bioihbjkbjnl/mcl2 huggingface dataset:
ISSUE3: International Study on Syncope of Uncertain Etiology 3
Condition: Syncope
MeSH terms: Syncope
Intervention: Dual chamber pacemeker
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 511.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: syncope; implantable loop recorder

Summary:

      ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to
      assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated
      syncope.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Suspected or certain neurally-mediated syncope, based on the Guidelines recently
             published by the Task Force on Syncope of the European Society of Cardiology 2,3
             (Appendix 1);

          -  More than 3 syncope episodes in the last 2 years;

          -  Clinical presentation of syncope of sufficient severity requiring treatment initiation
             in the physician's and patient's judgement.

          -  Age > 40 years.

          -  Negative carotid sinus massage.

          -  Patients accept to have an ILR implantation.

        Exclusion criteria:

          -  Carotid sinus hypersensitivity

          -  Suspected or certain heart disease and high likelihood of cardiac syncope:

          -  Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;

          -  Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic,
             drop-attack, TIA, intoxication, cataplexy);

          -  Subclavian steal syndrome;

          -  Psychologically or physically (due to any other illness) or cognitively unfit for
             participation in the study according to the opinion of the investigator;

          -  Patient compliance doubtful;

          -  Patient geographically or otherwise inaccessible for follow-up;

          -  Patient unwilling or unable to give informed consent;

          -  Life expectancy <1 year.
Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Fluorouracil 0.5%
Intervention description: Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions
Intervention MeSH terms: Fluorouracil
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: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to measure adherence to the study drug (Carac) for the
      treatment of actinic keratoses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any male or female 50 years of age or older with moderate to severe actinic keratoses
             of the face and anterior scalp diagnosed by a dermatologist will be eligible for
             participation.

        Exclusion Criteria:

          -  Age less than 50.

          -  Known allergy or sensitivity to topical Carac® in the subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for actinic
             keratosis while participating in the study.

          -  Subjects should not receive surgical or cryotherapy while participating in the study.

          -  Pregnant women, women who are breast feeding, or women of child bearing potential who
             are not practicing two acceptable methods of birth control
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
Condition: Cystic Fibrosis; Pneumonia; Pseudomonas Aeruginosa Infection
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Intervention: meropenem
Intervention description: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Intervention MeSH terms: Meropenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Acute Pulmonary Exacerbations; Pseudomonas aeruginosa

Summary:

      This study will determine the concentrations of the antibiotic meropenem when administered as
      a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an
      acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour
      infusion will be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cystic Fibrosis

          -  Hospitalized with acute pulmonary exacerbation

          -  Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an
             appropriate antibiotic treatment

        Exclusion Criteria:

          -  Known allergy to meropenem

          -  Require less than 3 days of meropenem in the hospital

          -  Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen

          -  Known fungal or viral infection

          -  Females in their 2nd or 3rd trimester of pregnancy

          -  Moderate to severe renal dysfunction, as defined by a creatinine clearance less than
             50 ml/min/1.73m2 (by use of Schwartz method)

          -  History of solid organ transplantation within previous 6 months

          -  Active or recent (within 30 days) participation in another antibiotic clinical trial
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium Bromide; Fluticasone Propionate/Salmeterol
Intervention description: Long-acting muscarinic antagonist; Inhaled corticosteroid plus long-acting bronchodilator
Intervention MeSH terms: Fluticasone; Xhance; Bromides; Tiotropium Bromide; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 342.0
Sex: All
Minimum age: 40 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Spirometry; COPD

Summary:

      The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR
      DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA®
      HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg
      (TIOTROPIUM) in patients with COPD.

      SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.

      ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COPD diagnosis

          -  At least 10 pack year smoking history

          -  Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of
             predicted normal

          -  An FEV1/FVC ratio of less than or equal to 0.70

        Exclusion Criteria:

          -  Current diagnosis of asthma

          -  Other respiratory disorder other than COPD

          -  Abnormal and clinical significant ECG

          -  Chest x-ray clinically significant abnormality not believed to be due to COPD

          -  Body Mass Index of greater than or equal to 40/kg/m2

          -  Use of Long Term Oxygen Therapy

          -  Lung resection surgery

          -  Women pregnant or lactating at Visit 1

          -  Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Sequential Multiple Assignment Treatment for Bipolar Disorder
Condition: Bipolar I Disorder; Bipolar II Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium; Divalproex; Lamotrigine; Quetiapine
Intervention description: Therapeutic dosage as indicated by participants condition with blood levels. LI will be dosed to attain Li of ≥0.5mEq/L (milliequivalents per liter).; DV will be dosed to attain DV levels of ≥45mg/L.; LM will be incrementally dosed up to 400 mg/day, or, in combination with DV, 200 mg/day. Dosage may be reduced for adverse effects to one half of the target dose.; QT will be started at 50 mg/day and titrated up to 300 mg as tolerated. QT will be discontinued if not tolerated at 100mg/day and the patient will be treated according to guidelines.
Intervention MeSH terms: Lamotrigine; Valproic Acid; Quetiapine Fumarate; Lithium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare which of the two mood stabilizers (drugs that help to
      steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is
      more effective in patients with bipolar disorder over 26 weeks. The study will also compare
      if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus
      lithium or divalproex used with lamotrigine is more effective when symptoms of depression
      develop.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I
             or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)

          -  Male or female ≥ 18 years old

          -  Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania &/or depression for ≥ 2
             weeks

          -  One of the following indicators of recent active illness: a depressive or manic or
             hypomanic or mixed episode in the past 12 months

          -  If female of child bearing age must use effective birth control.

