bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg iv every 4 weeks, total of 6 infusions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra
      (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an
      inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive
      RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6
      infusions).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)

          -  Inadequate response to DMARDs

          -  Body weight < 150 kg

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months of enrollment

          -  Rheumatic autoimmune disease other than RA

          -  American College of Rheumatology (ACR) functional class IV

          -  Prior history of or current inflammatory joint disease other than RA

          -  Previous treatment with any biologic drug that is used in the treatment of RA

          -  Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

          -  Pregnant or lactating women

          -  Active current or history of recurrent infection, active TB within the previous 3
             years, HIV infection
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Condition: Xerophthalmia; Blepharitis
MeSH terms: Blepharitis; Xerophthalmia
Intervention: Systane Ultra eyedrops; Refresh eye drops
Intervention description: Four times a day; Four times a day
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry
      Eyes
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject age is between 40 and 65 years old.

          2. Corneal fluorescein staining present in at least one/five sectors of at least one
             cornea

          3. At least one question out of 6 questions on dry eye symptom present often or all the
             time.

             based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry,
             gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.

          4. At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least
             one eye

          5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of
             Marx's line in line with Meibomian orifice)

          6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain
             from non-trial topical eye medications for 6 weeks.

          7. Use of lubricants during the week before recruitment (ranging from 3 times in the week
             to less than 6 times a day every day).

          8. Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3
             times over week to less than 6 times a day in all days.

        Exclusion Criteria:

          1. Known history of thyroid disorders (diagnosed by physician).

          2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).

          3. No ocular surgery within 6 months and LASIK within 1 year.

          4. Any intake of central nervous system and hormonal drugs within last 30 days and
             inability to withhold such drugs for at least 6 weeks.

          5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with
             lagophthalmos.

          6. Anticipated necessity to wear contact lens in the duration of the study.

          7. Not living in the same household as another participant of the study.

          8. Any other specified reason as determined by clinical investigator.
Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
Condition: Myopia
MeSH terms: Refractive Errors
Intervention: LASIK correction of myopic refractive errors
Intervention description: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: refractive; LASIK

Summary:

      The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and
      effective for the correction of myopic refractive errors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or greater

          -  Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better

          -  Uncorrected visual acuity (UCVA) of 20/40 or worse

          -  Less than 0.75D difference between cycloplegic and manifest refraction sphere.

          -  Demonstration of refractive stability

          -  Anticipated post-operative stromal bed thickness of at least 250 microns

          -  Willing and capable of returning for follow-up examinations for the duration of the
             study.

        Exclusion Criteria:

          -  Women who are pregnant, breast-feeding, or intend to become pregnant over the course
             of the study

          -  Concurrent use of topical or systemic medications that may impair healing

          -  History of any medical conditions that could affect wound healing

          -  History of prior intraocular or corneal surgery, active ophthalmic disease, or other
             ocular abnormality

          -  Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative
             eye(s)

          -  Known sensitivity or inappropriate responsiveness to any of the medications used in
             the post-operative course
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mesalamine; Placebo
Intervention description: Pharmaceutical form: Granules in sachet; Route of administration: Oral use; Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g
      extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic
      remission in subjects with UC. The duration of treatment for each subject was 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

        Exclusion Criteria:

          -  Evidence of other forms of inflammatory bowel disease

          -  Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus
             [HBV], or hepatitis C virus [HCV])

          -  Disease limited to proctitis <15 cm

          -  Short bowel syndrome

          -  Prior colon resection surgery

          -  History of severe/fulminant UC

          -  Intolerant or allergic to aspirin or salicylate derivatives

          -  Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days

          -  Women who are pregnant or nursing

          -  History of known malignancy

          -  History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune
             diseases, or mental/ emotional disorders, that would interfere with their
             participation in the trial
Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: BDP Nasal Aerosol; Placebo
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: allergic rhinitis; pediatric subjects; BDP nasal aerosol

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Beclomethasone
      dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit
             (SV).

          -  A documented history of PAR to a relevant perennial allergen for a minimum of 12
             months (6 months for subjects 4 to 5 years of age) immediately preceding the study
             Screening Visit (SV).

          -  A demonstrated sensitivity to at least one allergen known to induce PAR through a
             standard skin prick test.

          -  Other criteria apply.

        Exclusion Criteria:

          -  History of physical findings of nasal pathology, including nasal polyps or other
             clinically significant respiratory tract malformations, recent nasal biopsy, nasal
             trauma (e.g., nasal piercing) or surgery, atrophic rhinitis, or rhinitis medicamentosa
             (all within the last 60 days prior to the Screening Visit [SV]).

          -  History of a respiratory infection or disorder (including, but not limited to
             bronchitis, pneumonia, chronic sinusitis or influenza) within the 14 days preceding
             the Screening Visit (SV), or development of a respiratory infection during the Run-In
             Period.

          -  Active asthma requiring treatment with inhaled or systemic corticosteroids and/or
             routine use of beta-agonists and any controller drug (e.g., theophylline, leukotriene
             antagonists). History of intermittent use (less than or equal to 3 uses per week) of
             inhaled short acting beta-agonists prior to the Screening Visit (SV) is acceptable.

