bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: travoprost ophthalmic solution 0.004%; travoprost 0.004% / timolol 0.5% combination ophthalmic solution; Bimatoprost ophthalmic solution 0.01%
Intervention description: Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.; DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.; LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Intervention MeSH terms: Timolol; Bimatoprost; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost
      ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination
      ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution
      0.004%) monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open angle glaucoma or ocular hypertension

          -  Best corrected visual acuity of 20/100 or better in both eyes

        Exclusion Criteria:

          -  Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks

          -  Previous treatment with LUMIGAN® RC or DuoTrav®

          -  History of LASIK, LASEK, RK or PRK in the study eye(s)

          -  Active ocular inflammation
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide/timolol maleate fixed combination
Intervention description: Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
Intervention MeSH terms: Timolol; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma

Summary:

      The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA®
      from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment
             dispersion glaucoma in at least one eye (study eye).

          -  Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the
             Screening Visit.

          -  IOP considered safe in both eyes in such a way that should assure clinical stability
             of vision and optic nerve throughout the study period.

          -  Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each
             eye.

          -  IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on
             brimonidine/timolol fixed combination therapy.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.

          -  History of ocular herpes simplex.

          -  Abnormality preventing reliable applanation tonometry.

          -  Corneal dystrophies.

          -  Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either
             eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

          -  Intraocular conventional surgery or laser surgery in study eye(s) less than three
             months prior to the Screening Visit.

          -  Risk of visual field or visual acuity worsening as a consequence of participation in
             the study, in the investigator's best judgment.

          -  Progressive retinal or optic nerve disease from any cause.

          -  Use of systemic medications known to affect IOP which have not been on a stable course
             for 7 days prior to the Screening Visit or an anticipated change in the dosage during
             the course of the study.

          -  Pregnant or lactating.

          -  Other protocol-defined exclusion criteria may apply.
The Prophylactic Use of Topical Cyclosporine A 0.05% to Prevent Graft Versus Host Disease Related Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Graft vs Host Disease
Intervention: Cyclosporine A 0.05%; Arificial Tear
Intervention description: Topical cyclosporine A 0.05% (Restasis) three times a day for 18 months.; Artificial Tear - three times a day for 18 months.
Intervention MeSH terms: Cyclosporine; Lubricant Eye Drops; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Graft versus Host Disease; GVHD

Summary:

      The purpose of this study is to determine whether Restasis is an effective treatment for
      preventing the occurrence and progression of dry eye syndrome in patients who have recently
      received a bone marrow transplant and are at risk to graft-versus-host disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  At least 18 years of age

          -  Approved candidate for allogeneic HSCT

          -  Ability to understand and provide informed consent to participate in this study

          -  Willingness to follow study instructions and likely to complete all required visits

        Exclusion Criteria:

          -  History of ocular or eyelid surgery

          -  History of glaucoma or ocular hypertension

          -  History of herpetic eye disease

          -  Patient with acne rosacea, blepharitis, or meibomitis, in the opinion of the
             investigator

          -  Any ocular disorder or condition (including ocular infection, trauma, and disease)
             that could possibly interfere with the interpretation of the study results

          -  Recent (3-month) history of wearing contact lens

          -  Anticipated contact lens wear during any portion of the study

          -  Recent (3-month) history of current use of topical steroids or antiglaucoma agents

          -  Any punctal occlusion within 2 months of the screening visit

          -  Significant sign or symptoms of dry eye (the definition of "dry eye" used for
             exclusion criteria is compatible with the recommendations of the NEI/Industry Workshop
             on Clinical Trials in Dry Eyes (Lemp, 1995) (see Appendix 1and 2))

          -  History of connective tissue disease or diabetes

          -  Any condition (including language barrier) that precludes patient's ability to comply
             with study requirements including completion of study
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Intervention: Rocuronium; Placebo
Intervention description: 0.6 mg/Kg once; Normal saline same amt as 0.6mg/kg of study drug
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Healthy volunteers: No

Summary:

      Those infants who received the muscle relaxation in combination with the vagolytic (reduce
      vagus nerve impulses) and pain medication will have reduced time to successful intubation
      (placement of tube into the lungs), a decrease in the number of attempts, and better
      intubation conditions reported by the practitioner. The objectives of the study include: 1.)
      Does the medication protocol outlined in this study provide optimal intubation conditions?
      (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.)
      Does the addition of a muscle relaxant prior to intubation contribute to less attempts and
      achieving successful intubation as opposed to neonates who do not receive the muscle
      relaxant.
    

