bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Arformoterol Tartrate Inhalation Solution; Arformoterol Tartrate Inhalation Solution; Placebo
Intervention description: Nebulized arformoterol tartrate inhalation solution 15 microgram twice a day (BID); Nebulized arformoterol tartrate inhalation solution 30 microgram once a day (QD); Placebo inhalation solution (citrate buffered 0.9% saline solution) once a day
Intervention MeSH terms: Pharmaceutical Solutions; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: COPD; Chronic Bronchitis; Emphysema

Summary:

      To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD
      (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate
      inhalation solution 15μg/2 mL BID in subjects with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects must be at least 45 years old at the time of consent.

          -  Subjects must have a pre-established primary clinical diagnosis of COPD.

          -  Subjects must have a baseline FEV1 of ≤ 65% of predicted normal value at Visit 1.

          -  Subjects must have a FEV1 ≥ 0.70L at Visit 1.

          -  Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.

        Exclusion Criteria:

          -  Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness
             severity grade of 2 (as measured by the Modified Medical Research Council [MMRC]
             Dyspnea Scale Score) at Screening.

          -  Subjects with life-threatening/unstable respiratory status, including upper or lower
             respiratory tract infection, within the previous 30 days prior to Visit
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Intervention MeSH terms: Timolol; Ophthalmic Solutions; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma

Summary:

      The purpose of this study was to assess the safety and efficacy of switching to Azarga from
      prior pharmacotherapy in patients with open-angle glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion
             glaucoma in both eyes.

          -  Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within
             one week of screening/baseline visit.

          -  Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which
             would be the study eye, at screening.

          -  Must be willing to discontinue the use of all other ocular hypotensive medications
             prior to receiving the study medication for the entire course of the study.

          -  Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better
             in each eye.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Known medical history of allergy, hypersensitivity, or poor tolerance to any component
             of the medication to be used in the study deemed clinically significant in the opinion
             of the principal investigator.

          -  Any abnormality preventing reliable applanation tonometry in either eye.

          -  Risk of visual field or visual acuity worsening as a consequence of participating in
             this study, in the investigator's best judgment.

          -  Pregnant or lactating.

          -  Participation in any other investigational study within 30 days of screening visit.

          -  Other protocol-defined exclusion criteria may apply.
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Condition: Diabetic Retinopathy; Macula Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: Yellow micro-pulse laser; Diode micro-pulse laser
Intervention description: applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea; applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: micro-pulse laser; trans-foveal

Summary:

      Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment
      for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need
      of repeated injections, which carries both economic and compliance problems to the
      patients.there is a growing evidence that recognises the effectiveness of the use of
      micropulse laser (MPL) in treatment of DME. with MPL, it is possible to deliver a
      subthreshold laser that is above the threshold of biochemical effect but below the threshold
      of a visible, destructive lesion thereby preventing collateral damage.The MPL technique is
      available at near - infrared 810 nm diode laser (diode MPL) and at 577 nm (yellow MPL). The
      current study was conducted in order to compare the efficacy of both MPL techniques in the
      treatment of center involving DME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  bilateral diabetic macular edema

          -  center involving confirmed by Optical coherence tomogram (OCT)

        Exclusion Criteria:

          -  any non-diabetic macular edema

          -  significant media opacities

          -  previous laser treatment, any intraocular surgery within the past 6 months

          -  previous intravitreal injections of any drug within the past 6 months
Effects of Nicorandil on Angina Symptoms in Patients With Coronary Slow Flow
Condition: Slow Coronary Flow; Normal, or Near Normal Coronary Angiography; Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Intervention: Nicorandil; Nitroglycerin
Intervention description: nicorandil (10mg tablets, two times a day); sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
Intervention MeSH terms: Nicorandil; Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 54.0
Sex: All
Healthy volunteers: No
Keywords: Slow coronary flow phenomenon; Angina pectoris; chest pain; nicroandil

Summary:

      Slow coronary flow is an angiographically diagnosed phenomenon defined as delayed
      opacification of epicardial arteries in the absence of significant arterial narrowing and
      blockade. Endothelial dysfunction at the level of microarteries have been proposed as the
      main pathological mechanism in this regard. Available evidence suggest that standard
      anti-angina medications (e.g. nitroglycerin) that solely target large coronary trunks might
      not provide adequate symptomatic relief in patients with slow coronary flow phenomenon. It is
      hypothesized that anti-angina medications which exert vasodilatory effects in large coronary
      arteries as well as small dividing branches might be superior to nitroglycerin in
      amelioration of angina symptoms. The present randomized clinical trial was thus designed and
      conducted to compare the short-term efficacy of nicorandil (a dual-acting anti-angina
      medication with effects on both large and small coronary vessels) with nitroglycerin in a
      group of patients with slow coronary flow presented with frequent angina episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  on coronary angiographic studies, arterial narrowing did not exceed 50% in any of the
             three main coronary arteries; (

          -  a delayed opacification in at least one of the main coronary arteries was documented.
             Delayed opacification was defines as corrected TIMI frame count > 23 fps

        Exclusion Criteria:

          -  comorbid cardiovascular condition other than mild coronary atherosclerosis and
             coronary slow flow

          -  refusal to participate

          -  discontinuation of treatment

          -  not returning for the follow up visit
The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Golimumab
Intervention description: GLM 50 mg subcutaneously once monthly.
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine the difference in the annual incidence rate of
      uveitis attacks in participants with ankylosing spondylitis (AS) before start initial
      anti-TNF therapy and after treatment with golimumab (GLM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  May not have been treated with GLM prior to study enrollment

          -  Must be able to provide retrospective data concerning extra-articular manifestations
             and episodes with a recall period of at least 12 months prior to anti-TNF use

          -  Must have definite AS according to the modified New York criteria in the Netherlands

          -  Must be candidate for treatment with anti-TNF agent according to the Assessment of
             SpondyloArthritis International Society (ASAS) consensus

          -  Must be able to adhere to dose and visit schedules

        Exclusion Criteria:

          -  Any exclusion criteria stated in the Summary of Product Characteristics for golimumab

          -  Use of any investigational biological or chemical agents within 30 days or 2
             half-lives (whichever is longest) of screening
Medrol Dosepak Taper for Delayed Post-op Recovery After TKA
Condition: Total Knee Arthroplasty
Intervention: Methylprednisolone; Placebo
Intervention description: 21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM <90° at 8 weeks; 21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM <90° at 8 weeks
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methylprednisolone; Delayed recover; range of motion

Summary:

      To evaluate the efficacy of a methylprednisolone taper on patients with decreased range of
      motion (ROM) or delayed recovery in the acute postoperative period following total knee
      arthroplasty (TKA).

      Patients with decreased ROM or delayed recovery six weeks to three months post-TKA will
      improve ROM and patient-reported outcomes at two weeks post-treatment initiation of
      methylprednisolone taper, as compared to similar patients who receive a placebo taper.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient undergoing primary TKA with a diagnosis of osteoarthritis

          -  ≥ 18 years old

          -  ROM <90° by 3 weeks postoperatively without improvement to >90° by 6 weeks

          -  Requiring a 30-pill oxycodone refill

          -  NSAID allergy

          -  Thigh circumference discrepancy >2cm between legs from 3 to 6 weeks

          -  Defense and Veterans Pain Rating Scale (DVPRS) > 5 between 3 and 6 weeks

          -  Willingness to undergo randomization

        Exclusion Criteria:

          -  Reported chronic corticosteroid or opiate use

          -  Suspected or confirmed periprosthetic joint infection

          -  Revision TKA

          -  Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture,
             or post-traumatic arthritis

          -  American Society of Anesthesiologists (ASA) score ≥ 4

          -  Reported history of liver or renal disease

          -  Uncontrolled diabetes

          -  Immunosuppression

          -  ≤ 18 years old

          -  Inability to take oral medications

          -  Unable to provide consent
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Cyclosporine; Tacrolimus
Intervention description: Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.; Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Post Liver Transplant

Summary:

      The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug,
      on the clearance of the hepatitis C virus in liver transplant subjects being treated with
      peg-interferon and ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females age 18 years and older

          -  HCV RNA positive by PCR after liver transplantation

          -  Elevated ALT at any time point after liver transplantation

          -  Protocol liver biopsy (standard of care) consistent with Stage greater than or equal
             to 2 of Ishak fibrosis score after liver transplantation

          -  Able to provide written informed consent

          -  Willing to practice acceptable birth control during the study period.

