bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients
Condition: Disorders Associated With Peritoneal Dialysis
MeSH terms: Insulin Resistance
Intervention: icodextrin; Dianeal
Intervention description: glucose sparing dialysis solution; glucose based dialysis solution
Intervention MeSH terms: Icodextrin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Peritoneal dialysis; Renal replacement therapy; Dialysis solutions; Icodextrin

Summary:

      1. LOCATION OF STUDY: Multicentric study in Brazil.

        2. PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD
           were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with
           those produced by 2,5% glucose for the long-dwell.

        3. PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the
           differences with regard to baseline values of this variable for the two groups as well
           as in each group, which showed control of the glucose metabolism.

      STAGE OF THE STUDY : Phase IV postmarket study

      DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either
      to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.

      SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30
      Dianeal® 60 30

      Duration: 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1.10.1 Older than 18 years old.

          -  High PET value, average-high or average-low.

          -  Cause of renal chronic disease other than diabetes mellitus.

          -  Patient in APD

          -  Prevalent patient in APD (defined as at least 90 total days of dialysis therapy)

        Exclusion Criteria:

          -  Not willing to participate.

          -  A Charlson comorbidity index >7, or a life expectancy < 12 months as assessed by the
             treating physician.

          -  Positive VIH.

          -  Episodes of peritonitis during the month preceding the randomization.

          -  Significant cardiovascular, metabolic or infectious complications during the month
             preceding the randomization.

          -  Patients with active cancer.

          -  Patients with known allergies to corn starch polymers.

          -  Patients who are unable to provide an informed consent because of significant
             psychiatric disorder or mental illness

          -  Patients not meeting adequacy goals several months after the change in the dosage
             regime.
Best Management of Muscle Relaxation- Objective Monitoring
Condition: Residual Paralysis, Post Anesthesia
MeSH terms: Paralysis; Delayed Emergence from Anesthesia
Intervention: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex
Intervention description: The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
Intervention MeSH terms: Rocuronium; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that the investigators can reduce residual
      paralysis to a very low incidence, and that the investigators can do this while preserving a
      role for the older and less expensive reversal agent neostigmine. The investigators consider
      this an evidence-based approach because previous reports clearly indicate that neostigmine is
      effective for reversal of the most shallow neuromuscular blocks, a level of block now
      referred to as minimal block. The Investigators also know from previous data that a
      substantial proportion of patients have minimal block. Sugammadex will be used when the block
      to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio
      is <40%.

      The investigators hypothesize that this protocol will be associated with an incidence of
      residual paralysis of less than 3%. The investigators plan is to study 200 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are 18 years or older

          -  Undergoing surgery expected to last less than 6 hours at HMC or UWMC

          -  Have ASA physical status I-III

          -  Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for
             endotracheal intubation or intraoperative neuromuscular block (NMB)

        Exclusion Criteria:

          -  Allergy to NMBDs, neostigmine, or sugammadex

          -  Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)

          -  Pregnant or lactating women

          -  Non English speaking

          -  Unable to provide informed consent

          -  Severe renal failure with eGFR less than 20 ml/min
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin (TA-7284); GLP-1 analogue
Intervention description: The patients will receive Canagliflozin orally for 52 weeks
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284)
      in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12
             weeks before administration of investigational dug

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  Patients with HbA1c of ≥7.0% and <10.5%

          -  Patients who were not administered diabetes therapeutic drugs prohibited for
             concomitant use within 12 weeks before administration of investigational drug

        Exclusion Criteria:

          -  Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic
             disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)

          -  Patients with severe diabetic complications (proliferative diabetic retinopathy, stage
             4 nephropathy, or serious diabetic neuropathy)