Eligibility criteria:

        Inclusion criteria:

          1. Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.

          2. Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher

          3. Infants who require endotracheal intubation on a non-emergent basis

          4. Signed informed consent by parents

        Exclusion criteria:

          1. intubations that occurred in the delivery room or for other emergent basis,

          2. absence of intravenous access

          3. abnormality of the airway

          4. known or family history of neuromuscular disorder

          5. renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1
             day of age)

          6. known hepatic insufficiency (abnormal liver function or coagulation laboratory
             results)

          7. Current diagnosis of pulmonary hypertension

          8. Any infant deemed by the attending neonatologist as unstable or unfit for the study
Hormones Inflammation and Thrombosis
Condition: Acute Coronary Syndrome; Thrombosis
MeSH terms: Thrombosis; Acute Coronary Syndrome; Inflammation
Intervention: Aspirin 81 mg
Intervention description: Aspirin 81 mg orally daily for 7 days
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acute coronary syndrome; clotting; hormones; women

Summary:

      The investigators are attempting to determine if the response to aspirin in women is related
      to the level of estrogen and progesterone that a woman has.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women age 18-80

          2. Signed informed consent.

        Exclusion Criteria:

          1. History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),

          2. On chronic aspirin therapy,

          3. On chronic NSAID therapy.

          4. Chronic anticoagulation with coumadin,

          5. Known thrombocytopenia (Platelet count < 100,000),

          6. Pregnancy (self-report),

          7. Currently on any type of contraceptive or hormone replacement therapy,

          8. Hysterectomy and/or oophorectomy.

          9. Recent GI bleeding

         10. Bleeding diathesis

         11. Chronic Systemic Infection
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Intervention: Esomeprazole 40 mg
Intervention description: Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole
      (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with
      symptomatic erosive esophagitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients between the ages of 15 and 80 years

          -  with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the
             stomach,

          -  who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are
             recruited.

        Exclusion Criteria:

          1. coexistence of peptic ulcer or gastrointestinal malignancies,

          2. pregnancy,

          3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis
             and uremia),

          4. previous gastric surgery,

          5. allergy to esomeprazole,

          6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and

          7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol
Intervention description: Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab pegol - Cimzia; Rheumatoid Arthritis; Power Doppler Ultrasonography; Italy; Moderate-severe Rheumatoid Arthritis

Summary:

      The study aims to evaluate the predictability of early response to Certolizumab pegol in
      combination with Methotrexate at one year in patients with moderate to severe rheumatoid
      arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months
             but not longer than 5 years

          -  positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide
             (anti-CCP)

          -  active RA disease

          -  subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic
             Drug (DMARD).

          -  subject is naïve to RA related biologics

        Exclusion Criteria:

          -  a diagnosis of any other inflammatory arthritis

          -  history of infected joint prosthesis, or other significant infection

          -  known Tuberculosis (TB) disease or high risk of acquiring TB infection
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Condition: Pulmonary Heart Disease
MeSH terms: Heart Diseases; Pulmonary Heart Disease
Intervention: Definity
Intervention description: one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 4; DEFINITY®; hemodynamics; pulmonary artery pressure

Summary:

      The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse
      effects during Right Heart Catheterization. This research was requested by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Appropriate candidate scheduled to undergo right heart catheterization and measurement
             of pulmonary artery hemodynamics for clinical reasons

          -  Be male or female above the age of 18

          -  Female patients who no longer have child-bearing potential

          -  Women of Child-Bearing Potential(WOCBP) who:

               1. are not pregnant and have been using an adequate and medically approved method of
                  contraception

               2. have a negative urine pregnancy test

          -  Be able and willing to communicate effectively with study center personnel.