          -  Have any of the following conditions that are judged by the investigator to be
             clinically significant and/or affect the subject's ability to participate in the
             clinical trial.

          -  Other criteria apply.
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Condition: COPD Asthma
MeSH terms: Asthma
Intervention: Spirometry at initial visit; Albuterol; Spirometry at 12-month follow-up
Intervention description: Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.; The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.; At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic
      Error in COPD and Asthma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1.Age >40 years of age

          -  2. Use of a maintenance respiratory medication and one of the following in the past
             year:

          -  3. Diagnosis of asthma and/or COPD

          -  4. No spirometry test performed in the past 3 years

          -  5. Past or current smoker or is exposed to tobacco

        Exclusion Criteria:

          -  Unable to perform adequate spirometry

          -  Non-English speaking

          -  Pregnancy

          -  Plans to move from the Chicago Area within the next year

          -  Seen by pulmonary specialist in the past 3 years

          -  Any terminal illness with a life expectancy of <6 months

          -  Life threatening (e.g. intensive care admission and/or use of mechanical ventilation)
             respiratory failure event in the past year.
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Condition: Rosacea
MeSH terms: Rosacea; Erythema
Intervention: CD07805/47 gel; Placebo
Intervention description: applied topically once daily; applied topically once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosacea

Summary:

      Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema
      associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once
      daily is more efficacious than vehicle and provides an acceptable safety profile in the
      treatment of facial erythema associated with rosacea.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female who is at least 18 years of age or older.

          2. A clinical diagnosis of facial rosacea.

          3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
             and at Baseline/Day 1 (prior to the study drug application).

          4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
             at Baseline/Day 1 (prior to the study drug application).

        Key Exclusion Criteria:

          1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
             rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
             that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
             keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
             telangiectasia.

          2. Presence of three (3) or more facial inflammatory lesions of rosacea.

          3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
             sedatives, systemic anesthetics, or alpha agonists.

          4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac
             glycosides, beta blockers or other antihypertensive agents.

          5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Condition: Pediatric Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: TA-650
Intervention description: TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Infliximab; REMICADE; TA-650

Summary:

      The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity
      index (CAI) score and other evaluation indicators in pediatric patients with moderate to
      severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2,
      and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also
      evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have been diagnosed as ulcerative colitis at least 3 months prior to
             screening.

          -  Have active ulcerative colitis despite adequate conventional therapy.

        Exclusion Criteria:

          -  Patients who have severe pancolitis.

          -  Patients who have undergone surgery for ulcerative colitis within 8 weeks before
             enrollment or who were judged to require surgery for ulcerative colitis at enrollment.

          -  Patients who have a history of treatment with infliximab or other biologic products
             (anti-TNFα agents, anti-IL-6 agents, etc.).
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Recurrence
Intervention: Hexvix; Standard white light cystoscopy
Intervention description: Single Instillation, Transurethral Resection of the Bladder
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 789.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Cancer; Hexvix; Fluorescence; Cystoscopy

Summary:

      The purpose of this study is to document the additional detection of papillary bladder cancer
      and the reduced early recurrence due to the improved detection and resection of these tumors
      after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        The patients should be indicated for a cystoscopic examination for suspected or verified
        papillary bladder cancer and fulfill one or more of the following criteria:

          -  Patients with more than one initial bladder tumor confirmed on an outpatient
             cystoscopy.

          -  Patients having recurrence within 12 months confirmed on an outpatient cystoscopy

          -  Patients with more than one papillary lesion at recurrence independently of the time
             of the recurrence confirmed on an outpatient cystoscopy

        Exclusion Criteria:

          -  Patients with known tumors in the prostatic urethra or distal urethra

          -  Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting
             in marked amounts of blood in the urine, which may interfere with fluorescence
             cystoscopy. Where the bleed is light, the patient should not be excluded if in the
             investigator's opinion, rinsing during cystoscopy will alleviate the possible
             interference with fluorescence cystoscopy).

          -  Patient with porphyria.

          -  Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.

          -  Participation in other clinical studies with investigational drugs either concurrently
             or within the last 30 days.

          -  Pregnant or breast-feeding (all women of child-bearing potential must document a
             negative serum or urine pregnancy test at screening and use the contraceptive pill or
             intrauterine device (IUD) during the treatments and for at least one month
             thereafter).

          -  Patients who have received BCG or chemotherapy within three months prior to the
             initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of
             seeding after resection.

          -  Conditions associated with a risk of poor protocol compliance.
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Solanezumab; Placebo
Intervention description: 400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.; Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1457.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This study is an open-label extension study in Alzheimer's patients who have completed
      participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN
      (NCT00904683).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets National Institute of Neurological and Communicative Disorders and
             Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
             for probable Alzheimer's Disease

          -  Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks

          -  Must continue to have a reliable caregiver who is in frequent contact with the patient
             for the entire study

          -  Must have good vein access to administer infusions

          -  Agrees not to participate in studies of any other investigational compounds for the
             duration of their participation in Study LZAO

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational drug or device or off-label use of a drug or device
             (other than the study drug/device used in this study), or concurrently enrolled in any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN
             study