bioihbjkbjnl/mcl2 huggingface dataset:
Dichotic Listening as a Predictor of Medication Response in Depression
Condition: Major Depressive Disorder; Dysthymia
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
Intervention: escitalopram; bupropion; imipramine
Intervention description: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d; bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d; imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted
Intervention MeSH terms: Bupropion; Imipramine; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This study will recruit 100 depressed patients to test whether the previous finding of an
      association between treatment response (with treatment groups including placebo, imipramine,
      and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also
      found with a different type of commonly used anti-depressant, bupropion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages between 18-65

          2. Meets Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) criteria for current
             Major Depression, Dysthymia or Depression Not Otherwise Specified

        Exclusion Criteria:

          1. Known Hearing impairment

          2. Active suicidal ideation (history of suicide attempts will be evaluated on a case by
             case basis).

          3. Hamilton Rating Scale for Depression (HAMD), 21-item total score >20

          4. Current (past 6 months)alcohol and/or drug abuse or dependence

          5. Medical condition likely to require intervention contraindicated with study medication
             (e.g., known arrhythmia likely to be exacerbated by Imipramine)

          6. Bipolar I

          7. Psychosis

          8. Non-response to adequate trial of study medication (i.e., > or = 4 weeks on > or =
             bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d)

          9. Premenopausal women not using known effective birth control

         10. Not currently depressed (whether considered due to current treatment or not)

         11. History of seizure, seizure disorder, anorexia nervosa, or bulimia

         12. Left-handed -
High Dose Influenza Vaccine in Nursing Home - Pilot Study
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: HD Fluzone Vaccine; SD Fluzone Vaccine
Intervention description: Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).; Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2957.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Randomized Controlled Trial; Influenza; Influenza vaccine; Flu Vaccine; Fluzone; HD Fluzone; Nursing Homes; Hospitalization; Mortality; Health Care worker vaccination; ADL decline; Pilot; Effectiveness

Summary:

      The purpose of this pilot evaluation is to help determine the feasibility and power needed to
      prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing
      influenza mortality and hospitalization in a nursing home population in the U.S., compared to
      the standard-dose influenza vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Long-term care facilities in one of the 122 cities that serve as Center for Disease
             Control and Prevention (CDC) surveillance sites

        Exclusion Criteria:

          -  Facilities already systematically administering HD vaccine to their residents

          -  Facilities for whom over half the residents are on Medicare (short-stay)

          -  Facilities in which over half the residents are on Medicare Part A (SNF)

          -  Facilities having fewer than 50 long-stay residents

          -  Hospital-based facilities

          -  Facilities with more than 20% of the population under age 65

          -  Facilities with mandated (employment-dependent) seasonal influenza vaccination

          -  Facilities not submitting MDS data
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Nitric Oxide; Prostacyclin
Intervention description: inhaled nitric oxide; inhaled prostacyclin
Intervention MeSH terms: Epoprostenol; Nitric Oxide; Tezosentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart failure; hypertension, pulmonary; heart failure, right-sided; heart-assist devices; Heart Transplantation

Summary:

      Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO)
      and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either
      heart transplant or for left ventricular assist device (LVAD) placement. The investigators
      hope to learn if these two medications, when given together after surgery, improve right
      heart function by lowering blood vessel pressures in the lungs. The investigators hope to
      learn if the combined effects of these two medications are better than either medication used
      alone. Participants were selected as a possible participant in this study because right heart
      problems are common during and after surgery for heart transplant and for LVAD placement. In
      addition, iNO is always given during and after these two types of surgeries at Stanford to
      help improve how the right heart functions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult cardiac surgical patients scheduled to undergo either heart transplantation or
             LVAD placement

        Exclusion Criteria:

          -  Patients with prior documented allergic reactions or intolerance to either nitric
             oxide or prostacyclin will be excluded. Patients not undergoing heart transplantation
             or LVAD placement will be excluded.
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Bisoprolol
Intervention description: Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.
Intervention MeSH terms: Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Diabetes Mellitus; Bisoprolol

Summary:

      The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm
      study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day
      bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects with hypertension, either newly diagnosed or treated but currently
             uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2
             diabetes mellitus (T2DM) (that is, greater than or equal to [>=] 130/80 mmHg)

