bioihbjkbjnl/mcl2 huggingface dataset:
Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
Condition: Anesthesia; Urethral Obstruction
MeSH terms: Urethral Obstruction; Pain, Postoperative
Intervention: Placebo; Gabapentin
Intervention description: Placebo pill administered orally 1 hour before planned surgical procedure; Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind, Randomized, Placebo Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study's objective is to determine the efficacy of preoperative gabapentin in relieving
      postoperative pain, reducing opioid use and improving quality of recovery in subjects
      undergoing urologic surgery.

      Investigators hypothesize that subjects receiving gabapentin will have lower pain scores,
      less opioid consumption and better quality of recovery as compared to subjects who are given
      a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years to 75 years

          -  Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy
             with Ureteral stent placement

        Exclusion Criteria:

          -  Age less than 18 or more than 75 years

          -  Acetaminophen allergy

          -  Gabapentin allergy

          -  Hydromorphone allergy

          -  Chronic use of gabapentin

          -  History of chronic pain (Pain for > than 3 months)

          -  Chronic renal insufficiency (Creatinine > 1.3)

          -  Seizure disorder

          -  Psychiatric disorders (medically treated)

          -  Chronic use of anticonvulsants, antidepressants, antipsychotics (use > 3 months)

          -  Antacids ingested within 2 hours prior to surgery

          -  History of gastric or duodenal ulcer

          -  Pregnant or lactating

          -  Inability to communicate in English
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Abiraterone; Placebo for Enzalutamide; Prednisone
Intervention description: 160 mg by mouth once daily; 1000 mg by mouth once daily; Sugar pill manufactured to mimic Enzalutamide 40 mg capsule; 5 mg by mouth twice daily
Intervention MeSH terms: Prednisone; Prednisolone; Abiraterone Acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 509.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if continued treatment with Enzalutamide is
      effective in patients with metastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with metastatic castration-resistant prostate cancer

          -  Progressive disease on androgen deprivation therapy

          -  Patients must agree to continue androgen deprivation therapy with a GnRH
             agonist/antagonist throughout the study or have had a prior bilateral orchiectomy

          -  ECOG performance score ≤ 1

          -  Estimated life expectancy of ≥ 12 months

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
             enzalutamide for the treatment of prostate cancer

          -  Prior participation in a clinical trial of an investigational agent that inhibits the
             androgen receptor or androgen synthesis (unless the treatment was placebo)

          -  History of brain metastasis, active leptomeningeal disease or seizure

          -  Severe cardiovascular or hepatic disease

          -  Pituitary or adrenal dysfunction
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Tiotropium
Intervention description: QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day; Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to
      show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung
      function. Similarly, this study aims to evaluate patient preference after experiencing both
      treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate
      to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at
      screening despite being treated with tiotropium
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed an Informed Consent Form

          -  stable COPD according to current guidelines (GOLD 2013)

          -  airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a
             post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit 2.

          -  current or ex-smokers who have a smoking history of at least 10 pack years

          -  Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit
             1

          -  Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).

        Exclusion Criteria:

          -  Pregnant or breast feeding mothers

          -  Patients with conditions contraindicated for treatment

          -  Patients with a history of clinically significant diseases

          -  Patients who have a clinically significant renal disease

          -  Patients with myocardial infarctions less than 6 months prior to study entry

          -  Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular
             failure.

          -  Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck
             obstruction or urinary retention

          -  Patients with a history of malignancy of any organ system

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics,
             and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks
             prior to Screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to Screening

          -  Patients with any history of asthma.
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
Condition: Non Erosive Reflux Disease; Chronic Gastritis
MeSH terms: Gastroesophageal Reflux; Gastritis; Gastritis, Atrophic
Intervention: Esomeprazole; Esomeprazole
Intervention description: 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment; 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GI; Nexium; Phase IV; Co-diagnosed NERD

Summary:

      To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and
      2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis
      patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heartburn and/or regurgitation symptoms last for at least 3 months

          -  Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis)
             within 2 weeks prior to randomization GerdQ score =8

        Exclusion Criteria:

          -  Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus,
             malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp
             eradication therapy will be excluded

          -  If Hp positive, patients could take Hp eradication therapy after the study completion
             Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Condition: Skin/Soft Tissue Infections; Methicillin Resistant Staphylococcus Aureus (MRSA)
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Soft Tissue Infections
Intervention: linezolid; vancomycin
Intervention MeSH terms: Vancomycin; Linezolid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1077.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine if linezolid is superior to vancomycin in the treatment of complicated skin and
      soft tissue infections due to MRSA in adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with signs or symptoms consistent with infection, and if
             available, laboratory findings consistent with staphylococcal infection (e.g., Gram
             stain and culture results).

          -  Signs and symptoms consistent with infection

          -  Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

        Exclusion Criteria:

          -  Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA
             activity (other than linezolid or vancomycin) for more than 24 hours and treatment
             extended into the 72 hour period prior to the first dose of study drug, unless
             documented to be a treatment failure (72 hours of treatment and not responding).

          -  Subjects with uncomplicated skin or superficial skin structure infection such as
             superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that
             only need surgical drainage for cure.

