bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions
Condition: Cheek Line Depressions
MeSH terms: Depression; Depressive Disorder
Intervention: Juvéderm® VOLIFT®™ with Lidocaine
Intervention description: Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic
      radial cheek line skin depressions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of dynamic radial cheek lines

          -  Agrees not to make any changes to skin care routines, or to have any facial procedures
             or treatments during the study

        Exclusion Criteria:

          -  Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat,
             or other permanent, or semi-permanent dermal fillers or be planning to undergo any of
             these procedures during the study

          -  Undergone temporary facial dermal filler injections with any substance in the face in
             the 12 months prior to study entry

          -  Received botulinum toxin therapy of any serotype in any facial area within the
             previous 6 months agrees not to receive it during the study
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Condition: Dehydration
MeSH terms: Dehydration
Intervention: hylenex-facilitated subcutaneous Lactated Ringer's infusion
Intervention description: single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dehydration; fluid therapy; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Summary:

      The purpose is to evaluate the ease of use and technical challenges encountered during
      subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human
      hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery
      systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these
      delivery systems is also being evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, aged 18 to 60 years

          -  intact normal skin without potentially obscuring features on both anterior thighs in
             the area intended for infusion

          -  agreeing to no fluid intake for 12 hours prior to start of study infusion

          -  vital signs within normal range or, if outside normal range, deemed not clinically
             significant

          -  metabolic panel, hematology, virology and standard 10-test urine dipstick tests within
             normal range, or if outside normal range, deemed not clinically significant

          -  if female of child-bearing potential,negative serum pregnancy tests

          -  negative urine drug screens

          -  written informed consent for participation

        Exclusion Criteria:

          -  lower extremity edema

          -  lower extremity pathology that could interfere with study outcome

          -  history of cardiovascular disease

          -  rales on lung auscultation

          -  known allergy to hyaluronidase or other ingredient in the formulation of hylenex

          -  pregnancy or breast-feeding a child

          -  exposure to any experimental drug within 30 days prior to study participation

          -  previous participation in this study
Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Intervention: metronidazole 1% gel; azelaic acid 15% gel
Intervention description: Apply topically once daily on one side of the face for three weeks; Apply topically twice daily on the opposite side of the face for three weeks
Intervention MeSH terms: Metronidazole; Azelaic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in
      subjects with healthy skin applied according to product labeling for three weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female adults (ages 18 years or older)

          -  Subjects with healthy skin as determined by the clinical grader

        Exclusion Criteria:

          -  Subjects with a degree of skin pigmentation that interferes with the reading of skin
             reactions

          -  Subjects with known allergy to one of the components of the study drugs (refer to the
             package inserts for MetroGel® 1% and Finacea® Gel 15%)

          -  Subjects who have participated in another investigational drug or device research
             study within 30 days of enrollment

          -  Subjects with a washout period for topical treatment on the treated area less than 1
             week for corticosteroids and/or 4 weeks for retinoids

          -  Subjects with a washout period for systemic treatment less than 1 week for medications
             that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months
             for retinoids

          -  Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis,
             rosacea, or other topical conditions on the area to be treated

          -  Subjects who foresee unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc.)
Comparison of Local Anesthetic Infusion Pump Versus Depofoam Bupivacaine for Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Depobupivacaine; OnQ pump; 0.25% Bupivacaine
Intervention description: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.; group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.; group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: local anesthetic continuous infusion pump; local injection of Exparel

Summary:

      Effective post surgical pain control in patients undergoing unilateral deep inferior
      epigastric perforator (DIEP) free flap reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non pregnant women

          -  age 18 years or older

          -  scheduled to have unilateral DIEP flap breast reconstruction.

