bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Condition: Non-ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Infarction
Intervention: Tirofiban
Intervention MeSH terms: Tirofiban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 140.0
Sex: All
Minimum age: 19 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Tirofiban; Resistance to antiplatelet agents

Summary:

      Investigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for
      Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with NSTE-ACS who need PCI

          -  loaded with aspirin and clopidogrel at least 6 h before the procedure

        Exclusion Criteria:

          -  thrombocytopenia (platelet count <100,000/μL)

          -  history of hemorrhagic stroke

          -  history of ischemic stroke in the recent 2 year

          -  history of major surgery 6 months prior
Effect IV Ibuprofen and Inflammatory Responses
Condition: Gallbladder Disease
MeSH terms: Gallbladder Diseases
Intervention: ibuprofen; sugar water/placebo
Intervention description: single preoperative dose prior to surgery; single preoperative dose prior to surgery
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: laparoscopic cholecystectomy

Summary:

      This study is being done because the investigators wish to study ways to improve recovery
      after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the
      body's attempt to protect itself and to start the healing process. Some surgical
      complications are related to the body's natural inflammatory response. Although mainly a
      healing response, inflammation can also have side effects which delay recovery. The
      investigators wish to determine the effect of a medication known as ibuprofen on recovery.
      You may know ibuprofen by the name Advil or Motrin. The medication will be given through the
      vein prior to the start of the surgery. Three blood samples will be taken, two while the
      patient is under anesthesia. The subject will be asked to complete several questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing laparoscopic cholecystectomy under general anesthesia

          -  American Society of Anesthesiologists status of 1, 2 or 3 (as determined by the
             anesthesiologists)

          -  not pregnant of breast feeding

        Exclusion Criteria:

          -  cognitively impaired

          -  using antipsychotic drugs

          -  chronic use of steroids or opioids

          -  subject has received COX inhibitors within 3 days if surgery

          -  subjects for whom opiates, benzodiazepines and COX inhibitors are contraindicated

          -  subjects with a history of bleeding disorders or peptic ulcer disease
Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: sertraline; Nortriptyline; Lithium
Intervention MeSH terms: Lithium Carbonate; Sertraline; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: Patients start treatment according to the algorithm and follow a sequence of steps. There is no comparison between groups. It is a single group. Primary and secondary outcomes are only assessed at the end of the protocol, not at each step.
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cost effectiveness; Unipolar Depression; Major Depression Disorder; Quality of life disorder

Summary:

      To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using
      medications available in the Brazilian Public Healthcare System (SUS), and assessment of the
      quality of life of these patients.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of unipolar depression episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ages between 18 and 65;

          2. current acute unipolar depression episode;

          3. total capacity to understand and respond to self-applied instruments;

          4. the presence of symptoms in the last 30 days;

          5. abstinence for at least 30 days for drug addicts

        Exclusion Criteria:

          1. presence of Organic Brain Syndrome (OBS);

          2. pregnancy or lactation;

          3. criteria for psychiatric hospitalization.
Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Factor IX recovery
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to collect data around the period of the conversion from
      plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a
      retrospective history of the bleedings in the 3-month period before the conversion, the
      recovery with pdFIX just before the conversion and with BeneFIX just after the conversion,
      and a prospective history of the bleedings in the 3 month period following the conversion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderately to severe haemophilia B patient (FIX activity < or equal to 2%) for whom
             the switch from pdFIX to BeneFIX has already been decided by the investigator

          -  Previously treated patients (PTP) with > or equal to 150 ED to any FIX product

          -  Male patients, aged > or equal to 12 years

          -  Absolute CD4 count > or equal to 300/microL

          -  Normal platelet count (> or equal to 100 000/microL)

          -  Patient is in a non-bleeding state and has not received any coagulation FIX within
             five (5) days of recovery

          -  Written informed consent obtained prior to study entry (for patients aged < 18 years,
             parents' signature or subject legally acceptable representative obtained prior to
             study entry)