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Known hypersensitivity or contraindication to or greater heart block

          -  Previous heart transplant

          -  Known right-to-left shunt (including atrial septal defect)

          -  Severe pulmonary artery hypertension (i.e., > 75 mmHg

          -  Current uncontrolled ventricular tachycardia

          -  Second-degree or greater heart block

          -  Any contraindications for the use of a right heart catheter
Retreatment of Recurrent Dupuytren's Contractures
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture; Contracture
Intervention: Collagenase clostridium histolyticum
Intervention description: up to three 0.58 mg injections
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: XIAFLEX; XIAPEX; Dupuytren's disease; contracture

Summary:

      The objectives of this study are to assess the safety and efficacy of AA4500 in the
      retreatment of recurrent contractures in joints that were effectively treated with AA4500 in
      a previous Auxilium-sponsored Phase 3 study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Be currently participating in the AUX-CC-860 follow-up study

          3. Have at least one joint with all of the following:

               -  The joint was effectively treated (had a correction to 5 degrees or less at the
                  Day 30 evaluation after the last injection of AA4500) in a previous Auxilium
                  Phase 3 study

               -  The effectively treated joint has an increase in contracture of at least 20
                  degrees compared with the Day 30 value after the last injection of AA4500 in a
                  previous Auxilium Phase 3 study

               -  A palpable cord is present in the joint to be treated

          4. Be able to comply with the study visit schedule as specified in the protocol

        Exclusion Criteria:

          1. Is a pregnant or lactating female or female intending to become pregnant during the
             study

          2. Has hypersensitivity to AA4500 or any of the AA4500 excipients

          3. Is currently receiving or plans to receive anticoagulant medication or has received
             anticoagulant medication (except for equal to or less than 150 mg aspirin daily and
             over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before
             injection of AA4500
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: Gabapentin; Acetaminophen; Celecoxib
Intervention MeSH terms: Acetaminophen; Celecoxib; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the investigators' study is to assess the efficacy of a single dose of
      preoperative gabapentin within an enhanced recovery after surgery protocol in acute
      postoperative pain reduction for women undergoing a minimally invasive hysterectomy.
      Participants who consent to participate will be randomized to either a control group without
      gabapentin or to a study arm and receive gabapentin 600 mg prior to their planned surgery.
      The investigators will collect data on postoperative narcotic use, subjective pain as rated
      by a numeric pain scale, in addition to any adverse effects of single dose gabapentin use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing a minimally invasive hysterectomy with surgeons operating within the
             Christiana Care Health System at the Newark location only.

          -  at least 18 years of age

          -  able to swallow tablets or capsules

        Exclusion Criteria:

          -  liver failure

          -  renal failure

          -  prior gastric bypass

          -  gastroparesis

          -  recent or current regular gabapentin use

          -  hypersensitivity to gabapentin, acetominophen, or celecoxib

          -  procedure is converted to laparotomy for any indication. (Mini-laparotomy for specimen
             removal alone will not be excluded.)
Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Condition: Anxiety Disorders; Parkinson Disease
MeSH terms: Parkinson Disease; Anxiety Disorders
Intervention: rotigotine transdermal patch; placebo
Intervention description: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily; Participants will receive a placebo transdermal patch to be worn daily
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 21 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Anxiety Disorders; Parkinson Disease; rotigotine

Summary:

      This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing
      anxiety in people with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 Anxiety
             Disorder

          -  Stable medical history and general health

          -  On stable anti-parkinsonian therapy for 2 weeks before enrollment

        Exclusion Criteria:

          -  Unstable medical disease of comorbid psychiatric disease

          -  Dementia

          -  Subjects with less than one year duration of Parkinson's

          -  Current treatment with a dopamine agonist