bioihbjkbjnl/mcl2 huggingface dataset:
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™ -B; Hepatitis B immunoglobulin (HBIg)
Intervention description: 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study; 1 intramuscular injections at birth (primary study)
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 16 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B immunoglobulin; Hepatitis B antibody persistence

Summary:

      To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after
      administration of the first dose of the study vaccine. The Protocol Posting has been updated
      in order to comply with the FDA Amendment Act, Sep 2007.

      No additional subjects will be recruited during this long-term follow-up study and no vaccine
      will be administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had received at least one dose of the study vaccine in the primary study

          -  Written informed consent obtained from each subject before each blood sampling visit

        Exclusion Criteria:

          -  None
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Condition: Chronic Kidney Disease; Renal Insufficiency
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Intervention: Omniscan
Intervention description: OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD - Chronic Kidney Disease; GBCA - Gadolinium-based contrast agent; GFR - Glomerular Filtration Rate; MRI - Magnetic Resonance Imaging; NSF - Nephrogenic Systemic Fibrosis; Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.

Summary:

      This will be an international, multi-center, post-marketing surveillance study in patients
      with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI.
      Omniscan will be administered intravenously at the medical discretion of the prescribing
      physician.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has been referred for a clinically indicated MRI examination with a
             gadolinium-based contrast agent.

          -  The subject has known or suspected chronic kidney disease with an eGFR greater than or
             equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned
             index OMNISCAN administration.

          -  The subject agrees to be contacted for follow-up for 24 months.

        Exclusion Criteria:

          -  Patients with known or suspected NSF based on biopsy confirmation or the onset of
             signs and symptoms of NSF lasting at least 7 days as follows:

               1. skin - swelling, hardening and tightening; reddened or darkened patches; burning
                  or itching;

               2. eyes - yellow raised spots on whites of eyes; or

               3. bones and muscle - stiffness in joints; difficulty in moving or straightening of
                  arms, hands, legs or feet; bone pain especially in hips and ribs or muscle
                  weakness.

          -  Patients allergic to any GBCA.

          -  Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within
             30 days prior to the planned OMNISCAN administration.

          -  Patients with acute renal insufficiency of any severity due to the hepato-renal
             syndrome or in the peri operative liver transplantation period.
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Condition: Contraception
Intervention: Levonorgestrel-releasing intrauterine device (LNG-IUS); Copper T380A intrauterine device (CuT380A)
Intervention description: Teens are randomly assigned to receive the LNG-IUS after completing a screening visit.; Teens are randomly assigned to Copper T380 after the screening visit
Intervention MeSH terms: Copper; Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: Female
Minimum age: 14 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intrauterine device, contraception, unplanned pregnancy

Summary:

      This is a pilot study to determine the feasibility for a randomized controlled trial of two
      forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the
      Copper T 380A.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy, sexually active females age 14 to 18 who:

          -  Are interested in long term, reversible contraception

          -  Have regular menstrual cycles (21-35 days)

          -  Are not planning a pregnancy within the next 6 months

        Exclusion Criteria:

        Sexually active females age over the age of 18 or who:

          -  Are not interested in long term, reversible contraception

          -  Do not have regular menstrual cycles (21-35 days)

          -  Are planning a pregnancy within the next 6 months
Vitamin D Plus Fluticasone Propionate
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Vitamin D3; Placebo; Fluticasone Propionate
Intervention description: 4000 IU once daily; Placebo taken once daily; 200 mcg daily, intranasal
Intervention MeSH terms: Vitamin D; Cholecalciferol; Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The objectives of this study would be to see if the addition of vitamin D to fluticasone
      propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis
      compared to fluticasone propionate treatment alone.
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females between 18 and 45 years of age.