        Exclusion Criteria

          -  Any other known bleeding disorder in addition to haemophilia B

          -  History of, or current detectable factor IX inhibitor (> or equal to 0.6 BU by
             Bethesda inhibitor assay)

          -  History of anaphylaxis to any coagulation factor IX

          -  Patient with a known hypersensitivity to hamster protein

          -  Patient with a hypersensitivity to the active substance or to any of the excipients

          -  Patient unable to be off FIX replacement therapy for at least 5 days without bleeding
             Patient with hepatic or renal impairment (ALT [SGPT] and AST [SGOT] > 5 x Upper Limit
             Normal (ULN), total bilirubin > 20mg/l, albumin < 25 g/l, prothrombin time > 1.25 x
             ULN, serum creatinine > 1.25 x ULN)

          -  Treatment with any investigational drug or device within the past 30 days

          -  Any condition that, in the Investigator's judgment, makes participation in the study
             not advisable
Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Levosimendan; Placebo
Intervention description: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.; Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.
Intervention MeSH terms: Simendan
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: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cardiac Failure; Severe Heart Failure

Summary:

      The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary
      exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients
      with severe heart failure in stable clinical conditions (NYHA - New York Heart Association -
      class III, with a peak VO2 (Oxygen consumption ) < 12 ml/min/kg) on top of optimized standard
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  informed consent of the study signed

          -  severe heart failure in stable clinical condition (NYHA class III, peak VO2 <12 ml /
             kg / min) in optimized medical therapy. The clinical stability is defined by the
             stability of the therapy, the weight and urine output for 3 days

        Exclusion Criteria:

          -  unstable patients from a clinical point of view, not in optimized therapy

          -  patients unable to perform a CPET (Cardiopulmonary Exercise Test) .

          -  are excluded from the protocol also patients with absolute contraindications to CPET
             (acute myocardial infarction, severe aortic stenosis, myocarditis or pericarditis,
             active, acute thromboembolism, sepsis,unstable angina, uncontrolled arrhythmia.

          -  age < 18 years.
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Condition: Healthy
Intervention: Prilosec OTC (omeprazole-magnesium); Prevacid
Intervention description: Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast; Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast
Intervention MeSH terms: Omeprazole; Lansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Normal Healthy Subject Population

Summary:

      The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid
      suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  normal subjects who are age 18-65

          -  generally healthy

          -  non-childbearing potential females or those using birth control

        Exclusion Criteria:

          -  history of significant GI disease

          -  any significant medical illness

          -  history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or
             other proton pump inhibitors

          -  currently using GI medications

          -  GI disorder or surgery leading to impaired drug absorption
Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.
Condition: Barrett's Esophagus; Esophageal Cancer
MeSH terms: Esophageal Neoplasms; Barrett Esophagus
Intervention: Cryo Spray Ablation; Cryo Spray Ablation
Intervention description: Cryo Spray Ablation 4 cycles x 10 seconds treatment; Cryo Spray Ablation 2 cycles x 20 seconds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Barrett's Esophagus; Esophageal Cancer; Esophageal Dysplasia; Low Grade Dysplasia; High Grade Dysplasia

Summary:

      The purpose of this study is to evaluate the treatment effect, depth of injury, and side
      effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray
      AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy
      (EGD) using surgical resection specimens from subjects undergoing esophagectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years of age

          -  Esophagectomy planned based on clinical situation not related to this study.

          -  Deemed operable based on institutional criteria.

        Exclusion Criteria:

          -  Pregnant

          -  Esophageal stricture preventing passage of endoscope or catheter.

          -  Known history of unresolved drug or alcohol dependency that would limit ability to
             comprehend or follow instructions related to informed consent, post-treatment
             instructions, or follow-up guidelines.

          -  Refusal or inability to give consent.

          -  Concurrent chemotherapy.

          -  Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment
             area including, but not limited to, cryospray therapy, laser treatment, photodynamic
             therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency
             ablation, or argon plasma coagulation.

