bioihbjkbjnl/mcl2 huggingface dataset:
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Etanercept; Placebo; Placebo
Intervention description: Etanercept 50 mg once-weekly; Etanercept 50 mg once-weekly; Etanercept placebo once-weekly; Etanercept placebo once-weekly
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; etanercept; methotrexate; infliximab; adalimumab; anti-drug antibody

Summary:

      The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to
      placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or
      adalimumab plus methotrexate. This comparison will be performed for all subjects and
      separately for subjects who are anti-drug antibody positive for one of these medications.
      From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect
      of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of
      etanercept in these subjects will also be evaluated throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Met the 1987 ACR Revised Criteria for RA

          2. A history of inadequate response to infliximab or adalimumab in combination with
             methotrexate.

          3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

        Exclusion Criteria:

          1. ACR functional class IV

          2. Prior treatment with etanercept; both infliximab and adalimumab; or any
             immunosuppressive biologic agent other than infliximab or adalimumab.

          3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate
             efficacy response.
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Condition: Post-operative Urinary Retention
MeSH terms: Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: Active drug; Lactose-filled capsules identical to active drug
Intervention MeSH terms: Tamsulosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 610.0
Sex: Male
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to
      tamsulosin versus a placebo.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male patient age 50 - 85 years

          -  Undergoing elective spine surgery at least 5 days after enrollment

          -  Preop visit done at office practice

        Exclusion Criteria:

          -  Currently on tamsulosin or other alpha-adrenergic blocking drug

          -  Allergy to tamsulosin

          -  Allergy to lactose

          -  Serious or life-threatening allergy to sulfa drugs

          -  Emergent procedure

          -  History of spinal trauma, spinal infection or spinal cord tumor

          -  Pre-existing indwelling urinary catheter

          -  History of orthostatic hypotension or current orthostatic hypotension

          -  History of prostate, urethral or bladder surgery

          -  Renal failure

          -  Non-English speaking

          -  Unable to provide informed consent
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: hydrocortisone 17-butyrate 0.1% Cream preparation; hydrocortisone 17-butyrate 0.1% Ointment preparation; hydrocortisone 17-butyrate 0.1% Lipocream preparation
Intervention description: Apply medication twice a day to affected areas of atopic dermatitis; Apply medication twice a day to affected areas of atopic dermatitis; Apply medication twice a day to affected areas of atopic dermatitis
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to better understand adherence to Locoid when people
      use it to treat atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years of age.

          -  Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria.
             (2 or 3 on severity scale)

          -  Subjects must have >5% TBSA and <30% to be enrolled.

          -  Women of child bearing potential will be allowed to participate in the study, and
             these subjects will be required to use at least one form of birth control.

        Exclusion Criteria:

          -  Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the
             subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study.

          -  Requiring >130 gm of cream in a 2 week period.

          -  Having facial or groin involvement of their disease.

          -  Pregnant women and women who are breast feeding are to be excluded. Women of child
             bearing potential will be allowed to participate in the study, and these subjects will
             be required to use at least one form of birth control.
Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
Condition: Insomnia; Primary Insomnia; Psychophysiologic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Zolpidem; Sugar Pill
Intervention description: 10 mg of Zolpidem
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Insomnia; Sleep; zolpidem; Ambien; Hypnotics

Summary:

      We want to assess whether "how and when" one takes sleep medication results in similar or
      different outcomes with respect to symptom relief. We also want to know whether taking
      medication for a period of time provides continued benefit once the medication is stopped.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 25 - 55

          -  a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00
             a.m.

          -  Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic
             Insomnia according to the International Classification of Sleep Disorders manual
             (ICSD).

          -  complaint of disturbed sleep must have the following characteristics: >30 minutes to
             fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no
             more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of
             >4 nights/ week and a problem duration >6 months.

        Exclusion Criteria:

          -  Unstable medical or psychiatric illness

          -  Use of medication that may cause insomnia or may be reduce the effectiveness of
             zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids,
             bronchodilators, calcium channel blockers, beta blockers, etc.)

          -  symptoms suggestive of sleep disorders other than insomnia

          -  polysomnographic data indicating sleep disorders other than insomnia

          -  Evidence of active illicit substance use or fitting criteria for alcohol abuse or
             dependence

          -  inadequate language comprehension

          -  pregnancy

          -  first-degree relatives with bipolar disorder or schizophrenia
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Nateglinide 120 mg; Acarbose 50 mg
Intervention description: Nateglinide 120 mg was supplied as tablets.; Acarbose 50 mg was supplied as tablets.
Intervention MeSH terms: Acarbose; Nateglinide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes mellitus, type 2; nateglinide; acarbose; hyperglycemia; dyslipidemias; C-reactive protein

Summary:

      This study was conducted to demonstrate superiority of nateglinide in postprandial glucose
      fluctuation, dyslipidemia, and inflammatory status improvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed type 2 diabetes mellitus patients

          -  HbA1c > 6.5 and < 9.0%

          -  Fasting fingertip capillary blood glucose (FCBG) < 9 mmol/L after 2 weeks diet control

        Exclusion Criteria:

          -  History of acute metabolic complications in the past 3 months or of severe diabetic
             complications or severe infections or active substance abuse

          -  Liver disease

          -  Patients under oral hypoglycemic drugs and/or insulin treatment, or corticosteroid
             treatment within past 4 weeks

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
Condition: Rib Fractures
MeSH terms: Fractures, Bone; Rib Fractures
Intervention: Saline infusion; Lidocaine infusion
Intervention description: Normal saline infusion at 10mL/hour; Lidocaine infusion at 1.0mg/kg/hr
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current cornerstone of pain control for rib fractures is oral and intravenous opioids,
      especially in the form of patient-controlled analgesia (IV PCA), which are are associated
      with multiple adverse effects including sedation, respiratory depression, cough suppression,
      and increased risk of delirium.

