bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: Sabin mOPV2
Intervention description: Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate.
One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine
      type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 1 to 5 years of age, previously vaccinated with three or four doses of IPV.

          2. Healthy without obvious medical conditions that preclude entry of the subject into the
             study as established by the medical history and physical examination.

          3. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per
             country regulations.

        Exclusion Criteria:

          1. Previous vaccination against poliovirus outside the national immunization schedule.

          2. Any confirmed or suspected immunosuppressive or known immunodeficient condition
             including human immunodeficiency virus (HIV) infection.

          3. Family history of congenital or hereditary immunodeficiency.

          4. Major congenital defects or serious uncontrolled chronic illness (neurologic,
             pulmonary, gastrointestinal, hepatic, renal, or endocrine).

          5. Known allergy to any component of the study vaccines or to any antibiotics.

          6. Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          7. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a
             contraindication for vaccination (the child can be included at a later time if within
             age window and all in/exclusion criteria are met.).

          8. Member of the subject's household (living in the same house or apartment unit) has
             received OPV in the last 3 months.

          9. Subject who, in the opinion of the Investigator, is unlikely to comply with the
             protocol or is inappropriate to be included in the study for the safety or the
             benefit-risk ratio of the subject.
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Mavenclad®
Intervention description: Participants with Relapsing Multiple Sclerosis (RMS) received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.
Intervention MeSH terms: Cladribine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Mavenclad®; Cladribine; Health-related Quality of Life

Summary:

      The main purpose of the study was to assess the health-related quality of life (HRQoL)
      through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in
      highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2
      years (24 months).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Highly active RMS as defined by:

          -  One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or
             more T2 lesions, while on therapy with other disease modifying drugs (DMDs).

          -  Two or more relapses in the previous year, whether on DMD treatment or not.

          -  Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.

          -  Other protocol defined inclusion criteria could apply.

        Exclusion Criteria:

          -  Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for
             immunoglobulin G (IgG) and/or immunoglobulin M (IgM).

          -  Current or previous history of immune deficiency disorders including a positive human
             immunodeficiency virus (HIV) result.

          -  Currently receiving immunosuppressive or myelosuppressive therapy with, for example,
             monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine,
             or chronic use of corticosteroids.

          -  History of tuberculosis, presence of active tuberculosis, or latent tuberculosis

          -  Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance
             Imaging (MRI).

          -  Active malignancy.

          -  Other protocol defined exclusion criteria could apply.
A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures.
Condition: Supracondylar Fractures
MeSH terms: Fractures, Bone
Intervention: Fentanyl; Ropivacaine
Intervention description: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.; Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
Intervention MeSH terms: Fentanyl; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 78.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study compares nerve blocks to IV pain medicines in children with broken arms. We are
      trying to see if blocking the nerves in the broken arm results in better pain control and
      less side effects than injections of morphine into a vein after surgery for a broken elbow.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Supracondylar fracture (2) Age 2-17 years (3) American Society of Anesthesiologists
        Status 1 -3 (4) Scheduled for closed reduction with percutaneous pinning under general
        anesthesia

        Exclusion Criteria:

          1. Pulseless extremity

          2. Compromised neurologic status on exam (specifically assessment of radial, ulnar, and
             median nerve)

          3. Known allergy to local anesthetics (7) Not scheduled for closed reduction with
             percutaneous pinning under general anesthesia

          4. Bleeding diathesis

          5. American Society of Anesthesiologist (ASA) status 4 or higher.

          6. Sleep apnea by polysomnography
Study of the Durability of Glycemic Control With Nateglinide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Nateglinide; Glimepiride
Intervention description: Nateglinide 90~120mg three times a day; Glimepiride 1~2mg once a day
Intervention MeSH terms: Glimepiride; Nateglinide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Nateglinide; Pancreatic beta cell function

Summary:

