bioihbjkbjnl/mcl2 huggingface dataset:
Ranitidin Versus Omeprazole in Patients Taking Clopidogrel
Condition: Coronary Artery Disease; Drug Interaction Potentiation
MeSH terms: Coronary Artery Disease
Intervention: omeprazole; Ranitidine; Clopidogrel
Intervention description: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.; Influence of ranitidine on clopidogrel pharmacodynamics will be evaluated.; Clopidogrel added to ASA therapy at the first medical visit, Open label 75 mg once a day will be given to all individuals as part of the protocol (since main outcome of interest is clopidogrel effect. Actual comparison arms are double blind ranitidine and omeprazole
Intervention MeSH terms: Omeprazole; Ranitidine; Ranitidine bismuth citrate; Clopidogrel; Purinergic P2Y Receptor Antagonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: clopidogrel; omeprazole; ranitidin; interaction; aggregability

Summary:

      Previous reports have shown a possible drug interaction between clopidogrel and proton pump
      inhibitors (PPI´s), which could result in increased number of adverse cardiovascular events
      among patients on dual antiplatelet therapy(DAPT). Because of this, ranitidin has been
      proposed as an alternative drug to PPI´s for prophylaxis of gastrointestinal bleeding in
      patients who need DAPT. The study´s aim is to test the hypothesis that ranitidin doesn´t have
      any influence on clopidogrel pharmacodynamic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old

          -  Coronary artery disease, defined as previous myocardial infarction and/or coronary
             angioplasty and/or CABG surgery and/or coronariography showing obstruction of at least
             50 % in one of major epicardial vessels

          -  Treatment with Acetylsalicylic Acid (ASA) 100 mg/day

        Exclusion Criteria:

          -  Use on the last 7 days of any other antiplatelet drug beside ASA or oral anticoagulant

          -  Previous utilization of PPI or ranitidine in the last 7 days before randomization

          -  Any active bleeding

          -  Pregnancy or woman of childbearing age without contraceptive method

          -  Hemoglobin < 10 g/dL or hematocrit < 30 %, hematocrit > 50 %, platelets < 100.000/mm3
             or > 500.000/mm3; creatinin clearance < 50 ml/minute

          -  Percutaneous coronary intervention (PCI) on the last 30 days before randomization (or
             PCI on the last year when drug-eluted stents are used); CABG surgery on the last 90
             days; acute coronary syndrome on the last 60 days

          -  Active malignant neoplasm

          -  Active peptic ulcer disease on the last 60 days or upper gastrointestinal bleeding any
             time in life

          -  Known allergy to the drugs clopidogrel, ranitidine or omeprazole

          -  Refuse to participate in the study
Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Intervention: Tacrolimus
Intervention description: dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary Nephrotic syndrome

Summary:

      To determine the efficacy of tacrolimus in the management of NS(nephrotic syndrome) , the
      investigators designed this prospective study. The investigators will enroll 100 children
      with NS(frequent relapse steroid dependent NS, steroid resistance NS) who will be treated
      with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level
      between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. Other therapies
      will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs,
      multivitamins and lipid-lowering agents.

      Follow-up is every second week for the first 4 weeks, then monthly. After initiation of
      tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Frequent relapse nephrotic syndrome

          -  steroid resistance nephrotic syndrome

        Exclusion Criteria:

          -  secondary nephrotic syndrome

          -  estimated glomerular filtration rate < 60 mL/min/1.73m2

          -  with active hepatitis
Evaluate Effectiveness of Epiduo® Gel in Reducing Antibiotic Sensitive & Resistant Strains of Propionibacterium (P)Acnes
Condition: P Acnes Colonization
MeSH terms: Acne Vulgaris; Hypersensitivity
Intervention: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Intervention description: Apply once daily
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing
      antibiotic sensitive and resistant strains of P acnes in vivo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female subjects 18 years of age and older, with no past or
             present history of any significant internal disease

          -  Subjects who:

