bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; Placebo; Methotrexate
Intervention description: 4 mg/kg or 8 mg/kg IV/month every 4 weeks.; IV/month; 10-25 mg/week
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs
      and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in
      combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid
      arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg
      IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week.
      The anticipated time on study treatment is 1-2 years and the target sample size is 500+
      individuals. After completion of the 2 year study participants could participate in the
      optional 3 year open label extension phase (year 3 to 5).
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients at least 18 years of age with moderate to severe active RA for at least
             6 months;

          -  inadequate response to a stable dose of MTX;

          -  patients of reproductive potential must be using reliable methods of contraception.

        Exclusion Criteria:

          -  major surgery (including joint surgery) within 8 weeks before entering study, or
             planned surgery within 6 months after entering study;

          -  prior treatment failure with an anti-tumor necrosis factor agent;

          -  women who are pregnant or breast-feeding.
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone, 0.4mg; Placebo plug with no drug
Intervention description: Ophthalmic Insert; Ophthalmic Insert
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the efficacy and safety of OTX-DP as a
      dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a positive history of ocular allergies and a positive skin test reaction to a
             perennial allergen and a seasonal allergen

          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of
             instillation

        Exclusion Criteria:

          -  History of refractive surgery (including LASIK procedures) within the past 2 years

          -  History of retinal detachment, diabetic retinopathy, or active retinal disease

          -  Presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit

          -  History of IOP increase as a result of steroid treatment

          -  A female who is currently pregnant, planning a pregnancy, or lactating
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Vardenafil ODT (STAXYN, BAY38-9456); Placebo
Intervention description: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT); Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Intervention MeSH terms: Vardenafil Dihydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 362.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction

Summary:

      This study investigates the safety and efficacy of a new dosage form of Vardenafil, an
      orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo
      (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,
      patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be
      determined by laboratory and other evaluations. Efficacy will be determined by the results of
      different questionnaires and the patient diary that will be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 18 years-of-age or older

          -  Stable, heterosexual relationship for at least 6 months

          -  A history of erectile dysfunction (ED) for at least 6 months

        Exclusion Criteria:

          -  Any underlying cardiovascular condition, including unstable angina pectoris

          -  History of myocardial infarction, stroke or life-threatening arrhythmia within 6
             months prior to visit 1

          -  Uncontrolled atrial fibrillation / flutter at screening

          -  History of surgical prostatectomy for prostate cancer

          -  Hereditary degenerative retinal disorders

          -  History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy
             (NAION), temporary or permanent loss of vision

          -  Presence of penile anatomical abnormalities

          -  Subjects who have been confirmed with phenylketonuria (PKU)

          -  Spinal cord injury

          -  Resting or postural hypotension or hypertension

          -  Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens,
             alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus
             (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and
             erythromycin

          -  Use of any treatment for ED within 7 days of Visit 1

          -  History of congenital QT prolongation

          -  History of syncope within the last 6 months prior to entry into the study
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Intervention: risedronate sodium (Actonel); Placebo
Intervention description: risedronate tablet once a day for one year followed by risedronate once a day for two years; placebo tablet once a day for one year followed by risedronate once a day for two years
Intervention MeSH terms: Risedronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 4 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Primary disease: Osteogenesis Imperfecta

Summary:

      Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There
      are no approved drugs for the treatment of OI in children, even though some intravenous (IV)
      bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic
      study, data showed that risedronate was well tolerated in 28 children with OI. This three
      year study will test the safety and efficacy of risedronate in the treatment of children with
      OI. For the first year, patients will be randomized to the risedronate and placebo groups in
      a 2:1 ratio. For the second and third years of the study, all patients will receive
      risedronate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OI diagnosis

          -  increased risk of fracture: either has a history of at least 1 radiographically
             confirmed, non-traumatic or low impact fracture plus low bone mineral density (BMD) or
             has very low BMD with or without a history of fractures.

