bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Contact Lens Wear on Immune Cell Density and Morphology of the Ocular Surface
Condition: Myopia; Refractive Error
MeSH terms: Refractive Errors
Intervention: ReNu MultiPlus® MultiPurpose Solution; OPTI-FREE® RepleniSH®; Clear Care®
Intervention description: Contact lens care regimen; Contact Lens care regimen; Contact lens care regimen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contact lens; Lens care

Summary:

      The purpose of this study is to utilize in-vivo confocal microscopy to describe differences
      in corneal epithelial immune status across three lens care regimens in new contact lens
      wearers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be 18 years of age and may be of any race and either gender.

          2. Subjects must not have ever worn contact lenses.

          3. Subjects must have normal, healthy eyes.

        Exclusion Criteria:

          1. Subjects must not use additional lens cleaners.

          2. subjects must not have any ocular or systemic disease.

          3. Subjects must not have history of ocular surgery/trauma within the last 6 months.
Use of Topical Tranexamic Acid and Bacitracin in Dialysis Patients
Condition: Arteriovenous Fistula
MeSH terms: Arteriovenous Fistula; Fistula
Intervention: Topical Tranexamic Acid 5% with bacitracin; Topical Tranexamic Acid 25% with bacitracin
Intervention description: Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.; Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
Intervention MeSH terms: Bacitracin; Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemodialysis; fistula; clotting; tranexamic acid; bacitracin

Summary:

      This study will investigate how the use of Tranexamic acid and Bacitracin applied to the
      bleeding site after the hemodialysis fistula needle is removed will affect Time to Clot and
      Infection Rate
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dialysis patients with fistulas (native arterio-venous)

        Exclusion Criteria:

          -  Previous sensitivity to or adverse reaction to Tranexamic acid or Bacitracin.

          -  Active infection.

          -  Stenosis of fistula.
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg oral administration; Oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: capsule; endoscopy; prokinetic; lubiprostone; Normal; volunteers

Summary:

      This investigation is designed to compare lubiprostone and placebo for cleansing and
      propulsion in preparation for capsule endoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers

        Exclusion Criteria:

          -  Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade
Condition: Neuromuscular Blockade
MeSH terms: Disease
Intervention: rocuronium; sugammadex; placebo
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: surgical conditions; laparoscopy

Summary:

      To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no
      neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with
      pneumoperitoneum 12 mmHg.

      Hypothesis:

      Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to
      skin surface, cm) compared to no neuromuscular blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients > 18 years old

          -  elective laparoscopic operation

          -  can read and understand Danish

          -  informed consent

        Exclusion Criteria:

          -  BMI > 30 kg/cm2

          -  known allergy to medications that are included in the project,

          -  severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or
             hemodialysis),

          -  neuromuscular disease that may interfere with neuromuscular data,

          -  lactating or pregnant,

          -  impaired liver function,

          -  converting to laparotomy,

          -  perioperative use of neuromuscular blocking agents before randomization,

          -  pneumoperitoneum set to >12 mmHg on the insufflator
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V
Intervention description: Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:
15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal
      V fulfills the EMEA requirements for re-registration of influenza vaccines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female and male adults

          -  Aged ≥18 to ≤60 years or >60 years on Day 1

          -  Written informed consent

        Exclusion Criteria:

          -  Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or
             other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Prior vaccination with an influenza vaccine in the past 330 days

          -  Known hypersensitivity to any vaccine component

          -  Previous history of a serious adverse reaction to influenza vaccine

          -  History of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of the study vaccine,
             incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent
             (inhaled or topical steroids are allowed)

          -  Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Pregnancy or lactation

          -  Participation in another clinical trial

          -  Employee at the investigational site, or relative or spouse of the investigator

          -  Suspected non-compliance
The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications
Condition: Postoperative Complications; Neuromuscular Blockade
MeSH terms: Postoperative Complications
Intervention: Sugammadex; Neostigmine
Intervention description: At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow; At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
Intervention MeSH terms: Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sugammadex; Neuromuscular Blockade

Summary:

      Substantial respiratory morbidity has been associated with postoperative residual paralysis,
      which is fairly common after general anesthesia involving a neuromuscular blocking agent.
      Common practice in United States is to reverse neuromuscular blockade with neostigmine at the
      end of surgery. A new drug with evidence of more complete neuromuscular reversal has been
      developed, sugammadex. The objective of this study is to determine if a strategy of
      rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects with
      any postoperative pulmonary complication, compared to neostigmine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 70 years

          -  Elective surgery Monday through Friday in the South Operating Rooms of Oregon Health
             and Science University (OHSU)

          -  Planned general endotracheal anesthesia

          -  Expected surgical duration ≥ 3 hours

        Exclusion Criteria:

          -  Prisoners

          -  An inability to consent for surgery or anesthesia

          -  Surgery for which neuromuscular blockade is contraindicated (e.g. neurosurgical,
             orthopedic, and head and neck surgery in which nerve monitoring will be employed)

          -  A known neuromuscular disorder

          -  Stage 4 chronic kidney disease or worse (estimated glomerular filtration rate < 30
             ml/min)

          -  Liver Disease

          -  An allergies to Sugammadex, Rocuronium, Neostigmine, or Glycopyrrolate

          -  Patients taking Toremifene
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single-arm study will evaluate the safety, tolerability and efficacy of
      tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who
      experience an inadequate clinical response to a stable dose of non-biologic disease modifying
      anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be
      administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be
      administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6
      infusions. The anticipated time on study treatment is 24 weeks. The target sample size is
      50-150 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration

          -  inadequate clinical response to non-biologic DMARDs or anti-TNF

          -  bodyweight </=150 kg

        Exclusion Criteria:

          -  rheumatic autoimmune disease or inflammatory joint disease other than RA

          -  major surgery within 8 weeks prior to screening or planned major surgery within 6
             months following screening
Pilot Evaluation of Atomoxetine on Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Adolescents With Cannabis abusE
Condition: Attention Deficit Hyperactivity Disorder; Cannabis Abuse
MeSH terms: Hyperkinesis; Marijuana Abuse; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder with Cannabis Abuse; Marihuana Abuse; Comorbid Cannabis Abuse

Summary:

      The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD
      (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid
      cannabis abuse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis ADHD based on the Diagnostic and Statistical Manual of Mental Disorders
             (DSM-IV-TR)

          -  At least 1.5 standard deviations above the age norm for their diagnostic subtype using
             published norms for the ADHD Rating Scale-IV-Parent Version

          -  Cannabis Abuse or dependence based on the DSM-IV-TR, and using a minimum of 5 joints
             per week

        Exclusion Criteria:

          -  Weight under 20 kilograms (kg)

          -  Patients at serious suicidal risk

          -  Patients with alcohol or drug abuse (other than cannabis)

          -  Patients who in the investigator's judgement are likely to need psychotropic
             medication + psychotherapy apart from atomoxetine
Efficacy of a Combination of Amlodipine/Valsartan on 24H Blood Pressure Control With One Nocturnal or Diurnal Intake a Day
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine; Valsartan
Intervention description: 5 mg or 10 mg tablets.; 160 mg capsules.
Intervention MeSH terms: Amlodipine; Valsartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; ambulatory blood pressure monitoring

Summary:

      This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label,
      blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients
      with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5
      mg alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years

          -  Essential uncontrolled or naive hypertensive patients (SBP ≥= 140 mmHG, DBP - >/=90 mm
             Hg, or SBP >= 130 mmHg, DBP >= 80 mmHg if diabetes or renal impairment) except
             patients treated with amlodipine, or intolerant of ARBs and/or calcium channel
             blockers.

        Exclusion Criteria:

          -  Severe hypertension : SBP >= 180 mmHg, DBP >= 110mmHg

          -  Pregnancy

          -  Allergia to ARBs and/or to calcium channel blockers

          -  Antihypertensive tritherapy at V1

          -  History of heart failure, pectoris angina, stroke, myocardial infarction

          -  Diabetes type I

          -  Renal impairment
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
Condition: Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain
Intervention: Fentanyl
Intervention description: Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Low back pain; Fentanyl transdermal patch; Durogesic-D-Trans

Summary:

      The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino
      participants with osteoarthritis (disorder which is seen mostly in older persons in which the
      joints become painful and stiff) and chronic (lasting a long time) low back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with osteoarthritis and chronic low back pain

          -  3 months of persistent moderate to severe pain levels

          -  More than 3 times a week frequency or daily moderate to severe pain

          -  Moderate to severe pain at Baseline (at least a score of 4 in the 11-point numerical
             pain scale) Exclusion Criteria

          -  History of allergy to fentanyl transdermal patch or its components and history of
             illicit drug use for the past 3 months

          -  Active skin disease preventing application of the transdermal system

          -  Chronic pulmonary disease (lung disorder)

          -  Participants susceptible to intracranial (inside the skull) effects of carbon dioxide
             retention

          -  Pregnant and breastfeeding mothers
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Phase 1: Etanercept; Phase 1: Methotrexate; Phase 2: Optional ETN, SSZ, HCQ, MTX; Phase 1: Methotrexate; Phase 1: Conventiaonal DMARD
Intervention description: Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24; Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.; Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128.
Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128.
Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128.
Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.; Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.; Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: enbrel; moderate arthritis; severe arthritis; rheumatoid arthritis

Summary:

      The purpose of this 2 phased, open-label study is to compare the safety and efficacy of
      etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin
      American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a
      randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that
      allows the investigator to choose continuation with the phase I treatment or the addition,
      discontinuation or titration of other DMARD therapy already being utilized for the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Rheumatoid Arthritis (RA)

          -  Currently receiving a suboptimal response to a stable dose of methotrexate for
             treatment of Rheumatoid Arthritis (RA)

          -  Active Rheumatoid Arthritis (RA) at time of screening and baseline

        Exclusion Criteria:

          -  Previous or current treatment with etanercept, other tumor necrosis factor-alpha
             inhibitors, or other biologic agents

          -  Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than
             methotrexate, at screening

          -  Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate,
             within 3 months before screening
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
Condition: Sepsis
MeSH terms: Sepsis
Intervention: Doripenem
Intervention description: Doripenem 1 gm administered over 4 hours X 3 doses
Intervention MeSH terms: Doripenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Pharmacodynamics; Doripenem; Trauma; sepsis; Trauma patients with sepsis

Summary:

      The study hypothesis is to measure how the drug doripenem is cleared from the body of
      critically ill trauma patients. The investigators will measure blood drug concentrations and
      calculate how much the drug distributes in the body and how fast it is removed from the body.
      There is little information on how drugs are cleared in critically ill patients and the wrong
      dose of a drug could make it ineffective. The investigators will use this information to
      predict the most reasonable dose to treat infections effectively in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are 18 years of age or older

          -  Admitted to Emory surgical intensive care unit (ICU) service

          -  Have a diagnosis of sepsis that requires empiric antimicrobial therapy

          -  Obtained written informed consent from the patient or a first-degree relative if the
             patient is unable to give informed consent due to his/her medical condition prior to
             initiation of any study procedure

        Exclusion Criteria:

          -  Surgical ICU length of stay less than 24 hours

          -  Acute or chronic renal dysfunction (urine output less than 0.5 mL/kg/hr or calculated
             creatinine clearance of less than 50 mL/min)

          -  Pregnancy

          -  Known allergy to beta-lactam antibiotics

          -  Non-English-speaking patients