bioihbjkbjnl/mcl2 huggingface dataset:
Aspirin Responsiveness in Women at Risk for Cardiac Events
Condition: Heart Disease
MeSH terms: Heart Diseases; Cardiovascular Diseases
Intervention: Aspirin
Intervention description: Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this pilot study is to evaluate the prevalence of biological aspirin
      resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness
      will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women
      identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then
      re-tested for aspirin responsiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women at least 19 years old

          -  Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary
             prevention of cardiovascular disease.

          -  Able and willing to provide informed consent

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Known CHD

          -  Currently taking clopidogrel or ticlopidine

          -  Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours

          -  Allergy or hypersensitivity to salicylates

          -  Use of other OTC or prescription analgesics or anti-inflammatory medication in the
             past two weeks

          -  Currently participating in another investigational drug or device study
Pharmacogenetics of SGLT2 Inhibitors
Condition: Diabetes Mellitus; Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Intervention: Canagliflozin
Intervention description: A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: SGLT2; SLC5A2; SLC5A4; SLC5A9; SLC2A9; GLUT9; SGLT3; SGLT4; pharmacogenomics

Summary:

      Sodium-dependent glucose transporter-2 (SGLT2) inhibitors are a new class of anti-diabetic
      drugs, which increase urinary glucose excretion thereby promoting weight loss and decreasing
      plasma glucose levels. We hypothesize that the pharmacodynamic response to SGLT2 inhibitors
      (specifically canagliflozin) varies among individuals, and that a proportion of this
      inter-individual variation can be explained by genetic variation. This is a pilot study in
      healthy, non-diabetic subjects in whom glucose and other related metabolites in the urine and
      plasma will be measured before and after administration of a single dose of canagliflozin.
      This will allow us to characterize the inter-individual variation in the pharmacodynamic
      response to canagliflozin as well as determine if changes in glucose and other related
      metabolite levels are associated with variants in various candidate genes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Of Amish descent

          -  Age 21 or older

          -  BMI 18-40 kg/m2

        Exclusion Criteria:

          -  Known allergy to canagliflozin

          -  History of diabetes, random glucose greater than 200 mg/dL, or HbA1c greater than or
             equal to 6.5%

          -  Currently taking diuretics, antihypertensive medication, uric acid lowering
             medications, or other medication that the investigator judges will make interpretation
             of the results difficult

          -  Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or
             other diseases that the investigator judges will make interpretation of the results
             difficult or increase the risk of participation

          -  Seizure disorder

          -  Positive urine human chorionic gonadotropin (hCG) test or known pregnancy within 3
             months of the start of the study

          -  Estimated glomerular filtration rate less than 60 mL/min

          -  Currently breast feeding or breast feeding within 3 month of the start of the study

          -  Liver function tests greater than 2 times the upper limit of normal

          -  Hematocrit less than 35%

          -  Currently symptomatic for urinary tract or yeast infection or history of two or more
             urinary tract or yeast infections in the past 12 months.

          -  Abnormal thyroid stimulating hormone (TSH)
Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans
Condition: Type 2 Diabetes; Obesity
MeSH terms: Obesity
Intervention: Doxycycline; Placebo
Intervention description: generic doxycycline 100mg twice daily; Placebo comparator to doxycycline
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: doxycycline; insulin resistance; obesity; inflammation

Summary:

      Obesity is a heightened state of inflammation in which production of cytokines and matrix
      metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin
      resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance
      insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes
      (DM2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory, medically stable, able to give informed consent, and comply with the
             protocol.

          -  Obesity with BMI >30 kg/m2.

          -  DM2 for less than 10 years.

          -  7.5% < HA1C < 10%

          -  Taking insulin and/or oral medications (biguanide, sulfonlylurea, etc.)

        Exclusion Criteria:

          -  Mental states that would preclude complete understanding of the protocol and
             compliance.

          -  Chronic illness such as renal failure (with creatinine clearance <80 ml/min for
             Specific Aim 2).

          -  Women of child-bearing age because of the potential hazard to the fetus (doxycycline
             may cause permanent discoloration of the teeth and deposition in bone inhibiting
             growth) and because doxycycline may render oral contraceptives less effective.

          -  Nursing mothers.

