bioihbjkbjnl/mcl2 huggingface dataset:
IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
Condition: Transplantation, Kidney
Intervention: Optison; Ultrasound (US); Contrast-enhanced ultrasound (CEUS)
Intervention description: A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.; Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help
      evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus
      help direct the biopsy to the most abnormal part of the renal cortex. This should maximize
      detection and increase the odds of demonstrating the true grade/severity of the
      histopathological abnormality.
    

Eligibility criteria:

        Inclusion

          -  Ability to provide informed consent

          -  Male and female >18 years

          -  Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24
             months post transplant including patients undergoing biopsy to evaluate a recent rise
             in serum creatinine so called for cause biopsies and patients undergoing routine
             protocol (surveillance) biopsies without other evident of renal dysfunction

        Exclusion:

          -  Pregnant women or women who are nursing an infant are not able to participate in this
             study

          -  Known patent forearm ovale (PFO)

          -  Significant heart disease
ALPHA Sitagliptin Add on to Metformin (0431-103)
Condition: Diabetes Mellitus
Intervention: sitagliptin phosphate
Intervention description: Sitagliptin 100 mg/day - tablet for 24 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 608.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Canadian physicians to experience in real life clinical practice the efficacy and
      tolerability of adding sitagliptin to their patients who have their glycemic levels
      inadequately controlled while on metformin
    

Eligibility criteria:

        Inclusion Criteria:

        Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study
        Entry
Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer)
Condition: Uveitis, Posterior; Uveitis, Intermediate; Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis
Intervention: Acthar Gel
Intervention description: Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.

      Also, safety information when using it for this purpose will be collected.
    

Eligibility criteria:

        Inclusion criteria:

          -  Is male or nonpregnant, nonlactating female

          -  Has been diagnosed with current severe NIPPU

          -  Has active disease at the Baseline Visit as defined by the presence of at least 1 of
             the following parameters in at least one eye despite at least 2 weeks of maintenance
             therapy with oral prednisone (or oral corticosteroid equivalent):

               1. Has active, inflammatory, chorioretinal and/or inflammatory retinal vascular
                  lesion

               2. Has ≥ 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN)
                  criteria]

               3. Has ≥ 1.5+ vitreous haze

          -  Is willing to taper current doses of corticosteroid and immunomodulatory therapy to
             the minimum effective dose during the study.

          -  If under treatment with any immunosuppressants, immunomodulators, or biologic agents
             for a comorbid condition, has been on a stable dose for 2 weeks before screening

        Exclusion criteria:

          -  Has proliferative or severe nonproliferative diabetic retinopathy, clinically
             significant macular edema due to diabetic retinopathy, neovascular/wet age-related
             macular degeneration, abnormality of vitreoretinal interface with the potential for
             macular structural damage independent of the inflammatory process or severe vitreous
             haze that precludes visualization of the fundus at the Baseline Visit

          -  Has Type 1 or Type 2 diabetes mellitus, tuberculosis, history of hepatitis, peptic
             ulcer, active infection, or any contraindication for treatment with Acthar Gel
Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium; Placebo
Intervention description: Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device.; Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COPD; Tiotropium; Spiriva

Summary:

      This study is being done to examine the influence of Tiotropium (good or bad) on heart
      function at rest and during exercise in patients with moderate to severe chronic obstructive
      pulmonary disease (COPD).
    

Eligibility criteria:

        Chronic obstructive pulmonary disease (COPD) participants-

        Inclusion criteria:

          -  Body Mass Index (BMI) <36

          -  Moderate to severe COPD patient, (similar to or slightly better than Gold Guidelines
             Stage 2-3, forced expiratory volume in one second [FEV_1] <60% of age predicted)

          -  Smoking history of 10 pack years or more

          -  Clinical diagnosis of COPD

          -  Not on daytime oxygen

        Exclusion criteria:

          -  Clinical diagnosis of asthma

          -  Myocardial infarction within the last 6 months, or known ischemia

          -  Serious uncontrolled cardiac arrhythmia (i.e., atrial fibrillation or ventricular
             tachycardia) or hospitalization for heart failure within the previous year

          -  Known moderate to severe renal impairment

          -  Known moderate to severe symptomatic prostatic hypertrophy or bladder neck obstruction

          -  Known narrow angle glaucoma

          -  Current radiation or chemotherapy for a malignant condition

          -  Inability to give informed consent

          -  On systemic corticosteroids at unstable doses or on regular daily doses of 20 mg or
             more of prednisone (or equivalent)

          -  Not fully recovered from an exacerbation of COPD for at least 30 days

          -  Inability to perform light to moderate activity for orthopedic reasons or who
             significantly desaturated with exercise (percentage of available hemoglobin that is
             saturated with oxygen [SaO_2] < 85% on screening test

        Healthy controls -

        Inclusion:

        - Age and gender matched to COPD participants

        Exclusion:

        - Subjects who are unable to engage in exercise testing due to existing comorbidities
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
Condition: Dehydration
MeSH terms: Dehydration
Intervention: hyaluronidase (human recombinant)/rehydration fluid
Intervention description: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 2 Months
Maximum age: 10 Years
Healthy volunteers: No
Keywords: dehydration; fluid therapy; pediatrics; emergency medicine; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Summary:

      The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous
      (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the
      rehydration of pediatric patients with mild to moderate dehydration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child, 2 months to 10 years of age

          -  Body weight less than 42 kg

          -  Presenting at emergency department with mild to moderate dehydration (Gorelick
             dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe
             signs and symptoms) requiring parenteral rehydration

        Exclusion Criteria:

          -  In shock or life-threatening situation (other than dehydration)

