bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
Condition: Hyperhomocysteinemia; Obesity
MeSH terms: Hyperhomocysteinemia
Intervention: Folic Acid; placebo
Intervention description: yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand; sugar tablet manufactured to mimic folic acid tablet
Intervention MeSH terms: Folic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 9 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Folic acid; Folate; Homocysteine; Obese; Children

Summary:

      The purpose of the present study was to determine whether folic acid supplementation could
      reduce plasma homocysteine in obese children and to determine the association between dietary
      folate, serum folate and homocysteine level through the randomized double blinded placebo
      controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age between 9-18 years

          -  Diagnosed obesity (BMI more than median plus two of standard deviation for age and sex
             according to WHO reference 2007)

        Exclusion Criteria:

          -  Secondary obesity

          -  Thalassemia disease

          -  Renal and hepatic dysfunction

          -  Drugs: anticonvulsant, estrogen, thiazides, metformin, cholestyramine, methotrexate,
             fibrates, nicotinic acid

          -  Previous vitamin supplementation 1 month before study
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Condition: Mycoses
MeSH terms: Mycoses
Intervention: rhGM-CSF group; rhG-CSF+rhGM-CSF group; rhG-CSF group
Intervention description: subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).; a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).; subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
Intervention MeSH terms: Molgramostim; Lenograstim; Sargramostim
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Healthy volunteers: No
Keywords: Allo-HSCT; rhGM-CSF; Systemic fungal infection (SFI)

Summary:

      We conducted a prospective, multicenter, open-label randomized trial to compare the
      antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF),
      Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and
      rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 14~60 years old

          -  Allogenic hematological stem cell transplantation(HSCT) patients.

          -  Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or
             Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper
             limit of normal, creatinine < upper limit of normal.

          -  Informed consent.

        Exclusion Criteria:

          -  Evidence of proven, probable or possible fungal infection at the time of enrollment.

          -  Patients were receiving anti-fungal treatment with proven SFI before transplantation.

          -  A history of hypersensitivity to G-CSF or GM-CSF.
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Condition: Hepatitis B; Hepatitis; Hepatitis, Viral, Human; Hepatitis B Immunization
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis, Viral, Human; Hepatitis
Intervention: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Intervention description: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:
1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Intervention model description: non-responders to conventional treatment of hepatitis B vaccination and consent to participate
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Health workers with biological risk in their tasks, who have been vaccinated as
      non-responders to conventional vaccination against Hepatitis B. To provide Health
      workers-staff with an additional protection tool against hepatitis B infection. To evaluate
      the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NHS workers -including university students doing their internships in health centres
             dependent on the National Health System (inclusion of students is regulated and
             limited by specific instructions on labour prevention in each autonomous community).

          -  Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti
             HBsAb titers <10 mIU / ml following the application of six doses of conventional
             vaccine at 20 μg doses (two complete guidelines).

        Exclusion Criteria:

          -  Known allergy to the active substance or any of the other ingredients of the medicinal
             product (included in section 6 of the product data sheet).

          -  Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.

          -  Subjects have a serious infection with fever.

          -  Subjects for whom informed consent is not obtained.

          -  Subjects that have not revoked the consent initially signed.
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine patch - transdermal; placebo
Intervention description: 21 mg patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine dependence; cigarette; smoking; nicotine replacement therapy; positron emission tomography

Summary:

      The proposed research will provide significant new gender-specific information of scientific
      and clinical relevance on the function of the mu-opioid system in nicotine dependence and
      therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to
      explain the differences in the prevalence of smoking in men and women, sex-specific
      differences in nicotine craving and withdrawal as well as the poorer therapeutic response to
      NRT. This work may pave the way to the design of improved pharmacotherapies that can more
      effectively target the endogenous opioid system in the treatment of nicotine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 - 60 years old