      This multi-center, randomized controlled study aims to evaluate the durability and efficacy
      of nateglinide therapy for long term glycemic control compared with glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  age>=18years

          -  no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

               -  metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day,
                  gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or
                  sulfonylurea <6months)

          -  6.5% ≤ HbA1c ≤ 8.5%

               -  patients on no anti hyperglycemic agent for 3 months : HbA1c at screening

               -  patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

        Exclusion Criteria:

          -  attending other clinical trials in 3months

          -  type I diabetes mellitus

          -  taking systemic steroid in 1month or requiring steroid therapy during clinical trial

          -  acute myocardial infarction in 6months

          -  alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis

          -  severe liver disease or AST, ALT ≥ 2.5 x ULN

          -  renal insufficiency (serum creatinine > 2.0mg/dl)

          -  other severe diabetic complication

          -  drug hypersensitivity history to nateglinide or sulfonylurea

          -  pregnant or plan to become pregnant during the clinical trial, lactation
Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Bupivacaine
Intervention description: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 155.0
Sex: All
Healthy volunteers: No

Summary:

      The objective of the study is to compare the efficacy of adductor canal blocks versus
      periarticular bupivacaine injections for pain management in total knee arthroplasty. This
      randomized clinical trial will compare outcomes between adductor canal blocks, periarticular
      bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this
      study will help determine the most appropriate perioperative pain management strategy for
      patients undergoing a total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients undergoing an unilateral primary total knee arthroplasty under the care of the
        two senior arthroplasty surgeons.

        Exclusion Criteria:

        - Allergy to bupivicaine or liposomal bupivicaine.
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy
Condition: Post-operative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant 80 mg Oral Capsule; scopolamine transdermal; Total intravenous anesthesia; Dexamethasone; Ondansetron; Reglan; Ondansetron; Compazine; Sugammadex; Propofol; dexmedetomidine; Fentanyl; Sevoflurane; Desflurane
Intervention description: aprepitant 80 mg orally one hour prior to scheduled surgery; scopolamine transdermal patch one hour prior to scheduled surgery; Maintenance of anesthesia without the use of inhaled anesthetics.; Dexamethasone 8 mg intraoperatively; Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.; Postoperatively scheduled Reglan; Postoperatively scheduled ondansetron; Postoperatively as needed compazine for breakthrough PONV; Reversal with sugammadex; Intravenous anesthesia will be maintained through IV propofol; maintenance of anesthesia in the intervention arm; intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance; inhalational anesthesia; inhalational anesthesia
Intervention MeSH terms: Dexamethasone; Fentanyl; Scopolamine; Dexmedetomidine; Ondansetron; Aprepitant; Metoclopramide; Prochlorperazine; Propofol; Sevoflurane; Desflurane; Butylscopolammonium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bariatric Procedure

Summary:

      Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and
      vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses
      on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and
      aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The
      investigators hypothesize that the intervention group will experience a reduction of
      nausea-related prolonged hospital stay and significantly improve patient-reported quality of
      recovery from surgery and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (18 years and older) undergoing LSG

        Exclusion Criteria:

          -  Allergy to medications delineated in the protocol (muscle blockade, anesthetics,
             reversal agents)

          -  Inability to provide informed consent

          -  History of chronic nausea and emesis requiring medication

          -  Poorly controlled diabetes (HgA1c>9 mg/dl),

          -  History of previous bariatric or gastro-esophageal surgery
Network-Level Effects of Nitrous Oxide in the Human Brain
Condition: Healthy
Intervention: Nitrous Oxide Gas for Inhalation
Intervention description: Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on
      the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is
      limited knowledge on how this drug affects functional networks in the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index <30

          2. Must be right-handed

          3. Must be capable of giving written informed consent

        Exclusion Criteria:

