bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin glargine
Intervention description: Treat-to-target (individually adjusted dose) titration according to titration algorithm.
S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued; Treat-to-target (individually adjusted dose) titration according to titration algorithm.
S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 457.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, South America and the United States of America (USA).

      The aim of this clinical trial is to determine whether two insulin treatments given once
      daily are equally effective with respect to the blood glucose lowering effect in subjects
      with type 2 diabetes inadequately controlled on metformin treatment with or without an
      additional anti-diabetic drug (OAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for at least 6 months

          -  Stable treatment with a total daily dose of at least 1500 mg metformin or maximum
             tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas,
             meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at
             least 3 months

          -  Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)

          -  HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory
             analysis (one re-test within one week is allowed)

          -  Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

        Exclusion Criteria:

          -  Any contraindication to insulin detemir or insulin glargine according to the local
             labelling

          -  Receipt of any investigational product within 4 weeks

          -  Anticipated change of dose of any systemic treatment with products, which in the
             Investigator's opinion could interfere with glucose metabolism (e.g. systemic
             corticosteroids)

          -  Clinically significant diseases which, in the Investigator's opinion may confound the
             results of the trial or pose additional risk in administering trial product

          -  Any other condition that the Investigator feels would interfere with trial
             participation or evaluation of results
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Condition: Asthma
MeSH terms: Asthma
Intervention: Xolair; Placebo
Intervention description: Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;; Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; allergen challenge; bronchoprovocation; Methacholine challenge; serum Immunoglobulin E; Nitric Oxide; skin prick test

Summary:

      This study was intended to demonstrate that patients with standard and high immunoglobulin E
      (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients, body weight between 40-150 kg aged 18-65 years
             (inclusive)

          -  Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the
             predicted normal value for the patient

          -  Positive skin prick test to a specific allergen

          -  Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an
             aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening

        Exclusion Criteria:

          -  Current active smokers

          -  Patients who have been hospitalized or had emergency treatment for an asthma attack in
             the 12 months prior to study start

          -  History of bleeding disorders

          -  History of drug allergy

          -  Pregnant women or nursing mothers

          -  Females of childbearing potential, regardless of whether or not sexually active, if
             they are not using a reliable form of contraception (surgical contraception or double
             barrier methods (to be continued for at least two months following last dose) are
             acceptable).

          -  Sexually active males who have not been sterilized and are not using a condom

          -  History of immunocompromise, including a positive HIV

          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

          -  History of drug or alcohol abuse within 12 months of study start

        Other protocol-defined inclusion/exclusion criteria may apply
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Condition: Pain
Intervention: Gabapentin; Placebo
Intervention description: Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain.; Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Perioperative pain; Outpatient surgery; Obstetrics/gynecology; Pain management

Summary:

      This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2
      hours preoperatively in conjunction with perioperative paracervical block for surgical
      abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce
      perioperative and postoperative pain associated with surgical abortion. Additionally, the
      researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and
      consumption of pain medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women >=18 years-old

          -  Presenting for a surgical abortion

          -  Fluency in English and able to provide informed consent

          -  Has a driver to take them home following the procedure

        Exclusion Criteria:

          -  Allergy, sensitivity or contraindication to gabapentin

          -  Severe renal disease

          -  Currently using gabapentin or pregabalin

          -  Contraindication to outpatient abortion under local anesthesia
Opioid Free Management After Ureteroscopy
Condition: Kidney Stone
MeSH terms: Kidney Calculi
Intervention: Norco 5milligram-325milligram Tablet; Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Intervention description: Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later.; Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blinded
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ureteroscopy; Opioid; Non-Opioid; Stent Placement; Nephrolithiasis

Summary:

      The purpose of this research study is to compare how well two medications work to control
      post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ureteroscopy performed for renal stones

          -  Age over 18 years

          -  Two kidneys

        Exclusion Criteria:

          -  Solitary Kidney

          -  Poor kidney function (GFR<30)

          -  Allergy to either Ibuprofen or Norco

          -  Pelvic Kidney
Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Condition: Vaginal Surgery
Intervention: Belladonna and Opium Suppositories; Placebo Suppositories
Intervention description: Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.; Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Belladonna; Morphine; Suppositories; Vaginal; Surgery; Postoperative; Pain

Summary:

      Our primary aim is to determine whether the routine use of belladonna and morphine
      suppositories will improve pain control following vaginal surgery. Treatment will begin
      immediately following surgery and every 8 hours for 16 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic
             Hospital. This would include a vaginal hysterectomy with culdoplasty or
             post-hysterectomy prolapse repair, including culdoplasty with or without
             anterior/posterior repair.

        Exclusion Criteria:

          -  Participation in another trial using an investigational product.

          -  Pregnancy.

          -  Scheduled for a non-vaginal surgical procedure.

          -  Scheduled for a robotic hysterectomy.

          -  Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal
             surgery).

          -  There is a known hypersensitivity to belladonna and/or opium.

          -  Contraindication to narcotic use.

          -  Chronic pain with preoperative pain score greater than 4 out of 10 points.

          -  Clinically significant substance abuse.