          -  must meet DSM-IV criteria for nicotine dependence and be actively smoking

        Exclusion Criteria: subjects must meet study guidelines for medical and mental health
        status.
Effect of Fentanyl on Coughing and Recovery After Anesthesia With an LMA Laryngeal Mask Airway)for Airway Management
Condition: Ambulatory Surgery; Coughing
MeSH terms: Cough
Intervention: Saline; Fentanyl
Intervention description: 2 ml at induction 1-2 ml boluses as needed; Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ambulatory surgery; Pain management; Perioperative outcomes; Fentanyl; Coughing during insertion of an LMA; Ambulatory surgery procedures

Summary:

      The purpose of this research is to evaluate the effectiveness of fentanyl for reducing
      coughing during the perioperative period (i.e., insertion of an LMA [Laryngeal Mask Airway]
      device, maintenance period during surgery, and awakening [emergence] from general anesthesia)
      for ambulatory surgery procedures. Also to assess the effects of fentanyl on the
      postoperative outcomes, (e.g., pain, postoperative nausea and vomiting, return of bowel
      function [constipation], resumption of normal activities of daily living).

      Fentanyl is one of the most common used anesthetic adjuncts for ambulatory surgery because of
      its anesthetic-sparing effects and alleged ability to reduce coughing during instrumentation
      of the patient's airway.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients scheduled to undergo outpatient arthroscopic surgery procedures

          -  Willingness and ability to sign an informed consent document

          -  No allergies to anesthetic or analgesic medications

          -  18 - 80 years of age

          -  American Society of Anesthesiologists (ASA) Class I - III adults of either sex

          -  Women of childbearing potential must be currently practicing an acceptable form of
             birth control, and have a negative urine pregnancy test

        Exclusion Criteria

          -  Patients with known allergy, hypersensitivity or contraindications to anesthetic or
             analgesic medications

          -  Patients with clinically-significant medical conditions, such as brain, heart, kidney,
             endocrine, or liver diseases, peptic ulcer disease or bleeding disorders

          -  Pregnant or lactating women

          -  Subjects with a history of alcohol or drug abuse within the past 3 months

          -  Any other conditions or use of any medication which may interfere with the conduct of
             the study (e.g., asthmatic patients history of asthma, chronic cough, or upper
             respiratory tract infection during the previous 2 wk or recent treatment with
             angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.
Pneumococcal Vaccines in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: PCV13; PPSV23
Intervention description: Single 0.5 ml dose of PCV13 administered via intramuscular injection; Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 19 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Vaccine; Pneumococcal; Pneumonia

Summary:

      Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine
      if they are given Prevnar initially.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of asthma

        Exclusion Criteria:

          -  Research exemption requested

          -  History of PCV-13 vaccination

          -  History of cochlear implant

          -  Cerebrospinal Fluid (CSF) leak

          -  Congestive Heart Failure (CHF)

          -  Diabetes Mellitus (DM)

          -  Chronic Kidney Disease (CKD)

          -  Human Immunodeficiency Virus (HIV)

          -  Common Variable Immune Deficiency (CVID)

          -  Patients who have received the PPSV23 vaccine in the last 5 years

          -  Women who are pregnant will also be excluded from the study by performing 2 point of
             care urine pregnancy tests ( prior to vaccinations)
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Bupivacaine; Morphine; Methylprednisolone; Cefazolin; Normal saline; Midazolam; Propofol; Dexamethasone; 8 MHz. Chiba needle, 22 G / 4 inches
Intervention MeSH terms: Cefazolin; Dexamethasone; Methylprednisolone; Midazolam; Morphine; Bupivacaine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Nerve Block; Rehabilitation; Knee Replacement, Total

Summary:

      Total knee replacement is associated with severe post-operative pain. The purpose of this
      study is to compare two methods of treatment for pain control following Total Knee
      Replacement with an accelerated physical therapy protocol to aid the achievement of rehab
      milestones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with osteoarthritis scheduled for primary tricompartmental total knee
             arthroplasty with a participating surgeon

