bioihbjkbjnl/mcl2 huggingface dataset:
Acthar Gel in Participants With Pulmonary Sarcoidosis
Condition: Sarcoidosis, Pulmonary
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Intervention: Acthar Gel; Placebo
Intervention description: Acthar Gel for subcutaneous (SC) injection (80 units per 1 mL); Placebo gel for SC 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: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if Acthar Gel is safe and effective to treat
      pulmonary sarcoidosis.

      Participants will be randomly assigned (like flipping a coin) to receive a shot under their
      skin of Acthar Gel or a matching placebo gel that has no drug in it. They will receive their
      assigned shot twice a week for 24 weeks.

      All participants who complete the 24-week treatment period will be eligible to receive Acthar
      Gel for 24 more weeks, even if they were originally in the placebo group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has biopsy-confirmed sarcoidosis meeting American Thoracic Society criteria ≥ 1 year
             at screening (Visit 1)

          -  Has protocol-defined symptomatic pulmonary disease

          -  Has been receiving a stable prednisone dose between 5 mg and 40 mg (or equivalent) for
             pulmonary sarcoidosis, for at least 4 weeks before screening, or a stable dose of
             another disease-modifying anti-sarcoidosis drug for at least 3 months before screening

          -  Has lung function within protocol-defined parameters

        Exclusion Criteria:

          -  Has at least a 10% change in forced vital capacity (FVC) on spirometry between Visits
             1 and 2

          -  Has pulmonary arterial hypertension requiring treatment

          -  Has been treated with antitumor necrosis factor-α antibody within the past 3 months

          -  Has any pulmonary condition that requires treatment, therefore impeding corticosteroid
             tapering
Persantine: Variation in Response Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: dipyridamole
Intervention description: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Intervention MeSH terms: Dipyridamole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to understand why different people respond differently
      to the medication Persantine. The effects of Persantine will be evaluated by performing
      echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart
      in patients undergoing a clinically indicated percutaneous coronary intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 21 years old

          -  Patient undergoing cardiac catheterization with planned PTCA or with a significant
             coronary lesion of either the LAD or Circumflex

        Exclusion Criteria:

          -  Theophylline or oral Persantine use in 24hrs

          -  Second or third degree AV block, or sick sinus syndrome without a functioning
             pacemaker

          -  Active asthma or bronchospasm

          -  Patients with severe hepatic insufficiency

          -  Patients experiencing an acute transmural infarction at the time of the index visit

          -  Conditions that are known to affect resistive vessel function or myocardial flow
Does Allopurinol Prolong a Treated, Acute Gout Flare?
Condition: Gout
MeSH terms: Gout
Intervention: allopurinol; Placebo (sugar pill)
Intervention MeSH terms: Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gout; allopurinol

Summary:

      This is a double blind placebo controlled study to determine whether starting allopurinol
      during a treated acute gout attack will have any effect on the duration of the attack.
    

Eligibility criteria:

        Inclusion Criteria requires both of:

          -  Crystal proven gout, and

          -  An acute gout attack within 72 hours of first treatment

        Plus one of the following:

          -  At least 2 gout attacks in past 12 months

          -  Tophus

          -  Nephrolithiasis

          -  24hr urine uric acid greater than 1000mg

        Exclusion Criteria:

          -  Inability to return for examinations

          -  Glomerular filtration rate (calculated) less than 50 milliliters per minute

          -  Allopurinol use in past 6 months

          -  Ongoing cancer therapy

          -  Concomitant azathioprine or cyclophosphamide

          -  Any one of the following liver enzymes greater than 1.25 times the upper limit of
             normal:

               -  AST [Aspartate aminotransferase]

               -  ALT [Alanine aminotransferase]

               -  alkaline phosphatase

          -  Pre-gout pain in involved joint of more than 3 on a scale of 1-10

          -  Neurologic deficit around the involved joint
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost 0.01%; travatan 0.004%; timolol 0.5%; hypromellose 0.3%
Intervention description: Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.; Travatan 0.004% administered to both eyes once daily for 12 weeks.; Timolol 0.5% administered to both eyes once daily for 12 weeks.; Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Intervention MeSH terms: Timolol; Bimatoprost; Travoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%)
      alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS
      0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or glaucoma that requires treatment with medication

          -  Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

        Exclusion Criteria:

          -  History of LASIK, LASEK, RK, and/or PRK in the study eye(s)

          -  History of any intraocular surgery or glaucoma laser surgery in the study eye(s)
             within 3 months

          -  Use of topical, periorbital, intravitreal or systemic steroid within 3 months or
             expected use during the course of study
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia ( PHN )
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Lyrica (pregabalin); Placebo
Intervention description: Capsule, 300 mg/d, BID, 8 weeks treatment; Capsule, 300 mg/d, BID, 8 weeks treatment
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 223.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin; Postherpetic Neuralgia ( PHN )

Summary:

      To prove pregabalin is effective in relieving pain compared with placebo in subjects with
      postherpetic neuralgia (PHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Chinese subjects, ages ≥18 at screening

          -  Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia
             (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes
             zoster skin rash

          -  At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale
             (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

          -  At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog
             scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)

          -  At randomization (V2), subjects must have completed at least 5 daily pain diaries
             (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days

        Exclusion Criteria:

          -  Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain
             Visual Analog Scale (VAS) at randomization as compared to screening

          -  Subjects who have a high variability in pain scores during the 1 week screening
             period, with any difference between two scores ﹥3
Minimizing Nausea and Vomiting During Spinals for CS
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Glycopyrrolate; Normal Saline
Intervention description: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose; 1ml of normal saline will be given intravenously with the administration of the spinal dose
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of
      crystalloids, with placing the spinal, along with administering a phenylephrine infusion and
      glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and
      good intra and post-operative pain relief.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pregnant

