bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Uveitis Steroid Treatment (MUST) Trial
Condition: Uveitis
MeSH terms: Uveitis
Intervention: fluocinolone acetonide intraocular implant; oral corticosteroid with immunosuppressive agents as needed
Intervention description: RETISERT™ (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 μg/day, decreasing over the first month to a steady state between 0.3-0.4 μg/day over approximately 30 months.; Prednisone
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Infliximab; Fluocinolone Acetonide; Cyclophosphamide; Chlorambucil; Methotrexate; Azathioprine; Tacrolimus; Cyclosporins; Daclizumab; Immunosuppressive Agents; Alkylating Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: uveitis; non-infectious intermediate uveitis; non-infectious posterior uveitis; non-infectious panuveitis

Summary:

      The purpose of this study is to compare the effectiveness of standardized systemic therapy
      versus fluocinolone acetonide implant therapy for the treatment of severe cases of
      non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13 years or older

          -  Best-corrected visual acuity of hand motions or better in at least one eye with
             uveitis

          -  Intraocular pressure 24 mm Hg or less in all eyes with uveitis

        Exclusion Criteria:

          -  Inadequately controlled diabetes

          -  Uncontrolled glaucoma

          -  Advanced glaucomatous optic nerve injury

          -  A history of scleritis; presence of an ocular toxoplasmosis scar.

          -  HIV infection or other immunodeficiency disease for which corticosteroid therapy would
             be contraindicated according to best medical judgment
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Paricalcitol
Intervention description: 2 mcg oral Paricalcitol once per day for 7 days
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Vitamin D

Summary:

      The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney
      functioning. The investigators hypothesize that the increase in serum creatinine observed in
      recent paricalcitol trials is a function of reduced creatinine secretion and not an actual
      reduction in kidney function. 16 patients will have kidney function measured via iothalamate
      clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being
      washed off the paricalcitol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Stage 3 or 4 CKD

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Serum Calcium > 10 g/dL

          -  Serum Phosphorous > 6 g/dL

          -  On > 400 units/d Vitamin D therapy

          -  Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine
             secretion

          -  On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)

          -  Allergic to radiocontrast dye
The Effect of Lumify™ Eyedrops on Eyelid Position
Condition: Eyelid Droop
MeSH terms: Blepharoptosis
Intervention: Brimonidine tartrate ophthalmic solution 0.025%; Sterile balanced saline solution
Intervention description: One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface); One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
Intervention MeSH terms: Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see if Lumify™ has an effect on eyelid position.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 and above able to provide informed consent to participate

          -  Subject with stable ocular health, defined as no ocular conditions requiring ongoing
             topical therapy or recent surgical intervention

        Exclusion Criteria:

          -  Adults unable to consent

          -  Prisoners

          -  Pregnant women.

          -  Known contradictions or sensitivities to study medication (brimonidine)

          -  Ocular surgery within the past 3 months or refractive surgery within the past six
             months

          -  Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital
             surgery

          -  Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or
             blepharospasm)

          -  Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 <
             1mm)

          -  Any ocular or systemic condition that, in the opinion of the investigator, would
             confound study data, interfere with the subject's study participation, or affected the
             subject's safety or trial parameters

          -  Presence of an active ocular infection

          -  Prior (within 5 days of beginning study treatment) use of eye whiteners (eg,
             vasoconstrictors), decongestants, antihistamines (including over the counter and
             herbal topical ophthalmic medications), phenylephrine dilating drops, any other
             topical ophthalmic agents

          -  Inability to sit comfortably for 15 - 30 minutes
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 50; biphasic human insulin 50
Intervention description: Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.; Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Biphasic Insulins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and
      safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50
      (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2
      diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months

          -  Currently treated with premixed human insulin 50 BID for at least 3 months prior to
             screening visit (Visit 1)

          -  Currently treated with unchanged total daily dose of at least 1500 mg metformin or
             maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to
             screening visit

          -  Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)

        Exclusion Criteria:

          -  Treatment with any insulin secretagogue, alfa-glucosidase inhibitors,
             thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like
             peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening

          -  Previous use of any insulin other than premixed human insulin 50 BID within 3 months
             prior to Visit 1

