bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Lispro Low Mixture (LM); Insulin Glargine; Prandial Insulin Lispro
Intervention description: Participant-dependent dose, administered subcutaneously for 24 weeks; Participant-dependent dose, administered subcutaneously for 24 weeks; Participant-dependent dose, administered subcutaneously for 24 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Metabolic Diseases; Diabetes Mellitus, Type 2; Glargine; Diabetes Mellitus; Insulin LISPRO; Insulin

Summary:

      The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal
      insulin glargine and once-daily prandial insulin lispro, in participants with Type 2
      Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with type 2 diabetes mellitus

          -  Have been taking metformin and/or pioglitazone

          -  Have received treatment with basal insulin glargine, injected once a day, for greater
             than or equal to 90 days

          -  Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal
             to 7.5% and less than or equal to 10.5

          -  Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles
             per liter [mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)], or
             greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that
             further titration of basal insulin glargine is not possible for safety reasons

          -  Not pregnant or breastfeeding

        Exclusion Criteria:

          -  Have Type 1 Diabetes

          -  Their stable dose of pioglitazone is greater than the maximum dose approved for use in
             combination with insulin in their country

          -  Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).

          -  Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the
             screening visit and the total duration of the prandial insulin treatment was greater
             than 2 weeks

          -  Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry
             into the study

          -  Have cardiac disease with a functional status that is Class III or IV

          -  Have a history of renal or liver disease

          -  Have had a blood transfusion or have a blood disorder
Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing
Condition: Asthma
MeSH terms: Respiratory Sounds
Intervention: OM-85 BV (Broncho-Vaxom); OM-85 BV (placebo)
Intervention description: 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months; 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months
Intervention MeSH terms: Broncho-Vaxom
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: No
Keywords: wheezing; asthma; childhood; OM-85 BV; Broncho-Vaxom

Summary:

      The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on
      respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of
      attacks and effect on serum cytokine levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6
             months

          -  Children with asthma who had at least 3 wheezing attacks in the last 6 months

        Exclusion Criteria:

          -  Chronic lung disease

          -  Immun deficiency

          -  Malabsorption

          -  Anatomic abnormalities of the respiratory tract

          -  Gastroesophageal reflux disease
A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Pregabalin; Placebo
Intervention description: Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.; Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic neuropathy; Pregabalin; Lyrica

Summary:

      This study is designed to examine how pregabalin affects parameters of autonomic nerve
      regulation in correlation with change in pain, anxiety, and depressive symptoms in patients
      with diabetic neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients aged 18 years or older

          -  Meet criteria for diagnosis of diabetic neuropathy

          -  Average daily pain scores greater than or equal to 4 by Visual Analog Scale

          -  Ability to give informed consent

          -  No pregnancy

        Exclusion Criteria:

          -  Patients with clinically significant psychiatric disorders requiring vigorous
             interventions, i.e., moderate to severe depressive disorder, psychotic disorders,
             PTSD, obsessive compulsive disorder, panic disorder, substance abuse, or personality
             disorders, or active suicidal/homicidal ideations, or past history of active suicidal
             ideation and/or attempts

          -  Patients on gabapentin which cannot be discontinued, meaning a dose greater than
             1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she
             is willing to stop taking the medication, he or she can participate in the study.
             These patients must take the last dose of gabapentin the night before starting the
             study.

          -  Patients being non-compliant with diabetic control

          -  Inability to wear the LifeShirt

          -  Unable to participate or answer questions using a personal digital assistant input
             device
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: montelukast sodium; inhaled corticosteroid
Intervention description: Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months; Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess real-world effectiveness of montelukast in children (2
      to 14 years) with asthma and allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 2 and 14 years old

          -  Diagnosed with asthma, classified as mild persistent asthma according to Global
             Initiative Asthma Guidelines (GINA)

          -  Diagnosed with comorbid allergic rhinitis

        Exclusion Criteria:

          -  Patients with suspected sinus infection

          -  Prior treatment with high dose inhaled corticosteroid requiring a dose higher than
             beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in
             severe cases
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Placebo
Intervention description: Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration; Matching placebo tablets, oral administration
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: nebivolol; Bystolic ™; Hypertension; Hispanic; Hypertension in Hispanic patients

Summary:

      This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic
      patients with stage 1 or stage 2 hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or
             Latino ethnicity

          -  Females must be post-menopausal, or not pregnant and using an approved contraceptive
             regimen

          -  Meet criteria for stage I or II hypertension

          -  Currently not treated, or being treated with no more than two anti-hypertensive
             medications

        Exclusion Criteria:

          -  Secondary hypertension

          -  Are taking three or more antihypertensive agents

          -  Have uncontrolled or poorly controlled diabetes mellitus type I or type II

          -  Evidence of other concurrent disease or conditions that might interfere with the
             conduct of the study

          -  Participation in any investigational study within 30 days of Screening (Visit 1).

          -  Have a history of hypersensitivity to nebivolol or other β-blockers, or any
             contraindication to β-blocker use
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Methotrexate; Etanercept; Methotrexate; Placebo; Methotrexate
Intervention description: Subcutaneous (SC), 50 mg, once weekly for 88 weeks; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).; Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).; Subcutaneous (SC), once weekly from week 36 to week 88.; Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.
If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 834.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Active Rheumatoid Arthritis

Summary:

      To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate
      with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis.

          -  Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but
             no more than 25 mg/week) for the treatment of rheumatoid arthritis.

          -  Active rheumatoid arthritis at the time of screening.

