bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of the Athero-Protective Effects of Clopidogrel
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Clopidogrel; Placebo
Intervention description: Clopidogrel 75 mg PO qday for 6 weeks; Placebo PO qday for 6 weeks
Intervention MeSH terms: Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators would like to investigate whether clopidogrel will help lower the level of
      harmful markers in patients with coronary artery disease, and at the same time will help
      increase the cells that are useful in repairing the damaged blood vessels. The investigators
      will give half of the patients clopidogrel and the other half a sugar pill, placebo, and
      check the levels of these markers and helpful cells in each group. At the same time the
      investigators will check how well these patient's blood vessels work using ultrasound imaging
      of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's
      blood vessels are. After 6 weeks of drug therapy, the patients will switch to the other drug
      and these same tests will be performed after an additional 6 weeks of therapy. The drug taken
      by the patient will not be known to the patient or the researchers. The patients will
      continue on their prescribed medical therapy during the duration of the 12 week study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females without child bearing potential aged 21-80 years

          -  Known coronary artery disease by angiogram or documented myocardial infarction.

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Treated with clopidogrel or ticlodipine in the previous 3 months

          -  Age < 21 or >80 years

          -  Premenopausal females with potential for pregnancy

          -  Allergy to clopidogrel or aspirin

          -  Initiation or change in dose of any concomitant medical therapy within 2 months before
             the study

          -  Uncontrolled hypertension with BP>180 mmHg systolic and >120 mmHg diastolic

          -  Treated with coumadin therapy

          -  Intolerance or allergy to statins

          -  Acute infection in previous 4 weeks

          -  History of substance abuse

          -  Uninterpretable PAT test

          -  Current neoplasm

          -  Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X
             normal)

          -  Acute coronary syndrome, heart failure, CVA, coronary intervention within 3 months

          -  Known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.

          -  Inability to give informed consent

          -  Inability to return to Emory for follow-up
Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: apremilast
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      12 weeks open label with Otezla® and NUVB, followed by 6 month double blind Otezla®
      (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy
    

Eligibility criteria:

        Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:

          1. Male or female adult ≥ 18 years of age;

          2. Diagnosis of chronic plaque-type

          3. Moderate to severe plaque type psoriasis as defined at baseline by:

               -  PASI score of 12 or greater,

               -  PGA score of 3 or greater

               -  BSA affected by plaque-type psoriasis of 10% or greater,

          4. Able and willing to give written informed consent prior to performance of any
             study-related procedures

        Exclusion Criteria:

        Subjects who meet any of the following criteria will be excluded from participation in this
        study:

          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic,
             and/or guttate psoriasis) or drug induced psoriasis

          2. Subjects with previous exposure to apremilast

          3. Malignancy or history of malignancy, except for:

               -  treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

               -  treated [ie, cured] malignancy with no evidence of recurrence within the previous
                  5 years.
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: ambrisentan
Intervention description: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
Intervention MeSH terms: Ambrisentan
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: 19 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; PAH; WHO Group 1

Summary:

      The primary objective of this study is to assess the safety and tolerance of changing
      patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients followed routinely in the pulmonary vascular disease clinic at the University
             of Alabama in Birmingham, greater than or equal to 19 years of age.

          2. World Health Organization (WHO) PAH Type I

          3. WHO class I-IV symptoms (no functional class exclusion).

          4. On bosentan, twice a day, with a maximum daily dose of 250mg, on a stable dose for 3
             months with no clinical indication to discontinue the drug (i.e., increased liver
             function studies or other intolerance). Patients may be on other drug therapies for
             PAH, and also may be on oxygen therapy (intermittent or continuous).

        Exclusion Criteria:

          1. Known intolerance or allergy to ambrisentan.

          2. Prior therapy with ambrisentan.

          3. Current therapy with two phosphodiesterase-5 inhibitors.

          4. Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and
             prostanoids) within 4 weeks of baseline study visit.

          5. Planned addition of prostanoid for clinical reasons within 3 months of baseline study
             visit.

          6. Active participation in another clinical study involving the medical therapy of PAH.

          7. Uncontrolled systemic hypertension or angina pectoris

          8. Serum creatinine greater than 2.5 at or within 4 weeks of baseline.

          9. Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline
             study visit.

