bioihbjkbjnl/mcl2 huggingface dataset:
Post Marketing Surveillance for ADACEL™ in South Korea
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany
Intervention: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Intervention description: 0.5 mL, intramuscular (IM)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 659.0
Sex: All
Minimum age: 11 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adacel; Diphtheria; Tetanus; Pertussis

Summary:

      This safety surveillance study is being conducted in accordance with Korea Food and Drug
      Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new
      drug".

      The study objective is to assess within 30 days post-administration, the safety of ADACEL™
      administered under the real clinical practice.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Subjects who are 11 through 64 years of age (as indicated in the currently approved
             local product labeling) , who are given a single dose of the study vaccine, during a
             routine health-care visit, as active booster immunization for the prevention of
             tetanus, diphtheria and pertussis.

          -  Written informed consent obtained from the subject. For subjects below the legal age
             of consent, written informed consent must be obtained from the parent or legal
             guardian (legally acceptable representative -LAR) of the subject.

        Exclusion Criteria :

          -  None
Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Condition: Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Intervention: lab draws and imaging
Intervention description: 1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1013.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-therapeutic; interventional

Summary:

      This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects
      with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and
      evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of
      subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is >18 years of age at the time of consent.

          -  Subject has a confirmed diagnosis of plaque psoriasis by clinical judgment.

          -  Subject is able to read and complete questionnaires.

          -  Subjects planning to undergo radiographic evaluation, should not have any
             contraindications to MRI.

        Exclusion Criteria:

          -  None.
Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof
Condition: Cataract
MeSH terms: Cataract
Intervention: aspherical intraocular lens; spherical intraocular lens
Intervention description: implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation); implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cataract; aspherical intraocular lenses; functional vision

Summary:

      This study is to compare intraindividually the functional vision provided by two different
      posterior chamber intraocular lenses: AMO Tecnis Z9000 and Alcon SA60AT Acrysoft. To see if
      the aspherical intraocular lenses provide better functional vision than traditional spherical
      intraocular lenses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bilateral cataracts, eligible for phacoemulsification with primary implantation of a
             posterior chamber IOL

          -  Willing and able to comply with scheduled visits and other study procedures

        Exclusion Criteria:

          -  Preoperative ocular pathology potentially affect visual acuity. EX: diabetic
             retinopathy, macular degeneration, corneal opacity, glaucoma, visual field
             defect...etc.

          -  Previous ocular surgery. Ex: refractive surgery, vitreoretinal surgery...etc.

          -  Patients who cannot cooperative with the study procedures
Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Intervention: Sugammadex Injection [Bridion]; Neostigmine+Glycopyrronium
Intervention description: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.; Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: emergence delirium; tonsillectomy

Summary:

      The aim of this study is to investigate the effect of sugammadex vs. a conventional
      acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during
      sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features
      of sugammadex compared to neostigmine will be examined by measuring the time from start of
      administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and
      0.9.

      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty
      during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of
      neuromuscular blockade with sugammadex in pediatric patients maintained with
      sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular
      blockade and decreased possibility of residual blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist (ASA) physical status I or II, preschool children
             scheduled for an elective tonsillectomy with or without adenoidectomy will be included
             in the study.

        Exclusion Criteria:

          -  Patients will be excluded in cases of emergency surgery, developmental, psychological,
             cognitive or communication disorders, known or suspected neuromuscular disorders that
             may impair neuromuscular blockade, significant renal or hepatic dysfunction,
             coagulation disorders, family history of malignant hyperthermia, allergy to any of the
             drugs included in the study protocol, or usage of medication known to interact with
             rocuronium or sugammadex.
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: dexamethasone intraocular suspension, 9%; Prednisolone Acetate 1% Oph Susp
Intervention description: single dose intracameral corticosteroid; topical ophthalmic steroid drop
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled prospective study.
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To compare the signs and symptoms of dry eye after cataract surgery between subjects
      randomized to receive intraoperative dexamethasone in addition to the use of a standard
      topical post-op treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing bilateral cataract surgery