          -  Severe dehydration

          -  Requires intravenous (IV) therapy for another indication

          -  Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample
             collection)

          -  Already received rehydration therapy IV within prior 48 hours or substantial oral
             fluid immediately before enrollment

          -  Condition precluding subcutaneous injection or infusion site evaluation in anterior
             thigh or other elected infusion site

          -  Reason for hospital admission or extended emergency department stay other than
             dehydration

          -  Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX

          -  Hyponatremia or hypernatremia

          -  Hypokalemia

          -  Medical condition likely to interfere with ability to fully complete study or have
             protocol-specified assessments

          -  Medical history, screening examination finding or historical clinical laboratory
             result precluding safe participation in study or which might adversely effect
             interpretation of study results

          -  Participated in study of any investigational drug or device within 30 days prior to
             this study
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
Condition: Hypertension; Hypercholesterolemia
MeSH terms: Hypertension; Hypercholesterolemia
Intervention: Amlodipine besylate/atorvastatin calcium single pill combination
Intervention description: Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion
Intervention MeSH terms: Amlodipine; Atorvastatin; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1531.0
Sex: All
Minimum age: 35 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To investigate whether a Caduet based treatment strategy might result in greater reduction in
      total cardiovascular risk as compared to usual care in subjects with hypertension and
      additional risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypertension with three additional risks factors (for example: smoking, type 2
             diabetes, family history of early heart disease, history of stroke, age over 55 (men)
             and 65 (women)

        Exclusion Criteria:

          -  Subjects currently receiving a statin or stopped statin within 6 months prior to
             enrollment.

          -  Subjects with a history of myocardial infarction and subjects with coronary bypass
             graft or intra-coronary interventions.
Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: FluarixTM
Intervention description: All subjects will receive a single dose of FluarixTM. For children less than 9 years of age who have not previously been vaccinated against influenza, a second dose will be given after an interval of at least 4 weeks (Group B).
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 883.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Korea; FluarixTM

Summary:

      The present study collects data on safety and reactogenicity of the vaccine in the local
      target population (600 or more subjects) as per the requirement of Korean Food and Drugs
      Administration (KFDA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female > 6 months of age at the time of the first vaccination.

          -  Subjects who the investigator believes that they and/or their parents/guardians can
             and will comply with the requirements of the protocol should be enrolled in the study.

          -  Free of obvious health problems as established by medical history and clinical
             examination judged by the investigator before entering into the study.

          -  If the subject is female, she must be of non-childbearing potential, or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after vaccination.

        Exclusion Criteria:

          -  Clinical signs of acute febrile illness at the time of entry into the study.

          -  Any treatment with immunosuppressive drugs, including oral and parenteral
             corticosteroids.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine or previous severe reaction to influenza virus vaccine.
Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI)
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Nitrofurantoin; Placebo
Intervention description: Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively; Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: urinary tract infection; gynecologic surgery; post-operative complications; nitrofurantoin

Summary:

      This is a study of patients undergoing gynecologic surgery who require post-operative
      catheterization to determine if prophylactic antibiotic treatment decreases the risk of
      post-operative urinary tract infection in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing urogynecologic surgery

          -  Receive postoperative catheterization

        Exclusion Criteria:

          -  Age less than 21 years old

          -  Pregnancy

          -  Allergy, contraindication or intolerance to Nitrofurantoin

          -  Do not speak English

          -  Dependent on trans-urethral catheter to accomplish voiding preoperatively

          -  Undergoing interstim device placement, urethral diverticulum surgery or fistula
             surgery

          -  Sustain intraoperative urinary tract injury requiring postoperative catheterization
Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Spiriva HandiHaler
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Enrollment: 1328.0
Sex: All
Healthy volunteers: No

Summary:

      To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH
      maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the
      real life setting of COPD patients, previously treated with short-acting bronchodilator on
      regular or as-needed basis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male and female ambulatory outpatients being seen in a participating physicians office
             for routine care,

          -  Patients with a clinical diagnosis of COPD (all stages according to Global Initiative
             for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with
             long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy
             within the product label and a maximum of the last 4 weeks (0.-28. days before Visit
             1),

          -  Patients previously treated with short-acting bronchodilators on regular or as-needed
             basis for at least 3 months before change to long-acting anticholinergic treatment,

          -  Patient fluent in language of questionnaire and having the cognitive and functional
             abilities required to fill in the questionnaire alone.

        Exclusion criteria:

          -  Uncooperative patients as judged by the physician,

          -  Patients with any conditions excluded as per Country specific package insert,

          -  Patients currently enrolled in any clinical trial,

          -  Patients with COPD exacerbation or any acute disease in the last 3 months before Visit
             1.
A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device
Condition: Multiple Sclerosis; Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Rebif®
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing-Remitting; Rebif; RebiSmart; Patient support program

Summary:

      This is a randomized, comparative, and multicenter study to assess the impact of a patient
      support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in
      subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™
      device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 18 or older

          -  A diagnosis of relapsing-remitting multiple sclerosis according to the revised
             McDonald Criteria (2010)

          -  Treatment with Rebif® 22 or 44 mcg subcutaneously three times a week in accordance to
             the Summary of product characteristics

          -  Rebif® administered by the RebiSmart™ device

          -  Provided a signed informed consent form

        Exclusion Criteria:

          -  Has received any components, except for technical support, of MinSupport Plus prior to
             study entry

          -  Has difficulty reading and/or understanding Swedish

          -  Has a mental condition rendering the subject unable to understand the nature, scope
             and possible consequences of the study, and/or evidence of an uncooperative attitude

          -  No access to computer

          -  Participation in another clinical study