bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
Condition: Chronic Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Intervention: LCZ696; Enalapril; Placebo matching enalapril; Placebo matching LCZ696
Intervention description: LCZ696 100 mg bid for 2 weeks followed by LCZ696 200 mg bid for 10 weeks. Treatment was administered as oral tablets.; Enalapril 5 mg bid for 2 weeks followed by enalapril 10 mg bid for 10 weeks. Treatment was administered as oral tablets.
Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid.; Patients randomized to LCZ696 arm also received placebo matching enalapril (enalapril 0 mg tablets) to ensure the blinding during the entire course of the study.; Patients randomized to enalapril arm also received placebo matching LCZ696 (LCZ696 0 mg tablets) to ensure the blinding during the entire course of the study.
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LCZ696; sacubitril/valsartan; VO2peak; heart failure; systolic heart failure; heart failure with reduced ejection fraction; exercise capacity

Summary:

      The purpose of the study was to determine the effect of LCZ696 vs. enalapril on improvement
      of exercise capacity in patients with chronic heart failure with reduced ejection fraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of chronic heart failure (NYHA class III) and reduced
             ejection fraction (LVEF ≤ 40%)

          -  Reduced ability to exercise, evidenced by VO2peak ≤ 18 ml/min per kg

          -  Patients had to be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d
             or equivalent for at least 4 weeks prior to the screening visit and until
             randomization visit.

        Exclusion Criteria:

          -  History of hypersensitivity or allergy to any of the study drugs, drugs of similar
             chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected
             contraindications to the study drugs

          -  Previous history of intolerance to recommended target doses of ACEIs or ARBs

          -  Known history of angioedema

          -  Requirement of treatment with both ACEIs and ARBs

          -  Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
             symptoms that may require intravenous therapy)

          -  Symptomatic hypotension

          -  Impaired renal function

          -  Pregnant or nursing (lactating) women
Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Condition: Coronary Artery Disease; Carotid Artery Diseases; Atherosclerosis
MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis
Intervention: Atorvastatin; Niacin; Colesevelam; Placebo Niacin; Placebo Colesevelam
Intervention description: 10 to 80 mg of atorvastatin each day; 2000 mg of niacin each day; 3.8 g of colesevelam each day; Placebo niacin each day; Placebo colesevelam each day
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Atorvastatin; Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Magnetic Resonance Imaging; Atherosclerotic Plaque; Lipid Lowering Therapy

Summary:

      Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls
      of arteries. This study will examine the effectiveness of a combination of
      cholesterol-lowering medications at decreasing the fat content of atherosclerotic deposits in
      people who have coronary artery disease or carotid artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically established coronary artery disease or carotid artery disease with greater
             than 15% stenosis by ultrasound

          -  Family history of cardiovascular disease

          -  Apolipoprotein B level greater than or equal to 120 mg/dL (LDL level should be between
             100 and 190 mg/dL without medication)

          -  Has been undergoing lipid therapy for no more than 12 months before study entry

          -  Medically stable

          -  Medically able to undergo MRI procedure

        Exclusion Criteria:

          -  Uses pacemaker or has metallic implants

          -  Has immediate plans for carotid endarterectomy

          -  History of alcohol or drug abuse

          -  Active liver disease or liver dysfunction, defined by elevations in alanine
             aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than 1.5 times
             the upper limit of normal

          -  Serum creatine kinase (CK) level greater than 3 times the upper limit of normal before
             study entry

          -  Serum creatinine level greater than 2.5 times the upper limit of normal

          -  Diabetes, with a fasting glucose level greater than 150 mg/dL or hemoglobin A1c
             (HbA1c) level greater than 8% before study entry

          -  Uncontrolled high blood pressure, defined as average resting systolic blood pressure
             greater than 200 mm Hg or average resting diastolic blood pressure greater than 95 mm
             Hg
Corticosteroids for Acute Migraine in the Emergency Department
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: metoclopramide; Dexamethasone; methylprednisolone acetate
Intervention description: metoclopramide 10mg intravenous infusion over 15 minutes; dexamethasone 10mg intramuscular injection; methylprednislone acetate 160mg intramuscular injection
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Metoclopramide; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an emergency department based randomized trial in which we compare two different
      treatment for migraine headache. The goal is to decrease the number of headache days during
      the week after ED discharge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine without aura criteria (International Classification of Headache Disorders 3B
             )

