bioihbjkbjnl/mcl2 huggingface dataset:
Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Condition: Cataract
MeSH terms: Cataract
Intervention: AcrySof ReSTOR Aspheric IOL model SN6AD1
Intervention description: Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Bilateral Cataract; IOL; ReSTOR; Aspheric

Summary:

      The objective of this study is to prospectively evaluate the visual parameters in a series of
      patients after phacoemulsification cataract surgery in a series of patients bilaterally
      implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prospective subjects should be 21 years of age and older, be of any race and gender
             and meet study entry criteria. Subject must require extraction of cataracts followed
             by implantation of a posterior chamber intraocular lens (IOL). Subjects must be
             candidates for bilateral removal of the natural crystalline lens followed by
             implantation of a multifocal IOL and be willing and able to complete all follow-up
             visits.

        Exclusion Criteria:

          -  Subjects with pre-existing conditions that could skew the results or are
             contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study.
             Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for
             subject groups that should be excluded from this study.

        All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by
        Keratometry (K) readings. If the surgeon determines that a correction of cylinder is
        necessary postoperatively, this may be performed after the three month evaluations are
        completed.
Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Condition: Severe Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: Rifaximin
Intervention description: Rifaximin 550 MG BID
Intervention MeSH terms: Rifaximin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to characterize the steady state plasma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver
             cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically
             impaired subjects will have a MELD score of >25.

        Exclusion Criteria:

          -  Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients
             and/or vehicles used in the formulation, or any other clinically significant
             allergies.

          -  Subject has participated in an investigational drug or device study within 30 days
             prior to Day 1 (Baseline).

          -  Subject has any concurrent illness (other than liver cirrhosis), disability or
             circumstance that may affect the interpretation of clinical data, could cause
             noncompliance with treatment or visits or otherwise contraindicates participation in
             this study in the opinion of the investigator.
Sleep and Breathing in the General Population - Chemical Stimuli
Condition: Sleep-disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes
Intervention: Zolpidem; No Treatment
Intervention description: A nonbenzodiazepine hypnotic; The Control condition in which participants do not receive medication.
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After an initial assessment to determine eligibility, participant complete two in-lab night studies in a randomized manner including one night with the administration of zolpidem and another without zolpidem.
Masking: Single (Outcomes Assessor)
Masking description: Personnel conducting assessment of outcomes and data analysis are blinded to treatment.
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sleep-disordered Breathing; central sleep apnea

Summary:

      Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus
      of this proposal is to identify the role of the physiologic path involving cortical arousals
      in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is
      to identify the acute effects of administering zolpidem on sleep and respiratory outcomes,
      and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study
      will shed light on the mechanisms underlying CSA that involve cortical arousals and will
      guide future therapeutic interventions for CSA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index
             (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.

        Exclusion Criteria:

          -  less than 18 years old

          -  pregnant or breastfeeding female

          -  have severe respiratory disease that require to be on oxygen

          -  recent health event that may affect the ability to participate in the study,

          -  Body Mass Index (BMI) is >40 kg/m2

          -  significant insomnia

          -  mental instability

          -  recent health event that may affect sleep

          -  if at any time the principal investigator (PI) identifies that a certain drug is not
             suitable, or are unable to use the device that is used to treat sleep apnea, will be
             not be allowed to participate in the study
The Effect of Lipitor on Aortic Stenosis
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Intervention: atorvastatin (Lipitor)
Intervention description: atorvastatin 40 mg by mouth once daily
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: calcific aortic valve stenosis; echocardiography, transthoracic

Summary:

      The purpose of this study is to find out if an approved medicine that is used to lower
      cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve
      in patients with a condition called aortic stenosis. Patients who have aortic stenosis who
      volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a
      physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of
      the heart) at the start of the study and every 6 months, stopping at 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate calcific AS of a tricuspid or bicuspid aortic valve

          -  Echocardiographic derived mean pressure gradient >10 mmHg and an aortic valve area of
             0.9 to 1.7 cm2 by continuity equation.

          -  Laboratory evidence of LDL-c>70 mg/dl within 12 months prior to recruitment.

