bioihbjkbjnl/mcl2 huggingface dataset:
PROMUS Element Plus US Post-Approval Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: PROMUS Element Plus Coronary Stent System; Aspirin; P2Y12 antagonist
Intervention description: PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).; Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.; Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.
Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily)
Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling)
Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided.
Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates; Ticlopidine; Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2681.0
Sex: All
Healthy volunteers: No
Keywords: drug-eluting stent; DES; atherosclerosis; everolimus

Summary:

      This study is designed to observe clinical outcomes in patients receiving the PROMUS Element
      Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
      Patients will have symptomatic heart disease or documented silent ischemia. This is a
      prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years.
      Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The population will include consecutive, consented patients.

        Exclusion Criteria:

          -  There are no exclusion criteria in this all-comers study.
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
Condition: Cryptogenic Sensory Polyneuropathy
MeSH terms: Polyneuropathies
Intervention: Nortriptyline; Duloxetine; Pregabalin; Mexiletine
Intervention MeSH terms: Mexiletine; Pregabalin; Duloxetine Hydrochloride; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: CSPN; neuropathy; pain; pain management

Summary:

      The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of
      the University of Kansas Medical Center, is to learn about the safety and effectiveness of
      nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory
      polyneuropathy (CSPN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cryptogenic sensory polyneuropathy.

          -  Likert Pain Score of greater than or equal to 4.

          -  Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or
             similar class of medication for at least 7 days from baseline study visit.

        Exclusion Criteria:

          -  Any medical condition or current medication that would prevent them from taking either
             nortriptyline, duloxetine, pregabalin or mexiletine.

          -  Unable to give consent.

          -  Unable or not willing to comply with the study.

          -  Other causes for polyneuropathy.
Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study
Condition: Syphilis
MeSH terms: Syphilis
Intervention: Benzathine penicillin G intramuscular 7.2 million units; Benzathine penicillin G intramuscular 2.4 million units
Intervention description: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).; A single dose of intramuscular 2.4 million units of benzathine penicillin G
Intervention MeSH terms: Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new
      cases per year. Due to shared transmission route and risk factors, co-infection with syphilis
      and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the
      response to syphilis treatment in HIV-infected patients. They support the claim that patients
      with HIV have a slower decrease in syphilis antibody titers, and that they may progress to
      neurosyphilis in earlier stages.

      The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment
      Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis
      or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients
      (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a
      randomized controlled trial in order to compare the efficacy of three- versus single-dosed
      regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis
      in HIV-infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with HIV by ELISA and confirmed by Western blot

          -  Positive Rapid Plasma Reagin and treponema pallidum particle agglutination tests

        Exclusion Criteria:

          -  History of penicillin allergy

          -  Diagnosis of late latent syphilis

          -  Diagnosis of neurosyphilis

          -  Antibiotic use with significant activity against Treponema pallidum within the
             preceding two weeks
Stress Ulcer Prophylaxis in the Intensive Care Unit
Condition: Gastrointestinal Bleeding; Stress Ulcers
MeSH terms: Gastrointestinal Hemorrhage; Ulcer
Intervention: Pantoprazole; Saline (0.9%)
Intervention description: 40 mg x 1 daily intravenously from ICU admission to ICU discharge; 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Intervention MeSH terms: Pantoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stress ulcer prophylaxis; Proton pump inhibitor; Pneumonia; Clostridium difficile infection

Summary:

      Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however
      the quantity and quality of evidence is low and potential harm has been reported.

      The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton
      pump inhibitor in adult critically ill patients in the ICU.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Acute admission to the ICU

          -  Age ≥ 18 years

          -  One or more of the following risk factors:

               -  Shock (continuous infusion with vasopressors or inotropes, systolic blood
                  pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)

               -  Acute or chronic intermittent or continuous renal replacement therapy

               -  Invasive mechanical ventilation which is expected to last > 24 hours

               -  Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) >
                  1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours

               -  Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)

               -  History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds)
                  within 6 months prior to hospital admission

               -  History of chronic liver disease (portal hypertension, cirrhosis proven by
                  biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding
                  or hepatic encephalopathy in the past medical history)

        EXCLUSION CRITERIA:

          -  Contraindications to PPI

          -  Ongoing treatment with PPI and/or H2RA on a daily basis

          -  GI bleeding of any origin during current hospital admission

          -  Diagnosed with peptic ulcer during current hospital admission

          -  Organ transplant during current hospital admission

          -  Withdrawal from active therapy or brain death

          -  Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG

          -  Consent according to national regulations not obtainable
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Condition: COPD; COPD Exacerbation; Lung Diseases; Respiratory Disorders; Pulmonary Disease; Chronic Obstructive Lung Diseases; Chronic Obstructive Airway Disease
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive; Respiration Disorders; Respiratory Tract Diseases
Intervention: Roflumilast; Placebo
Intervention description: Roflumilast 500 µg, oral administration, once per day; Dose-matched placebo, oral administration, once per day.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2354.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Exacerbations; Roflumilast; Daliresp

Summary:

      To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination
      (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Male or female patients at least 40 years of age

          -  2. History of COPD (according to Global Initiative for Chronic Obstructive Lung
             Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated
             with chronic productive cough for 3 months in each of 2 consecutive years (with other
             causes of productive cough excluded). Only patients with chronic bronchitis will be
             included (concomitant emphysema is permitted)

          -  3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio
             (postbronchodilator) < 70% at Screening (Visit 1)

          -  4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)

          -  5. At least two documented moderate or severe COPD exacerbations within 12 months
             prior to Screening (Visit 1)

          -  6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)

          -  7. Former smokers (defined as smoking cessation at least 1 year ago) or current
             smokers (including patients who ceased smoking within the past year) both with a
             smoking history of at least 20 pack-years

        Exclusion Criteria:

          -  1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with
             antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1)
             (ie, patients must be clinically stable)

          -  2. Known alpha-1-antitrypsin deficiency

          -  3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of
             childhood asthma is not exclusionary.)

