bioihbjkbjnl/mcl2 huggingface dataset:
Anti-inflammatory Effects of Simvastatin
Condition: Inflammation; Atherosclerosis; Hypercholesterolemia
MeSH terms: Atherosclerosis; Hypercholesterolemia; Inflammation
Intervention: Simvastatin 40mg; Ezetimibe 10mg
Intervention description: Simvastatin administered daily for 6 weeks; Ezetimibe administered daily for 6 weeks
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research study is to determine which of the two ingredients of Vytorin
      (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 18 to 75 years of age.

          2. Obese (BMI ≥30 kg/m2)

          3. LDL cholesterol of ≥100 mg/dl

          4. Not taking any vitamins or antioxidants

        Exclusion Criteria:

          1. Currently using anti-hyperlipidemic therapies

          2. Triglycerides >500 mg/dl.

          3. Myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery
             in the past 6 months.

          4. Patient on chronic use of non-steroidal anti-inflammatory drugs or steroids

          5. Hepatic disease

          6. Renal impairment.

          7. History of drug or alcohol abuse

          8. Participation in any other concurrent clinical trial

          9. Use of an investigational agent or therapeutic regimen within 30 days of study.

         10. Smoker

         11. Pregnancy

         12. Premenopausal women who are not on birth control pills and have not had a hysterectomy
             or tubal ligation

         13. Anemia with hemoglobin <12 g/dl
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
Condition: Labor Pain; Complications; Cesarean Section; Pregnancy
MeSH terms: Labor Pain
Intervention: Epidural anesthesia; Combined spinal and epidural anesthesia
Intervention description: ￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.
Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.; A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 46.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: trial of labor after cesarean; vaginal birth after cesarean; epidural vs combined spinal epidural

Summary:

      To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on
      the success of Trial of Labor After Cesarean (TOLAC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients meeting ACOG guidelines for TOLAC

          -  at least one previous elective cesarean delivery

          -  <40 weeks gestational age (GA)

          -  vertex singleton pregnancy with use of continuous fetal monitoring

        Exclusion Criteria:

          -  Patient refusal of regional anesthetic or with contraindication for regional
             anesthesia

          -  BMI >40

          -  associated comorbidities such as gestational diabetes, preeclampsia, abnormal
             placentation
Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Regadenoson
Intervention description: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.
Intervention MeSH terms: Regadenoson
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure the changes in cardiac function during a Lexiscan
      pharmacologic stress test using cardiac magnetic resonance imaging test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Myocardial rest/regadenoson stress perfusion PET study within 60 days

          -  Normal rest LVEF (greater than or equal to 50%)

          -  No change in symptoms or treatment between the PET and the MRI study

          -  Willing to consent to the study

          -  Male or female who is either post-menopausal, surgically sterile, or if has a
             childbearing potential, a negative pregnancy test within 2 days prior to the MRI
             study.

        Exclusion Criteria:

          -  Renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73m2) within 6
             months

          -  Metallic implants, pacemaker, blood vessel clip (contra-indicated for MRI)

          -  Patient size exceeds MRI bore/table limits: (Max body diameter > 60 cm, weight > 136
             kg)

          -  History of gadolinium contrast allergy or intolerance

          -  Second or third degree AV block

          -  Sinus node dysfunction

          -  Acute myocardial infarction (past 3 months)

          -  Actively wheezing or with acute asthma or bronchospastic attacks requiring changes in
             therapy within the past 30 days

          -  Patients that have experienced a previous hypersensitivity reaction thought to be
             related to regadenoson
Persistent Postpartum Hypertension Pilot Trial
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: Nifedipine Extended-Release Tablets
Intervention description: Antihypertensive
Intervention MeSH terms: Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment Arm vs Active Control Arm
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study is a pilot, open-label, randomized controlled trial of postpartum women with
      hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the
      study to provide data that may provide guidance regarding blood pressure management of
      patients with non-severe postpartum hypertension. There are limited guidelines for best
      practice with persistent, non-severe hypertension, and treatment in this situation is usually
      at the provider's discretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Antepartum diagnosis of gestational hypertension

          -  preeclampsia

          -  superimposed preeclampsia without antepartum chronic hypertension medication

          -  Delivery at 23 weeks or greater

          -  Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours
             apart)