        Exclusion Criteria:

          -  Left ventricular ejection fraction <50%

          -  Valvular area of 0.9 cm2 and a mean gradient >30 mmHg

          -  Rheumatic heart disease

          -  >Moderate (2+) aortic insufficiency

          -  Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
             HMG-CoA Reductase Inhibitors (statins)

          -  End-stage renal disease (ESRD)

          -  History of thoracic radiation

          -  Unable or unwilling to sign informed consent

          -  Unable to unwilling to return for follow-up

          -  Other clinically important renal, pulmonary, hepatic, neurological, endocrine, or
             hematological disorders, vasculitis, or any other situation or medical condition that,
             in the investigator's opinion, would make survival for the duration of the study
             unlikely, or would otherwise interfere with optimal participation in the study or
             produce a significant risk to the patient

          -  Severe pulmonary hypertension (>55 mmHg)
12- Week Open Label Treatment of Refractory Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Depression; Bipolar Disorder
Intervention: Aripiprazole
Intervention description: Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar Depression; Refractory

Summary:

      1. Determine the change in symptomatology and function in refractory bipolar depression,
           when treated with combination of DEP+AZP for a period of 12 weeks

        2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory
           bipolar depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of bipolar disorder I or II according to M.I.N.I.

          -  patient has signed informed consent

          -  male, or female who is using effective birth control if of child bearing age

          -  age 18 and above

          -  currently in a depressed phase, with or without psychotic features, of the illness
             based on DSM-IV/MINI criteria

          -  score of more than 19 on the MADRS

          -  history of treatment refractory bipolar depression as defined by failure of the
             depressive episode to respond to a mood stabilizer alone or a combination of 2 or more
             mood stabilizers or a combination of a mood stabilizer and an antidepressant

        Exclusion Criteria:

          -  current liver disease,

          -  illness precluding the use of depakote er

          -  patients who have been treated with a DEP and AZP combination in the past

          -  Alcohol/drug dependence in the past one month

          -  CNS neoplasms, demyelinating diseases, degenerative neurological condition or active
             CNS infection

          -  history of seizure, known EEG with frank paroxysmal activity, known CT of brain
             showing gross structural abnormalities, cerebral vascular disease by history or
             structural brain damage from trauma

          -  thyroid dysfunction

          -  unstable general medical condition

          -  require antipsychotic other than abilify
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Condition: Saphenous Vein Graft Disease
MeSH terms: Thrombosis
Intervention: Aspirin; Ticagrelor
Intervention MeSH terms: Aspirin; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Saphenous vein graft disease; Coronary artery bypass graft surgery; Antiplatelet therapy; Coronary artery disease; Secondary prevention; Graft patency

Summary:

      Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude
      in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including
      recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While
      aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts
      continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin
      and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more
      pronounced platelet inhibition, and may substantially improve graft patency following CABG
      compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on
      saphenous vein graft patency following CABG. In this context, the investigators seek to
      compare vein graft patency between patients randomized to receive aspirin therapy, the
      current standard of care, or ticagrelor treatment, starting in the early postoperative
      period, and continuing for 2 years after CABG.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of informed consent prior to any study specific procedures

          2. Female and/or male patients aged 18-90 years

          3. Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective
             of concurrent valve surgery

        Exclusion Criteria:

          1. Inability to provide informed consent

          2. Pregnancy or seeking pregnancy

          3. Patients undergoing redo-CABG

          4. Serum creatinine >1.8 mg/dL (need for contrast with CT coronary angiogram)

          5. Hypersensitivity or allergy to aspirin or ticagrelor

          6. Anticipated need for postoperative anticoagulation with coumadin, dabigatran or
             rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE)

          7. History of gastrointestinal hemorrhage

          8. Active pathological bleeding

          9. History of intracranial hemorrhage

         10. Severe hepatic impairment

         11. Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole,
             clarithromycin, nefazadone, ritonavir, and atazanavir)
CONCERTA Lab School Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: CONCERTA (methylphenidate HCl) or placebo; CONCERTA (methylphenidate HCl) or placebo
Intervention description: Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2; Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 9 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; Attention Deficit Hyperactivity Disorder

Summary:

      The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate
      HCl), is safe and effective in improving academic performance and behavior in children with
      Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADHD diagnosis of all subtypes (except Not Otherwise Specified)

          -  Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale
             (ADHD RS-IV) scores > =90th percentile relative to the general population of children
             by age and gender

          -  Patients currently receiving ADHD medication must be inadequately managed on their
             current stimulant dose and meet this criteria at the screening visit

