bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
Condition: Metabolic Syndrome; Schizophrenia
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia
Intervention: Aripiprazole; Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
Intervention description: Tablets, Oral, 5 to 30 mg, once daily, 16 weeks; Tablets, Oral, According to summary of product characteristics (SmPC)
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Antipsychotic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or
      quetiapine in the treatment of schizophrenia and currently presenting with metabolic
      syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a
      range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical
      antipsychotic treatment prior to the study enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients:

          -  with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at
             least 3 months

          -  with diagnosis of metabolic syndrome

          -  not treated for 1 of the parameters of metabolic syndrome
IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery
Condition: Acute Pain; Hyperalgesia
MeSH terms: Hyperalgesia; Acute Pain
Intervention: IV acetaminophen; Placebo
Intervention description: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.; Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cardiac surgery; Acute Pain; Wound Hyperalgesia; Intravenous Acetaminophen; Patient Satisfaction

Summary:

      Patients undergoing cardiac surgery experience significant postoperative pain, which may
      impact postoperative outcomes. The aim of this single center, double-blind, randomized,
      placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly
      decrease 24 hour postoperative opioid consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  (1) subjects who clinically consented to elective sternotomy for coronary artery
             bypass grafting (CABG), heart valve repair or replacement under general anesthesia,
             and (2) ages between 18 and 75 years

        Exclusion Criteria:

          -  (1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic
             pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6)
             allergy to acetaminophen, (7) severely impaired liver and kidney function and (8)
             previous sternotomy
Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin
Intervention description: Sitagliptin (100mg, per oral) once a day.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Dipeptidyl peptidase IV inhibitors; Glucagon-like peptide 1

Summary:

      The purpose of this study is to confirm the mechanism of reduced response to DPP-4 inhibitor
      in some patients with type 2 diabetes and evaluate appropriate patients to treat with DPP-4
      inhibitor
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetic patients with less than 15 yrs of disease duration

          -  BMI between 22-27 kg/m2

          -  HbA1c ≤ 9% at recruitment

               1. Study group

        After change sulfonylurea to sitagliptin in case of metformin and sulfonylurea therapy

          1. Increase of fasting blood glucose over 20 mg/dL or postprandial glucose over 30 mg/dL
             within several days or

          2. Increase of HbA1c over 1% within 2-3 months without abrupt increase of blood glucose
             levels within several days

               -  Sulfonylurea dose : less than glimepiride 4mg or gliclazide 120mg or
                  glibenclamide 10mg

               -  Metformin dose : 500~2000mg

          3. Reduced response to sitagliptin should be made a decision by investigators after
             understanding the condition of patients surely.

        2. Control group

          -  Age, sex, BMI matched patients with same condition of study patients

          -  After change sulfonylurea to sitagliptin in case of metformin plus sulfonylurea
             therapy, no change of blood glucose levels like above or stable HbA1c change within 1%
             within 2-3 months

        Exclusion Criteria:

          -  Other causes of increase of blood glucose levels except drug change

          -  Patients with history of insulin treatment

          -  Patients taking thiazolidinediones, alpha-glucosidase inhibitors, GLP-1 analogue or
             DPP-4 inhibitors

          -  Patients with renal, hepatic dysfunction

          -  Patients with diabetic complications such as coronary heart disease, cerebrovascular
             disease, proliferative diabetic retinopathy or diabetic gastroparesis

          -  Patients taking medications affecting glucose level
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
Condition: Disc Herniation; Lumbosacral Radiculopathy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Intervention: CT-guided corticosteroid+ bupivicaine; Standard medical care
Intervention description: CT-guided corticosteroid+ bupivicaine Also get standard medical care; Naproxen + Oxycodone/ Acetaminophen
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Disc herniation; Lumbosacral radiculopathy; Corticosteroids

Summary:

      Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe
      that it is functionally disabling. The purpose of this randomized clinical trial is to
      determine if corticosteroid medication, delivered directly to the area near the herniated
      disc, can improve the pain and functional disability associated with a herniated disc.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults <60y

          -  < 1m of symptoms

          -  Symptoms consistent with herniated disc

          -  MRI demonstrates corresponding disc

          -  Back pain resulting in functional disability

        Exclusion Criteria:

          -  Chronic pain

          -  Daily pain medication

          -  Frequent back pain

          -  On the job injury
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Condition: Constipation
MeSH terms: Constipation
Intervention: Polyethylene glycol (MiraLAX, BAY81-8430); Mannitol
Intervention description: Oral solution, 17g polyethylene glycol, one time; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Intervention MeSH terms: Mannitol; Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Study to gather information on the acceptability of a new flavor system with increasing
      levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG)
      3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel
      movements. The taste of the various preparations will be measured by use of a rating scale.
    

Eligibility criteria:

        Male and female subjects, aged 18 years and older, suffering with occasional constipation
A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®); Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention description: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.; Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.
Intervention MeSH terms: Travoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Comfort

Summary:

      The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in
      the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older.

          -  Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or
             exfoliation glaucoma in both eyes.

          -  Best corrected visual acuity of 20/200 Snellen or better in each eye.

          -  Intraocular pressure within protocol-specified range.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Any abnormality preventing reliable applanation tonometry in the study eye(s).

          -  Any eye conditions or procedures as specified in protocol.

          -  Progressive retinal or optic nerve disease from any cause.

          -  Use of contact lenses in the study eye(s).