          2. History of tree, grass and/or ragweed allergic rhinitis.

          3. Positive skin test to tree, grass and/or ragweed antigen.

          4. Positive response to screening nasal challenge.

        Exclusion Criteria

          1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

          2. Pregnant or lactating women.

          3. Upper respiratory infection within 14 days of study start.
Acamprosate in the Treatment of Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Intervention: acamprosate
Intervention description: Two 333mg tablets taken three times daily.
Intervention MeSH terms: Acamprosate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acamprosate, impulse-control disorders

Summary:

      The purpose of this study is to see whether acamprosate (Campral) will curb the desire to
      gamble in people with pathological gambling disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will meet DSM-IV (Diagnostic and Statistical Manual 4th Edition) criteria for
             Pathological Gambling Disorder

          -  Patients will achieve a SOGS (South Oaks Gambling Screen) score greater than or equal
             to 5

          -  Patients will be 18 years old or older

          -  Patients will speak standard English

          -  Patients will be able to give written Informed Consent

          -  Patients will be able to understand and cooperate with study procedures

        Exclusion Criteria:

          -  Patients having a current (past 3 months) substance use disorder (except dependence)

          -  Patients having a Hamilton Depression Rating score of greater than or equal to 18 or a
             score on #1 (depressed mood) greater than 1.

          -  Patients having a clinically significant medical illness

          -  Patients at risk for aggressive or suicidal behavior

          -  Patients who have received the following interventions within the proscribed time
             prior to study entry: 1) a monoamine oxidase inhibitor within the previous 21 days; 2)
             long-acting phenothiazines within the previous 3 months; 3) other psychotropic drugs
             within the previous 14 days; 4) flu- oxetine within the previous 4 weeks.

          -  Patients having severe antisocial or borderline personality disorder

          -  Patients with a past or current diagnosis of schizophrenia, schizoaffective disorder,
             psychotic disorder, bipolar disorder, or delirium, dementia, or other clinically
             significant cognitive disorder.

          -  Patients initiating individual, group, or couple psychotherapy during the three moths
             prior to study entry (excluding Gambler's Anonymous)

          -  Patients having prior exposure to acamprosate
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketamine; Placebo; Hydromorphone PCA
Intervention description: Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.; Patients who received ketamine-matching placebo were given saline infusions; Intravenous hydromorphone PCA
Intervention MeSH terms: Ketamine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Postoperative pain; Opioid dependent patients; Acute pain control

Summary:

      Patients who are dependent on opioids often have poor pain relief after major surgery. This
      study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of
      intravenous opioids for postoperative pain will improve pain relief in this subset of
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic pain > 6 months

          -  Long term use of opioids

          -  Major surgery

        Exclusion Criteria:

          -  Use of regional anesthetic techniques

          -  No need for intravenous (IV) patient controlled analgesia (PCA) after surgery
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Intervention: Regional Anesthesia; General Anesthesia
Intervention description: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.; Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 643.0
Sex: All
Maximum age: 60 Weeks
Healthy volunteers: No
Keywords: Infants; scheduled; unilateral; bilateral; repair

Summary:

      The primary purpose of the GAS study is to determine whether different types of anesthesia
      (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in
      equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of
      apnea in the post-operative period after both regional and general anesthesia for inguinal
      hernia repair in infants. This study is important as it will provide the greatest evidence
      for safety or toxicity of general anesthesia for human infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or
             without circumcision)

          -  Any infant whose gestational age is 26 weeks or more (GA = 182 days)

          -  Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)

        Exclusion Criteria:

          -  Any child older than 60 weeks post-menstrual age

          -  Any child born less than 26 weeks gestation

          -  Any contraindication to general or spinal/caudal anesthesia (for example:
             neuromuscular disorder or coagulopathy)

          -  Pre-operative ventilation immediately prior to surgery

          -  Congenital heart disease that has required ongoing pharmacotherapy

          -  Known chromosomal abnormality or any other known acquired or congenital abnormalities
             (apart from prematurity) which are likely to affect development

          -  Children where follow-up would be difficult for geographic or social reasons

          -  Families where English is not the primary language spoken at home

          -  Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade
             3 or 4 intra ventricular hemorrhage (ICH) (+/- post hemorrhage ventricular dilation)

          -  Previous exposure to volatile anesthesia or benzodiazepines as a neonate or in the
             third trimester in utero.
Effect of Weight and/or Obesity on Dapsone Drug Concentrations
Condition: Obesity; Leprosy; Tuberculosis
MeSH terms: Tuberculosis; Leprosy; Obesity
Intervention: Dapsone
Intervention description: 100 mg PO x 1 dose
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Pharmacokinetics; Dapsone; Leprosy; Tuberculosis

Summary:

      This study will find how weight affects the dosing of a drug called dapsone. Currently, the
      amount of dapsone a patient receives is the same regardless of the patient's weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, age >18 years, of all racial and ethnic origins.

