bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
Condition: Dyslipidemia; Hypertension
MeSH terms: Dyslipidemias
Intervention: Amlodipine besylate; Amlodipine besylate/atorvastatin calcium single pill combination; Amlodipine besylate; Amlodipine besylate/atorvastatin calcium single pill combination
Intervention description: Amlodipine besylate 5 mg; Amlodipine/atorvastatin single pill combination 10/20 mg; Amlodipine besylate 10 mg; Amlodipine/atorvastatin single pill combination 5/20 mg
Intervention MeSH terms: Calcium, Dietary; Amlodipine; Atorvastatin; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate whether an aggressive multi-risk factor
      management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in
      greater percentage of patients achieving blood pressure and low density lipoprotein
      cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol
      Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach
      (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with
      hypertension and additional risk factors, including dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and
             who also have 3 additional cardiovascular risk factors, including dyslipidemia.

        Exclusion Criteria:

          -  Subjects who are taking the following prohibited medications within 14 days of
             screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3
             antihypertensive agents (including Norvasc)

          -  Subjects that have not been on a stable dose of Norvasc for at least 4 weeks

          -  Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular
             Disease (PVD)
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Condition: Pediatric Obesity; Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Intervention: Placebo; VI-0521 Mid Dose; VI-0521 Top Dose
Intervention description: po once daily; po once daily; po once daily
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Adolescent Obesity; Childhood Obesity; Qsymia; Pharmacokinetics; VI-0521; Phentermine; Topiramate

Summary:

      The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in
      obese adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent;

          -  Provide written assent (of study subject);

          -  Adolescent ≥12 and <18 years of age;

          -  Have a BMI ≥ the 95th percentile of BMI for age and gender;

          -  Female subjects must be using adequate contraception;

          -  Willing and able to comply with all study requirements

        Exclusion Criteria:

          -  Condition or disease interfering with metabolism;

          -  Any medical treatment with insulin;

          -  Hyperthyroidism, or clinically significant hypothyroidism;

          -  Any history of bipolar disorder or psychosis, major depressive disorder, or history of
             suicidal behavior or ideation, or any use of antidepressant medications;

          -  Use of chronic systemic glucocorticoid or steroid therapy;

          -  History of any eating disorders;

          -  Any history of laxative abuse;

          -  Prior bariatric surgery;

          -  Any history of nephrolithiasis;

          -  Any history of epilepsy, or treatment with anti-seizure medications;

          -  Positive urine drug screen;

          -  Current smoker or smoking cessation within the previous 3 months of screening;

          -  Obesity of a known genetic or endocrine origin;

          -  Treatment with any over-the-counter or prescription weight loss drug, or
             attention-deficit/hyperactivity disorder (ADHD);

          -  Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to
             any drug;

          -  Use of any investigational medication or device for any indication or participation in
             a clinical study within 30 days prior to screening; or

          -  Any medical or surgical condition which would impair the ability of the subject to
             complete the study, compromise the quality of study data, or pose an unacceptable risk
             to the safety of the subject.
Veteran Stress and Learning Study
Condition: Stress Disorders, Posttraumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Hydrocortisone; D-Cycloserine; Placebo
Intervention description: 25 mg/oral one hour prior to extinction task; 50 mg/oral one hour prior to extinction task; One hour prior to extinction task
Intervention MeSH terms: Cycloserine; Hydrocortisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Stress Disorders, Posttraumatic; Hydrocortisone; Cycloserine; Extinction, Psychological; PTSD; San Francisco

Summary:

      This is a research study examining the use of two medications, Hydrocortisone and
      D-Cycloserine, compared to an inactive substance (placebo), on their ability to reduce fear
      responses and memory of fear in Veterans with symptoms of Posttraumatic Stress Disorder
      (PTSD). These responses will be tested using a fear learning and memory task administered by
      computer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans and civilians with an age range of 18 to 65 years

          -  Participants must be physically healthy volunteers

        Exclusion Criteria:

          -  Individuals who fall outside the age range

          -  Individuals with medical conditions that would interfere with participation

          -  Other criteria
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant plus Ondansetron; Ondansetron plus placebo
Intervention description: Aprepitant plus Ondansetron; Ondansetron plus placebo
Intervention MeSH terms: Ondansetron; Aprepitant
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Postoperation, nausea, vomiting, anesthesia, plastic surgery

Summary:

      Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for
      prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48
      hours after surgery.

      Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in
      patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up
      to 48 hours after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  ASA (American Society of Anesthesiologists physical status) 1-3

          -  Male and female Age 18 to 65 years

          -  Plastic surgical procedure (Breast, Face, Liposuction, etc., and excluding peripheral
             procedures such as hand surgery and limited-scope split-thickness skin grafts) of at
             least 1 hour in duration

          -  General anesthesia

          -  Presence of 2 (men)/3 (women) or more risk factors for PONV

          -  Ambulatory surgery with same-day discharge planned

        Exclusion Criteria:

          -  Patient refusal

          -  Patients who have received other antiemetics prior to their procedure

          -  History of allergy or sensitivity to study drugs

          -  Pregnancy - Patients are asked date of last menstrual period, use of birth control,
             tubal ligation, if they have had unprotected sexual intercourse and if they think if
             there is any possibility of being pregnant, and when appropriate, a pregnancy test
             will be obtained which is the standard of care at Magee-Womens Hospital.

          -  Patients with a history of chronic opioid use (chronic pain syndrome) as these
             patients will be less likely to have PONV
Sildenafil in Heart Failure With Reactive Pulmonary Hypertension
Condition: Heart Failure With Reactive Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure
Intervention: Sildenafil; Placebo
Intervention description: 20 mg three times daily by mouth for 90 days; One capsule three times daily by mouth for 90 days
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Sildenafil 20mg taken three times a day is
      effective in the treatment of Heart Failure with Reactive Pulmonary Hypertension. This is a
      double-blind, placebo controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Known chronic heart failure appropriately treated with Angiotensin converting enzyme
             (ACE) inhibitors and beta blockers, unless contraindicated or poorly tolerated

          -  indication for right heart catheterization

          -  pulmonary artery mean pressure >25 mmHg

          -  pulmonary capillary wedge pressure > 15 mmHg

          -  pulmonary vascular resistance > 3 Wood units

        Exclusion Criteria:

          -  hypersensitivity, allergy, or intolerable side effect to sildenafil

          -  history of primary pulmonary hypertension, connective tissue disorder, severe chronic
             obstructive pulmonary disorder (COPD), pulmonary embolism, or left to right shunt

          -  co-morbidities, limited exercise intolerance:

               -  morbid obesity (BMI >40)

               -  COPD with oxygen dependence

               -  severe peripheral vascular disease with intermittent claudication

               -  status post amputation of lower extremity at any level

               -  severe degenerative joint disease preventing normal walking
Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients
Condition: Systemic Fungal Infections
MeSH terms: Mycoses
Intervention: Posaconazole
Intervention description: A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
Intervention MeSH terms: Posaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to try to find out how critically ill patients receiving the
      anti fungal medication, posaconazole, process it in their body. Investigators would like to
      study if the recommended doses of posaconazole achieve adequate concentrations in the
      patients blood to treat fungal infections.The disease process in critically ill patients can
      profoundly influence the concentration of anti fungal medication in the blood. The process by
      which a drug travels through the body in blood, how it is broken down and removed by the body
      is called pharmacokinetics (PK).

      This information is important to know because if antifungal levels are low in the blood, the
      fungal infection has an opportunity to become resistant to the antifungal medication which
      can lead to the medication being less effective against the fungal infection potentially
      exposing future patients with infection to a limited range of effective antifungals.

      Investigators can measure the PK by taking blood samples at specific times after the anti
      fungal medication is given.

      This study will enroll 8 patients who are admitted to the intensive care unit and are being
      treated with an antifungal medication for a fungal infection. Patients will be consented and
      given a single dose of posaconazole and serial blood samples will be collected just prior to
      the dose and at 15, 45,75 minutes during the infusion and at 3, 5, 8, 12, 18, 24, 30 36 and
      48 hours . Information about the patients stay in the ICU will also be collected including
      blood pressure, temperature, blood test results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years

          -  Admission for ICU care

          -  The presence of suspected or confirmed fungal infection requiring systemic antifungal
             therapy

          -  Presence of central venous access for drug administration

        Exclusion Criteria:

          -  Age < 18 years

          -  Pregnancy

          -  Prescription of drugs that are known to interact with posaconazole

          -  Oral posaconazole use within the last two week prior to enrolment

          -  Documented history of drug reaction to the triazole antifungal medications
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Condition: Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis
MeSH terms: Infections; Communicable Diseases; Appendicitis; Peritonitis; Intraabdominal Infections; Cross Infection; Cholecystitis; Acalculous Cholecystitis; Diverticulitis
Intervention: tigecycline; ceftriaxone sodium + metronidazole
Intervention description: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours); Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.
Intervention MeSH terms: Metronidazole; Ceftriaxone; Tigecycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Complicated intra-abdominal infection; Appendicitis with abscess; Perforated diverticulitis; Purulent peritonitis; Complicated cholecystitis

Summary:

      This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and
      efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects
      with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms
      of cIAI will be included for enrollment. Subjects will be stratified at randomization for
      Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10.
      Subjects will be followed for efficacy through the test-of-cure assessment. Safety
      evaluations will occur through the treatment and post-treatment periods and continue through
      resolution or stability of the adverse event(s).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of complicated intra-abdominal infection that requires surgery
             within 24 hours.

          -  Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as
             nausea, vomiting, abdominal pain.

        Exclusion Criteria:

          -  Cancer

          -  Medicines that suppress the immune system

          -  Dialysis
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Condition: Blood Loss, Surgical
MeSH terms: Blood Loss, Surgical
Intervention: rThrombin, 1000 IU/mL
Intervention description: At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the immunogenicity and safety of recombinant
      Thrombin (rThrombin) in patients with prior rThrombin exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of
             treatment with rThrombin in that study or the recipient of commercially-available
             rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass
             surgical procedure

          -  Age of 18 years or older at time of consent

          -  Bleeding indicating treatment with rThrombin during the course of the surgical
             procedure

          -  Signed informed consent document approved by an institutional review board or
             independent ethics committee

        Exclusion Criteria:

          -  Currently undergoing a procedure requiring cardiopulmonary bypass or involving the
             aortic arch

          -  Known hypersensitivity to rThrombin product or any of its components

          -  Currently undergoing a surgical procedure where the use of other thrombin-containing
             hemostatic agents is planned

          -  Medical, social, or psychosocial factors that, in the opinion of the investigator,
             could affect the participant's safety or compliance with study procedures

          -  Treatment with any experimental agent within 30 days of study enrollment or treatment
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery
Condition: Delirium
MeSH terms: Delirium; Emergence Delirium
Intervention: IV acetaminophen & IV propofol; IV acetaminophen & IV dexmedetomidine; IV propofol & placebo; IV dexmedetomidine & placebo
Intervention description: use of IV tylenol and IV propofol for pain and sedation (respectively); use of IV tylenol and IV dexmedetomidine for pain and sedation (respectively); use of IV propofol for sedation and morphine, the drug of choice for cardiac pain; use of IV dexmedetomidine for sedation and morphine, the drug of choice for cardiac pain
Intervention MeSH terms: Acetaminophen; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: analgesics; cardiac surgery; sedation

Summary:

      Investigators will assess the incidence and duration of postoperative delirium in patients
      ≥60 years old undergoing coronary artery bypass grafting (CABG), with/without valve surgery
      (aortic and/or mitral) based on different regimens for postoperative sedation and analgesia.
      Patients will receive either intravenous (IV) dexmedetomidine and IV acetaminophen or
      standard postoperative management using IV propofol with morphine or hydromorphone. The
      Confusion Assessment Method (CAM) will be used to assess delirium in these patients.
      Investigators also seek to compare postoperative (48 hours) analgesic requirements in
      patients with or without IV acetaminophen. Investigators will finally assess postoperative
      cognition in post-surgical patients up to one year post-discharge using a cognitive
      assessment scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 60 years of age

          -  Undergoing CABG with/without valve (aortic and/or mitral) procedure requiring bypass

        Exclusion Criteria:

          -  Pre-operative Left Ventricular Ejection Fraction (LVEF) < 30%

          -  Emergent or urgent procedures, aortic surgery

          -  Pre-existing cognitive impairment (defined based on a short screening assessment),
             Parkinson's disease, Alzheimer's disease, recent seizures (<3 months)

          -  Prophylactic medications for cognitive decline

          -  Serum creatinine > 2 mg/dl

          -  Liver dysfunction (liver enzymes > 4x the baseline, since patients will have a
             baseline liver function tests), history and exam suggestive of jaundice

          -  Known history of alcohol or drug abuse (>10 drinks per week)

          -  Hypersensitivity to any of the study drug and percutaneous procedures

          -  Non-English speaking