         10. In the opinion of the investigator, a change in PAH therapy would present significant
             risk to the subject.

         11. In the opinion of the investigator, the participant is unlikely to survive for 12
             weeks after study entry.

         12. In the opinion of the investigator, the participant is likely to undergo lung or
             heart-lung transplantation within 12 weeks of study entry.

         13. A woman of childbearing potential who is not using an acceptable form of
             contraception.

         14. Pregnancy.

         15. In the opinion of the investigator, a participant who is not capable or willing to
             follow the study procedures.
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Condition: Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Dexmedetomidine Injection
Intervention description: Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.
Enrollment: 120.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD
      assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years
      undergoing hip surgery under spinal anaesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American society of Anesthesiology (ASA) status of I-III

          -  Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

        Exclusion Criteria:

          -  Patient not willing to be a part of the study

          -  Patients were aged <60 or >75 years

          -  Patients with accompanying medical conditions that may affect the level of
             consciousness, such as stroke, stupor or dementia, or patients with abnormalities in
             hepatic or renal function, electrolyte imbalance

          -  Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or
             hypotension [mean arterial blood pressure (MAP) <70 mmHg]

          -  Patients who had recently received a sedative or opioid drug

          -  Patients with a MoCA (Montreal Cognitive Assessment) score <26

          -  Patients with persistent hypotension and bradycardia intra-operatively even after
             giving Mephentermine will be excluded from the study
Tranexamic Acid for Craniofacial Surgery
Condition: Craniosynostosis; Bleeding
MeSH terms: Craniosynostoses
Intervention: Tranexamic acid; saline
Intervention description: 100 mg/kg load, then 10 mg/kg/hr; Placebo
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: antifibrinolytic, tranexamic acid

Summary:

      This is a randomized, blinded, prospective study that will investigate the potential benefit
      of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric
      patients undergoing craniofacial surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

        The inclusion of the patients will depend on the following criteria:

          1. All pediatric patients scheduled for primary or secondary repair of craniosynostosis
             with a frontal orbital advancement, or cranial vault reconstruction.

          2. Patients will be between the ages of 6 months and 18 years old.

          3. They will be > than 5 kg.

          4. All subjects being evaluated in the Craniofacial Clinic for primary or secondary
             repair of craniosynostosis will potentially be included in the study. Prior to
             inclusion in the study potential participants will be screened by history and
             laboratory data. The laboratory data will include a complete blood count, PT, PTT,
             type and cross, factor V leiden, anticardiolipin antibody, and lupus anticoagulant.
             The history will be obtained from the parents or current care takers. The medical
             records may be reviewed if there is a need for clarification.

        Exclusion Criteria:

        Patients that will be excluded from the study include the following:

          1. Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and
             lupus anticoagulant

          2. Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for
             craniofacial surgery have preoperative blood work performed which includes a type and
             screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected
             in their coagulation profile proceed on to a complete hematologic evaluation that
             includes an evaluation for Von Willebrand's Disease.

          3. History of thrombotic episodes in the patient

          4. Renal failure or hepatic failure.

          5. Infants less than 5 kg

          6. Age < 6 months or > 18 years old
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: simvastatin; Comparator: Placebo
Intervention description: simvastatin 20mg daily at nights for 12 weeks. Tablets; placebo daily at nights for 12 weeks. Tablets
Intervention MeSH terms: Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early
      detection of improvement of endothelial function with simvastatin could be a clue for future
      intervention trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female Patients Over 18 Years Old

          -  Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College
             of Rheumatology (ACR)

          -  Signed Informed Consent Form (ICF)

        Exclusion Criteria:

          -  Patients With LDL-C Below 90 mg/dL

          -  Pregnant Or Breast Feeding

          -  Diabetes Mellitus

          -  Or Any Clinically Relevant Organ Disfunction
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium or Valproate with placebo (PBO); Lithium or Valproate with Aripiprazole
Intervention description: Tablets, Oral, once daily
lithium 250-2100 mg/day
valproate 250-2500mg/day
Placebo once daily; Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
lithium 250-2100 mg/day
valproate 250-2500mg/day
aripiprazole 15-30 mg/day
Intervention MeSH terms: Valproic Acid; Aripiprazole; Lithium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder with a recent manic or mixed episode

