bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
Condition: Dissection of Thoracic Aorta
MeSH terms: Acute Kidney Injury; Heart Arrest
Intervention: recombinant human erythropoietin; saline
Intervention description: We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.; We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and
      reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the
      lower extremities and successive reperfusion results in injury to remote organs, including
      kidneys. So, there has been considerable interest in the development of therapeutic
      strategies aimed at attenuating IR injury. One such group of agents that are attracting
      interest due to their potential protective effects on vascular endothelium is the
      erythropoietin.

      However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not
      been fully clarified. Therefore, the purpose of this study is to determine whether the
      prophylactic administration of erythropoietin reduce the incidence of acute kidney injury
      (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The
      investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min
      before the commencement of ischemia. The differences between the control and study groups are
      observed by clinical indicators such as serum creatinine, TNF-α, NGAL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults above age of 20

          2. Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest

        Exclusion Criteria:

          1. pregnancy or lactation

          2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis

          3. past history of thoracic aortic surgery

          4. malignancy 5. preoperative acute kidney injury

          5. chronic renal replacement therapy

          6. allergy or hypersensitivity to erythropoetin

          7. history of erythropoetin treatment

          8. death during or one day after surgery

          9. no consent

         10. reoperation within seven days of the first surgery
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine 8 mg; Placebo
Intervention description: Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.; Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 990.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Overactive; Overactive urinary bladder; Overactive Bladder

Summary:

      Patients with overactive bladder are often treated with tolterodine, a medication that helps
      relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes
      patients do not have a satisfactory response, and may benefit from trying an alternative oral
      medicine. Fesoterodine is related to tolterodine by producing the same active substance that
      acts on the bladder, but potentially at higher and more effective levels. So, a patient who
      has a poor response to tolterodine may still obtain a good response to fesoterodine. This
      study will help find out if this is what happens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of overactive bladder with symptoms for at least 6 months.

          -  Moderate to severe incontinence episode frequency and subsequent sub-optimal response
             to tolterodine

          -  Women of child-bearing potential must not intend to become pregnant, be pregnant or
             producing breast milk at the time of study entry, and must use contraception

        Exclusion Criteria:

          -  Conditions or prior treatment that may also affect bladder function

          -  Clinically significant urinary tract infection (UTI)

          -  Ongoing treatment with overactive bladder medications (these can be stopped at the
             first visit to allow entry into the study).
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Fentanyl ITS
Intervention description: 40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IONSYS; Fentanyl Iontophoretic Transdermal System; Postoperative pain

Summary:

      The purpose of this study is to evaluate in daily clinical practice the safety and efficacy
      of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of
      moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe)
      pain in participants who have undergone elective spine or orthopedic (related to bones)
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who will undergo elective spine or orthopedic (related to bones) surgery

          -  Participants who are expected to have moderate (medium level of seriousness) or severe
             (very serious) pain requiring parenteral (given by injection) opioids (morphine like
             medications) for at least 48 hours after surgery

          -  Participants who have been admitted to the Post Anesthesia Care Unit (PACU) after
             general anesthesia, spinal anesthetic of less than 4 hours duration of action or
             epidural (outside the spinal cord) anesthesia

          -  Participants who are alert and breathing spontaneously for at least 30 minutes in the
             PACU

          -  Participants with a pain score less than or equal to 4 out of 10 on a Numerical Rating
             Scale (NRS) at movement of the operated limb or body region, after titration to
             comfort according to current postoperative procedures

        Exclusion Criteria:

          -  Participants with active systemic skin disease or active local skin disease that
             prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS)
             application

          -  Participants with a history of allergy or hypersensitivity to fentanyl and/or an
             allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride

          -  Participants who received regular treatment with transdermal strong opioids within 14
             days prior to surgery

          -  Participants who are known or suspected to have abused any drug substance or alcohol

          -  Participants who will probably require additional surgical procedures within 72 hours
A Pharmacodynamic Study With Ticagrelor in African American Patients
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor; Clopidogrel
Intervention description: Min - 90mg/Max - 180mg tablets (loading dose); 75mg (once daily)/Max - 600mg tablets (loading dose)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stable Coronary Artery Disease, CAD

Summary:

      The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African
      American patients with stable coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures

          -  Male or female patients aged 18 years or older

          -  Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment

          -  Females must be post menopausal or surgically sterile Self-identified as African
             American

        Exclusion Criteria:

          -  Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or
             prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel,
             ASA dose other than 75 to 100 mg daily) during study period

          -  Patients who had ACS or stent placed within 12 months of screening Patients with a
             history of moderate or severe hepatic impairment

          -  Current smokers, including the use of tobacco containing products in the past 1 month
             of randomization Patients required dialysis
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Raltegravir; Efavirenz
Intervention description: Raltegravir 400mg oral twice daily; Efavirenz 600mg oral at bedtime
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Efavirenz; Raltegravir; Combination antiretroviral therapy

