bioihbjkbjnl/mcl2 huggingface dataset:
Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids
Condition: Barrett's Esophagus; Obesity
MeSH terms: Barrett Esophagus; Esophagitis; Inflammation
Intervention: Omega-3 polyunsaturated fatty acids; Placebo
Intervention description: 3 capsules a day of Omega 3 polyunsaturated fatty acids taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal. Active drug will consist of 1200 mg of a ω3 FFA preparation containing 675 mg EPA and 300 mg DHA.; 3 capsules a day of placebo (1200 mg of ethyl oleate 3 capsules a day) taken orally for six months; 2 capsules with breakfast and 1 capsule with their evening meal.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Omega-3 fatty acid

Summary:

      This study is being done to understand the effect of dietary omega-3 fats in decreasing
      tissue inflammation in Barrett's esophagus.
    

Eligibility criteria:

        Inclusion Criteria

          -  Presence of BE defined as ≥ 1 cm of visible columnar mucosa in the distal esophagus
             with intestinal metaplasia on histology.

          -  Absence of high grade dysplasia or EAC on baseline histology.

          -  BMI > 30 kg/m2 or waist circumference > 102 cm in men, > 88 cm in women.

          -  Ability to give informed consent.

        Exclusion Criteria

          -  Allergy to ω3 FFAs, fish or shellfish.

          -  Presence of high grade dysplasia or cancer on histology.

          -  Pregnant and or breastfeeding women

          -  Presence of esophagitis on initial endoscopy or symptoms of refractory GERD (heartburn
             or regurgitation ≥ 2 times a week) indicative of uncontrolled gastroesophageal reflux.

          -  Inability to give informed consent.

          -  Currently taking Omega3 FFA as prescription.

          -  Anti-coagulant therapy (Plavix, Warfarin, Coumadin)

          -  AST or ALT level > three times upper limit of normal at baseline

          -  LDL > 200 mg/dl at baseline.

          -  INR > 2
Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: fluticasone furoate; Placebo
Intervention description: 2 puffs in each nostril once daily for 1 week; 2 puffs in each nostril once daily for 1 week
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to help us to a better understanding of how nose and eye
      symptoms are related in patients with allergies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 45 years of age.

          2. History of grass and/or ragweed allergic rhinitis.

          3. Positive skin test to grass and/or ragweed antigen.

          4. Positive response to screening nasal challenge.

        Exclusion Criteria:

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Upper respiratory infection within 14 days of study start.
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: rosiglitazone; glyburide
Intervention MeSH terms: Rosiglitazone; Glyburide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 25 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: thiazolidinedione; sulfonylurea; endothelial function

Summary:

      The purpose of this study is to compare the vascular effects of two commonly used diabetes
      medications, rosiglitazone and glyburide in type 2 diabetic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 25-75 years

          -  Type 2 diabetes mellitus for less than or equal to 10 years

          -  Pre-screening HbA1c > 6.5 %

          -  Screening 110 mg/dl < fasting plasma glucose < 240 mg/dl after 2 weeks of metformin
             500 mg twice daily (b.i.d.)

        Exclusion Criteria:

          -  Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period
             of 30 days)

          -  Known contraindications to use of thiazolidinedione or sulfonylurea

          -  Female patients must be postmenopausal, surgically sterile, or using adequate
             contraception

          -  Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines

          -  Subcutaneous insulin use

          -  Elevated liver enzymes (2.5 times the upper limit of the reference range)

          -  Serum creatinine >160 mmol/l

          -  Anemia (Hb <11 g/dl for men or <10 g/dl for women)

          -  Body mass index (BMI) <22 or >42 kg/m2

          -  History of ketoacidosis

          -  Angina/New York Health Academy class III/IV cardiac insufficiency

          -  Electrocardiographic evidence of marked left ventricular hypertrophy

          -  Uncontrolled hypertension according to AHA guidelines

          -  Hemoglobinopathy
Corticosteroid Pulse After Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Solumedrol; Placebo
Intervention description: 100mg, given once within 2 hours of the end of the ablation procedure; Normal saline (1.6 cc)
Intervention MeSH terms: Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Corticosteroid; Radiofrequency catheter ablation for atrial fibrillation

Summary:

      Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20%
      of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease
      inflammation caused by the ablation and thus improve healing and decrease the chance of
      recurrence of atrial fibrillation.