      In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in
      the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that
      IVL is overall well tolerated and have shown other beneficial effects such as
      anti-inflammatory properties. To this date, there have been no published randomized clinical
      trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture
      pain.

      Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide
      improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours
      compared to placebo in adult patients with acute traumatic rib fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all adult patients admitted to Stanford Health Care with two or more acute traumatic
             rib fractures

        Exclusion Criteria:

          -  hemodynamically instability

          -  mechanical ventilation

          -  polytrauma (defined as bone or organ injury outside the thorax)

          -  pregnancy

          -  incarceration

          -  local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome,
             Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or
             intraventricular block)

          -  chronic opioid use.
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: Povidone-Iodine; Normal Saline
Intervention description: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine; Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 173.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Scoliosis; Spine fusion; 0.35% povidone-iodine

Summary:

      This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal
      patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of
      povidone-iodine and normal saline irrigation at reducing bacterial contamination of the
      surgical wound will be measured by collecting cultures before and after irrigation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 3 to 18 years on day of surgery

          2. diagnosis of spinal deformity

          3. undergoing elective posterior spine multi-level instrumentation surgery

        Exclusion Criteria:

          1. Documented renal failure

          2. documented allergy to iodine or shellfish

          3. previous spine fusion surgery

          4. undergoing elective posterior spine single-level instrumentation surgery

          5. undergoing anterior spine multi-level instrumentation surgery

          6. current antibiotic use.
Dexmedetomidine in Pediatric Tonsillectomy
Condition: Pediatric Adenotonsillectomy; Post Operative Analgesia
Intervention: Dexmedetomidine 0.75 mcg/kg; Morphine 50 mcg/kg; Morphine 100 mcg/kg; Dexmedetomidine 1 mcg/kg
Intervention description: Single intra-operative administration of dexmedetomidine 0.75 mcg/kg over 10 minutes for analgesia.; Single intra-operative administration of morphine 50 mcg/kg over 10 minutes for analgesia; Single intra-operative dose of morphine 100 mcg/kg over 10 minutes for analgesia; Single intra-operative administration of dexmedetomidine 1 mcg/kg over 10 minutes for analgesia
Intervention MeSH terms: Dexmedetomidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adenotonsillectomy; Postoperative analgesia; Pediatrics

Summary:

      The hypothesis of this study is that the administration of an intra-operative dose of
      dexmedetomidine will result in adequate analgesia without respiratory depression thereby
      resulting in an early discharge from the post anesthetic care unit following
      adenotonsillectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between ages 3 and 17 years with American Society of Anesthesiology
             classification 1 or 2.

        Exclusion Criteria:

          -  Children less than 3 years

          -  Children with uncorrected cardiac lesions

          -  Children with heart block or liver impairment

          -  Children with American Society of Anesthesiology Class 3 or 4.
Mirabegron and Urinary Urgency Incontinence
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron
Intervention description: Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.
Intervention MeSH terms: Mirabegron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All patients receive mirabegron daily for 12 weeks
Masking: None (Open Label)
Masking description: There is no masking scheme
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Urgency Incontinence; Mirabegron; Myrbetriq; Betmiga

Summary:

      This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive
      bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB.
      The purpose of this study is to estimate the number of women who respond to a medication
      called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A
      secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment
      and change in symptom severity over 12 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥
             5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary
             incontinence or mixed urinary incontinence-urgency predominant)

          -  No contraindications to taking mirabegron

          -  Patients on current OAB therapy will undergo a two-week drug washout period prior to
             baseline assessment

        Exclusion Criteria:

          -  Neurologic disease known to affect the lower urinary tract

          -  Systemic immunologic deficiency

          -  Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent
             culture-proven UTIs

          -  History or current pelvic malignancy or radiation

          -  Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II

          -  A contraindication to receiving mirabegron

          -  Women of childbearing potential who are pregnant or nursing or intend to become
             pregnant during the study, or who are not practicing a reliable method of
             contraception

          -  Must not have taken any antibiotics in the 4 weeks prior to enrollment
Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
Condition: Esophageal and Gastric Varices
MeSH terms: Esophageal and Gastric Varices
Intervention: carvedilol; cyanoacrylate
Intervention description: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.; The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gastric varices; cyanoacrylate; carvedilol

Summary:

      Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal
      bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective
      β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is
      not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to
      gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 20 to 80 years

          -  Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within
             24 h of bleeding

          -  Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

        Exclusion Criteria:

          -  Previous treatment of gastric varices, including endoscopic therapy, transjugular
             intrahepatic porto-systemic shunt, or surgery

          -  Contraindications to non-selective beta-blockers or cyanoacrylate injection

          -  Serum total bilirubin >10 mg/dL

          -  Grade III/IV hepatic encephalopathy

          -  Hepato-renal syndrome

          -  Severe heart failure (NYHA Fc III/IV)

          -  Chronic kidney disease under renal replacement therapy

          -  Refractory ascites

          -  Malignancy other than hepatocellular carcinoma

          -  Pregnancy

          -  Pacemaker use

          -  Refusal to participate
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care; Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Intervention description: Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.; Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1976.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Large Simple Trial

Summary:

      The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of
      Exubera in routine clinical practice.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible for receiving Exubera treatment based on the approved local label

        Exclusion Criteria:

          -  Pregnant or lactating

          -  Have a progressive fatal disease or a life expectancy that prohibits them from
             participating in a five-year research study