          -  Must have ASA physical status classification of 1,2, or 3

        Exclusion Criteria:

          -  concurrent or recent medical condition that could interfere with study participation

          -  history of any of the following:

          -  hepatitis

          -  alcohol/substance abuse

          -  uncontrolled psychiatric disorders

          -  known allergy/ contraindication to any of the following:

          -  amide-type local anesthetics

          -  opioids

          -  propofol

          -  Body weight of less than 50 kg

          -  have participated in another study involving an investigational medication with in the
             past 30 days

          -  taking analgesics, antidepressants, or glucocorticoids within the 3 days before
             surgery
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
Condition: Secondary Hyperparathyroidism; Chronic Kidney Disease
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol; Calcitriol
Intervention description: 1 mcg daily, adjusted to achieve 40-60% PTH suppression; 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTH; Active Vitamin D; hypercalcemia; Chronic Kidney Disease

Summary:

      Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to
      bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may
      have different effects on blood calcium. This study will randomize patients with SHPT and
      stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the
      incidence of high blood calcium, and effectiveness of SHPT treatment.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age >18; Able to give informed consent

          2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD
             equation

          3. intact PTH (iPTH) >120 pg/ml at baseline

          4. albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline

          5. Phosphorus < 4.6 mg/dL at baseline

          6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

        Exclusion Criteria

          1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol,
             doxercalciferol; paricalcitol; alfacalcidol)

          2. Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per
             day within the previous 30 days.

          3. history of primary HPT

          4. On prednisone > 30 days within the previous 6 months

          5. receiving bisphosphonates or calcitonin within the previous 12 months

          6. Non-elective hospitalization within the previous 30 days.

          7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.

          8. History of renal or other organ transplant

          9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism

         10. Receiving cinacalcet within 4 weeks prior to screening.

         11. An active drug/alcohol dependence or abuse history

         12. History of non-compliance with visits or medications that preclude study compliance in
             the opinion of the investigator

         13. Pregnant, or able to become pregnant and unwilling to use a birth control method
             considered reliable by the principal investigator
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone
Condition: Post-operative Pain Control
MeSH terms: Pain, Postoperative
Intervention: acetaminophen/codeine vs acetaminophen/oxycodone
Intervention description: pain medications
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone; Codeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to Group 1 or Group 2
Masking: Double (Participant, Investigator)
Masking description: Randomization was accomplished by the pharmacy and the medication bottles were not labeled.
Enrollment: 200.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Photorefractive Keratectomy; Post-operative Eye Pain; Refractive Surgery

Summary:

      Photorefractive keratectomy (PRK) is a refractive error correction procedure that helps
      eliminate or reduce the dependence on corrective lenses. An important aspect of PRK is
      post-operative pain management. Post-operative pain can be significant in the first three to
      five days and is typically controlled utilizing various modalities including narcotic pain
      medication. Simple observation suggests a difference in the post-operative pain levels of
      patients utilizing the more potent oxycodone- versus the less potent codeine-containing
      acetaminophen preparations. There have been no studies performed to explore any differences
      in perceived pain comparing these two medications when used following PRK. This study is
      designed to answer this question by means of a pain survey conducted in the first five days
      post-op. This may help better manage similar patients in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  M/F >21 years of age (PRK is not done on anyone under the age of 21 at this surgery
             center)

          -  Have met all criteria for bilateral PRK

        Exclusion Criteria

          -  Patients who do not meet the criteria for refractive surgery

          -  Patients receiving LASIK

          -  Patients known to have an allergy to either of the study pain medications

          -  Patients receiving refractive surgery on only one eye

          -  Pregnant women, children, military basic trainees, prisoners and detainees

          -  Subject has used narcotics in the last 6 months
Mechanisms and Treatment of Intradialytic Hypertension
Condition: Intradialytic Hypertension
MeSH terms: Hypertension
Intervention: Carvedilol
Intervention description: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
Intervention MeSH terms: Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension; Hemodialysis

Summary:

      1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis
           patients if blood pressure elevations with hemodialysis are associated with decreased
           endothelial cell function (measured by brachial artery flow mediated dilation and
           endothelial progenitor cell number), both of which are novel mechanistic markers in the
           causal pathway for detrimental cardiovascular outcomes; and