        Exclusion Criteria:

          -  Any bisphosphonate use within one year of enrollment
Actuation Indicator Trial in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Ipratropium bromide
Intervention MeSH terms: Bromides; Ipratropium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Enrollment: 142.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the performance, accuracy, and handling of
      the actuation indicator in patients with COPD. The actuation indicator is integrated into
      mouthpiece of the ipratropium bromide HFA inhalation aerosol device. As part of Boehringer
      Ingelheim's program to qualify an actuation indicator for use with the ipratropium bromide
      HFA inhalation aerosol device, this study is intended to complement the results from the
      ongoing in-vitro studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of COPD based on medical history at a severity to require maintenance
             treatment with a bronchodilator

          2. Male or female patients 40 years of age or older

          3. A smoking history of more than ten pack-years. A pack-year is defined as the
             equivalent of smoking one pack of 20 cigarettes per day for a year

          4. Must be able to use the study MDI with the mouthpiece containing actuation indicator

        Exclusion Criteria:

          1. Significant diseases other than COPD are excluded. A significant disease is defined as
             a disease which in the opinion of the investigator may either put the patient at risk
             because of participation in the study or a disease which may influence the results of
             the study or the patient's ability to participate in the study

          2. Malignancy for which the patient has undergone resection, radiation therapy or
             chemotherapy within the last three months. Patients with treated basal cell carcinoma
             are allowed

          3. History of asthma

          4. Significant history active alcohol or drug abuse

          5. Known active tuberculosis

          6. Known narrow-angle glaucoma

          7. Current significant psychiatric disorders

          8. Pregnant or nursing women or women of childbearing potential not using a medically
             approved means of contraception (i.e., oral contraceptives, intrauterine devices or
             diaphragm with spermicide, or Norplant®)

          9. Known hypersensitivity to anticholinergic drugs, any other component of the
             ipratropium bromide, HFA-134a or MDI components

         10. Previous participation in this trial

         11. Patients who are currently participating in another trial and/or who have received
             investigational drug within the past 30 days
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Tamoxifen; Exemestane
Intervention description: Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.; Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Intervention MeSH terms: Tamoxifen; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4740.0
Sex: Female
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      To compare the sequential administration of exemestane with administration of further
      tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already
      received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall
      survival (OS), incidence of contralateral breast cancer and long-term tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal women with histologically or cytologically confirmed primary breast
             adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously
             for between 2 and 3 years and one month, and still free of disease

        Exclusion Criteria:

          -  unresectable breast cancer

          -  ER negative primary tumor
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Accelerated partial breast irradiation (APBI); Whole breast irradiation (WBI)
Intervention description: Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT); Conventional whole breast irradiation (WBI)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 520.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Breast cancer; Early breast cancer; Adjuvant breast cancer; Accelerated partial breast irradiation; Intensity modulated radiotherapy

Summary:

      The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole
      breast radiotherapy to accelerated partial breast irradiation using intensity-modulated
      radiotherapy technique in selected early breast cancer patients after breast conserving
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at presentation >40 y

          -  Tumor size <25 mm

          -  Wide excision or quadrantectomy with clear margins (>5 mm)

          -  Clips placed in tumor bed

          -  Full informed consent from patient

        Exclusion Criteria:

          -  Cardiac dysfunction

          -  Forced expiratory volume in 1 second (FEV1) <1 L/m

          -  Extensive intraductal carcinoma

          -  Multifocal cancer

          -  Psychiatric problems

          -  Recurrent breast cancer
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: tacrolimus; everolimus; Basiliximab; Mycophenolic Acid; Corticosteroids
Intervention description: Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.; Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation; Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4; Dose of 1440 mg/day from transplantation to month 6 post- transplantation; Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus; Basiliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Everolimus,; liver transplantation,; early introduction,; renal function

Summary:

      The aims of the study was to evaluate the safety and efficacy of early introduction one month
      post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de
      novo liver transplant recipients and to evaluate if it leads to a better renal function 6
      month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS.