          -  Previous use of insulin intensification treatment (premixed insulin thrice daily,
             basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more
             than 14 days
Assessing the Efficacy of IV Ibuprofen for Treatment of Pain in Orthopedic Trauma Patients
Condition: Pain
Intervention: IV Ibuprofen; placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: , randomized, double-blind, parallel-group, placebo-controlled study. Eligible patients who signed the informed consent were randomized to either IV Ibuprofen (Caldolor®) or Placebo via a computer-generated randomization list.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Staff, including the principal investigator, study coordinator, and trauma nurses and the patients were blinded as to the treatment they received. In order to maintain the double-blind protocol, all IV bags had identical appearance and label.
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ibuprofen; Caldolor; orthopedic trauma

Summary:

      STUDY OBJECTIVES:

        1. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing pain in orthopedic trauma patients with fractures of the extremities, face,
           pelvis and/or ribs compared to patients not receiving the medication.

        2. To evaluate the effectiveness of around the clock (OTC) IV ibuprofen (8 doses) in
           decreasing the use of opioid analgesics among orthopedic trauma patients with fractures
           of the extremities, face, pelvis, and/or ribs compared to compared to patients not
           receiving the medication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Trauma patient admitted to Trauma ICU or Trauma Step-Down Units.

          2. Fracture of ribs, face, extremities and/or pelvis

          3. Age between 18 and 75 years old

          4. Adequate IV access

          5. Able to self report and communicate pain severity

        Exclusion Criteria:

          1. History of allergy or hypersensitivity to any component of IV Ibuprofen, aspirin (or
             aspirin related products) NSAIDs, or COX-2 inhibitors

          2. Any intracranial or spinal cord trauma

          3. History of clinically significant bleeding disorders including ITP, DIC or platelet
             dysfunction

          4. Recent history of intracranial surgery or stroke (within past 30 days)

          5. History of ulcers, gastritis or previous GI bleeding

          6. Renal Impairment (Creatinine > 3.0 mg/dL)

          7. Pregnant or breastfeeding

          8. Otherwise unsuitable in the opinion of the treating physician at time of
             randomization.
Nebivolol in Patients With Systolic Stage 2 Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Placebo
Intervention description: 5 mg, titrated to 20 mg, once daily oral administration; 5 mg or 20 mg once daily, oral administration
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 433.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Nebivolol; Bystolic TM; Hypertension; Stage 2 Hypertension

Summary:

      The primary object of this study is to evaluate the efficacy and safety of 6 weeks of
      nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male of female, 18 to 64 years of age at screening

          -  mean seated heart rate at least 60 bpm

          -  diagnosed systolic stage 2 hypertension

          -  unremarkable physical exam findings

        Exclusion Criteria:

          -  high risk due to secondary hypertension or former stage 3 hypertension by JNC6

          -  concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)

          -  currently taking medication that cannot be stopped during the course of the study

          -  participating other clinical trials

          -  member of the study center personnel

          -  documented drug abuse

          -  contra indication to beta blocker

          -  abnormal lab finding

          -  poor compliance

          -  other conditions judged by investigator that is not suitable for the study
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Condition: Acute Otitis Media; Otitis Media; Ear Infection
MeSH terms: Otitis; Otitis Media
Intervention: Montelukast; Placebo
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 99.0
Sex: All
Minimum age: 18 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Ear Infections; Otitis Media

Summary:

      The objective of this pilot study is to evaluate the efficacy of treatment with montelukast
      as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 months to 5 years old.

          -  Diagnosis of current AOM

        Exclusion Criteria:

          -  Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft
             palate, anatomic predisposition, major congenital anomaly or syndrome, or severe
             systemic disease

          -  Use of:

               -  Any investigational medications within the past 30 days, systemic or oral or
                  nasal steroids within the past 30 days

               -  Accolate® in the past 7 days

               -  Antibiotics within the past week, except for Zithromax®, which will be 21 days

               -  Long acting second generation antihistamines (i.e., Claritin®, Clarinex®,
                  Allegra® and Zyrtec®) within the past 72 hours.