          -  18 years or older

          -  English speaking

        Exclusion Criteria:

          -  Need for continuation of antepartum antihypertensive medication

          -  Contraindication of calcium channel blocker use

          -  Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after
             delivery

          -  Requires a 2nd oral antihypertensive medication for blood pressure control inpatient

          -  Acute cardiomyopathy or heart failure

          -  Creatinine ≥1.5

          -  Blood pressure <90/60 within 24 hours of discharge
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
Condition: Malaria; Falciparum
MeSH terms: Malaria
Intervention: Artesunate-mefloquine; Atovaquone-proguanil; Artemether-lumefantrine
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Mefloquine; Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 265.0
Sex: All
Minimum age: 12 Years
Keywords: Malaria; hearing; co-artemether; auditory; Plasmodium falciparum; marsh fever; Plasmodium infections; remittent fever; paludism; artemether; artemisinins; benflumetol; lumefantrine

Summary:

      To evaluate the potential effects of artemether- lumefantrine on the auditory function
    

Eligibility criteria:

        Inclusion Criteria

          -  12 years of age or older

          -  Accepts Healthy Volunteers

          -  P. falciparum parasitemia between 1,000 and 100,000 parasites/μl

          -  History of fever or presence of fever (temperature ≥ 37.5°C)

        Exclusion Criteria

          -  Signs/symptoms of severe/complicated malaria

          -  Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2
             months

          -  History of any drug-related hearing impairment

          -  Abnormal hearing function at study entry

          -  Exposure to sustained loud noises, by self-report, within the past 24 hours

          -  Present ear problems

          -  Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child
             bearing age)

        Other protocol-defined inclusion/exclusion criteria may apply.
Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone; Tazarotene
Intervention description: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks; Tazarotene Cream 0.1%, 1 pea-size amount QD x 12 weeks
Intervention MeSH terms: Nicotinic Acids; Dapsone; Tazarotene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene
      cream 0.1% compared with tazarotene cream 0.1% monotherapy in treating moderate to severe
      facial acne vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Facial acne vulgaris characterized by the following: 30-100 facial inflammatory
             lesions; and 25-100 facial non-inflammatory lesions; stable disease, non-rapidly
             regressing facial acne vulgaris; and, 3 or more nodules and/or cysts (diameter of 1cm
             or greater). Female subjects of childbearing potential must have a negative pregnancy
             test at baseline and practice reliable method of contraception throughout the study

        Exclusion Criteria:

          -  Non-compliance with washout period; history of clinically significant anemia or
             hemolysis; skin disease/disorder that might interfere with diagnosis or evaluation of
             acne vulgaris; allergy or sensitivity to any component of the test medications
Endophenotype for Alcohol Misuse in Healthy Minority Populations
Condition: Healthy
Intervention: Naltrexone; placebo; alcohol; Sham alcohol
Intervention description: 50 mg/day for two days prior to the alcohol challenge session; placebo pills; 190 proof alcohol prepared to 11% volume mixed with fruit juice.; non-alcoholic placebo alcohol
Intervention MeSH terms: Ethanol; Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Naltrexone; Alcohol

Summary:

      The purpose of the study is to understand the relationship between what an individual
      inherited from their family (genetics), how they respond and feel after drinking alcohol, and
      how they respond to pre-treatment with naltrexone, a medication that blocks some of the
      effects of alcohol and is approved for the treatment of alcoholism. The investigators are
      conducting this study on those of African descent because there is almost no research focused
      on this group and the association with genetics. The investigators seek to enroll 40 people
      in the study. Participation will consist of 4 different alcohol challenge sessions in a cross
      over design. Each session will be separated by at least 10 days. In total, there will be four
      challenge sessions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female and 21 years of age or older

          -  Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per
             week

          -  Of African descent by self report

        Exclusion Criteria:

          -  Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine

          -  Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana,
             or amphetamine at the screening visit

          -  Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder,
             schizophrenia, or any psychotic disorder

          -  The presence of unstable or serious medical illness; including history of stroke,
             seizure disorder, severe liver disease (AST or ALT > 5X normal at the time of
             randomization), or unstable cardiac disease