          -  Allergy to tetracyclines.

          -  Subjects taking the following drugs: penicillin or it's derivatives, anticoagulant
             therapy, antacids containing aluminum, calcium, or magnesium, iron-containing
             preparations, bismuth subsalicylate, barbiturates, carbamazepine, phenytoin or
             methoxyflurane, thiazolidinediones (TZD)
Antithrombotic Effects of Ticagrelor Versus Clopidogrel
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Intervention: Ticagrelor + ASA + Bivalirudin; Clopidogrel + ASA + Bivalirudin
Intervention description: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.; Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
Intervention MeSH terms: Aspirin; Hirudins; Bivalirudin; Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antiplatelet; ticagrelor; clopidogrel; bivalirudin; thrombosis

Summary:

      The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and
      bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and
      bivalirudin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers between 18 and 65 years old.

          -  Body mass index (BMI) 18 - 30 kg/m2 inclusive.

          -  Healthy as assessed by a detailed medical history and physical examination.

          -  Laboratory est results within the normal range.

          -  Ability to provide signed informed consent.

        Exclusion Criteria:

          -  History of clinically relevant disease, bleeding, acute infectious disease or signs of
             acute illness.

          -  Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a
             physician.

          -  Use of medication within one month prior to study drug administration.

          -  History of drug abuse or alcohol consumption >20 g/day.

          -  Inability to abstain from intensive muscular effort or sport competition.

          -  Loss of >400 mL blood or blood donation within 3 months.

          -  Positive serology for hepatitis B (HBs Ag) or hepatitis C.

          -  Conditions associated with hemorrhagic risk.

          -  Positive pregnancy test.
Comparison Between Losartan and Benazepril in Diabetic Hypertensive Patients Not Controlled by Amlodipine
Condition: Hypertension; Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus
Intervention: Benazepril; Losartan
Intervention description: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.; Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
Intervention MeSH terms: Losartan; Benazepril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypertension; Diabetes Mellitus; Vascular stiffness; Endothelial function

Summary:

      The purpose of this study is to compare losartan and benazepril in diabetic patients whose
      high blood pressure is not controlled by amlodipine and its relationship to statin current
      use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatorial patients with age between 40 and 70 years-old.

          -  Systemic arterial hypertension previously diagnosed and in use of two or less
             anti-hypertensive drugs in the preceding 4 weeks.

          -  Type 2 diabetes mellitus in use of oral medication that were not changed in the
             preceding 4 weeks. Glycated hemoglobin A1c less than 9.0%.

          -  Accepted the consent form.

        Exclusion Criteria:

          -  Office systolic blood pressure equal or more than 180 mmHg, with or without treatment

          -  Office diastolic blood pressure equal or more than 110 mmHg, with or without treatment

          -  Evidences of a secondary cause for hypertension

          -  Glycated hemoglobin A1c > 9.0%

          -  Insulin therapy

          -  Chronic kidney disease stage 4 or 5 or in dialysis

          -  Advanced target organ lesion, obtained by history or additional exams, and defined by:
             previous myocardial infarction, heart failure with ejection fraction less than 40%,
             cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease
             (claudication or doppler with obstruction > 50% of vascular lumen), retinopathy with
             visual loss, symptomatic neuropathy.

          -  Cardiac arrhythmias, except for ectopic beats

          -  Any clinical or disabling condition that, in the opinion of the investigators, may
             confound or prejudice study results.

          -  Severe mitral regurgitation.

          -  Women in fertile age without contraceptive methods in use.

          -  Breastfeeding women.
The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Staphylococcal Infections; Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Sodium hypochlorite (bleach) baths; Mupirocin ointment; Water; Petrolatum Ointment
Intervention description: Sodium hypochlorite (bleach) baths twice weekly for 3 months; Intranasal mupirocin 2% ointment BID x five days (3 times total for subjects; one time only for family members); Water baths twice weekly for three months; Intranasal petrolatum ointment twice daily for five days
Intervention MeSH terms: Mupirocin; Sodium Hypochlorite; Eusol; Petrolatum
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary
      complication of atopic dermatitis (AD), but also as a culprit in the worsening of this
      condition. In addition, the recent development of community acquired methicillin-resistant S.
      aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of
      acute infections and maintenance therapy. The investigators would like to perform a
      randomized investigator-blinded placebo-controlled study of children aged 6 months to 17
      years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial
      infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the
      relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to
      clinical response to oral cephalexin therapy and severity of the AD; and 3) whether
      concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and
      sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical
      stability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months to 17 years of age