Summary:

      The purpose of this clinical research study is to learn if outpatients with bipolar mania who
      are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms
      on a combination treatment of aripiprazole plus lithium or valproate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women > or = to 18 years of age meeting Diagnostic and Statistical Manual for
             Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I
             disorder, currently experiencing a manic or mixed episode with a history of one or
             more manic or mixed episodes or sufficient severity to require hospitalization and/or
             treatment with a mood stabilizer or antipsychotic.
Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
Condition: Fontan Procedure
Intervention: Aspirin
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop
      complications many years after their operation. Studies have shown that some of these
      patients develop an ongoing inflammatory state, which may be the cause of these late
      complications. Aspirin is a common over the counter anti-inflammatory medication used for
      many other chronic diseases. This study may help determine if aspirin therapy can limit the
      inflammation seen in Fontan patients and prevent these late complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who have Fontan repair of single ventricle

        Exclusion Criteria: Persons with the following history, conditions, or behavior will be
        excluded

          -  Active protein losing enteropathy within the past three years

          -  Congestive heart failure

          -  Active arrhythmias

          -  Taking Coumadin (Warfarin)

          -  Bleeding disorder

          -  Known esophageal varicies

          -  Consuming more than 10 alcoholic drinks per week.

          -  Pregnant

          -  Planning to become pregnant
Intubation of Patients With an Unstable Cervical Spine Using the CMAC Device
Condition: Laminectomy
Intervention: Fiberoptic bronchoscope; CMAC
Intervention description: Fiberoptic bronchoscope device; CMAC Device
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: C-MAC; Fiberoptic bronchoscope; Laryngoscopy; Cervical spine injury; Glottic view; Tracheal intubation

Summary:

      The purpose of this study is to evaluate whether tracheal intubation with the CMAC device
      decreases the time required for intubation as compared to intubation with the fiberoptic
      bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the
      fiberoptic bronchoscope are currently commonly used in standard of care practices in the
      intubation of patients with cervical spine injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with an unstable Cervical-spine as a result of C-spine injury.

          -  Patients scheduled to undergo inpatient surgical procedures under general anesthesia.

          -  Willingness and ability to sign an informed consent document.

          -  18-80 years of age.

          -  ASA Class I - III adults of either sex

        Exclusion Criteria:

          -  Patients deemed to be at significant airway risk to necessitate awake fiber optic
             intubation.

          -  Patients with a history of oral-pharyngeal cancer or reconstructive surgery.

          -  Emergency surgeries.

          -  Any other conditions which may interfere with the conduct of the study.
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Xalatan; Travatan Z
Intervention description: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime; one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Intervention MeSH terms: Travoprost; Latanoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
Enrollment: 58.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: glaucoma; impression cytology; ocular surface changes; prostaglandins

Summary:

      To determine whether one glaucoma eye drop is less likely to cause changes to the surface of
      the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan
      Z.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21 or older

          -  Able to understand protocol and agree to 3 visits

          -  Any type of glaucoma

          -  Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy
             accepted

          -  Naïve: No prior glaucoma treatment (medical or surgical)

          -  If patient non-compliant, must be off meds 3 months

          -  Xalatan: At least one month use

        Exclusion Criteria:

          -  Both Groups: Any history of ocular surface disease

          -  Dry eye syndrome or prior Restasis use

          -  Prior ocular surgery other than cataract extractions

          -  Uveitis or other inflammatory disease of the eye or adnexa

          -  Systemic medications that might influence ocular inflammation

          -  Any active inflammation or infection

          -  Pregnancy or intention to become pregnant

          -  Naïve: Prior use of topical glaucoma medication unless off for 3 months.

          -  Use of preserved artificial tear preparations in last 30 days and more than one year
             history of chronic use

          -  Xalatan: Prior use of Travatan or Travatan Z