          -  Non-English speaking Spanish speakers will be included in the study.

          -  We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese
             (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index
             is calculated using the volunteer's height and weight (Formula: weight (lb) / [height
             (in)]2 x 703). Half of each group will be male; the other half will be female.

        Exclusion Criteria:

          -  Pregnant or nursing or unwilling to use a reliable contraception method during the
             study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic
             changes that accompany pregnancy may alter the concentration-time profile of dapsone,
             so that the pregnancy and post-partum state would be a confounding variable.

          -  Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline
             phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of
             normal.

          -  History of allergies to dapsone, sulfones, or sulfonamides.

          -  Dapsone, sulfones, or sulfonamides are contraindicated for any reason.

          -  Volunteers unwilling to comply with study procedures.

          -  Current suspected or documented infection of any kind.

          -  Volunteers with colon resection, gastric bypass, lap band, or any other conditions
             inhibiting gastric absorption of drug.

          -  Current or previous participation within 28 days of enrollment in another research
             study that involves the use of medication, contrast, or any other compound that may
             alter blood count and/or blood chemistry (liver function, kidney function or
             electrolyte balance), unless waved by PI.

          -  Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days)
             prior to study enrollment, unless waved by PI.

          -  Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.

          -  Creatinine clearance < 70 ml/minute (min) as estimated by the Cockcroft-gault
             equation.
Effects of N-acetylcysteine on Low T3 Syndrome
Condition: Acute Myocardial Infarction; Euthyroid Sick Syndrome; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Euthyroid Sick Syndromes; Syndrome; Infarction
Intervention: N-acetylcysteine
Intervention description: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Euthyroid Sick Syndrome; low T3 syndrome; deiodases; oxidative stress; ischemic heart disease

Summary:

      The propose of this study is to determine whether N-acetylcysteine is effective in reversing
      the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of acute myocardial infarction with less than 12 hours of evolution

          -  reperfusion therapy (primary angioplasty)

        Exclusion Criteria:

          -  Thyroid disease

          -  Chronic renal disease with renal replacement therapy

          -  hepatic insufficiency

          -  immunosuppression
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Condition: HIV; Osteopenia; Osteoporosis; HIV Infections
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Raltegravir
Intervention description: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV+; Raltegravir; Tenofovir; osteopenia; osteoporosis; bone markers; treatment experienced

Summary:

      The purpose of this study is to determine if low bone mineral density (a measurement of how
      thick and strong bones are) improves in adults with HIV infection who switch their HIV
      medication tenofovir to another HIV medication raltegravir.

      Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic
      patients switching from ART including tenofovir disoproxil fumarate (TDF) and a
      ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. provision of written, informed consent

          2. HIV-infected adults at least 18 years of age

          3. receiving stable ART including TDF and a r/PI for the previous 6 months

          4. no prior PI genotypic resistance or known replication of HIV in patients receiving a
             PI

          5. plasma HIV RNA < 50 copies/ml for at least the previous 3 months

          6. spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual
             energy x-ray absorptiometry (DEXA)

             Exclusion Criteria:

          7. participation in any other clinical trial (unless approved by the study PI)

          8. use of TDF for previously active chronic hepatitis B infection

          9. receiving or requiring therapy for low BMD (including prior fragility fracture)

         10. using oral corticosteroids or inhaled fluticasone

         11. virological failure on, or intolerance to, RAL

         12. contra-indication to RAL therapy (see appendix 2)

         13. breast-feeding

         14. pregnancy

         15. secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency,
             hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone > 25% below
             lower limit of reference range and/or luteinizing hormone > 2 x upper limit of normal
             (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference
             ranges