        Exclusion Criteria:

          -  central corneal staining with fluorescein and/or a tear film osmolarity of greater
             than 340 in either eye
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Placebo; Vitamin D and calcium supplementation; ibandronate [Bonviva/Boniva]
Intervention description: po monthly for 6 months; As prescribed; 150mg po monthly for 6 months
Intervention MeSH terms: Vitamin D; Ibandronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will determine the rapidity of suppression of the bone resorption marker sCTX in
      post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
      Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with
      vitamin D and calcium supplementation. The anticipated time on study treatment is
      approximately 7 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women who have been newly diagnosed with post-menopausal osteoporosis, requiring
             treatment;

          -  naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3
             months, at least 5 years before screening.

        Exclusion Criteria:

          -  patients on hormone replacement therapy (HRT) within the last 3 months;

          -  patients on other osteoporosis medication within the last 3 months;

          -  sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal
             level;

          -  hypersensitivity to any component of ibandronate;

          -  contraindication for calcium or vitamin D therapy;

          -  history of major gastrointestinal upset;

          -  malignant disease diagnosed within the previous 10 years (except resected basal cell
             cancer).
Total Intravenous Anesthesia in Sinus Surgery
Condition: Advanced Chronic Rhinosinusitis
Intervention: Propofol; Sevoflurane
Intervention MeSH terms: Propofol; Sevoflurane; Isoflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve
      visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease
      in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation
      associated with inhaled anesthetics. This may be especially important in cases of advanced
      inflammatory sinus disease, when visualization may be most compromised. The goal of this
      study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled
      anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing endoscopic sinus surgery

          -  Advanced inflammatory sinus disease, defined as allergic fungal sinusitis, chronic
             rhinosinusitis with nasal polyposis, chronic rhinosinusitis with eosinophilia, or
             rhinosinusitis with pan-sinus opacification (Lund-Mackay score >12).

        Exclusion Criteria:

          -  Noninflammatory sinonasal disease

          -  Disease extending through the skull base or orbital wall

          -  American Society of Anesthesiologists Preoperative Health Status >II

          -  Known non-pharmacologic coagulopathy (platelet < 50000/mL, international normalized
             ratio > 1.2)

          -  Preoperative anticoagulants within 7 days of surgery

          -  Allergy to one of the study medications

          -  Age under 18 years

          -  Non-English-speaking
Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients
Condition: Infection in Solid Organ Transplant Recipients
Intervention: prophylactic Valganciclovir
Intervention description: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis, with stratified dose reductions for impaired renal function. Max dose was 900 mg.
Intervention MeSH terms: Valganciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and
      prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children.
      valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC)
      (0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety.
      Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few
      published dosing algorithms result in AUC out of range.

      Objective: To prospectively validate a Valganciclovir administration dosing regimen and
      compare it to other dosing algorithms.

      Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary
      pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing regimen
      was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For impaired renal
      function, stratified dose reduction was used. Blood was withdrawn at steady state: 2, 5 and
      10 hours post dosing. Drug level was analyzed by high pressure liquid chromatography (HPLC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. children and adolescents 0-18 years old

          2. Solid Organ Transplantation admitted after transplantation

          3. Treatment with prophylactic Valganciclovir

          4. Glomerular Filtration Rate (GFR) >= 60 mL/min/1.73 m2

        Exclusion Criteria:

          1. Treatment with ganciclovir IV

          2. Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2

          3. Imipenem treatment

          4. Cluster organ transplanted -
The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
Condition: Hepatectomy
MeSH terms: Arterial Occlusive Diseases
Intervention: Ketamine; Placebo
Intervention description: Ketamine: 0.25 mg/kg, intravenously, one dose.; saline solution
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: hepatectomy; IL 6; organ failure; ketamine; Pringle

Summary:

      The purpose of this study is to determine whether ketamine is effective to inhibit
      interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 21 or older