          -  Headache rated as moderate or severe in intensity

        Exclusion Criteria:

          -  Concern for secondary cause of headache

          -  Contra-indications to investigational medications
Wound Fluid Protease Levels During Use of Novel Wound Dressing
Condition: Venous Stasis Ulcers
MeSH terms: Varicose Ulcer
Intervention: Novel Dressing
Intervention description: Topical wound dressing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to characterize the way leg wounds respond to a new type of
      wound dressing, compared to wounds in patients who are not using the new dressing. The
      investigators will collect wound fluid for biochemical analysis, and they will measure the
      wound healing that occurs with and without the new dressing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of venous insufficiency

          -  One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without
             evidence of clinical infection

          -  Ankle/brachial index 0.8 and above

          -  Duration of wound up to one year

          -  Able to return to wound clinic for weekly evaluations

          -  Has signed Institutional Review Board approved informed consent

        Exclusion Criteria:

          -  Exposed bone or tendon or necrotic wound base

          -  Signs or symptoms of cellulitis or osteomyelitis at the target ulcer

          -  Allergy to a component of the novel dressing or compression wrap

          -  Third degree burn

          -  Vasculitis, severe rheumatoid arthritis or other collagen vascular disease

          -  Receiving antibiotics

          -  Pregnant or lactating
Neural Correlates In Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Donepezil hydrochloride
Intervention description: Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Functional magnetic resonance imaging examination; Alzheimer's Disease; Donepezil hydrochloride; Aricept

Summary:

      The objective of this study was to identify neural correlates of cognitive improvement after
      3 months of donepezil hydrochloride treatment using either or both of two functional magnetic
      resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and
      Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in
      the early stage of Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to
             30 are allowed).

          -  Diagnostic evidence of Alzheimer's disease.

          -  Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.

        Exclusion Criteria:

          -  Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
Condition: Erectile Dysfunction; Metabolic Syndrome
MeSH terms: Erectile Dysfunction; Metabolic Syndrome; Syndrome
Intervention: Vardenafil (Levitra, BAY38-9456); Placebo
Intervention description: Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks; Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
Intervention MeSH terms: Vardenafil Dihydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 150.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Vardenafil; Erectile Dysfunction; Double-blind study

Summary:

      This is a controlled, randomized, multi-center prospective study of vardenafil to determine
      efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic
      Syndrome. This study will explore the rate of patients who do need to switch to the highest
      dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re
      nata)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable heterosexual relationship

          -  History of erectile dysfunction for at least 6 months

          -  IIEF- EF Domain entry score (at Visit 2): >21 points

          -  Documented metabolic syndrome according to the IDF (International Diabetes Foundation)

          -  Subjects motivated for erectile dysfunction treatment

          -  Documented, dated, written informed consent

        Exclusion Criteria:

          -  Any underlying cardiovascular condition

          -  History of myocardial infarction

          -  Uncontrolled atrial fibrillation

          -  Resting hypotension

          -  Postural hypotension within 6 months of Visit 1

          -  History of congenital QT prolongation

          -  Bleeding disorder

          -  History of prostatectomy because of prostate cancer

          -  Hereditary degenerative retinal disorders

          -  History of loss of vision because of NAION (non-arteritic anterior ischemic optic
             neuropathy)

          -  29 Additional Exclusion Criteria
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Intervention: HiRes 90K Bionic Ear System
Intervention description: Cochlear implant system
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HiResolution Bionic Ear; severe to profound hearing loss; bilateral implantation

Summary:

      Normal hearing listeners gain important everyday benefits from listening with two ears
      (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of
      bilateral hearing include the ability to determine where sounds are coming from and the
      ability to hear sounds and understand speech in noisy environments. Based upon these
      advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants
      (one in each ear) and (2) compare HiResolution sound processing with conventional sound
      processing.
    