      In this study patients will be randomized to receive intravenous steroids or not immediately
      following the ablation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Drug refractory, symptomatic paroxysmal atrial fibrillation

        Exclusion Criteria:

          -  Contraindication to solumedrol

          -  Persistent or permanent Atrial Fibrillation

          -  Previous history of radiofrequency ablation for atrial fibrillation
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Commercially available 0.5mg hard capsules, taken orally once per day
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-cohort, non-randomized, open-label multicenter
Masking: None (Open Label)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis; RMS; Relapsing Multiple Sclerosis (RMS); Multiple Sclerosis; MS; Multiple Sclerosis (MS); Fingolimod; FLUENT; Immune Phenotype; adult; FTY720

Summary:

      A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)
      after treatment with 0.5mg fingolimod
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing forms of Multiple Sclerosis

          -  Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR
             patients already on commercially prescribed fingolimod 0.5mg per day continuously for
             ≥ 2 years

        Exclusion Criteria (per USPI):

          -  Patients who in the last 6 months experienced myocardial infarction, unstable angina,
             stroke, transient ischemic stroke, decompensated heart failure requiring
             hospitalization or Class III/IV heart failure

          -  History or presence of Mobitz Type II second-degree or third-degree atrioventricular
             block or sick sinus syndrome, unless patient had a functioning pacemaker

          -  Baseline QTc interval ≥ 500 msec

          -  Treatment with Class Ia or Class III anti-arrhythmic drugs

          -  Patients who had a hypersensitivity reaction to fingolimod or any of the excipients
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Condition: Asthma
MeSH terms: Status Asthmaticus
Intervention: Racemic albuterol (R+S albuterol); Levalbuterol (R albuterol)
Intervention description: 20mg/hr continuous racemic albuterol; 10mg/hr continuous nebulized levalbuterol
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Levalbuterol; Albuterol; Children

Summary:

      This study will use a randomized, double-blind, controlled trial design in order to assess
      the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when
      delivered continuously in a high-dose regimen for children with severe exacerbations of
      asthma.

      Primary hypothesis

        -  Children with severe asthma receiving continuous levalbuterol will have a shorter
           duration of continuous therapy as compared to racemic albuterol.

      Secondary hypotheses

        -  Children receiving continuous levalbuterol will have improved lung function measured by
           forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.

        -  Children receiving continuous levalbuterol will have improved clinical asthma score as
           compared to racemic albuterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6-18 years of age

          -  Diagnosis of asthma with two previous visits to emergency department (ED) or primary
             care provider for asthma care

          -  Clinical decision by ED attending physician to begin continuous albuterol after
             standardized initial ED treatment.

        Exclusion Criteria:

          -  Clinical decision to begin continuous intravenous beta-agonist infusion (e.g.
             terbutaline)

          -  Clinical decision to admit to the Pediatric Intensive Care Unit

          -  Drug allergy or other contraindication to RAC or LEV

          -  Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac
             disease

          -  Pregnancy

          -  Prior enrollment in the study
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Condition: Bariatric Surgery Candidate
Intervention: Zoledronic Acid; Calcium citrate + vitamin D; Vitamin D3
Intervention description: 5mg zoledronic acid; Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3; 1000IU Vitamin D3 gummy
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Zoledronic Acid; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 25 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Roux-en-Y gastric bypass, sleeve gastrectomy

Summary:

      This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs
      after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men must be age ≥ 50

          -  Women must be age ≥ 25 and postmenopausal

          -  Planning to receive RYGB or SG surgery

        Exclusion Criteria:

          -  Age < 25

          -  Prior bariatric surgery

          -  Weight ≥ 400 lbs

          -  Liver or renal disease

          -  Hypercalcemia, hypocalcemia, or hypomagnesemia

          -  Serum 25-hydroxyvitamin D < 20 ng/mL

          -  History of bone-modifying disorders

          -  Use of bone-active medications

          -  Known sensitivity to bisphosphonates

          -  Extensive dental work involving extraction or dental implant within the past 2 months
             or planned in the upcoming 6 months
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Condition: COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: LABA based treatment: indacaterol; LAMA based treatment: tiotropium; LABA/ICS based treatment: salmeterol/fluticasone; LABA/ICS based treatment: budesonide/formoterol; theophylline based treatment; Other treatment
Intervention description: LABA based treatment: indacaterol; LAMA based treatment: tiotropium; LABA/ICS based treatment: salmeterol/fluticasone; LABA/ICS based treatment: budesonide/formoterol; theophylline based treatment; non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Intervention MeSH terms: Fluticasone; Budesonide; Theophylline; Formoterol Fumarate; Tiotropium Bromide; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2229.0
Sex: All
Healthy volunteers: No
Keywords: COPD; Chronic obstructive pulmonary disease (COPD),; Chronic obstructive lung disease (COLD),; Chronic obstructive airway disease (COAD),; Cronchitis,; Emphysema

Summary:

      This multi-center study is designed to describe natural history of disease, treatment and
      health care products in physician-diagnosed COPD patients who require adding daily
      maintenance therapy in real world.