        Exclusion Criteria:

          -  Unwilling or unable to comply with study requirements

          -  Renal impairment (serum creatinine > 1.5 mg/dL)

          -  If maintained on thyroid medication must be euthyroid for at least 1 month before
             Visit 1

          -  Patients who have had intolerable side effects to QTP, Li, Div, or LTG

          -  Patients whose clinical status requires inpatient care

          -  Drug/alcohol dependence within the past 30 days

          -  Pregnancy as determined by serum pregnancy test or breastfeeding

          -  History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per
             Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.
The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study
Condition: Fractures
Intervention: Acetaminophen; Ibuprofen
Intervention description: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).; ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications
      for providing pain control in children with fractures or those who have surgery to correct
      bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to
      suggest that these types of medications can adversely affect bone healing in adult patients
      with broken bones or those having spine fusion surgery. There is little data with regard to
      how these medications effect bone healing in children. With this project, the investigators'
      goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to
      demonstrate that these medications adequately control pain in children with broken bones or
      those who have had an osteotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Male aged 16 years or less or female aged 14 years or less

               -  Open physis on radiographs

               -  Fracture undergoing closed treatment or operative treatment or patient undergoing
                  elective osteotomy

        Exclusion Criteria:

          -  • Regular use of NSAIDs

               -  Allergy to NSAIDs

               -  Inability to take breakthrough medications due side effects or allergy

               -  Systemic illness

               -  Renal impairment

               -  Liver disease

               -  Polytrauma

               -  Uncontrolled diabetes

               -  Regular use of corticosteroids

               -  History of any skeletal dysplasia

               -  History of neuromuscular disorder

               -  History of bleeding disorder

               -  History of liver disorder

               -  Pathologic fracture

               -  Closed physes

               -  Male greater than 16 years old

               -  Female greater than 14 years old

               -  Pregnant or possibly pregnant females based on report and last menstrual period
Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery
Condition: Effects of; Anesthesia, in Labor and Delivery
MeSH terms: Hypotension
Intervention: Phenylephrine; Norepinephrine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypotension; Cesarean Delivery; Phenylephrine; Spinal Anesthesia; Norepinephrine

Summary:

      The purpose of the study is to determine if a medication called phenylephrine, which helps to
      control blood pressure, is more effective as a continuous intravenous (IV) infusion compared
      to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for
      a cesarean delivery. Good blood pressure control has been shown to decrease nausea and
      vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean
      delivery, all participants will receive spinal anesthesia with a local anesthetic and
      morphine (provides long term pain control after cesarean delivery). This study plans to
      enroll 80 pregnant research subjects 18 years and above. Patients will be randomly assigned
      according to a computer generated system to be in one of two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2

          -  Pregnant women with singleton pregnancy

          -  Gestational age greater than 36 weeks

          -  Cesarean delivery under spinal anesthesia

        Exclusion Criteria:

          -  Use of cardiac medication or medication for blood pressure control

          -  Cardiovascular disease

          -  Multiple gestation

          -  Gestation diabetes requiring insulin

          -  History of postoperative nausea and vomiting

          -  Refusal to be in study

          -  Gastric bypass surgery

          -  History of chronic opioid use (chronic pain syndrome)

          -  Emergent caesarean delivery for maternal and/or fetal distress

          -  Eclampsia

          -  Progressive neurologic disease

          -  Infection at insertion site

          -  Allergy to local anesthetics, narcotics or other study medications.
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Condition: HIV; AIDS; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias
Intervention: Stribild
Intervention description: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atripla; stribild; dreams

Summary:

      Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep
      disturbances.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV+ subjects 18 years of age or older

          -  estimated Glomerular Filtration Rate > 70 mL/min

          -  must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral
             Load < 50 copies/mL

          -  no antiretrovirals prior to the initiation of Atripla

          -  baseline genotyping

        Exclusion Criteria:

          -  pregnancy

          -  unable to provide informed consent

          -  enrolled in another study
Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
Condition: Cardiac Allograft Vasculopathy
MeSH terms: Vascular Diseases
Intervention: Perflutren Lipid Microsphere; RTMPE
Intervention description: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.; Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective
      non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and
      adult cardiac transplant recipients? Will perfusion deficits correlate with significant
      coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary
      Angiography (ICA), and identify diffuse small vessel disease more effectively than current
      non-invasive techniques?
    

Eligibility criteria:

        Inclusion:

          -  Cardiac transplant recipients (> or equal to 10 months post transplant)

          -  Clinically followed at Mayo Clinic, Rochester Minnesota

        Exclusion:

          -  Standard contraindications to the use of ultrasound contrast and pharmacologic stress

          -  Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or
             allograft rejection

          -  Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient
             right-to-left cardiac shunts

          -  Hypersensitivity to perflutren
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Condition: Gastrointestinal Mucosal Damage
Intervention: Ibuprofen; Paracetamol; Placebo
Intervention description: Liquid gelation capsules or tablets of 400 mg strength; Paracetamol fast dissolving tablets of 500 mg strength; Placebo tablets
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluated the effect of oral fast-dissolving formulations of paracetamol and
      ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic
      examinations were conducted to determine the gastrointestinal damage produced post a 7 day
      treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index: 18-30 kg/m^2

          -  Body Weight 60-80 kg

          -  Participant with both a normal stomach and proximal duodenum mucosa as evidenced by
             endoscopic results

        Exclusion Criteria:

          -  Participant with evidence of current/active, or a history of gastrointestinal disease

          -  Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver
             disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy

          -  Participant with a history of using antacids, H2 receptor antagonists, proton pump
             inhibitors, or misoprostol more than twice a month or has used any of these
             medications within 1 week of Visit 1.

          -  Participant with a current or recurrent disease, within 12 months of Visit 1, that
             could affect the action, absorption, disposition, or excretion of the study treatments
             or evaluation of the clinical or laboratory tests