        Exclusion Criteria:

          -  Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
             inhibitors, or other biologic agents.

          -  Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other
             than MTX within 28 days before baseline.

          -  Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at
             baseline.
A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Intervention: carboxymethylcellulose 0.5%/glycerin 0.9%; sodium hyaluronate 0.18%
Intervention description: 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.; 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi
      for the management of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Use of artificial tears for dry eye in both eyes for at least 3 months

          -  Use of preservative-free artificial tears at least twice daily for 2 weeks;

        Exclusion Criteria:

          -  Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy
             (PRK) surgery in the last 12 months

          -  Use of punctal plugs or contact lenses in the last month

          -  Active ocular allergy within last 2 years

          -  Best corrected visual acuity (BCVA) less than 20/200 in either eye
The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine injection; metformin; Placebo pill
Intervention description: Once daily for 14 weeks; Up to 4 pils per day (2g per day) maximum; Up to 4 pills per day
Intervention MeSH terms: Metformin; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: type 2 diabetes; insulin; insulin injection; metformin; C-reactive protein; insulin sensitivity; glycemic control; inflammation

Summary:

      The purpose of this study, which is being conducted at 100 centers throughout the United
      States, is to determine whether Lantus, a long-acting insulin injection, either alone or in
      combination with metformin, is effective in reducing C-reactive protein (CRP) in adults with
      type 2 diabetes. CRP is a marker of chronic low-level inflammation, a new risk factor for
      diabetes, heart attack, stroke, and other cardiovascular events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 to 79

          -  Type 2 diabetes, treated only by diet or oral drugs other than metformin

          -  HbA1c greater than or equal to 7% and less than or equal to 10%

          -  C-reactive protein greater than or equal to 2 mg/L

        Exclusion Criteria:

          -  Baseline use of metformin or insulin

          -  Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody

          -  History of congestive heart failure requiring drug therapy

          -  Active liver disease

          -  Kidney impairment

          -  Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin
             receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids
Intravenous Sub-dissociative Dose Ketamine Injection Versus Infusion for Analgesia in the Emergency Department
Condition: Pain
MeSH terms: Emergencies
Intervention: Ketamine IV Infusion; Ketamine IV push
Intervention description: Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.; Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; emergency department

Summary:

      Objective: The purpose of this study is to determine if administering ketamine as an
      intravenous (IV) infusion over 15 minutes, as compared to an IV push, will decrease adverse
      drug reactions without attenuating its analgesic effects.

      Study design: prospective, randomized, controlled, double-blind trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pain NRS ≥5

          -  Anticipated stay in ED ≥1 hour

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Vital sign abnormalities (SBP <90, SBP > 180, HR < 50, HR > 150, RR <10, RR > 30,
             weight <45 kg, weight > 115 kg)

          -  Arrhythmias

          -  Altered mental status (active psychosis/delirium)

          -  Administration of opioid pain medication in previous 1 hour

          -  history of acute head or ocular trauma

          -  presence of known intracranial mass or vascular lesion
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Intervention: Gentamicin and cefazolin; Cefazolin; Gentamicin
Intervention description: 80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation; 1000 mg cefazolin application intravenously 1 hour before operation; 80 mg gentamicin application intraoperatively
Intervention MeSH terms: Gentamicins; Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 276.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: inguinal hernia; infection prophylaxis; topical gentamicin

Summary:

      Aim of this study is to measure the effectiveness of topical gentamicin to prevent
      post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is,
      if it is effective as a prophylactic agent, to compare it's effect with intra venous single
      dose cefazolin sodium prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of inguinal hernia

        Exclusion Criteria:

          -  Femoral hernia

          -  Emergency cases
Kaletra and Viread in Antiretroviral Naïve Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Once daily
Intervention description: Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HIV; AIDS; HIV/AIDS; Treatment Naive

Summary:

      Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r,
      800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50
      copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients >18 years of age with documented HIV-1 infection

          2. Naïve to antiretroviral therapy

          3. Able and willing to provide written informed consent

          4. No CD4 restriction

          5. HIV-1 RNA levels >5000 c/mL

          6. Female patients must meet these additional criteria

               1. Non-childbearing potential

               2. Negative serum pregnancy test at screen

               3. Willingness to abstain from sexual intercourse or use double barrier
                  contraception

        Exclusion Criteria:

          1. Presence of any of the following:

               1. Aminotransferases >3xULN

               2. Hemoglobin concentration <8.0g/dl

               3. Absolute neutrophil count <800 cells/cubic mm

               4. Platelet count <50,000 cells/cubic mm

               5. Acute illness, or an acute illness ≤7 days

               6. Presence of Opportunistic Infection, or an OI within 30 days of screening

               7. Acute or chronic active Hepatitis B

               8. Hepatitis C

               9. Creatinine Clearance <50 mL/min

          2. Pregnant or breast-feeding women

          3. Presence of any illness, physical or behavioral conditions (i.e., substance abuse,
             excluding cannabis) that will impair the patient's ability participate

          4. Patient who, in the opinion of the investigator, will be unlikely to complete the
             study protocol and adhere to the study drug regimens

          5. Concurrent use of medications that may potentially interact with study medications
             including: astemizole, terfenadine, rifampin, dihydroergotamine, ergonovine,
             ergotamine, methylergonovine, cisapride, St. John's wort, lovastatin, simvastatin,
             pimozide, midazolam, triazolam, adefovir, cidofovir, acyclovir, ganciclovir, and
             valganciclovir.

          6. Patient suffers from a serious medical condition that may in the opinion of the
             investigator compromise his or her safety.