to distinguish other headaches from migraine

          -  Experiences headache of any kind at a frequency greater than or equal to 15 days per
             month

          -  History of resistance to sumatriptan, or non-response to 2 or more other triptans,
             defined as subjects who have not responded to an adequate dose and duration of
             treatment

          -  Current use of medication for migraine prophylaxis that has not been stable (no dose
             adjustment) for 30 days prior to screening

          -  Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)
Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: 1a - rMenB+OMV NZ and routine vaccines; 1b - rMenB+OMV NZ and routine vaccines; 2a - Routine and rMenB+OMV NZ vaccines; 2b - rMenB+OMV NZ and routine vaccines; 3a - rMenB+OMV NZ and routine vaccines; 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations; 4a- rMenB+OMV NZ and routine vaccines; 4b - rMenB+OMV NZ and routine vaccines
Intervention description: One dose of rMenB vaccine and routine vaccine at study month 12.; One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.; One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.; Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.; One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2249.0
Sex: All
Minimum age: 365 Days
Maximum age: 394 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: toddler; Meningococcal disease; prevention; vaccination

Summary:

      The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and
      Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster
      at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

        Exclusion Criteria:

          -  Previous ascertained or suspected disease caused by N. meningitidis;

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component;

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment/ alteration of the immune system,

          -  Receipt of, or intent to immunize with another vaccine, within 30 days prior to
             enrollment.
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Tiotropium 18 μg; Placebo to indacaterol
Intervention description: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.; Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).; Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1134.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol; tiotropium; bronchodilation

Summary:

      This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when
      combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients
      with chronic obstructive pulmonary disease (COPD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD]
             Guidelines, 2007) and:

               1. Smoking history of at least 10 pack-years

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30%
                  of the predicted normal value

               3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
             treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or
             during the run-in period

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening
             or during the run-in period

          -  Patients with a body mass index less than 15 or more than 40 kg/m^2

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor
Condition: Breast Cancer
Intervention: Daily Radiation Therapy; Weekly Radiation Therapy
Intervention description: 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.; 15 weekly radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 412.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: whole breast radiotherapy; tumor bed boost

Summary:

      All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen
      of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly
      boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated
      as the daily boost during accelerated prone radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre or post-menopausal women with stage 0,I, and II breast cancer

          -  Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm

          -  Status post segmental mastectomy, after sentinel node biopsy and/or axillary node
             dissection (DCIS and Tumors <5mm do not require nodal assessment)

          -  At least 2 weeks from last chemotherapy

          -  Patient needs to be able to understand and demonstrate willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Previous radiation therapy to the ipsilateral breast

          -  More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary
             radiation

          -  Active connective tissue disorders, such as lupus or scleroderma

          -  Prior or concurrent malignancy other than basal or squamous cell skin cancer or
             carcinoma in-situ of the cervix, unless disease-free >3 years

          -  Pregnant or lactating women
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
Condition: Heterozygous Familial Hypercholesterolemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: mipomersen sodium; placebo
Intervention description: 200 mg /mL; 1 mL matching placebo
Intervention MeSH terms: Mipomersen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: familial hypercholesterolemia

Summary:

      The purpose of this study is to determine whether mipomersen safely and effectively lowers
      low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial
      Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable
      dose of other lipid-lowering agents (including maximally tolerated statin therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)

          -  Diagnosis of Coronary Artery Disease (CAD)

          -  Stable lipid-lowering therapy for 12 weeks

          -  On maximally tolerated statin therapy with at least 1 statin at a dose greater than
             zero, per Investigator judgment

          -  Stable low-fat diet for 8 weeks

          -  Stable weight for 6 weeks

        Exclusion Criteria:

          -  Significant health problems in recent past including heart attack, stroke, coronary
             syndrome, unstable angina, heart failure, significant arrhythmia, orthostatic
             hypotension, uncontrolled hypertension, blood disorders, liver disease, cancer, or
             digestive problems

          -  Receiving apheresis treatment or last apheresis treatment within 8 weeks