bioihbjkbjnl/mcl2 huggingface dataset:
Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Intervention description: Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
Intervention MeSH terms: Olopatadine Hydrochloride; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 215.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis

Summary:

      The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once
      daily in patients previously treated with twice-daily, topical, ocular, anti-allergy
      medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older.

          -  History (within the past 24 months) of allergic conjunctivitis.

          -  Active signs and symptoms of ocular allergies.

          -  Ocular health within normal limits, as determined by the investigator or
             subinvestigator.

          -  Willing to avoid contact lens wear each study visit immediately prior to study
             medication instillation and for 10 minutes after instillation of study drug.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Contraindications or hypersensitivity to study medication or its components.

          -  One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the
             screening visit.

          -  Known history of recurrent corneal erosion syndrome.

          -  Ocular trauma or surgical intervention within 6 months prior to Visit 1.

          -  Participation in any other investigational study within 30 days before Visit 1.

          -  Pregnant or nursing.

          -  Other protocol-defined exclusion criteria may apply.
Low and High Dose Zonisamide in Children as Monotherapy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: zonisamide low dose group; zonisamide high dose group
Intervention description: Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.; Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.
Intervention MeSH terms: Zonisamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in
      children with epilepsy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Pediatric patients with epilepsy whose age is 2~15 years old.

          2. Patients had at least two seizures for the last 6 months before entry.

          3. Patients who had never taken antiepileptic drugs.

          4. Patients with no chance of progressive disease based on the result of magnetic
             resonance imaging (MRI) or electroencephalogram (EEG).

          5. Agreement of the guardian is needed.

        Exclusion criteria:

          1. Patients who have progressive central nervous system (CNS) disease.

          2. Patients with serious disorder.

          3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase
             [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the
             normal values.

          4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine)
             values more than three times the normal values.

          5. Hemolytic anemia.
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Condition: Cataracts
MeSH terms: Cataract
Intervention: Ketorolac Tromethamine; Bromfenac; nepafenac
Intervention description: ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery; Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery; drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Nepafenac; Bromfenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will
      be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects
      will be instructed to begin dosing the study medication in the operative eye the day before
      surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop
      of study medication will be instilled by operating room staff approximately every 15 minutes
      for a total of 3 doses. At the designated time a paracentesis will be performed at the start
      of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample
      will be immediately stored on dry ice and shipped to a laboratory for analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18 years of age or older

          -  Scheduled for cataract surgery by phacoemulsification

          -  Subjects must be willing to comply with all study requirements and be willing to give
             informed consent

        Exclusion Criteria:

          -  Any subject that has a history of uveitis or active iritis

          -  Subject can have o previous eye surgery with the exception of refractive surgery but
             not within 6 month

          -  No ocular use of prostaglandins within 2 weeks of surgery

          -  Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants
             within 14 days prior to surgery

          -  Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)

          -  Active ocular infection
A Study of The Relationship Between Drop in Hemoglobin and Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; ribavirin [Copegus]
Intervention description: 180 mcg subcutaneously weekly; 1000 mg or 1200 mg orally daily
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multicenter, phase IV study will evaluate the relationship between the drop
      in hemoglobin levels and sustained virological response in patients with chronic hepatitis C
      genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients
      will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously
      weekly. Anticipated time on study treatment, depending on virological response, will be 48 or
      72 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Chronic hepatitis C, genotype 1

          -  Treatment-naïve or patients who relapsed or failed to respond to previous combination
             therapy with interferon and ribavirin

          -  Detectable HCV-RNA

          -  Fertile males and females of child-bearing potential must agree to use two forms of
             contraception during treatment and for 6 months after treatment end

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Male partners of pregnant women

          -  History or evidence of a medical condition associated with chronic liver disease other
             than HCV

          -  Co-infection with active hepatitis A, hepatitis B and/or HIV virus

          -  Hepatocellular carcinoma

          -  History or evidence of oesophageal varices or other conditions consistent with
             decompensated liver disease

          -  Anemia

          -  Any patient with increased baseline risk for anemia (e.g. thalassemia, spherocyctosis,
             history of GI bleeding)

          -  History or evidence of significant cardiovascular disease

          -  Kidney disease

          -  Severe retinopathy

          -  History of severe psychiatric disease, especially depression

          -  Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment
             (including supraphysiologic doses of steroids and radiation) </= 6 months prior to
             first dose of study drug
Weight Loss With Risedronate for Bone Health
Condition: Bariatric Surgery Candidate; Bone Loss; Weight Loss
MeSH terms: Body Weight; Weight Loss
Intervention: Risedronate Sodium 150 MG; Placebo
Intervention description: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.; Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Intervention MeSH terms: Risedronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Masking: Double (Participant, Care Provider)
Masking description: Both participant and research associate charged with administering medication or placebo capsules will be blinded.
Enrollment: 24.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bone Health

Summary:

      This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and
      following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT)
      examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical
      weight loss associated loss of bone mass and quality.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects planning a sleeve gastrectomy procedure

          -  40-79 yrs of age

          -  Willingness to provide informed consent

          -  Agreement to all study procedures and assessments

        Exclusion Criteria

          -  Age <40 years

          -  Baseline weight >450 pounds

          -  Chronic anti-reflux treatment

          -  History of medical disorders known to affect bone metabolism

          -  Use of bone-active medications

          -  Known allergy to Risedronate
Enoxaparin Dosing in Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: Enoxaparin
Intervention description: Twice daily dosing
Intervention MeSH terms: Enoxaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enoxaparin dosing; Obesity

Summary:

      The purpose of this study is to determine an effective enoxaparin dosing strategy in
      medically ill, morbidly obese patients. This study will include adult patients greater than
      18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable
      patients such as prisoners, children, and pregnant women will not be enrolled in the study.
      Study participants will be contacted in person by the study personnel once inclusion criteria
      are met. Written informed consent will be obtained in person while hospitalized. Once the
      patient is consented they will be given enoxaparin and blood samples will be drawn. The data
      collected will be from the electronic medical record which is accessed only with a username
      and password so it is not publicly available. The data will be identifiable upon collection
      and will be kept on a password protected file on a computer in a locked office. The data will
      be de-identified after data analysis and only the study personnel will have access to the
      code that links identifiers to subjects. A HIPAA waiver will be requested to access existing
      data in order to identify patients for enrollment. All data will be collected in an office in
      the hospital. The study participants' burden will be minimal and dependent only on time of
      consent process since morbidly obese patients would be receiving this blood sample collection
      regardless of their participation in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned treating with twice daily enoxaparin

          -  BMI >= 40 kg/m2

        Exclusion Criteria:

          -  < 18 years of age

          -  CrCl < 30 ml/min

          -  Pregnancy

          -  Prisoner

          -  Active bleeding

          -  Already received 3 consecutive doses of enoxaparin

          -  Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3
             months
Hip Fracture Exparel Administration Trial Capsule During Hemiarthroplasty
Condition: Intracapsular Fracture of Femur; Femoral Neck Fractures; Hip Hemiarthroplasty
MeSH terms: Fractures, Bone; Femoral Neck Fractures; Femoral Fractures
Intervention: Bupivacaine liposome; Saline
Intervention description: A long-acting liposomal bupivacaine; Saline injection used as control
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be a total of 50 patients enrolled in this randomized blinded prospective two arm study. The participants will be randomized into either the control or the EXPAREL treatment group, with 25 patients in each cohort.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participants, Investigator(s), outcome assessors will all be blinded throughout the duration of the trial. Care providers pre- and post- op will be blinded as well, the operative team will not be blinded.
Enrollment: 50.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Exparel; Bupivacaine; Intracapsular Fracture of the Femur; Femoral Neck Fracture; Hip Hemiarthroplasty

Summary:

      This study will examine the efficacy of Liposomal Bupivacaine (Exparel) in hip fracture
      patients undergoing hip hemiarthroplasty for femoral neck fractures through a posterior
      approach. Post-operative measures will be assessing pain, overall opiate use, delirium,
      time-to-ambulation and discharge status.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women sixty-five years of age and older with isolated intracapsular hip fractures
        undergoing hemi arthroplasty through a posterior approach with the ability to consent to
        the study.

        Exclusion Criteria:

        Under sixty-five years of age, extracapsular hip fracture, suffer from any form of
        cognitive compromise that leaves them unable to consent, or if they are treated with any
        surgical modality other than hip hemiarthroplasty.
Low-dose Ketamine vs Morphine for Vaso-occlusive Crisis in Sicklers
Condition: Sickle Cell Crisis; Acute Pain
MeSH terms: Acute Pain
Intervention: Low dose ketamine; Morphine
Intervention description: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.; Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.
Intervention MeSH terms: Ketamine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial will inform of the role of Low dose ketamine in the acute treatment of
      severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary
      aim is to determine whether Low dose ketamine is non inferior to morphine in the management
      of acute painful sickle cell crises. The specific objectives will be to determine the maximal
      change in NRS pain score following administration of ketamine and to examine the safety
      profile of ketamine compared to morphine in this population.

      The investigators hypothesize that low dose ketamine will result in similar effective pain
      control as morphine alone and will not be associated with an increase in adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 7-18 years

          -  sickle cell anemia patient with severe acute painful crisis

          -  Parental consent and child assent where applicable

        Exclusion Criteria:

          -  Oxygen saturations below 90% on initial assessment

          -  Altered conscious and mental state that hinders communication

          -  Current enrollment in another clinical trial involving an investigational drug.

          -  History of a stroke

          -  Hypertension,

          -  Increased intracranial pressure.

          -  Glaucoma,

          -  Failed/ Difficult IV access
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
Condition: Health Care Associated Pneumonia; Osteomyelitis/Septic Arthritis; Endocarditis; Bacteremia; Acute Bacterial Skin and Skin Structure Infections
MeSH terms: Bacteremia; Osteomyelitis; Arthritis, Infectious; Healthcare-Associated Pneumonia; Endocarditis
Intervention: Vancomycin; Ceftaroline; Daptomycin; Linezolid
Intervention description: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;
Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;; Dose based on package insert labeling
CrCL > 50 mL/min: 600 mg IV q12h
CrCL 31-50 mL/min: 400 mg q12h
CrCL 15-30 mL/min: 300 mg q12h
CrCL < 15mL/min: 200 mg q12h;; Dose based on renal function and literature dosing recommendations
CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h
CrCL < 30 mL/min: 6 - 10 mg/kg IV q48h; 600 mg IV/PO q12h
Intervention MeSH terms: Vancomycin; Linezolid; Daptomycin; Ceftaroline fosamil
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of
      vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed
      and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical
      concern. This may be due to various reasons, including new dosing recommendations as well as
      an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity.
      This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin
      use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older

          -  Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia,
             osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and
             skin structure infections

          -  Expected to receive vancomycin for at least 72 hours and are within the first 72 hours
             of therapy

          -  Have at least two or more of the following risk factors for drug-induced
             nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four
             grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e.
             aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous
             contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5
             mg/dL).

        Exclusion Criteria:

          -  Pregnancy

          -  End-stage renal disease

          -  Receipt of more than 4 grams of vancomycin prior to enrollment on current admission

          -  Absolute neutrophil count < 1000/mm3