          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100
             mmHg

          -  Patients with serious renal or hepatic disease

          -  Patients with eGFR of <45 mL/min/1.73 m2

          -  Patients who are the excessive alcohol addicts

          -  Patients requiring insulin therapy

          -  Patients who are pregnant, lactating and probably pregnant patients and patients who
             can not agree to contraception
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: gatifloxacin; moxifloxacin 0.5% eye drops
Intervention description: Day 1-6 = 1 drop of study medication three times a day; Day 1-6 = 1 drop of study medication three times a day
Intervention MeSH terms: Moxifloxacin; Gatifloxacin; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Maximum age: 31 Days
Healthy volunteers: No

Summary:

      This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic
      solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of
      age
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with bacterial conjunctivitis

        Exclusion Criteria:

          -  chemical or foreign body trauma to either eye

          -  infection in either eye (besides bacterial conjunctivitis)

          -  white spots in the cornea or ulcers in either eye

          -  clinical diagnosis of chlamydia or gonorrhea in either eye
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Methotrexate; Placebo
Intervention description: Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2; Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2
Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2
Group 2b: Oral Methotrexate weekly for both Periods 1 and 2; Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2
Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 542.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change
      and clinical disease activity in subjects with early RA over 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis

          -  Has RA greater than or equal to 3 months and less than or equal to 2 years

        Exclusion Criteria:

          -  Received any previous treatment with MTX

          -  Received any previous treatment with ETN or other tumour necrosis factor antagonist
Arthralgia During Anastrozole Therapy for Breast Cancer
Condition: Early Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Anastrozole
Intervention description: 1mg/Day oral
Intervention MeSH terms: Anastrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer treatment; joint disorders

Summary:

      The purpose of this study is to describe the joint symptoms and structural joint changes
      under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment
             with anastrozole

          -  WHO performance status 0, 1 or 2

          -  Provision of written informed consent

        Exclusion Criteria:

          -  Recurrence of breast cancer, inflammatory rheumatism

          -  treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti
             estrogen, Herceptin

          -  Diabetes treated by insulin

          -  Severe renal or hepatic disease

          -  Known hypersensitivity to anastrozole
Unicirc vs Open Surgical Circumcision
Condition: Circumcision, Male
Intervention: Unicirc with tissue adhesive; Open Surgical
Intervention description: As above; As above
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical
      circumcision under local anesthetic with suturing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male

          -  Uncircumcised

          -  With normal penile anatomy

        Exclusion Criteria:

          -  Concurrent illness

          -  History of bleeding disorder

          -  Past reaction to local anesthetic

          -  Infection

          -  Penile abnormality which could complicate circumcision
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Condition: Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Intervention: montelukast sodium
Intervention description: montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both
      uncontrolled asthma and allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist
             (ICS/LABA) at any dosage

          -  Peak expiratory flow is > or = 80% of predicted value on the day of visit 1

          -  Uncontrolled as per Canadian asthma consensus guidelines

        Exclusion Criteria:

          -  Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis
             symptoms

          -  Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or
             ophthalmic corticosteroid
Efficacy of Oral vs. Intravenous Acetaminophen
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oral Acetaminophen; Intravenous acetaminophen
Intervention description: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision; 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acetaminophen; Postoperative pain; Sinus Surgery

Summary:

      The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the
      management of postoperative pain is understudied and largely unknown. In this observer
      blinded randomized clinical trial, investigators aim to determine the comparative efficacy of
      PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged 18 years or older

          -  Undergoing elective sinus surgery at Zale Lipshy Hospital

        Exclusion Criteria:

          -  Inability of the patient to follow directions or comprehend either English or Spanish
             language.

               -  Disorders of the liver which would make acetaminophen contraindicated (such as
                  hepatitis, liver failure, prior liver transplant, etc).

               -  Patients with chronic pain manifest by a baseline pain score > 4/10

               -  Chronic opioid use (>2 weeks continuously), or illicit drug abuse

               -  Body weight < 50 kg.

               -  Patients with contraindications to any of the study drugs (such as Malignant
                  Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).

               -  Patients who have taken analgesic medications on the morning of surgery (prior to
                  arrival).