      The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non-
      Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to
      low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full
      analysis set.

      A total of 2253 patients entered into the database, of which 24 patients were exclude during
      the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a
      total of 2229 patients enrolled successfully.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide informed consent

          -  Physician-diagnosis of COPD

          -  COPD patients requiring long-acting bronchodilator treatment

          -  Patients with spirometry available at baseline

        Exclusion Criteria:

          -  Patients who have a diagnosis of asthma.

          -  Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to
             Visit 1.

          -  Current clinical diagnosis of other chronic respiratory illnesses

          -  Concurrent participation in a clinical trial or use of an investigational drug.

          -  Active malignancy or history of malignancy of any organ system

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential with no contraception Other protocol-defined
             inclusion/exclusion criteria may apply.
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Condition: Renal Calculus; Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis; Pain, Postoperative; Calculi
Intervention: Ketorolac; Placebo
Intervention description: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.; 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Percutaneous; Nephrolithotomy; Kidney stones

Summary:

      The purpose of this study is to determine whether continuous intravenous ketorolac infusion
      reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing percutaneous nephrolithotomy for kidney stone disease

        Exclusion Criteria:

          -  History of nonsteroidal antiinflammatory drug allergy

          -  Asthma

          -  History of long-term opioid use

          -  Intraoperative blood loss greater than 300 mL

          -  Postoperative hemodynamic instability

          -  Active peptic ulcer disease

          -  Advanced renal impairment (Creatinine > 2.0 mg/dL)

          -  Bleeding diathesis

          -  Current use of probenecid

          -  Pregnancy
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
Condition: Sedation
Intervention: Midazolam; xylocaine; saline placebo
Intervention description: midazolam 0.2 mg/kg given intranasally; intransal xylocaine given in conjunction with intranasal midazolam; intranasal saline given as placebo
Intervention MeSH terms: Lidocaine; Midazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Months
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      Midazolam is often given before surgery to sedate a patient before anesthesia is given.
      Children are often given a small dose either by mouth or squirted into the nose. Children
      will often spit out the oral midazolam, making it difficult to know how much medicine, if
      any, they have received. Giving midazolam into the nose is more reliable, but children may
      complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also
      occur when midazolam is squirted alone into the nose. The purpose of this study is to see if
      adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam
      easier and more comfortable without affecting how the midazolam works as a sedative. This is
      follow up to the pilot study, Project # 994. This will expand the previous study, with
      additional participants and revised xylocaine concentration
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical
             procedure requiring mask anesthesia

          2. American Society of Anesthesiologists (ASA) Class 1 or 2

          3. Parent willing and able to provide written informed consent

          4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual
             Assessment Scale (VAS)

        Exclusion Criteria:

          1. ASA Class 3 or greater

          2. History of allergy to midazolam or xylocaine

          3. Presence of acute respiratory infection at time of surgery

          4. Parent unwilling or unable to provide informed consent

          5. Parent unwilling or unable to complete the OBD VAS
TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
Condition: Psychiatric Emergency; Aggression; Agitation
MeSH terms: Emergencies; Aggression
Intervention: Haloperidol + Promethazine + Chlorpromazine; Haloperidol + Promethazine
Intervention description: This is the usual treatment given by this hospital during an aggressive psychiatric episode.; This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
Intervention MeSH terms: Promethazine; Diphenhydramine; Haloperidol; Chlorpromazine; Haloperidol decanoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol
      + promethazine + chlorpromazine for agitated patients in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient will be eligible if (1) requiring emergency acute intramuscular sedation
             because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of
             the benefits between haloperidol plus promethazine vs haloperidol plus promethazine
             plus chlorpromazine.

          -  Gender - both male and female

          -  Age (18-64)

          -  Clinician is unaware on the effects of either treatment interventions

        Exclusion Criteria:

          -  If the clinician KNOWS one treatment has benefit over another for a particular person

          -  If the clinician is aware of a contra-indication of one of the treatments

          -  If there is an Advanced Directive expressing a wish for one or other, or another
             treatment in the emergency setting.

          -  If the clinician does not want to undertake for both personal and professional
             reasons.

          -  If the participant is known to be allergic to one or more of the interventions

          -  Already randomized

          -  Already sedated

          -  Accompanying person (Friend/Family/Police Officer) refuses patient trial entry