        2. To determine if lowering blood pressure with carvedilol in 25 ESRD subjects with blood
           pressure elevations with hemodialysis can improve endothelial cell dysfunction as a
           surrogate mechanistic marker for improving cardiovascular outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  on hemodialysis > 30 days

          -  aged 18 to 80 years old

          -  ability to provide informed consent

          -  Primary nephrologist deems patient is at target dry weight

          -  Predialysis SBP >140 or postdialysis SBP>130

        Exclusion Criteria:

          -  Patients with active wounds

          -  Blood pressure unable to be measured by routine mechanisms in the upper extremity

          -  Change in blood pressure medications in the previous 2 weeks

          -  Intolerance of beta or alpha-blockers

          -  pregnancy

          -  Resting heart rate <50

          -  Life expectancy < 6 months

          -  Current therapy with carvedilol or contraindication to carvedilol (ONLY in the
             intervention arm)
Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; pioglitazone
Intervention description: add sitagliptin100mg/d to pre-study OADs; add pioglitazone 30mg/d to pre-study OADs
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sitagliptin; pioglitazone; type 2 diabetes

Summary:

      This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with
      pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite
      dual therapy with metformin and a sulfonylurea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes patients who were treated with stable doses of sulfonylurea and
             metformin to their half maximally dose (sulfonylureas > half maximal dose, and
             metformin > 1500 mg/d) for > 10 weeks

          -  > 20 years old

          -  A1C: > 7.0 % and < 11%

        Exclusion Criteria:

          -  Insulin use within 12 weeks of the screening visit

          -  Any contraindications for use of sitagliptin or pioglitazone, impaired renal function
             (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase
             levels > 2.5 times the upper limit of normal

          -  Current or prepare to pregnancy and lactation
RESOunD: REbif Satisfaction On Discontinuing Oral Dimethyl Fumarate
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Rebif®
Intervention description: Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Rebif ®; Tecfidera ™; treatment change

Summary:

      This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment
      satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently
      being treated with, but are considering discontinuing treatment with Tecfidera™.
    

Eligibility criteria:

        Key inclusion Criteria:

          -  Diagnosis of relapsing form of MS

          -  Have declared a desire/plan to discontinue treatment with Tecfidera due to
             tolerability issues and/or lack of efficacy

          -  Expanded Disability Status Scale (EDSS) score 0 to 5.0 inclusive

          -  Other protocol defined inclusion criteria could apply

        Key exclusion Criteria:

          -  Pregnant or lactating

          -  Significant renal or hepatic impairment or other significant disease that would
             compromise adherence and completion of the trial

          -  Other protocol defined exclusion criteria could apply
A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Condition: Hyponatremia; Euvolemia; Hypervolemia
MeSH terms: Hyponatremia
Intervention: Conivaptan; placebo
Intervention description: ampoule or premix bag; ampoule or premix bag
Intervention MeSH terms: Conivaptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyponatremia; Euvolemia; Hypervolemia; Conivaptan; Vaprisol®; YM087

Summary:

      The study will evaluate the effectiveness and safety of multiple dosing regimens of IV
      conivaptan in subjects with euvolemic or hypervolemic hyponatremia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a serum sodium value between 115 and 133 mEq/L

          -  Subject is euvolemic or hypervolemic

        Exclusion Criteria:

          -  Clinical evidence of volume depletion or dehydration

          -  Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or
             treatment
A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Trivalent Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,
      inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in
      healthy adult volunteers aged between 18 and 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged between 18 and 60 years at the time of vaccination.

          -  Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically
             sterile) must be abstinent or be willing to use a medically accepted contraceptive
             regimen for the duration of the study. Females of child-bearing potential must return
             a negative urine pregnancy test result prior to vaccination with the vaccine.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to
             eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the
             vaccine.

          -  Clinical signs of an active infection.

          -  A clinically significant medical condition.

          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
             preceding study entry.

          -  Females who are pregnant or lactating.