               -  Allergy to acetaminophen
Esmolol Infusion During Laminectomy: Effect on Quality of Recovery
Condition: Laminectomy
Intervention: Esmolol; Saline
Intervention description: Esmolol group: Will receive 0.5 mg/kg IV bolus of esmolol during induction, and an infusion of esmolol at 0.3 mg/kg/hr intraoperatively.; Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group
Intervention MeSH terms: Esmolol
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Laminectomy; Esmolol Infusion; Quality of recovery; beta-blockers; Pain management; Postoperative pain; Opioid requirements; Intraoperative esmolol infusion; Return to normal activities of daily living

Summary:

      The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly
      administered during surgery to help control blood pressure and heart rate, on postoperative
      pain levels and requirements for pain medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo single-level or double-level laminectomy under general
             anesthesia

          -  Willingness and ability to sign an informed consent document

          -  No allergies to any of the anesthetic or analgesic medications being used for the
             study, as outlined in the study protocol

          -  Between 18-80 years of age

          -  American Society of Anesthesiologists (ASA) class I-III adults of either sex

        Exclusion Criteria:

          -  Patients who are ASA class IV or higher

          -  Patients with known allergy, hypersensitivity, or contraindication to the use of any
             of the medications being used for the study, as outlined in the study protocol

          -  Patients who are heavy chronic opioid users, defined for the purposes of this study as
             any patient who is taking the equivalent of 10mg of oral morphine per day or greater

          -  Pregnant or lactating women

          -  Patients with a history of drug or alcohol abuse within the past 3 months

          -  Patients with any other medical conditions or who are using any medications which may
             interfere with the conduct of the study (including patients taking clonidine, patients
             with EKG conduction defects and who are taking calcium channel blockers, patients with
             clinically significant congestive heart failure (CHF) or bronchospasm, or patients
             with second- or third-degree heart block, symptomatic sinus bradyarrhythmia, or
             nonsinus rhythm on preoperative EKG.)
Neurogenic Intermittent Claudication Evaluation Study
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis; Intermittent Claudication; Constriction, Pathologic
Intervention: Aperius™ PercLID™ System; Standalone Decompressive Surgery
Intervention description: Aperius™ PercLID™ System: implantation with the Interspinous Process Device Aperius.; Lumbar decompressive surgery without instrumentation or fusion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The objective of the NICE study is to provide clinical evidence proving that the Aperius™
      PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to
      clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with
      Neurogenic Intermittent Claudication, relieved by flexion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of symptomatic DLSS

          -  Presence of NIC

          -  Patient would be candidate for Standalone Decompressive Surgery

          -  Patient has signed Informed Consent form (ICF)

          -  Patient is 21 years old or older

        Exclusion Criteria:

          -  Previous lumbar surgery

          -  Patient is candidate for instrumented Decompressive Surgery

          -  Patient has back pain without leg pain

          -  Degenerative Spondylolisthesis greater than grade 1 (Meyerding)

          -  Symptomatic DLSS at more than 2 levels in the lumbar region

          -  Spinal stenosis is present at L5-S1 level
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Condition: Asthma
MeSH terms: Respiratory Sounds
Intervention: Nebulized Budesonide; Usual care (albuterol with or without oral steroid)
Intervention description: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks; Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
Intervention MeSH terms: Budesonide; Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 1 Year
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      Subjects aged 1-8 years who have been discharged from the emergency department/outpatient
      care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will
      be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of
      nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates
      during the 21-day follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 1-8 years old

          -  Discharge from emergency department/outpatient clinic with a diagnosis of asthma
             exacerbation after usual standard care

          -  Subjects must be able to show efficient use with a jet nebulizer

        Exclusion Criteria:

          -  Subjects requiring hospitalization

          -  Subjects receiving oral steroids 1 week prior to presentation to emergency department.

          -  Subjects with FEV1 < 50% of predicted

          -  Subjects with co-morbid medical conditions (renal or cardiovascular disease)

          -  Subjects with reported history of HIV

          -  Subjects unable to follow up for study visits

          -  Subjects who are frequently enuretic