      The renal function was estimated by glomerular filtration rate.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Man or woman aged 18 years or greater, recipient of a primary liver transplant from a
             deceased donor with whole or split liver

        Key Exclusion Criteria:

          -  Patient recipient of multiple solid organ or islet cell tissue transplants, or have
             previously received an organ or tissue transplant

          -  Recipient of a liver from a living donor or cadaveric non heart beating donor

          -  ABO incompatible transplant graft

          -  Transplantation following autoimmune liver hepatitis, primitive sclerosing cholangitis
             or primitive biliary cirrhosis

          -  Estimated glomerular filtration rate ≤ 30ml/min at selection

          -  History of malignancy within the 5 past years, other than non-metastatic basal or
             squamous cell carcinoma and hepatocellular carcinoma

          -  Alpha-foeto-protein > 1000 ng/ml (only in case of hepatocellular carcinoma)
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
Condition: Complicated Skin and Soft Tissue Infection
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Intervention: Ceftaroline fosamil; Vancomycin; Aztreonam
Intervention description: IV ceftaroline 600mg every 8 hours; IV vancomycin 15mg/kg every 12 hours; IV aztreonam 1 g every 8 hours
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil; Aztreonam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: complicated skin and soft tissue infections (cSSTI); skin infection; ceftaroline; wound infection; cellulitis; burn infection; bacterial infection; vancomycin

Summary:

      The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin
      plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18 years or older - Complicated skin and skin structure infection
             (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of
             sufficient severity such that it is expected to require at least 5 days of intravenous
             antibiotic therapy. patients must have a positive culture for MRSA that has been
             obtained from the skin infection site and/or blood samples at any time within the
             72hrs before the first dose.

        Exclusion Criteria:

          -  Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior
             to first dose of study drug - Uncomplicated skin and skin structure infections, skin
             infections suspected to be caused by viral or fungal pathogens - Diabetic foot
             infections, decubitus ulcers, ulcers due to peripheral vascular disease - Infection
             caused by human or animal bites, sternal wound infections, bone infection or arthritis
             due to an infection, critical limb ischemia of the affected limb - Chronic liver
             disease or severe impaired renal function, severe low white blood cell count, burns on
             greater than 15% of total body surface area, necrotizing skin infection, amputation
             required of primary site of infection, sustained shock
Dose Confirmation Efficacy Study (V260-007)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Intervention: RotaTeq™, rotavirus vaccine, live, oral, pentavalent; Comparator: Placebo matching RotaTeq™
Intervention description: Three doses of RotaTeq™ administered 28 to 70 days apart.; Placebo matching RotaTeq™ administered 28 to 70 days apart.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1312.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and
      the efficacy to prevent Rotavirus Gastroenteritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants

        Exclusion Criteria:

          -  History of abdominal disorders from a birth defect, intussusception, or abdominal
             surgery

          -  Known or suspected problems with immune system

          -  Fever at time of immunization

          -  Prior administration of a rotavirus vaccine

          -  History of known prior rotavirus disease

          -  Chronic diarrhea, or failure to thrive
Effect of MK0524A on Cholesterol Levels (0524A-048)
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: laropiprant/niacin (MK0524A); Comparator: placebo
Intervention description: Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks.
All patients will receive placebo for a 4 week run-in period before randomization; Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks
Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks.
All patients will receive placebo for a 4 week run-in period before randomization.
Intervention MeSH terms: Niacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 646.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: High Cholesterol; Excess lipids

Summary:

      The primary objective of the study is to assess the effects of MK0524A in reducing
      cholesterol levels in an Asian population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 70 years of age

          -  Females of reproductive potential must agree to take acceptable contraceptive
             precautions for the duration of the study

        Exclusion Criteria:

          -  Patient has a history of not being able to take niacin or niacin-containing products

          -  Patient consumes more than 2 alcoholic beverages per day

          -  Patient has poorly controlled Type 1 or Type 2 diabetes mellitus

          -  Patient engages in vigorous exercise or an aggressive diet regimen