        Exclusion Criteria:

          -  Decompensated Cirrhosis

          -  hemoglobin < 12 g/dl

          -  WBC < 3,500/cubic mm

          -  Platelets < 75,000/cubic mm

          -  Human immunodeficiency virus infection

          -  Pregnancy

          -  Positive HbsAg

          -  History of coronary artery disease, history of seizure disorder, poorly controlled
             autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis,
             intolerance to previous interferon-based therapy other than anemia or neutropenia

          -  History of suicidal ideation or suicidal attempts

          -  Creatinine > 2.0 mg/dl

          -  Severe non-hepatic illnesses
The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
Condition: Adverse Effects
Intervention: 4% lidocaine gel
Intervention description: 1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: lidocaine; pre-medication; mammography; pain; safety

Summary:

      The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine
      gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication
      to reduce discomfort during screening mammography does not result in adverse effects,
      electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or
      its principal metabolite, monoethylglycinexylidide (MEGX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  35 years and older

          -  intact skin on breasts and chest wall

        Exclusion Criteria:

          -  sensitivity or allergy to lidocaine

          -  liver or kidney dysfunction

          -  pregnant

          -  breast feeding

          -  currently smoke or chew tobacco

          -  used lidocaine products within 48 hours of baseline lab, EKG, or gel application

          -  exhibit neurological or cardiac signs or symptoms prior to gel application

          -  are taking antiarrythmic medications, ciprofloxacin, erythromycin products, or oral
             contraceptives

          -  history of Wolffe-Parkinson-White Syndrome (WPW) or congestive heart failure

          -  heart rate below 60 or above 100 beats per minute

          -  systolic blood pressure below 95 or above 180 mm Hg

          -  PR interval greater 200 msec, QRS duration greater than 120 msec, QTc greater than 450
             msec, or evidence of WPW on EKG

          -  have an automatic implantable cardioverter defibrillator (AICD) or cardiac pacemaker

          -  have had cancer, surgery, trauma, or myocardial infarction in the past 6 months
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Condition: Tonsillectomy; Adenoidectomy
Intervention: Acetaminophen
Intervention description: already included in arm/group descriptions
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical
      patients. The drug is available in an over the counter, inexpensive oral form as well as a
      considerably more expensive intravenous form. This study will compare opioid requirements and
      acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus
      intravenous routes given pre operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for
             obstructive sleep apnea with or without additional minor procedures such as sleep
             endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or
             ear exam. ( Minor additional procedures that are frequently combined with
             tonsillectomy and adenoidectomy but are not commonly considered to have pain that is
             significantly greater than the tonsillectomy and adenoidectomy).

        Exclusion Criteria:

          -  Patients who meet University of California Davis Children's Hospital (UCDCH) criteria
             for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively,
             exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep
             study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%,
             cardiac disease, difficult intubation.

          -  Patients with a known allergy to acetaminophen

          -  Patients with known hepatic insufficiency or severe hepatic disease

          -  Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

          -  Patients who are malnourished (ie lower levels of glutathione)

          -  Patients with severe renal impairment as defined by calculated creatinine clearance
             <20 ml/min (per modified Schwarz equation)

          -  Patients who are pregnant
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Acthar Gel; Placebo Gel
Intervention description: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection); 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is to study Acthar Gel in participants with active systemic lupus erythematosus
      (SLE).

      The doctor will assign eligible patients to one of two groups (like flipping a coin).

      Participants will receive the treatment assigned to their group for 24 weeks:

        -  Acthar Gel

        -  Placebo Gel, which looks like Acthar Gel, but has no medicine in it.

      The doctor or his staff will take measurements and ask questions to:

        -  see how well the gel is working

        -  see how safe it is for patients with SLE
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to participate in this trial, a patient must:

          -  Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised
             criteria

          -  Have active SLE

          -  Have moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or
             B in the mucocutaneous and/or musculoskeletal body systems at both Screening and
             Randomization Visits

          -  Have a documented history or screening result of

               1. positive antinuclear antibody (ANA), OR

               2. elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies

          -  Have been on prednisone (or prednisone equivalent) before the screening visit:

               1. at least 8 weeks, and

               2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

        Exclusion criteria:

        A patient is not eligible to participate if he/she:

          -  Has a history of sensitivity to adrenocorticotropic hormone (ACTH) preparations or
             porcine products

          -  Has active lupus nephritis

          -  Has active central nervous system (CNS) manifestations of SLE