          -  Mental condition that may impair the ability to provide study assessments.
Stepped Care for Depression and Musculoskeletal Pain
Condition: Pain; Depression
MeSH terms: Musculoskeletal Pain; Depression; Depressive Disorder
Intervention: Stepped Care; Antidepressants; Usual Care
Intervention description: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.; Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).; This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
Intervention MeSH terms: Antidepressive Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Back Pain; Knee Pain; Hip Pain; Stepped Care; Antidepressant; Relaxation Techniques; Exercise

Summary:

      This study will evaluate the effectiveness of a stepped care approach in treating depression
      and reducing pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or severe pain in the back, hips, or knees for at least 3 months prior to
             study entry

          -  History of or current use of at least one medication for pain

          -  English-speaking

        Exclusion Criteria:

          -  Moderate to severe cognitive impairment

          -  Schizophrenia or other psychotic disorders

          -  Receiving disability benefits for pain

          -  Anticipated life expectancy less than 12 months

          -  Pregnancy
Olanzapine for Acute Headaches
Condition: Headache
MeSH terms: Headache
Intervention: Standard of Care as per attending physician; 5mg rapidly dissolving olanzapine
Intervention description: Patients are randomized to standard of care medication (as determined by attending physician); 5mg rapidly dissolving olanzapine
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
Masking: None (Open Label)
Masking description: Open label, not blinded, randomized 2-arm trial
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is a prospective, randomized, feasibility trial with the primary aim of comparing
      how well oral rapidly dissolving olanzapine controls primary headache pain when compared to
      the current treatment strategies used in emergency departments which often require
      intravenous or intramuscular medications.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patient between 18-65 years of age presenting to the emergency department with
             acute primary headache

          2. Patient approved for inclusion by primary attending physician in the emergency
             department

        Exclusion Criteria:

          1. Age < 18 or > 65

          2. Pregnancy

          3. Known allergy to olanzapine

          4. Known QT prolongation or underlying condition that places patient at risk for QT
             prolongation

          5. Inability to give written consent (intoxication, altered mental status)

          6. Headache of organic origin (trauma, infection, previous recent head or neck surgery)

          7. Patient already prescribed daily olanzapine on an outpatient basis

          8. Patient has been administered olanzapine within the past 24 hours

          9. Language barrier
Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Intervention: Chloroquine diphosphate; prednisone; azathioprine
Intervention description: One pill of chloroquine diphosphate per day until the end of the study; Prednisone 5-15 mg/day until the end of the study; azathioprine 1-2mg/Kg/day until the end of the study
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate; Prednisone; Azathioprine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: autoimmune hepatitis; chloroquine; treatment

Summary:

      The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in
      conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in
      US. However, in Brazil the response to these treatments seems to be worse, approximately 35%
      in five years. Because of the side effects of the gold-standard treatment and the need for an
      alternative option for the no responsive patients, news drugs must be evaluated for this
      proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the
      treatment of rheumatological diseases for at the least five decades. Chloroquine was used as
      a single drug for up to two years for the maintenance of AIH remission in an open study.
      There was a 6.49 greater chance of relapse in the historical controls when compared with
      patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to
      investigate whether chloroquine in conjunction with prednisone can be used as an alternative
      treatment of AIH in a randomized study, and to evaluate its side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of autoimmune hepatitis according to Autoimmune Hepatitis International
             Group with indication for treatment

          -  No evidence of decompensated liver cirrhosis

          -  Non-pregnant women and women with no intention to become pregnant

          -  Willing to participate in the study

        Exclusion Criteria:

          -  Discrete biochemical changes and histological inflammatory activity absent / minimal
             (periportal / peri-septal: 0/1 +) or decompensated cirrhosis

          -  Cases of loss of follow up
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Condition: Heart Failure; Myocardial Infarction
MeSH terms: Influenza, Human; Heart Failure; Myocardial Infarction; Infarction
Intervention: High Dose Trivalent Influenza Vaccine; Standard Dose Quadrivalent Influenza Vaccine
Intervention description: High Dose Trivalent Influenza Vaccine; Standard Dose Quadrivalent Influenza Vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5388.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: influenza vaccine; cardiopulmonary hospitalization; heart failure; myocardial infarction; clinical trial

Summary:

      INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce
      cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine
      in high-risk cardiovascular patients with a recent history of myocardial infarction or heart
      failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three
      additional influenza seasons. The primary endpoint will be a composite of all-cause mortality
      or cardiopulmonary hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 18 years of age

          -  history of hospitalization for myocardial infarction within 1 year of enrollment OR a
             history of hospitalization for heart failure within 2 years of enrollment

          -  At least one of the following additional risk factors:

               -  Prior MI (if HF the index event above; or a second MI)

               -  Prior HF hospitalization (if MI the index event above; or a second HF event)

               -  Age ≥ 65

               -  Left ventricular ejection fraction (LVEF) < 40%

               -  Diabetes mellitus

               -  Obesity (BMI ≥ 30)

               -  Renal impairment (eGFR ≤ 60)

               -  History of ischemic stroke

               -  History of peripheral artery disease

               -  Current smoking

        Exclusion Criteria:

          -  Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6
             weeks after influenza vaccine

          -  Any non-cardiac condition that in the opinion of the investigator would lead to life
             expectancy less than 9 months.

          -  Receipt of influenza vaccine during current influenza season

          -  Any illness requiring treatment with antibiotics or anti-inflammatory medication
             within the past 14 days.

          -  Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.