bioihbjkbjnl/mcl2 huggingface dataset:
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Condition: Atrial Fibrillation
MeSH terms: Renal Insufficiency; Atrial Fibrillation
Intervention: Pradaxa, dabigatran etexilate
Intervention description: 75mg BID by oral
Intervention MeSH terms: Dabigatran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe
      renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by
      Cockcroft-Gault formula.

      The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with
      severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and
      simulation.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects diagnosed with non-valvular atrial fibrillation with an indication for the
             anticoagulation therapy,

          -  Subjects with severe renal function impairment defined as creatinine clearance between
             15 and 30 mL/min by Cockcroft-Gault formula,

          -  Male and female patients, age =18 years at entry

        Exclusion criteria:

          -  Contraindications to Pradaxa (history of a serious hypersensitivity reaction to
             Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart
             valve),

          -  Creatinine clearance <15ml/min or patients with End Stage Renal Disease on dialysis,

          -  Creatinine clearance >30 ml/min,

          -  Pre-menopausal women (last menstruation less than one year prior to informed consent)
             who are nursing or pregnant, or are of child bearing potential and are not practicing
             an acceptable method of birth control, or do not plan to continue using this method
             throughout the study. Acceptable methods of birth control include abstinence, tubal
             ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral,
             implantable or injectable contraceptives, double barrier method and vasectomised
             partner,

          -  Patients who are participating in another drug study,

          -  Patients who have participated in another drug study within 6 weeks,

          -  Patients considered unreliable by the investigator concerning the requirements for
             participating in the study, including a follow-up interview,

          -  Any condition the investigator believes would not allow safe participation in the
             study,
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide / formoterol fumarate (SYMBICORT); Budesonide
Intervention description: 160/4.5 μg x 2 actuations twice daily (bid); inhalation powder 180 μg x 2 inhalations bid (PULMICORT)
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to
      that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African
      American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  African American (self-reported)

          -  Documented clinical diagnosis of asthma as defined by the American Thoracic Society
             (ATS) for at least 6 months prior to Visit 2 and be in stable condition.

          -  FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48
             hours after LABA, of 45%-85%, inclusive, of predicted normal.

        Exclusion Criteria:

          -  Has been hospitalized at least once for an asthma related condition during the 6
             months prior to Visit 2, or has required emergency treatment due to an asthma related
             condition more than once in the 3 months prior to Visit 2.

          -  Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or
             rectal) for any reason within the 30 days prior to Visit 2.

          -  Has a respiratory infection or other viral/bacterial illness, or is recovering from
             such an illness at the time of Visit 3 that, in the Investigator's opinion, will
             interfere with the subject's lung function and/or ability to perform spirometry
Vilazodone for Treatment of Geriatric Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Vilazodone; Viibryd; Paroxetine; Paxil
Intervention description: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.; Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.
Intervention MeSH terms: Paroxetine; Antidepressive Agents; Vilazodone Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: depressed; geriatric; older adults; antidepressants; depression; anxious; major depressive disorder; MDD

Summary:

      The purpose of this study is to examine the effects of vilazodone for the treatment of
      depression in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  The presence of a major depressive disorder diagnosed according to the Diagnostic and
             Statistical Manual of Mental Disorders (DSM-IV) criteria

          -  A 24-item Hamilton Depression Rating Scale (HAMD) score of 17 or higher at baseline

          -  Mini-Mental State Exam (MMSE) score > 24.