          -  Other protocol-defined exclusion criteria may apply.
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: fluticasone furoate, fexofenadine
Intervention MeSH terms: Fluticasone; Xhance; Fexofenadine; Terfenadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 680.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: ragweed; once daily; fexofenadine; fluticasone furoate; allergic rhinitis

Summary:

      The primary objective of the study is to compare nighttime symptom relief of fluticasone
      furoate nasal spray versus oral fexofenadine
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent

          -  Otherwise healthy outpatient with mountain cedar allergy

          -  Male or eligible female Females of childbearing potential must commit to the
             consistent and correct use of an acceptable method of birth control

          -  Age 12 years or older at Visit 2

          -  Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar

          -  Adequate exposure to mountain cedar pollen

          -  Ability to comply with study procedures

          -  Literate

        Exclusion criteria:

          -  Significant concomitant medical conditions

          -  Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled,
             oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with
             the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior
             to Visit 1.

          -  Use of other allergy medications within specific timeframes relative to Visit 1

          -  Use of other medications that may affect allergic rhinitis or its symptoms

          -  Use of immunosuppressive medications eight weeks prior to screening and during the
             study

          -  Immunotherapy patients who are not stable on current dose

          -  Use of any medications that significantly alters the pharmacokinetics of fluticasone
             furoate or fexofenadine

          -  Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two
             products

          -  Use of contact lenses

          -  Recent clinical trial/experimental medication experience within 30 days of Visit 1

          -  Subject previously failed the 21-day screen period or failed to complete the treatment
             period

          -  Positive or inconclusive pregnancy test or female who is breastfeeding

          -  Employee or relative affiliation with investigational site

          -  Current tobacco use

          -  Active chickenpox or measles or exposure in the last 3 weeks
Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Condition: Aging; Inflammation
MeSH terms: Inflammation
Intervention: Typhoid Vaccine; Ascorbic Acid
Intervention description: All participants will receive the typhoid vaccine.; All participants will receive ascorbic acid.
Intervention MeSH terms: Ascorbic Acid; Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The vascular response to acute inflammation and oxidative stress is non-invasively assessed in individuals who are young with low fitness, older with low fitness, or older with high fitness.
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiorespiratory Fitness; Endothelial Function; Oxidative Stress

Summary:

      This study focuses on whether high cardiorespiratory fitness in older adults has a protective
      effect on the vascular response to acute inflammation in comparison to low-fit older and
      young adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females willing to provide informed consent

          -  18-35 or 55-75 years of age

          -  Non-smoker

          -  No use of anti-inflammatory medication within last 2 weeks

          -  Aerobically trained (defined as performing aerobic exercise on ≥4 days/week, for ≥30
             minutes, for at least the past 3 months AND a VO2max ≥75th age- and sex-specific
             percentile according to ACSM)

          -  /// OR /// Sedentary (defined as being involved in less than 30 minutes of
             moderately-intense physical activity per day, < 3 days/week AND a VO2max ≤ 50th age-
             and sex-specific percentile according to ACSM)

        Exclusion Criteria:

          -  Body mass index >35 kg/m2

          -  Pregnancy, hormone replacement therapy, or peri-menopausal

          -  Known cardiovascular (i.e. atherosclerosis, uncontrolled hypertension, stroke,
             myocardial infarction, etc.), inflammatory (i.e. Crohn's disease, arthritis, etc.), or
             metabolic (i.e. Diabetes mellitus) disease

          -  Medications known to influence cardiovascular outcomes (i.e. heart rate, blood
             pressure, endothelial function, etc)

          -  Regular use of medications to reduce inflammation (NSAIDS, aspirin, steroids, etc)

          -  Bleeding disorders

          -  Illness, other vaccination, or antioxidant use within 2 weeks prior to screening

          -  Typhoid vaccination within previous 2 years or prior adverse reaction

          -  VO2max in 51st - 74th age- and sex-specific percentile according to ACSM (measured
             during first testing visit)

          -  Non-English speaking participants
Isovue in Peripheral Digital Subtraction Angiography (DSA)
Condition: Peripheral Arterial Occlusive Disease
MeSH terms: Arterial Occlusive Diseases; Peripheral Arterial Disease
Intervention: iopamidol; iodixanol
Intervention description: Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).; Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peripheral arterial occlusive disease (PAOD)

Summary:

      No significant differences is expected in observed motion artifacts, heat or pain reported
      during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  provides written informed consent;

          -  at least 18 years of age;

          -  scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD

        Exclusion Criteria:

          -  pregnant or lactating female;

          -  known allergies to one more more ingredients in wither product;

          -  history of severe congestive heart failure (Class IV);

          -  previously enrolled or received an investigational compound within 30 days;

          -  history of hypersensitivity to iodinated contrast agents;

          -  renal impairment eGFR <60 mL/min/1.73m2, calculated using the MDRD study equation

          -  any other medical condition decreasing chances of obtaining reliable data
Liposomal Bupivacaine in Vaginal Hysterectomy
Condition: Vaginal Hysterectomy
Intervention: Liposomal bupivacaine; Bupivacaine Hydrochloride
Intervention description: Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.; We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This will be a blinded study where investigators, patients, and care providers will be blinded to treatment assignment.
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The aim of this study is to compare the effects of preemptive analgesia using liposomal
      bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament
      injection in patients undergoing vaginal hysterectomy. We hypothesize that the group
      receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior
      postoperative pain management. Enhancement in pain control should confer a decrease in opioid
      and other analgesic medication requirements, which may contribute to decreased nausea,
      vomiting, and higher overall patient satisfaction with pain control.
    

Eligibility criteria:

        INCLUSION CRITERIA

        1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without
        concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

        EXCLUSION CRITERIA

          1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater
             than normal values

          2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is
             greater than normal values

          3. Known history of prolonged QT (QTc greater than 500 m/s)

          4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral
             equivalents per day for a minimum of 1 month prior to surgery

          5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs,
             acetaminophen, gabapentin, sulfa drugs, or ondansetron

          6. Allergy to both oxycodone and hydromorphone

          7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior
             to study enrollment

          8. Adults lacking the ability to consent