          -  Needs treatment with any psychotropic medication (antidepressant, antipsychotic,
             benzodiazepine, or mood stabilizing medication)

          -  Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable
             method of contraception

          -  Insulin-dependent diabetes

          -  Any medical or psychological condition that could jeopardize the subject's safe
             participation in the trial as determined by the PI.
Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
Condition: Blepharitis
MeSH terms: Blepharitis
Intervention: Erythromycin; Besifloxocin
Intervention description: Topical erythromycin ointment twice a day; Topical Besifloxocin twice a day
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Besifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: blepharitis; topical erythromycin; topical besifloxocin

Summary:

      This study looks at the improvements in signs and symptoms in patients with inflammation of
      the lids, blepharitis, using two different FDA approved topical antibiotic agents,
      Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for
      microbiologic evidence of improvement.
    

Eligibility criteria:

        Inclusion Criteria:Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

        Exclusion Criteria: women of child bearing potential, eye surgery within three months of
        study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of
        topical or oral steroids in past two weeks unless stable dosage

        -
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin phosphate; Comparator: Sulfonylurea; Metformin
Intervention description: Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.; Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription; Participants could continue pre-study metformin as concomitant therapy during the study.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan
      is lower when treated with sitagliptin as compared to sulfonylurea treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Muslim men and women with type 2 diabetes

          -  Participants who intend to fast during the month of Ramadan

          -  Participants who have been on a stable dose of sulfonylurea for at least three months

        Exclusion Criteria:

          -  Participants with type 1 diabetes mellitus

          -  Pregnant or breast feeding women

          -  Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4)
             treatment

          -  Participants on insulin

          -  Participants on any class of oral diabetic therapy other than sulfonylurea or
             metformin
Antiepileptic Drugs and Osteoporotic Prevention Trial
Condition: Epilepsy; Bone Loss; Osteoporosis; Fractures
MeSH terms: Osteoporosis
Intervention: Risedronate; Placebo + Calcium and Vitamin D
Intervention description: 35 mgs/week + calcium and vit d; sugar pill + calcium 1200mgs/day and vitamin d at least 800IU
Intervention MeSH terms: Vitamin D; Risedronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: osteoporosis; bone mineral density; fracture; antiepileptic drug; seizure; Prevention of bone loss; Prevention of osteoporosis; Prevention of Fractures

Summary:

      Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel):

      Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone
      loss associated with the use of antiepileptic drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male gender

          -  Epilepsy

          -  Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium

          -  Normal renal function and normal Vitamin D and calcium levels

        Exclusion Criteria:

          -  Female gender

          -  Organ transplant

          -  Use of oral glucocorticoids

          -  Renal insufficiency (eGFR < 30ml/min)

          -  Severe swallowing disorder

          -  Severe esophagitis

          -  Patients taking sodium valproate for reasons other than epilepsy

          -  Previous treatment with osteoporosis drugs such as bisphosphonates, calcitonin or PTH
             analog
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
Condition: Smoking Cessation; Insurance Coverage
Intervention: Full Smoking Cessation Treatment Coverage (100%); No Smoking Cessation Treatment Coverage (0%)
Intervention description: This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.; None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1380.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking cessation; quit rates; reimbursement; drug coverage; effectiveness; cost-effectiveness; health policy; drug utilization; adherence; urine cotinine.

Summary:

      This study is based on the hypothesis that access to smoking cessation treatment (SCT)
      reimbursement may significantly increase the number of successful quitters in a population of
      smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by
      improving subject adherence to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Daily smokers (10 cigarettes per day or more);

          -  Smokers motivated to make a quit attempt within the next 14 days;

          -  Potential subjects must be outpatients;

          -  A subject must have a stable mental and physical medical condition (as per
             investigator's judgment).

        Exclusion Criteria:

          -  A subject currently eligible for smoking cessation treatment (SCT) reimbursement,
             whether from a public or a private drug insurance;

          -  A subject with an unknown drug insurance status;

          -  A subject living in a household where there is someone already recruited in the study;

          -  A subject with an unfilled SCT prescription issued within the past three months or
             with an unused SCT product;

          -  A subject with a life-threatening illness (ie, known or suspected cancer or other
             disease with a life expectancy of less than one year).