        Exclusion Criteria:

          -  Subjects will be excluded if they had any current and/or lifetime history of other
             psychiatric disorders (except unipolar depression with or without comorbid generalized
             anxiety disorder), or recent unstable medical or neurological disorders; any
             disabilities preventing their participation in the study; diagnosis of mild cognitive
             impairment (MCI)/dementia; those with known allergic reactions to paroxetine or
             vilazodone.
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Condition: Atrial Fibrillation; Heart Failure, Congestive
MeSH terms: Heart Failure; Atrial Fibrillation
Intervention: Pacemaker Medtronic EnRhythm
Intervention description: Pacemaker specific programming
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Physiological pacing; Antitachycardia pacing therapies

Summary:

      The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and
      atrial preventive and antitachycardia pacing therapies on the reduction of a composite
      clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular
      hospitalizations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Class I/Class II indications for dual chamber pacing

          -  Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since
             maximum 2 weeks

          -  History of atrial arrhythmias (at least one electrocardiogram [ECG] or Holter
             documented episodes in the last 12 months)

        Exclusion Criteria:

          -  Less than 18 years of age

          -  Pregnancy

          -  Unwilling or unable to give informed consent or to commit to follow-up schedule

          -  Medical conditions that preclude protocol required testing or limit study
             participation

          -  Enrolled or intend to participate in another clinical trial during the course of this
             study

          -  A life expectancy of less than 2 years

          -  Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac
             resynchronization therapy (CRT) device implant

          -  Anticipated major cardiac surgery within the course of this study

          -  Permanent III degree AV-block or history of AV node ablation

          -  History of permanent AF (as defined below)

          -  AF ablation (left pulmonary veins) or other cardiac surgery < 3 months

          -  Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted
             within two weeks)

          -  Uncontrolled hyperthyroidism
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Condition: Ureteral Patency
Intervention: Pyridium; Sodium Fluorescein; Mannitol; Normal Saline
Intervention MeSH terms: Mannitol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to
      identify the opening of the ureters to ensure that they are working correctly. Historically,
      indigo carmine, an intravenous medication that dyes the urine blue, has been used to help
      visualize the opening of the ureters with cystoscopy which is a camera placed inside the
      bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus,
      investigators need to evaluate other methods for assessing ureteral patency. Ideal
      alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are
      readily available and are easy to use.

      Examples of such agents currently being used to evaluate the ureters, include oral pyridium,
      IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by
      either dyeing the urine a different color such as pyridium and sodium fluorescein, or by
      having a different viscosity to urine such as mannitol. This study will compare three methods
      of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium
      fluorescein, and pyridium.
    

Eligibility criteria:

        Inclusion Criteria:

        - Planned cystoscopy

        Exclusion Criteria:

          1. Women who are pregnant

          2. Women with contraindications to pyridium, sodium fluorescein or mannitol:

               1. Intra-operative administration of nitric oxide, prilocaine and sodium nitrite

               2. Anuria

               3. Women with creatinine greater than 1 or Cr Cl < 50ml/minute

               4. Known allergy to pyridium, sodium fluorescein or mannitol.

          3. Women with a known urologic anatomical anomaly
Etomidate Versus Ketamine for Emergency Endotracheal Intubation: a Prospective Randomized Clinical Trial
Condition: Cardiopulmonary Arrest; Respiratory Arrest
MeSH terms: Heart Arrest; Emergencies
Intervention: Etomidate; Ketamine; Emergency Endotracheal Intubation; Mechanical Ventilation
Intervention description: Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.; Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.; Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.; Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
Intervention MeSH terms: Ketamine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 801.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: etomidate; ketamine; endotracheal intubation; anesthesia induction medications

Summary:

      Patients who are having problems breathing sometimes require placement of a breathing tube in
      their mouth and windpipe. The purpose of this breathing tube is to save the patient's life.
      It is common to give the patient a medication to sedate him or her before the breathing tube
      is placed. For patients who are gravely ill two medications are commonly used: etomidate or
      ketamine. Both medications have risks and benefits. Researchers at UT-Southwestern Medical
      Center and Parkland Memorial Hospital would like to do a study to figure out which one is
      better for our patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient (male or female) requiring emergency endotracheal intubation.

        Exclusion Criteria:

          -  Children (<18 years old).

          -  Women who are known to be pregnant.

          -  Any patient who has been previously randomized in the EvK Trial.

          -  Patients who require endotracheal intubation without sedative medication. For example,
             patients in full cardiac arrest.