          -  4. Body mass index (BMI) ≥ 45 kg/m2

          -  5. Patients with a history (within 5 years) or current diagnosis of cancer other than
             basal or squamous cell skin cancer
Prevention of Anthracycline or Trastuzumab Induced Cardiomyopathy by Metoprolol
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Intervention: Metoprolol
Intervention description: Metroprolol tartrate titrated up
Intervention MeSH terms: Metoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ejection fraction; anthracyclines; beta-adrenergic blockade; Patients receiving anthracyclines

Summary:

      The primary objective of this study is to investigate whether giving prophylactic metoprolol
      prior to and during anthracycline or trastuzumab therapy will decrease the incidence of
      anthracycline-induced cardiomyopathy. Patients are randomized to receive metoprolol or no
      treatment prior to anthracycline or trastuzumab treatment. The ejection fraction, as measured
      by nuclear ventriculography is measured before and after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have confirmed malignancy for which standard regimens of anthracyclines
             or trastuzumab are being offered as treatment at the University of Maryland Greenebaum
             Cancer Center. Patients must either receive 4 cycles of anthracycline for a total dose
             of 240 mg/m2 or six cycles of TAC for a total dose of 300 mg/m2 or trastuzumab.

          2. Age > 18 years

          3. Ability to understand and willingness to sign a written informed consent document.

          4. Women of childbearing potential may participate in this study only if they have a
             negative pregnancy test and agree not to become pregnant during the study. Woman of
             childbearing potential must use an effective method of birth control such as hormonal
             contraceptives (oral and implant) condoms, diaphragms, spermicidal foam or jelly,
             surgical (hysterectomy or tubal ligation) or intrauterine device.

        Exclusion Criteria:

          1. Patients who have established dilated or restrictive cardiomyopathy with EF < 40 %.

          2. Patients with severe mitral or aortic valve disease (valve area <1cm squared).

          3. Patients who have any contraindication to metoprolol, in particular bradycardia with
             HR < 50, or severe reactive pulmonary disease such as asthma. Patients who take
             mibefradil or psychiatric drugs (such as phenothiazines including chlorpromazine and
             thioridazine) will also be excluded from the study as they have serious interactions
             with beta-blockers

          4. Patients who have untreated thyroid function disorder.

          5. Pregnant and nursing women are excluded from this study because of potential risk for
             adverse events to the fetus.

          6. Patients with any impediment to swallowing tablets would be excluded.
Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Condition: Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Intervention: Zolpidem; Escitalopram; Placebo
Intervention description: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.; The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.; A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
Intervention MeSH terms: Zolpidem; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary Insomnia; Insomnia; Placebo-Controlled; Double-Blind; Polysomnography; PET Studies; Escitalopram; Zolpidem

Summary:

      This study will compare the symptoms, experiences, and laboratory sleep characteristics of
      young adults with and without insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physically healthy

          -  Meets DSM-IV criteria for primary insomnia

          -  For subjects interested in PET study only: right-handedness

        Exclusion Criteria:

          -  Currently taking antidepressants, antianxiety medications or medications for sleep
             disorders

          -  Currently experiencing symptoms of psychiatric disorders such as major depressive
             disorder, bipolar disorder, generalized anxiety disorder

          -  Significant or unstable acute or chronic medical conditions, such as seizure disorder,
             tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease

          -  Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder
Atorvastatin Pre-Treatment Study In Asian Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Atorvastatin; Atorvastatin
Intervention description: 80mg 12 hours pre-Percutaneous Coronary Intervention (PCI), 40mg 2 hours pre-PCI and 40mg daily after PCI for 30 days.; 40mg daily after PCI for 30 days.
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 499.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asia Lipitor Pre-treatment in Acute Coronary Syndrome

Summary:

      This present study is specifically designed to examine the efficacy and safety of a high
      pre-treatment dose of atorvastatin in Asian patients with NSTE-ACS in China and the Republic
      of Korea, by using a treatment paradigm similar to that employed in the ARMYDA-ACS study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-ST elevated ACS; LDL-C > 80 mg/dl

        Exclusion Criteria:

          -  ST elevated acute myocardial infarction; previously or currently treated with
             atorvastatin or other statins
Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Condition: Smoking Cessation
Intervention: Counseling; combination NRT
Intervention description: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking; Both groups will receive combination NRT to help with smoking cessation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: In vivo or standard of care
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and
      examine the underlying mechanisms of action associated with adherence.
    

Eligibility criteria:

        Inclusion Criteria:

        a) 18 years or older; b) qualifying as low income (as defined by making <150% above the
        poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least
        5 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than
        8 ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation
        of enrolling a large >50% African-American who average <10 CPD compared to Whites who
        average ~15 CPD.; and d) English speaking.

        Exclusion Criteria:

        a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or
        nursing (all women will be required to use an acceptable form of contraception); c)
        Currently enrolled in a smoking cessation treatment program, using NRT products, or
        prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement
        products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a
        pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or
        untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such
        as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition
        that interferes with the informed consent process (individuals stable on psychiatric
        medications will be included); or i) Daily or exclusive use of other tobacco products
        (e.g., electronic cigarettes, little cigars, etc.).
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Liposomal bupivacaine right injection; Liposomal bupivacaine left injection
Intervention description: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.; Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized controlled pilot study evaluating length of pain control with either
      liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients
      having bilateral mastectomies with immediate reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for bilateral mastectomy

        Exclusion Criteria:

          -  allergy to local anesthetics, prior breast surgery, asymmetric surgical plan