          -  Prior radiation therapy which involved the esophagus.
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Condition: HIV-Associated Lipodystrophy Syndrome
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Lipodystrophy; Syndrome
Intervention: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs); continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)
Intervention description: Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks; Protease inhibitor [PI] combination + 2 NRTIs
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; HIV Protease Inhibitors; Reverse Transcriptase Inhibitors; Protease Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV infections

Summary:

      The purpose of this clinical research study is to learn if human immunodeficiency virus
      (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral
      treatment (HAART) regimen have better changes in fat distribution after switching to
      atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks
             prior to screening. Subjects may not have experienced virological failure to more than
             one prior PI-containing regimen. Must be able to swallow tablets

          -  Viral load <400 c/mL at screening and stable for at least 6 months

          -  Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio >0.90
             and Waist Circumference >88.2 cm for men and Waist Circumference >75.3 for women

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  New HIV-related opportunistic infections

          -  Active alcohol or substance use

          -  Grade 4 lab toxicity

          -  History of taking atazanavir (ATV)

          -  Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors
             (NNRTI)
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
Condition: Drug Safety
Intervention: Iodixanol; Iopamidol
Intervention description: Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.; Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AE - Adverse event; Arteriography; IA - Intra-arterial; IOCM - Iso-Osmolar Contrast Medium; LOCM - Low-Osmolar Contrast Medium; Patient Comfort; Body Image Disturbance; Patient

Summary:

      The purpose of this study is to evaluate and compare overall patient comfort profile between
      an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media
      (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is over 18 years old.

          -  Subjects are referred to undergo a peripheral arteriography as part of their routine
             clinical care.

        Exclusion Criteria:

          -  The subject has known allergies to iodine or any prior history of adverse reaction to
             iodinated CM.

          -  The subject received another administration of CM within 24 hours prior to baseline or
             is scheduled to receive one within the 24 hour follow-up period.

          -  The subject is pregnant or lactating.

          -  The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to
             discontinue at the time of the study procedure.

          -  The subject manifests thyrotoxicosis or is on dialysis.
Carbetocin Versus Oxytocin and Hemodynamic Effects
Condition: Effects of; Anesthesia, in Pregnancy
Intervention: carbetocin 100 µg; oxytocin 5 u; placebo (NaCl)
Intervention description: Hemodynamic effect of; Hemodynamic effect of; Hemodynamic effect of
Intervention MeSH terms: Oxytocin; Carbetocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: cesarean delivery; blood pressure; cardiac output

Summary:

      A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with
      hemodynamic response as a primary outcome measure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pregnant women for planned cesarean section

        Exclusion Criteria:

          -  Bleeding disorders

          -  Placenta disorders
Trial of Comprehensive Migraine Intervention
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Naproxen; Sumatriptan; Migraine education; Reenforcement of diagnosis; Typical care
Intervention description: Naproxen 500mg PO bid prn headache; 100mg po q day prn headache; Educational program available through NIH/ national library of medicine/ X-plain; Patient advised has migraine headache and how the headache meets migraine criteria; Care to be determined by attending physician
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder
      is often not diagnosed and not appropriately treated. The goal of this proposal is to
      determine whether a migraine protocol designed for use in an emergency room can be used to
      deliver the headache care that many migraine patients never receive. This is a randomized
      trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care
      or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the
      following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational
      intervention, reading material, and headache diaries, 3) two migraine specific medications
      and 4) expedited referral to a headache specialist, if needed. Patients in the typical care
      arm will receive whatever intervention the emergency physician feels is most appropriate.
      Headache surveys will be used toll if the protocol improves migraine-related pain and
      functional disability one month after the ER visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine,

          -  Baseline migraine related disability of mild or worse,

          -  No current or past triptan use,

          -  Not satisfied with current headache care.

        Exclusion Criteria:

          -  Allergy or contraindication to study medications,

          -  Daily or near daily analgesic medication use.