          -  Age 18 to 80 years

          -  Planned use of regional anesthesia

          -  Ability to follow study protocol

          -  English speaking (secondary outcomes include questionnaires validated in English only)

        Exclusion Criteria:

        Hepatic or renal insufficiency Patients younger than 18 years old and older than 80
        Patients intending to receive general anesthesia Patients planning to go to rehab post
        operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one
        of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use
        (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3
        months) Diabetes Patients on workers compensation or disability
Pain, Agitation and Delirium (PAD) Protocol in the Duke CICU
Condition: Deep Sedation; Ventilators, Mechanical; Critical Illness
MeSH terms: Delirium; Critical Illness
Intervention: Midazolam; Propofol; Dexmedetomidine
Intervention description: IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.; IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.; IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventilators, Mechanical; Intensive Care Units; Deep Sedation

Summary:

      This study aims to examine the use of protocol directed sedation using the Duke PAD protocol
      with the current sedation medications of propofol or dexmedetomidine compared to the PAD
      protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial
      step toward understanding the best management of sedation in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted to the Duke CICU, who require intubation and sedation for
             mechanical ventilation that is expected to be >24 hours in duration will be included,
             unless they meet the specified exclusion criteria.

          -  Patients intubated within one hour prior to care transition to the CICU will also be
             screened for inclusion.

        Exclusion Criteria:

          -  Exclusion criteria include patients following resuscitation from cardiac arrest who
             are treated on the cooling protocol

          -  patients who have suffered a neurologic event (seizure, stroke) or who have baseline
             dementia, both of which could limit delirium assessment

          -  patients with child class B and C liver disease

          -  patients with known allergy to study medications.
Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
Condition: Bacteremia
MeSH terms: Bacteremia
Intervention: Vancomycin; Daptomycin
Intervention description: Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methicillin-resistant; Staphylococcus aureus

Summary:

      There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia
      (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA
      bacteremia over the last 40 years. This has been largely attributed to isolates with
      increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was
      approved several years ago for the treatment of SAB and is being increasingly used for MRSA
      bacteremia due to isolates with increased MIC. Increased doses have been recommended for both
      of these drugs in the treatment of this infection without a trial demonstrating their
      relative efficacy or safety at higher doses. This study will randomize patients with SAB due
      to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and
      daptomycin used at higher than traditional doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Signed informed consent

          -  All cases of suspected MRSA bacteremia as determined by a patient with at least one
             blood culture growing gram-positive cocci in clusters with a clinical syndrome
             consistent with true bacteremia including fever, hypothermia (temperature < 36.0º C),
             tachycardia (heart rate > 100 beats/minute), hypotension (systolic blood pressure < 90
             mm Hg) or other clinical features of sepsis.

          -  All cases of right-sided native valve endocarditis due to MRSA

          -  Patients who are diagnosed with left-sided native valve endocarditis after
             randomization will be continued in the study

          -  Patients with MRSA bacteremia associated with infected foreign bodies, including
             vascular prostheses, orthopedic prostheses
Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Condition: Upper Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Montelukast; Placebo
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Cold; Upper Respiratory Infection

Summary:

      Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for
      the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18 to 50 years of age.

          -  Male or female, who are not pregnant or lactating.

          -  Common cold symptoms for less than 24 hours.

          -  At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache,
             nasal drainage, nasal congestion, scratch throat, sneezing and malaise.

        Exclusion Criteria:

          -  Investigational medication in past 30 days.

          -  Known hypersensitivity to any ingredients in study medication.

          -  History of asthma or other chronic diseases.

          -  Females of childbearing potential who are not using a medically acceptable form of
             birth control.

          -  Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6
             months, nasal trauma within the past 2 months or presence of nasal polyps or nasal
             deformities causing significant nasal obstruction.

          -  Females with a positive urinary HCG test.

          -  Patients with a positive rapid antigen test for streptococcal infection.

          -  Common cold symptoms for more than 24 hours.

          -  Patients who are users of illicit drugs.

          -  Patients who are on rifampin or phenobarbital.