          -  Ability to read and understand English

          -  Ability to attend school regularly

        Exclusion Criteria:

          -  Estimated Full Scale IQ score of 80 or below, Severe Learning Disability

          -  History of or current, primary diagnosis of: severe anxiety disorder, conduct
             disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder,
             Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar
             Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of
             Tourette's Syndrome

          -  Weight < 3rd percentile for age

          -  History of hospitalization for treatment of a mood, anxiety, or psychotic disorder

          -  History of failed response to methylphenidate
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Condition: Post-Operative Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Anticoagulation Therapy
Intervention description: Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Intervention MeSH terms: Warfarin; Rivaroxaban; Dabigatran; Apixaban; Anticoagulants
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 562.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Left Atrial Appendage; Anticoagulation; CHA2DS2- VASc; HASBLED

Summary:

      Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or
      Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial
      Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2
      with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation
      (POAF) and receive the AtriClip will be followed for 365 days post index procedure.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients satisfying the following criteria will be considered the screening population and
        will be eligible for participation:

          -  Age > 18 years male or female.

          -  Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where
             direct access to the LAA is expected.

          -  No documented preoperative AF.

          -  CHA2DS2-VASc score of => 2.

          -  HASBLED score of => 2.

          -  Acceptable surgical candidate, including use of general anesthesia.

          -  Willing and able to provide written informed consent.

        Exclusion Criteria:

        Patients satisfying the following criteria will not be eligible for participation:

          -  Redo cardiac surgery.

          -  Mechanical heart valve or other anticipated or current requirement for anticoagulation
             therapy during the post-operative (30 day) period.

          -  Hypercoagulability conditions that may confound the study.

          -  Ejection Fraction < 30.

          -  Left Atrium > 6 cm.

          -  Severe Diastolic Dysfunction.

          -  Requires anticoagulation therapy.

          -  Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to
             signing informed consent.

        Intra-Operative Exclusion Criteria

          -  Presence of thrombus in the left atrium or LAA.

          -  LAA tissue is deemed friable or has significant adhesions (as evaluated by the
             surgeon) near or on the LAA making AtriClip placement overly risky.

          -  Left atrial appendage is outside the range of manufacturer's recommendations - width <
             29mm or > 50mm.

          -  Direct visualization access is not available for AtriClip placement.
Low Cylinder Toric
Condition: Cataracts
MeSH terms: Cataract
Intervention: Toric IOL (SN60T3)
Intervention description: Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Toric IOL

Summary:

      Study evaluates the visual outcomes and patient satisfaction after implantation of a toric
      intraocular lens (IOL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Cataracts

          -  Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)

        Exclusion Criteria:

          -  Preoperative ocular pathology

          -  Planned monovision
Nebivolol, Lifestyle Modification and Arterial Stiffness
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Lifestyle Modification; Nebivolol plus Lifestyle Modification
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central
      arterial stiffness and these effects may contribute to improved outcomes in hypertensive
      patients. However, the results of several studies suggest that beta-blockers may actually
      increase arterial stiffness. In contrast, there is limited evidence to suggest that
      nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide,
      reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few
      studies have addressed this issue and all of these studies relied on indirect, blood pressure
      dependent measures of arterial stiffness. In addition, none of these studies focused on
      middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening
      and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a
      therapy to reduce large artery stiffness, particularly among the latter population, remains
      unclear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 1 hypertension

          -  40-75 years

          -  Weight stable (+/-2 kg)

          -  Sedentary to recreationally active

          -  Willing to be randomized to one of three arms

          -  Verbal and written consent

          -  Approval by medical director

        Exclusion Criteria:

          -  Blood pressure outside stated range

          -  Diabetes or taking diabetes medications

          -  Total cholesterol >6.2 mmol/L; triglycerides >4.5 mmol/L

          -  Past or current ischemic heart disease, stroke, respiratory disease, endocrine or
             metabolic disease, neurological disease, or hematological-oncological disease

          -  Medications (including but not limited to antihypertensives, statins or other with
             anti-inflammatory actions) or antioxidant vitamins or supplements

          -  Known allergy or hypersensitivity to nebivolol or any of its components

          -  Inability to perform regular physical activity or participate in other components of
             lifestyle modification

          -  Pregnant or planning to become pregnant