          -  Aged at least 18 years old

          -  Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated
             hemoglobin of less than 7 percent

        Exclusion Criteria:

          -  Subjects who were already on beta-blocker therapy at the time of recruitment

          -  Subjects with heart rate of at most 60 beats per minute (bpm) at rest

          -  Subjects with secondary hypertension, congenital heart disease, coronary artery
             disease, peripheral arterial disease or congestive heart failure in any stage

          -  Subjects with coronary conduction disorders (bundle branch block)

          -  Subjects with signs of definitive target organ damage consistent with World Health
             Organization (WHO) Stage III or with severe renal or hepatic disease

          -  Subjects who are pregnant or expect to be pregnant within the 24-week study period

          -  Subjects on oral contraceptives

          -  Subjects with asthma or a history of asthma

          -  Subjects with documented severe renal disease

          -  Subjects on anti-neoplastic drugs
Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Hemoglobinuria, Paroxysmal
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Eculizumab
Intervention description: 5 mg/mL solution in 5% Dextrose
Intervention MeSH terms: Eculizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Alexion; Eculizumab; Paroxysmal Nocturnal Hemoglobinuria; PNH; Soliris

Summary:

      The primary objective of this study was to evaluate the pharmacokinetic (PK) and
      pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for
      pediatric and adolescent participants with PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants between 2 and 17 years of age;

          -  Diagnosed with PNH;

          -  Participants with ≥ 5% glycosylphosphatidylinositol-deficient red blood cells or
             granulocytes as confirmed by flow cytometry;

          -  Participants must have shown evidence of hemolytic anemia as documented by lactate
             dehydrogenase greater than the upper limit of normal or at least 1 transfusion in the
             past 2 years for anemia or anemia related symptoms;

          -  Written informed consent from a parent/guardian;

          -  Negative pregnancy test for females of child bearing potential at screening;

          -  Sexually active females must have documented a reliable and medically approved method
             of contraception;

          -  Participant must have been vaccinated against N. men, S. pneumo, and H. influ at least
             14 days prior to study drug initiation or received antibiotics for 14 days after the
             vaccinations.

        Exclusion Criteria:

          -  Prior eculizumab treatment;

          -  Presence or suspicion of active bacterial infection at baseline;

          -  Participation in another concurrent clinical study within at least 30 days prior to
             screening;

          -  History of meningococcal/pneumococcal/gonococcal disease;

          -  Pregnant, breast feeding, or intending to conceive during the study including the
             safety follow-up visits;

          -  Any other condition that could increase the participant's risk or confound the outcome
             of the study.
Probiotics to Promote Intestinal Health
Condition: Communicable Diseases; Infection; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions
MeSH terms: Communicable Diseases; Infections
Intervention: Probiotic; Placebo
Intervention description: 1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis; Sugar pill
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Probiotics

Summary:

      The purpose of this study is to evaluate the effectiveness of bacteria called Lactobacillus
      GG, a Probiotic, in preventing the growth of resistant bacteria in the digestive tract in
      patients on broad spectrum antimicrobials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 years old

          -  Admission to the non-ICU medical and surgical wards

          -  On broad spectrum antimicrobials with an anticipated length of stay of >48 hours

        Exclusion Criteria:

          -  Pregnancy

          -  Non English speaking

          -  Expected to die within 7 days

          -  Unable or unwilling to consent

          -  HIV infection with a CD4 count <200

          -  Neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to
             drop to less than 500)

          -  Clinically significant diarrhea or history of C. difficile infection in the last 3
             months

          -  History of VRE colonization and/or infection in the last year

          -  Transplant recipients
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Condition: Post-op Pain
MeSH terms: Pain, Postoperative
Intervention: Oral acetaminophen; IV acetaminophen
Intervention description: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.; Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip replacement; Knee replacement; randomized trial; acetaminophen; post-op pain management

Summary:

      The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip
      or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV
      acetaminophen
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  Able to provide written consent

          -  Able to read and write in English

          -  Weighing over 50 kg

          -  Will undergo total hip or total knee joint replacement

        Exclusion Criteria:

          -  Non-verbal patients

          -  Unable to use numeric pain scale

          -  Allergic to the test article

          -  Documented hepatic impairment or failure

          -  Current illicit drug use

          -  Requires traumatic or emergent surgery

          -  Pregnant women

          -  Women who are breastfeeding

          -  Prisoners

          -  Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of
             Attorney (POA)

          -  Unable to swallow oral capsules
Validation of a New Shortness of Breath With Daily Activities Questionnaire in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea; Chronic Disease
Intervention: Fluticasone propionate/salmeterol combination product; Salmeterol; Placebo
Intervention description: Fluticasone propionate/salmeterol combination product 250/50mcg DISKUS twice a day for 8 weeks; Salmeterol 50mcg DISKUS twice a day for 8 weeks; Placebo DISKUS twice a day for 8 weeks
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Pulmonary Disease, Chronic Obstructive; Dyspnea

Summary:

      The purpose of this study is to evaluate a new questionnaire to capture the patient
      experience of COPD. The information collected will be used to validate the Shortness of
      Breath with Daily Activities Questionnaire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 40 years of age

          -  Established clinical history of COPD by ATS/ERS definition

          -  Former or current smoker > 10 pack years

          -  Evidence of dyspnea

        Exclusion Criteria:

          -  Has a respiratory disorder other than COPD

          -  Cancer not in complete clinical remission

          -  Clinically significant cardiovascular, neurological, psychiatric, renal,
             gastro-intestinal, immunological, endocrine, or hematological abnormalities that are
             uncontrolled
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Intervention: Moderate Procedural Sedation with a sedative medication.; Deep Procedural Sedation with a sedative medication.; propofol
Intervention description: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.; procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
Intervention MeSH terms: Propofol; Hypnotics and Sedatives
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: propofol; moderate procedural sedation; deep procedural sedation; memory; emergency department

Summary:

      This study is a clinical trial of moderate sedation versus deep sedation with propofol for
      procedural sedation in the Emergency Department. The purpose of this study is to compare the
      rate of amnesia and respiratory depression rate in patients who receive moderate sedation to
      those that receive deep sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults undergoing procedural sedation with propofol in the emergency department

        Exclusion Criteria:

          -  < 18 years old

          -  Pregnant

          -  Previous allergic reaction to propofol

          -  Prisoner

          -  Unable to provide informed consent
Olmesartan Comparison to Losartan in Hypertensive Subjects
Condition: Hypertension
MeSH terms: Hypertension
Intervention: olmesartan medoxomil; Placebo; losartan potassium
Intervention description: Oral tablets, once daily, at either 20mg or 40mg daily.; placebo oral tablets once daily for two weeks; losartan potassium oral tablet at either 50mg or 100 mg daily dose.
Intervention MeSH terms: Losartan; Olmesartan; Olmesartan Medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 941.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of the FDA approved blood pressure
      medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged > 18 years who are not institutionalized and have signed
             informed consent.

          -  Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a
             mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive
             qualification study visits during the placebo run-in phase.

          -  The difference in mean cuff seated diastolic BP must be < 7 mmHg between two
             consecutive qualification study visits during the placebo run-in phase.

        Exclusion Criteria:

          -  Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.

          -  Subjects with serious disorders which may limit the ability to evaluate the efficacy
             or safety of olmesartan medoxomil and losartan potassium, including cardiovascular,
             renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal
             (including clinically significant malabsorption), endocrine/metabolic (with the
             exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at
             Screening), hematologic/oncologic (including an active malignancy other than basal
             cell carcinoma), neurologic and psychiatric diseases.

          -  Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass
             surgery or heart failure within the last 12 months.

          -  Subjects with any history of New York Heart Association Class III or IV congestive
             heart failure (CHF). A history of New York Heart Association Class I or II CHF may be
             exclusionary at the discretion of the Investigator.

          -  Subjects with a history of cerebrovascular accident or transient ischemic attack
             within the last 1 year.

          -  Subjects with clinically significant cardiac conduction defects, including second or
             third degree atrioventricular (AV) block, left bundle branch block, sick sinus
             syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any
             arrhythmia requiring medication.