          2. American Society of Anesthesiologists risk classification I and II

          3. Age > 18 years

          4. Non-laboring

          5. Patients with elective cesarean sections

        Exclusion Criteria:

          1. Non- English speakers

          2. Height < 4' 11"

          3. BMI >40 Kg/ mm

          4. Antiemetic drug use in the 24 hours prior to cesarean delivery,

          5. Hypertensive diseases of pregnancy

          6. Chronic hypertension receiving antihypertensive treatment

          7. Any other physical or psychiatric condition that may impair their ability to cooperate
             with study data collection.
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.
Intervention MeSH terms: Epoetin Alfa
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

Summary:

      This single arm study will evaluate the maintenance of hemoglobin levels, safety and
      tolerability of once-monthly intravenous administration of Mircera in dialysis patients with
      chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms)
      every four weeks depending on the previous dose of epoetin alfa administered in the week
      preceding first study drug administration. Patients will be treated for 12 weeks with follow
      up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients, >=18 years of age;

          -  chronic renal anemia;

          -  Hb concentration 10.5g/dL - 12.5g/dL;

          -  continuous intravenous maintenance therapy with epoetin alfa at the same dosing
             interval during the previous 2 months.

        Exclusion Criteria:

          -  blood transfusion within the previous 2 months;

          -  poorly controlled hypertension;

          -  significant acute or chronic bleeding;

          -  active malignant disease;

          -  congestive heart failure (NYHA Class IV).
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: bupropion & Citalopram; Bupropion & Placebo; Placebo & Citalopram; Placebo & Placebo
Intervention MeSH terms: Dexetimide; Bupropion; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: Female
Healthy volunteers: No

Summary:

      The purpose of this study is to document the clinical effects of bupropion and citalopram in
      a single subject with Friedreich Ataxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Friedreich Ataxia

        Exclusion Criteria:

          -  Unable to provide Informed Consent
Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Condition: Hernia
MeSH terms: Hernia
Intervention: Normal saline; Midazolam
Intervention description: Normal saline 2cc. one dose prior to OR; 1-2.5 mg
Intervention MeSH terms: Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Nondiabetics undergoing hernia repair.

Summary:

      This research is being done to investigate if patients who receive a commonly used sedative
      drug, known as midazolam, are likely to have high blood sugar levels during the stressful
      period during and immediately after surgery. A sedative drug is used to relax a person
      without making them sleepy. This drug is also helpful in reducing the memory of the stressful
      experience before the anesthesiologists administers anesthesia. Everyone has glucose or sugar
      in their blood stream. This sugar gives energy to our organs to allow them to work. Since
      high blood sugar levels may be associated with complications like wound infections, the
      investigators research is being done to find if patients who receive a sedative medication
      prior to their surgical procedure have lower blood sugars during the surgery then a patient
      who does not receive the sedation. The investigators would like to know if the administration
      of this commonly used drug will help patients maintain a normal glucose level during a
      stressful period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-diabetic preoperative fasting blood sugar level of 110 mg/dL or less.

        Exclusion Criteria:

          -  Fasting blood sugar > than 110mg/dL

          -  Subjects who are pregnant

          -  Subjects who do not speak English

          -  Subjects who are on steroids prior to admission

          -  Hypersensitivity to midazolam
Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting
Condition: Post-operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Ondansetron 4 MG; Ondansetron 8mg
Intervention description: dose as per arm selection; dose as per arm selection
Intervention MeSH terms: Ondansetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Random allocation by opaque envelope and random number generator. Investigator will draw up study medication and give to care-providers. Outcome assessor not present for drawing up of medications.
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ambulatory surgery; post-operative nausea and vomiting; general anesthesia

Summary:

      The aim is to evaluate the effectiveness of three different regimens of prophylactic
      ondansetron on the incidence and severity of post-operative nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I, II, III presenting for ambulatory surgery to be performed under general
             anesthesia

        Exclusion Criteria:

          -  Patients with allergies or contraindications to study medications
Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects
Condition: Endothelial Dysfunction
Intervention: Ezetimibe
Intervention MeSH terms: Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to show that Ezetimibe will improve endothelial function
      following high cholesterol meals in healthy subjects by decreasing absorption of cholesterol
      and thus affecting concentration and composition of remnant-like particles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adults over 18 yrs of age

        Exclusion Criteria:

          -  presence of known metabolic syndrome

          -  as history of coronary artery disease

          -  hypertension

          -  diabetes

          -  cardiomyopathy

          -  tobacco use
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: rosuvastatin
Intervention description: medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: plasma lipid profile; metabolic syndrome

Summary:

      The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid
      profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol,
      triglyceride) in patients with metabolic syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  metabolic syndrome (according to National Cholesterol Education Program (NCEP)
             Adenosine triphosphate (ATP) Ill criteria)

          -  LDL-Cholesterol > 130mg/dl

          -  HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females

          -  Triglycerides < 400 mg/dl

        Exclusion Criteria:

          -  With a concomitant coronary disease

          -  Currently under statin therapy or previously treated with statins within the last 6
             months
Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Etanercept (Enbrel); Placebo
Intervention description: 50 mg injection once weekly; placebo
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Axial Ankylosing Spondylitis; Adult

Summary:

      Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe
      and advanced ankylosing spondylitis.
    

Eligibility criteria:

        Inclusion criteria

          -  Active and severe ankylosing spondylitis

          -  Ankylosing spondylitis refractory to standard anti-rheumatic treatment

          -  Between 18 and 70 years of age

        Exclusion criteria

          -  Prior exposure to any TNF-inhibitor, including etanercept

          -  DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks
             of study drug initiation

          -  Dose of NSAIDs changed within two weeks of study drug initiation