          -  Moderate to severe atopic dermatitis

        Exclusion Criteria:

          -  Use of cephalexin or other antibiotic in last 6 weeks

          -  Allergy to cephalosporins
Comparison of Insulin Therapy in Treating Post-Transplant Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Insulin, Isophane; insulin glargine
Intervention description: daily dosing based on fasting morning glucose levels; daily dose based on fasting morning glucose levels
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Subjects will be randomized to
Insulin glargine (Lantus) or
Insulin isophane (NPH)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-transplant; diabetes mellitus; renal transplant; kidney transplant; lung transplant; heart transplant; insulin

Summary:

      To determine if the use of insulin isophane results in improved control of blood sugars
      compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart
      transplantation (NODAT).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be followed by the Inova Fairfax Hospital transplantation program for
             post-transplant care

          2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin
             hypoglycemic medication

          3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if
             it was required)

          4. Ability to read consent form and give consent in English.

        Exclusion Criteria:

          1. Use of insulin or non-insulin hypoglycemic medication before transplantation

          2. Cystic fibrosis patients

          3. Age < 18 years of age

          4. Pregnancy

          5. Non-English speaking subjects
Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean
Condition: Nausea; Vomiting; Satisfaction
MeSH terms: Nausea; Vomiting
Intervention: Acupressure Point P6 stimulator; Metoclopramide; Ondansetron
Intervention description: This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.; 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.; 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
Intervention MeSH terms: Ondansetron; Metoclopramide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation
      versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during
      elective cesarean section under regional anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female subjects ages 18 to 45

          2. Subjects with American Society of Anesthesiologists (ASA) Class I or II

          3. Subjects with elective primary or repeat cesarean delivery

          4. Subjects who receive combined spinal epidural anesthesia

          5. English and non-English speaking subjects will be included in the study

        Exclusion Criteria:

          1. Female subjects <18 years of age

          2. Subjects requiring emergent cesarean delivery

          3. History of placenta accrete

          4. Multiple gestation pregnancy

          5. ASA status III or higher

          6. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia

          7. History of any chronic medication use (other than prenatal vitamins), including
             inhaler medications

          8. Current urinary tract infection, pneumonia, or otitis media
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Condition: Diarrhea
MeSH terms: Gastroenteritis; Diarrhea
Intervention: Smectite; Placebo; Lactobacillus GG
Intervention description: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.; Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.; All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 3 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: diarrhea; probiotics; diosmectite

Summary:

      Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized,
      double blind, placebo-control trial was performed to assess the effectiveness of both LGG and
      smectite in management of children with acute gastroenteritis (AGE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  children < 5 years old

          -  diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1
             day but < 5 days

          -  inform consent sing

        Exclusion Criteria:

          -  diarrhea < 1 or > 5 days,

          -  a recent history of diarrhea indicated either by parents/guardian or hospital case
             notes,

          -  underlying chronic gastrointestinal disease,

          -  undernutrition (weight/height ratio below the 5th percentile),

          -  systematic infection,

          -  immune defects or immunosuppressive treatment
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine
Condition: Hemorrhage; Healthy
MeSH terms: Hemorrhage
Intervention: Ketamine Hydrochloride; Placebo
Intervention description: A total of 20 mg of Ketamine Hydrochloride will be administered intravenously; Subjects will receive placebo
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this project is to test how ketamine, an analgesics currently employed in the
      pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in
      humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-45 years of age

          -  Healthy

          -  Non-obese (body mass index less than 30 kg/m2)

          -  Body mass greater than or equal to 65 kg

        Exclusion Criteria:

          -  Subjects not in the defined age range

          -  Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses

          -  Any known history of renal or hepatic insufficiency/disease

          -  Pregnancy or breast feeding

          -  Body mass less than 65 kg

          -  Current smokers, as well as individuals who regularly smoked within the past 3 years

          -  Positive urine drug screen

          -  Currently taking pain modifying medication(s)