          1. History of obstructive sleep apnea;

          2. History of a difficult airway with a previous anesthetic

          3. Gastroesophageal reflux;

          4. Hypertension or other cardiovascular abnormalities;

          5. Pulmonary hypertension;

          6. History of recreational drug use;

          7. History of chronic alcohol abuse

          8. Having any chronic medical illness involving pain;

          9. History of major depression;

         10. History of psychosis or bipolar disorder;

         11. History of methylenetetrahydrofolate reductase deficiency;

         12. History of a known hypersensitivity to ketamine, midazolam, Zofran, labetalol or
             glycopyrrolate

         13. History of seizures or other neurologic disorders;

         14. Pregnant or nursing mothers;

         15. Tattoos on the head or neck region - all other tattoos are subject to determination by
             investigators;

         16. Contraindications to neuroimaging methods;

         17. Any impairment, activity or situation that in the judgment of the Study Coordinator or
             Principal Investigators would prevent satisfactory completion of the study protocol.
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
Condition: Transplant Glomerulopathy
Intervention: Acthar gel
Intervention description: Administration of the study drug in addition to the current maintenance immunosuppressive agents
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is an open label safety and feasibility trial using Acthar® in addition to the
      investigators center-specific standard therapy, which could include increase in maintenance
      immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in
      patients with chronic antibody-mediated rejection (CAMR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >18 years

          -  Morphologic diagnosis of CAMR, by light &/or electron microscopy any time after
             transplantation

          -  Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse
             peritubular capillary C4d staining by immunohistochemistry

          -  eGFR>25 ml/min

        Exclusion Criteria:

          -  Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous
             basal cell or squamous cell carcinoma).

          -  Lack of evidence of antibody involvement

          -  Pregnancy, lactation, or refusal to use birth control in women of child bearing
             potential

          -  Active infection, or history of HIV

          -  History of liver or thoracic transplant
A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Dysport® (abobotulinumtoxinA); Botox® (onabotulinumtoxinA)
Intervention description: Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units; Cross over injection of Dysport® (<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cervical dystonia; botulinum toxin

Summary:

      1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in
           comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment
           of Cervical dystonia.

        2. double blind, randomised, multi center, crossover study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age of both genders,

          -  Cervical dystonia

          -  symptoms with a minimum duration of 18 months,

          -  Negative pregnancy test in sexually active women,

          -  Able to participate in the study (understand goals of botulinum toxin A treatment and
             sign Informed Consent Form).

        Exclusion Criteria:

          -  Patient with cervical contractures

          -  Known significant underlying dysphasia

          -  Patients who have received botulinum toxin treatment within the past 4 months.

          -  Contraindication to botulinum toxin treatment

          -  Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert
             syndrome, ALS …)

          -  Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or
             denervation surgery, deep brain stimulation for cervical dystonia,

          -  Patients who required more than 500 units of Dysport or 200 units of Botox.

          -  Any concomitant treatment that could interfere with the action of botulinum toxin,

          -  Subjects having participated within the last 3 months or currently participating in an
             investigational drug study,

          -  Pregnancy,

          -  Lactation.
Senescent Immunity in Elders and Vaccine Responses (SILVER)
Condition: Flu Vaccine
Intervention: Fluzone-High Dose Quadrivalent; Fluad; Flublock
Intervention description: Seasonal influenza vaccination with FDA approved vaccines for this age group.; Adjuvanted (MF59) inactivated influenza vaccine; Recombinant hemagglutinin vaccine
Intervention MeSH terms: Hemagglutinins; Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking description: This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.
Enrollment: 10.0
Sex: All
Minimum age: 65 Years
Maximum age: 125 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adult 65 and older

Summary:

      To study the effects of age on the immune system's response to flu vaccine and to study the
      connection between the immune system and physical and cognitive changes associated with
      aging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 years and over

          -  Independent Living (including Assisted Living)

        Exclusion Criteria:

          -  Unable to understand the consent or the study.

          -  Allergic to any vaccine components, excluding eggs.

          -  History of Guillain-Barre.

          -  Residing in a long -term care facility such as a nursing home.