          -  Patients with a known allergy to ketamine or etomidate.

          -  Any individual wearing a MedAlert bracelet indicating that he/she has formally opted
             out of the EvK Trial.
Temperature Control in Central Fever in the Neuro-ICU
Condition: Fever; Brain Hemorrhage
MeSH terms: Intracranial Hemorrhages; Hemorrhage; Fever
Intervention: Gaymar Rapr-Round (external cooling blanket)
Intervention description: Application of the device per its approved labeling
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: subarachnoid hemorrhage; intracerebral hemorrhage; fever

Summary:

      There are few treatments for central fever (fever that is due to the central nervous system,
      as opposed to an infectious source). We hypothesize that an externally applied cooling
      blanket will reduce temperature in neurologically ill patients with central fever.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Two or more days with core temperature ≥ 100.4F

          -  Approval of the patient's primary attending physician

          -  Need for core temperature measurement independent of the study.

          -  Admission to the Neuro-ICU [intensive care unit] for an underlying condition

        Exclusion Criteria:

          -  Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central
             nervous system] infection or urinary tract infection.

          -  Expected death from any cause

          -  Known sensitivity to the device

          -  History of pre-admission hypothalamic dysfunction or known temperature dysregulation

          -  Use of 2 or more vasopressor medications, since this may make a local skin reaction to
             the device more likely

          -  Hemodynamic instability
Study of Nivolumab for Advanced Cancers in India
Condition: Non-Small Cell Lung Cancer (NSCLC); Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Kidney Cancer; Kidney Neoplasms; Renal Cancer; Renal Neoplasms
MeSH terms: Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Kidney Neoplasms
Intervention: Nivolumab
Intervention description: specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or
      Kidney Cancer in India.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior
             chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

          -  Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to
             randomization

        Exclusion Criteria:

          -  Participants with untreated, symptomatic central nervous system (CNS) metastases

          -  Participants with carcinomatous meningitis

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with a condition requiring systemic treatment with either corticosteroids
             or other immunosuppressive medications

          -  Other active malignancy requiring concurrent intervention

        Other protocol defined inclusion/exclusion criteria could apply
Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Condition: Cough Reflex Sensitivity
MeSH terms: Cough
Intervention: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan; dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo; dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa; placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan; placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
Intervention description: diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.; diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg
Intervention MeSH terms: Diphenhydramine; Promethazine; Phenylephrine; Oxymetazoline; Dextromethorphan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cough; cough reflex; capsaicin; diphenhydramine; phenylephrine; dextromethorphan; placebo

Summary:

      The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two
      liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa
      flavoring, and, dextromethorphan syrup, compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adult nonsmokers

          -  onset of acute, viral upper respiratory tract infection (common cold) within 72 hours
             of enrollment

        Exclusion Criteria:

          -  smokers

          -  history of asthma or other respiratory disorders
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Degludec; Insulin Glargine
Intervention description: Insulin Degludec 10 IU SC every 24 hours for 6 days; Insulin Glargine 10 IU SC every 24 hours for 6 days
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The
      long-acting insulin has showed to improve glycemic variability however the behavior of
      insulin glargine versus insulin degludec is unknown.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from
             25.0-34.9 kg/m2 Diagnosis of T2DM

          -  Fasting plasma glucose ≤300 mg/dL at the time of scrutiny

          -  A1C between 6.5 and 11%

          -  Written informed consent

        Exclusion Criteria:

          -  Women pregnant or breastfeeding

          -  Untreated thyroid disease and/or uncontrolled hypertension [≥150 systolic and
             diastolic ≥90]

          -  Consumption of oral agents or other medications or supplements with proven properties
             that modify the behavior of glucose. In the case of antihypertensives, these may be
             included if treatment was not modified previous 3 months and no change during the
             study.

          -  Total cholesterol >240 mg/dL

          -  Triglycerides ≥400 mg/dL

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice
             the normal range

          -  Glomerular filtration rate <60 mL/min [Cockcroft-Gault]