               -  show a high degree of fluorescence of the facial skin under a Wood's lamp,
                  indicating the presence of P acnes

               -  have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)

               -  have high level resistance to erythromycin, variable resistance to clindamycin,
                  resistance to tetracycline and variable resistance to doxycycline and minocycline

        Exclusion Criteria:

          -  Subjects who exhibit any skin disorders of an acute or chronic nature (e.g.,
             psoriasis, eczema, etc)

          -  Subjects who have taken topical or systemic antibiotics within 4 weeks prior to
             baseline assessments

          -  Subjects who have used other medications which may influence skin surface P acnes
             levels

          -  Subjects who are unwilling to refrain from using toners, astringents or other drying
             agents on the face during the study
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Lucentis
Intervention description: 0.3mg Lucentis
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The protocol will measure a number of cytokines in addition to vascular endothelial growth
      factor in response to 0.3mg Lucentis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetes mellitus

          -  Best corrected visual acuity 20/32 - 20/320

          -  Diabetic macular edema involving the center of the macula

          -  Optical coherence tomography central subfield thickness of at least 250 microns

        Exclusion Criteria:

          -  History of anti-vascular endothelial growth factor treatment in the past 12 months

          -  Any diabetic macular edema treatment in the past 4 months

          -  Heart attack, stroke, transient ischemic attack or acute congestive heart failure
             within 4 months
Effect of Urinary Alkalinization on Urine Uric Acid Precipitation and Crystallization in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes; Diabetic Nephropathy; Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 1
Intervention: sodium bicarbonate
Intervention description: All participants will receive 2 doses of 1950mg sodium bicarbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether alkalinization of urine uric acid by 2
      doses of sodium bicarbonate (1950mg) over 24-hours reduces precipitation and crystallization
      of urine uric acid over in adults with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (aged 18-45 years) with type 1 diabetes

          -  Participants must be able to be fasting prior to study visit and give informed
             consent.

        Exclusion Criteria:

          -  Non-type 1 diabetes

          -  History of eGFR <60 ml/min/1.73m2 or microalbuminuria or greater

          -  History of hypocalcemia or at risk of hypocalcemia

          -  Taking allopurinol or uric acid altering medications

          -  Ketogenic diet

          -  Ketonuria

          -  Taking phosphorus binders (e.g. sevelamer)

          -  Pregnant or breastfeeding

          -  Taking the following medications which may interact with sodium bicarbonate (e.g.
             phentermine, pseudoephedrine, antifungal medication, cephalosporin antibiotics [e.g.
             Keflex], tetracycline antibiotics [e.g. doxycycline], steroids or lithium)

          -  Taking SGLT-2 inhibitors

          -  Taking blood pressure medications
Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
Condition: Pancreatitis; Diabetes
MeSH terms: Pancreatitis
Intervention: Sitagliptin; Placebo
Intervention description: 100 mg PO daily; Placebo
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatitis; Pancreatectomy; Islet autotransplant; Sitagliptin; Diabetes

Summary:

      The purpose of the study is to test the effects of sitagliptin on the need for insulin (the
      hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet
      autotransplant for chronic pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Scheduled for total pancreatectomy and IAT at UM

        Exclusion Criteria:

          -  Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl

          -  Medical conditions which, in the opinion of the investigator, might impact islet
             function (e.g asthma or inflammatory disease requiring chronic systemic
             corticosteroids)

          -  Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL
             in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis.

          -  For female subjects, plans to become pregnant or unwillingness to practice birth
             control for 18 months.

          -  Islet yield <1,000 IE/kg body weight (exclusion for treatment with drug/placebo)
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Condition: Low Back Pain
MeSH terms: Low Back Pain
Intervention: Acetaminophen; Placebo comparator
Intervention description: 1 gram of intravenous Acetaminophen; placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen in transforaminal lumbar interbody fusion

Summary:

      The purpose of this project is to study the effects of preoperative followed by scheduled
      intravenous acetaminophen on pain control for 24 hours postoperatively after minimally
      invasive 1 or 2 level transforaminal lumbar interbody fusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years old

          -  Being scheduled to have elective primary minimally invasive 1 or 2 level
             transforaminal lumbar laminectomy interbody fusion

          -  ASA I, II, or III

          -  Informed consent form signed

        Exclusion Criteria:

          -  Anyone weighing less than 50kg (as this would require a dosing change).