Summary:

      A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based
      combination therapy in treatment-naïve patients with HIV-1 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are infected with HIV-1

          -  Patients have not yet received any treatment for HIV

          -  Patients with HIV viral RNA exceeds 5000 copies per ml

          -  Ages at least 20 years

        Exclusion Criteria:

          -  Patients with acute or decompensated chronic hepatitis

          -  Patients with chronic hepatitis and serum aminotransferase concentrations are more
             than five times the upper limit of the normal range

          -  Patients with renal insufficiency (need dialysis or have serum creatinine
             concentrations of more than twice the upper limit of the normal range

          -  Patients with any medical disorder that the use of study medications is
             contraindicated

          -  Pregnant or breastfeeding women

          -  Patients who are lack of expectation to maintain assigned study medication during
             study period

          -  Patients who have received therapy with investigational drugs in the previous 3 months
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Salmeterol 50 mcg BID; Fluticasone Propionate/Salmeterol 250/50 mcg BID; DISKUS inhaler
Intervention description: Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.; Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.; Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoporosis; Bone Mineral Density; Osteopenia; Chronic Obstructive Pulmonary Disease; COPD

Summary:

      This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits
      will include lung function tests and scans of your bones. The purpose of this study is to
      determine the effect of the steroid component of an inhaled product on bone mineral density
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion criteria:

          -  Established clinical history of COPD.

          -  Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.

          -  Smoking history of at least 10 pack-years, where both current and former smokers will
             be eligible.

          -  Must have at least one native, evaluable hip.

        Exclusion criteria:

          -  History of or evidence for metabolic bone diseases other than osteoporosis or
             osteopenia.
A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic
             criteria) for at least 1 year.

          -  Have diet and exercise therapy only (no oral antihyperglycemic medication for at least
             3 months prior to screening).

          -  Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL)
             at screening.

          -  Have a screening body weight of ≥50 and ≤80 kilograms.

        Exclusion Criteria:

          -  Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor
             agonists.

          -  Have had a clinically significant cardiovascular disease.

          -  Have a known clinically significant gastric emptying abnormality or have undergone
             gastric bypass surgery or restrictive bariatric surgery.

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease.

          -  Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were
             diagnosed with any type of acute pancreatitis.

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter
             squared.

          -  In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
             study.
Detemir: Role in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Detemir mixed with RAI injection; Insulin Detemir and RAI injection
Intervention description: Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection; Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: blood sugar; glycemic

Summary:

      Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given
      insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no
      difference in the patterns of blood sugars when detemir is given in the same syringe or in
      separate syringes with rapid acting insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)

          -  On insulin glargine for at least 3 months

          -  Age 10-25 years

          -  Not on medications that may affect glucose concentrations

          -  Hemoglobin A1C (HbA1C) of less than 9 %

          -  Body Mass Index (BMI) less than 95th % and more than 10th%

          -  Supportive family

        Exclusion Criteria:

          -  Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)

          -  Unable to adhere to insulin regimen

          -  Positive urine pregnancy test
The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
Condition: Hypertension
MeSH terms: Hypertension
Intervention: valsartan and amlodipine; valsartan and amlodipine
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 728.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; adults; Valsartan + Amlodipine; Angiotensin Receptor Blockers

Summary:

      The purpose of this trial is to compare blood pressure lowering efficacy of moderate
      Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 /
      10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients

          -  18 Years of age or older

          -  Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150
             mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a
             minimum period of 28 days prior to randomization

        Exclusion Criteria:

          -  Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200
             mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg

          -  Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all
             types of revascularization procedures in the last 6 months

          -  Treatment with valsartan or any combination antihypertensive treatment with 28 days
             prior to screening (Visit 1)
Intravenous Lidocaine Randomized Comparative Effectiveness Trial
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Intervention: Hydromorphone; Lidocaine
Intervention description: Hydromorphone intravenous infusion; Lidocaine intravenous infusion
Intervention MeSH terms: Lidocaine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, emergency department based, comparative effectiveness
      study of two medication for acute abdominal pain: intravenous lidocaine and intravenous
      hydromorphone. Patients will be enrolled during an emergency department visit and followed
      throughout their emergency department course and then by telephone 7 days later.
    

Eligibility criteria:

        Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute
        abdominal pain. Acute will be defined as pain for no more than seven days. At the time of
        enrollment, the ED treatment plan must include use of an intravenous opioid.

        Exclusion Criteria: Patients will be excluded from participation if they have cardiac
        conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval
        duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are
        hemodynamically unstable, as determined by the attending physician, are pregnant or
        breastfeeding, or have a known allergy to either medication. Patients will also be excluded
        if they have used prescription or illicit opioids within the previous week, or if they have
        a chronic pain disorder, defined as use of any analgesic medication on more days than not
        during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg
        will be excluded.

        -