Eligibility criteria:

        Inclusion Criteria:

          1. No previous implant experience.

          2. Age 18 years or older.

          3. Postlingual onset of hearing loss.

          4. Sensorineural hearing loss of a severe or greater degree in both ears.

          5. Normal/patent cochlear anatomy in each ear.

          6. English language proficiency.

          7. Willingness and ability to participate in all scheduled procedures.

        Exclusion Criteria:

        No exclusion criteria specified, except for the opposite of inclusion criteria listed
        above.
Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention description: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-angle glaucoma; Ocular hypertension

Summary:

      The purpose of this study is to compare two ophthalmic solutions in patients with open-angle
      glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.

          -  Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved
             IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.

          -  Best corrected visual acuity of -0.6 logMAR or better in each eye.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Treatment with BAK preserved artificial tears within 30 days of Visit 1.

          -  Known or suspected Sjogren's disease.

          -  Uncontrolled IOP.

          -  History or evidence of infectious or inflammatory ocular conditions.

          -  Progressive retinal or optic nerve disease.

          -  Ocular laser surgery within 3 months of Visit 1.

          -  Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal
             surface within 1 year of Visit 1.

          -  Current use of punctal plugs or punctal cautery.

          -  Use of systemic medications that has not been stable for 30 days prior to Visit 1.

          -  Use of contact lens within 30 days of Visit 1.

          -  Other protocol-defined exclusion criteria may apply.
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
Condition: Skin Aging
Intervention: botulinum toxin Type A
Intervention description: 20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: Female
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study evaluates the patient satisfaction and onset of effect following treatment with
      botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of any race, 35-55 years of age

          -  Moderate to severe glabellar wrinkles (lines between the eyebrows)

        Exclusion Criteria:

          -  Previous botulinum toxin therapy

          -  Subjects who are pregnant, breast-feeding, or who are of childbearing potential and
             not practicing a reliable method of birth control

          -  Subjects planning a facial cosmetic procedure or visible scars

          -  Previous cosmetic surgery to the upper face

          -  Medical condition that may increase their risk of exposure to botulinum toxin
             including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral
             Sclerosis, or any other disease that might interfere with neuromuscular function

          -  History of facial nerve palsy

          -  Allergy or sensitivity to any component of the study medication
A Preference Study Comparing Kristalose® and Liquid Lactulose
Condition: Constipation
MeSH terms: Constipation
Intervention: lactulose (Kristalose®); liquid lactulose
Intervention description: Crystals to be dissolved in water and taken as prescribed.; Liquid to be taken as prescribed.
Intervention MeSH terms: Lactulose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: constipation; laxative; lactulose; Kristalose®

Summary:

      This study will evaluate whether patients have an overall preference for Kristalose® or
      liquid lactulose based on taste, consistency, and portability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with recently diagnosed chronic constipation requiring treatment.

        Exclusion Criteria:

          -  Patients with galactosemia (galactose-sensitive diet).

          -  Patients less than 18 years of age.

          -  Patients currently on lactulose therapy.

          -  Inability to understand the requirements of the study or be unwilling to provide
             written informed consent (as evidenced by signature on an informed consent document
             approved by an Institutional Review Board [IRB]) and agree to abide by the study
             restrictions.
Loop Diuretics Administration and Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Intervention: furosemide infusion
Intervention description: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours
Intervention MeSH terms: Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: acute heart failure; diuretics; BNP; Renal function; acute decompensated Heart Failure,; volume overload

Summary:

      Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion
      and systemic fluid overload. In theory, continuous infusion should allow for a more
      consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the
      neurohormonal activation. This should lead to renal function improvement and BNP decrease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients took part in the random sample selection if they met the diagnostic criteria
             for acute decompensated HF.

          -  Patients with primary diagnosis of ADHF, volume overload with cardia dilation and LVEF
             <50%, and had BNP levels >100 pg/ml.

        Exclusion Criteria:

          -  Patients were excluded if they had received more than 2 IV doses of furosemide or any
             continuous infusion of furosemide 1 month before randomization

          -  If they had end-stage renal disease or the need for renal replacement therapy,
             isolated diastolic dysfunction.

          -  Recent myocardial infarction