          -  No known allergy to either montelukast or amoxicillin/clavulanate

          -  Have not responded to Augmentin® in the past
Effect of Pentoxifylline on Proteinuria in Korean Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Proteinuria; Diabetes Mellitus, Type 2
Intervention: Pentoxifylline; Placebo
Intervention description: Pentoxifylline 400mg three times a day; placebo tablet three times a day
Intervention MeSH terms: Pentoxifylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 174.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; pentoxifylline; proteinuria

Summary:

      This multi-center, randomized controlled study aims to evaluate the effects of pentoxifylline
      on proteinuria in Korean type 2 diabetic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  age >=20 years

          -  spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements

          -  patients on ACE-inhibitor or ARB as an anti-hypertensive drug

          -  blood pressure <= 150/100 mmHg

          -  HbA1c <10%

        Exclusion Criteria:

          -  taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months

          -  ischemic heart disease, stroke, malignant disease, severe infection in 6 months

          -  serum creatinine > 2.0mg/dl

          -  severe liver disease or AST, ALT > 3* ULM

          -  taking systemic steroid in 1 month

          -  pregnant or plan to become pregnant during the clinical trial

          -  lactation
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Condition: Renal Failure Chronic; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Intervention: glecaprevir/pibrentasvir treatment
Intervention description: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hemodialysis; renal failure; kidney transplant

Summary:

      Open label multi center study for the donation of HCV positive kidneys to HCV negative
      recipients with interventional treatment to prevent HCV transmission upon transplantation.
    

Eligibility criteria:

        Recipient Inclusion Criteria:

          -  Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2

          -  Listed for an isolated kidney transplantation

          -  Able to understand and adhere to the study visit schedule and all other protocol
             requirements, and must voluntarily sign and date an informed consent

          -  No available medically acceptable, compatible living kidney donor

          -  Subject must agree to use an effective method of birth control per protocol
             specifications

        Recipient Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to
             immunosuppressants utilized in kidney transplant

          -  Female who is pregnant, breastfeeding, or is planning to become pregnant during the
             course of the study

          -  History of HIV

          -  HCV RNA positive

          -  HBV surface Ag-positive or detectable HBV DNA

          -  Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased
             risk of causing early graft failure as assessed by the transplant nephrologist and/or
             investigator team

          -  Presence of clinically significant liver disease

          -  Transplant candidate requiring antibody desensitization protocol for transplantation

          -  Most recent calculated panel reactive antibody (cPRA) >80%.

          -  Prior recipient of a non-renal solid organ transplant

        Donor Organ Inclusion Criteria

          -  Deceased donor organ with kidney donor profile index (KDPI) ≤0.85

          -  HCV RNA-positive

        Donor Organ Exclusion Criteria

          -  Known prior HCV treatment with direct acting antiviral medication

          -  HIV RNA-positive

          -  HBV Surface antigen-positive or HBV DNA-positive
52 Week Trial of Liraglutide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Liraglutide; Placebos
Intervention description: Liraglutide will be compared to placebo for 24 weeks in a cross-over design; placebo will be compared to liraglutide for 24 weeks in a cross-over design
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: type 1 diabetes; overweight; insulin; liraglutide

Summary:

      To our knowledge, no trial has specifically studied the effect of liraglutide combined with a
      basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric
      model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of
      abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard
      euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this
      population.

      Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will
      present improved glucose control with decreased HbA1c, decreased fasting and mean weekly
      glucose concentrations and glycemic excursions as well as increased insulin sensitivity
      compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin
      treatment will also present improved endothelial function, lower body weight, central adipose
      tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or
             equal to 5 years

        Exclusion Criteria:

          -  diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic
             pancreatitis
Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)
Condition: Catheterization
Intervention: Hydrogel Silver Salts Coated Latex Urinary Catheter System; Bard silicone elastomer coated latex catheter system
Intervention description: Silver-coated catheter; Silicone-coated catheter
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: urinary tract infection; urinary catheter

Summary:

      Urinary catheters are often needed in hospital patients, but their use can increase the
      chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This
      study will try to determine if patients who get a new silver coated catheter will have slower
      to time to development of a CAUTI compared to patients who get an uncoated catheter.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female at least 18 years of age

          -  life expectancy of 3 months or more

          -  expected to require a urinary catheter for at least 48 hours

        Exclusion Criteria:

          -  recent urinary tract surgery or instrumentation

          -  presence of a urinary tract device

          -  concurrent genitourinary tract infection

          -  recent indwelling urinary catheter

          -  requires use of a non-study urinary catheter