          -  Hypersensitivity or contraindication to intravenous acetaminophen or opioids

          -  Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl

          -  Impairment of liver function-- defined as the inability to receive intravenous
             acetaminophen without dose adjustment as determined by the investigator; or history of
             chronic liver disease defined as history of hepatitis of any kind as recorded in the
             patient's chart

          -  Mental retardation recorded as a diagnosis in the patient's chart

          -  History of chronic pain (defined as currently receiving treatment from a specialist
             for pain)

          -  History of pain recalcitrant to intravenous morphine

          -  Impaired kidney function (defined as creatinine > 1.5)

          -  Anyone who is not a candidate for general anesthesia or any other portion of the
             investigator's standard of
Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: OnabotulinumtoxinA; Normal saline (placebo)
Intervention description: OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.; Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I)
      Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA
      (BOTOX®) in adults with chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of chronic migraine for at least 6 months prior to the screening visit

          -  Fifteen or more headache days during the 4-week screening period (≥4 headache episodes
             lasting ≥4 hours and ≥50 % of headache days are migraine)

        Exclusion Criteria:

          -  Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and
             fibromyalgia

          -  Use of headache prophylaxis medication within 4 weeks of the screening visit

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  Previous use of any botulinum toxin of any serotype for any reason

          -  Skin infections or acne that would interfere with the injection sites

          -  Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction,
             dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block
             treatments, or injection of anesthetics/steroids within 4 weeks of screening.
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg intravenously, every 4 weeks for 96 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra
      (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an
      inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs
      (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4
      weeks. Anticipated time on study treatment is 96 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Active moderate to severe rheumatoid arthritis

          -  Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)

          -  Current treatment at stable dose for >/=8 weeks

          -  Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab,
             Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have
             discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell
             repletion

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following baseline

          -  Rheumatic autoimmune disease other than RA

          -  Functional class IV (American College of Rheumatology Classification)

          -  Prior history or current inflammatory joint disease other than RA

          -  Oral corticosteroids at a dose of >10 mg/day prednisone equivalent

          -  Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core
             antibodies (HBcAb) or hepatitis C virus (HCV) antibody

          -  Current or history of recurrent bacterial, viral, fungal or mycobaterial infection

          -  History of or currently active primary or secondary immunodeficiency
Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH
Condition: Subarachnoid Hemorrhage; Stroke
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Intervention: IV acetaminophen; Oral acetaminophen; Oral placebo; IV placebo
Intervention description: Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.; Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.; Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period).; Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days).
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acetaminophen; interleukin-6; interleukin-1; thromboxane A2

Summary:

      This study compares the bioavailability of IV and PO acetaminophen in both blood and the
      cerebrospinal fluid (CSF) of patients following subarachnoid hemorrhage. The study will also
      compare the temperature and levels of inflammatory cytokines in both blood and CSF of
      patients treated with IV and PO acetaminophen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of subarachnoid hemorrhage (must be confirmed by CT, CT angiography, lumbar
             puncture, or MRI).

          -  Fisher Grade between 1-3 (subarachnoid blood without signs of intraventricular
             hemorrhage or parenchymal extension).

          -  Placement of an external ventricular drain.

          -  Adults aged 18-100 years.

        Exclusion Criteria:

          -  Anyone under the age of 18 or over the age of 100.

          -  Adult patients with subarachnoid hemorrhage with interventricular hemorrhage or
             parenchymal extension (Fisher Grade 4).

          -  Contraindication to acetaminophen such as a known hypersensitivity, severe hepatic
             impairment, or severe active liver disease.

          -  Severe renal impairment (creatinine clearance ≤ 30 mL/min).