          -  Planned liver resection with Pringle maneuver lasting 30-60 minutes

        Exclusion Criteria:

          -  Chronic illness requiring corticosteroids

          -  Cirrhosis

          -  Hemodynamic instability prior to surgery

          -  Diabetes

          -  Sepsis

          -  Surgical interventions or chemotherapy treatments within the past 30 days

          -  Pregnancy

          -  Illnesses that could potentially affect the hepatic circulation

          -  Arterial hypertension

          -  Ocular hypertension

          -  Allergy to ketamine

          -  Preoperative portal embolization

          -  Radiofrequency ablation

          -  Patients requiring emergency surgeries
Mechanisms of Lipodystrophy in HIV-Infected Pateints
Condition: HIV Infections
MeSH terms: Lipodystrophy
Intervention: Nelfinavir; Efavirenz
Intervention MeSH terms: Efavirenz; Nelfinavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HIV; Lipodystrophy; Treatment Experienced

Summary:

      The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not
      known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and
      reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

      The project therefore has the following aims: 1) to characterize metabolic abnormalities and
      changes in body fat distribution, 2) to develop objective criteria for defining the syndrome
      and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the
      lipodystrophy syndrome in HIV-infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV Positive

          -  No previous antiviral therapy

          -  18 to 70 years of age

        Exclusion Criteria:

          -  Patients with opportunistic infections or AIDS.

          -  Active intravenous drug users.

          -  Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications,
             dehydroepiandrosterone, oxandrolone, megace.

          -  Patients with diabetes mellitus.

          -  Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per
             week).

          -  Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to
             conceive (defined as women taking oral contraceptives, using barrier protection during
             intercourse or with a copper intrauterine device in place for > 3 months without
             complaints and a negative serum or urine pregnancy test within 30 days of study
             entry).

          -  Acute or chronic liver diseases; elevations of liver transaminases by more than two
             and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L,
             ) or a total bilirubin of > 1.5mg/dL.

          -  Anemia (hematocrit <32%).

          -  Abnormal thyroid function tests.

          -  Weight loss >10% from baseline in the past year.

          -  Recent (within the past year), history of suicide attempt.
Corticolimbic Degeneration and Treatment of Dementia
Condition: Dementia
MeSH terms: Dementia
Intervention: Memantine (Namenda®); Donepezil (Aricept®)
Intervention description: Drug treatment will begin with 5 mg/day of donepezil for six weeks. After six weeks of such treatment, the subjects symptoms will be re-evaluated and any side-effects of treatment assessed and recorded. If no serious side-effects of donepezil are encountered, the dose of donepezil will be increased to 10 mg/day. For subjects prescribed the combination of donepezil and memantine, memantine (20 mg/day) will be added to the drug treatment regimen after the dose of donepezil has been established (i.e., at six weeks). Again, memantine will be initially started at 10 mg/day and increased to its full dose only if no serious side-effects are encountered.; 5mg/day for six weeks and if no serious side-effects increased to 10mg/dy.
Intervention MeSH terms: Memantine; Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 50 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Dementia of the Alzheimer type

Summary:

      The overall purpose of this research is to determine if there is a relationship between your
      symptoms of Dementia of the Alzheimers type and changes in the size and shape of certain
      brain structures during combined Donepezil (Aricept®) and Memantine (Namenda®) treatment.
    

Eligibility criteria:

        Inclusion Criteria: 1) meets National Institute of Neurological and Communicative Disorders
        and Stroke and the Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA)
        Alzheimer's criteria for dementia of the Alzheimer's type (DAT), 2) Clinical Dementia
        Rating (CDR) score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or
        has a primary caregiver or legal guardian, who can give informed consent.

        Exclusion Criteria: 1) other psychiatric (e.g., depression) or neurological (e.g., CVA)
        disorders that would confound the assessment of dementia symptoms, 2) history of loss of
        consciousness, and 3) unstable or severe medical illness (e.g., hepatotoxicity) that would
        make donepezil or memantine treatment or participation in other aspects of the study
        unsafe.