          -  Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement
Condition: Obesity; Arthritis
MeSH terms: Arthritis
Intervention: propofol; Desflurane
Intervention description: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia; comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Intervention MeSH terms: Propofol; Desflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: elderly obese

Summary:

      You are invited to participate in a research study assessing your mental status in the first
      days after your surgery and how you will be doing in the 2 years following the surgery. The
      investigators hope to learn more about the incidence of postoperative confusion and a
      possible relation with 2 anesthesia techniques that are routinely used. The first one is an
      anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an
      anesthesia technique that uses the anesthetic propofol administered by infusion in a vein.
      The investigators are also looking to see if there is a relationship between anesthesia
      technique and cardiovascular outcomes. You were selected as a possible participant in this
      study because at your age this phenomenon appears to have a greater incidence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 65 years old

          -  Body mass index > 30 kg/m2

          -  Undergoing primary total knee arthroplasty surgery

          -  American society of anesthesiology classification II-III

        Exclusion Criteria:

          -  Patient refusal to participate in the study

          -  Patient refusal or failure of regional block

          -  Patients with preexisting neuro-cognitive disorders

          -  Known intolerance to any of the drugs to be used according to the study protocol
Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Condition: Pancreatitis
MeSH terms: Pancreatitis
Intervention: indomethacin suppository; Glycerin Suppository
Intervention description: 100mg rectal indomethacin 30min before ESWL; 30min before ESWL
Intervention MeSH terms: Indomethacin; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1370.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extracorporeal Shock Wave lithotripsy(ESWL); Prophylaxis; Indomethacin; Chronic pancreatitis

Summary:

      The purpose of the study is to determine whether rectal indomethacin reduces the incidence of
      post-ESWL pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter)
             undergoing P-ESWL

          -  at least 18 years old

          -  provides informed consent

        Exclusion Criteria:

          -  readmitted to the hospital during the enrollment of the study

          -  contraindications to ESWL

          -  suspected or established malignancy

          -  pancreatic ascites

          -  receiving NSAIDs within 7 days

          -  contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or
             renal dysfunction with serum creatinine >120 μmol/L)

          -  presence of coagulopathy or received anticoagulation therapy within 3 days

          -  acute pancreatitis within 3 days

          -  known active cardiovascular or cerebrovascular disease

          -  pregnant or breastfeeding women

          -  without a rectum (ie, status post-total proctocolectomy)
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin (TA-7284); Placebo; Insulin
Intervention description: The patients will receive Canagliflozin orally for 16 weeks; The patients will receive Placebo orally for 16 weeks
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284)
      in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving a stable dose and regimen of insulin 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 ≥7.5% 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 who are pregnant, lactating and probably pregnant patients and patients who
             can not agree to contraception
Tetracaine Compared to Placebo for Reducing Pain With Palivizumab - A Pilot Study
Condition: Pain
Intervention: tetracaine 4% gel; Placebo
Intervention description: tetracaine applied prior to 1 injection; placebo applied prior to 1 injection
Intervention MeSH terms: Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 1 Month
Maximum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a small study known as a pilot study. This pilot study is being done to see if a
      difference in pain from intramuscular palivizumab injection can be detected if tetracaine a
      topical numbing gel is used compared to no medication (placebo). If a difference is found in
      this pilot study, then a larger study may be done to confirm that there is a difference in
      pain experience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants between 1 month and 2 years of age receiving palivizumab at Surrey Memorial
             Hospital for 2 consecutive intramuscular injections during the 2007/8 season

          -  Parents need to complete informed consent.

        Exclusion Criteria:

          -  Allergy/sensitivity to tetracaine, or ester type anaesthetics.

          -  Infants who present with fever or illness that prevent administration of palivizumab.
Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation
Condition: CORONARY DISEASE
MeSH terms: Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease
Intervention: TIROFIBAN; CORONAROGRAPHY
Intervention description: intravenous infusion; standard procedure of coronarography
Intervention MeSH terms: Tirofiban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CORONARY DISEASE

Summary:

      The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main
      evolutionary risk of these patients is the coronary thrombosis and its self complications.
      The platelets aggregation plays a major role in the physiopathology of the ACS. The
      therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has
      been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of
      these products in the ACS with or without ST elevation, associated or not to coronarography,
      has clearly been demonstrated. This profit is more marked when patients are at high risk of
      complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high
      risk" for whom a coronarography is planned, in the last international recommendations of the
      European Cardiology Society (ESC), the American Heart Association and the American College of
      Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on
      coronarography with discordant results. The ideal delay of realization of this coronarography
      is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again,
      patients at high risk seem to benefit the more of such a strategy if it is set precociously.

      Objective To compare an invasive strategy associating an early administration of tirofiban
      and a coronarography achieved in the 6 hours after the randomization to a conservative
      strategy in a population of high risk patients with ACS without ST elevation.

      Design Multicentric, prospective, randomized study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High risk ACS without ST elevation

        Exclusion Criteria:

          -  Age <18 years

          -  Pregnancy

          -  Persistence of the ST elevation

          -  Recent left branch block

          -  Cardiac failure or cardiogenic shock (Kilip 3 or 4)

          -  Treatment by anti-vitamin K

          -  Contra-indication to the use of one of the following treatments: aspirin, clopidogrel,
             enoxaparine, anti GP IIb/IIIa (tirofiban)