bioihbjkbjnl/mcl2 huggingface dataset:
Late-Onset Treatment Study Extension Protocol
Condition: Pompe Disease (Late-Onset); Glycogen Storage Disease Type II (GSD-II); Glycogenesis Type II; Acid Maltase Deficiency (AMD)
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Intervention: alglucosidase alfa
Intervention description: IV infusion of 20 mg/kg; every other week (qow)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a
      critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the
      body's cells to break down glycogen (a stored form of sugar) within specialized structures
      called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates
      and is stored in various tissues, especially heart and skeletal muscle, which prevents their
      normal function. The objective of this extension study is to assess the long-term safety and
      efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were
      previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have completed protocol AGLU02704 (NCT00158600)

          -  Patient must provide signed, informed consent prior to performing any study-related
             procedures

          -  Patient (and patient's legal guardian if patient is under 18 years of age) must have
             the ability to comply with the clinical protocol

          -  A female patient of childbearing potential must have a negative pregnancy test at
             Baseline. (note: all female patients of childbearing potential and sexually mature
             males must use a medically accepted method of contraception throughout the study.)

        Exclusion Criteria:

          -  The patient has a medical condition, serious intercurrent illness, or other
             extenuating circumstance that, in the opinion of the Investigator, would preclude
             treatment with alglucosidase alfa.
Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)
Condition: Chronic Pain Due to Injury
MeSH terms: Chronic Pain
Intervention: Oxytocin; Placebo
Intervention description: Oxytocin 10 IU; Placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blinded crossover treatment with oxytocin and placebo (saline)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participant, Investigator, and outcomes assessor will be blinded. The Research Pharmacist will prepare the study medication and hold the randomization.
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteer; Oxytocin; Pupillometry

Summary:

      The goal of this study is to test the effects of oxytocin on heart rate variability and pupil
      diameter, both of which have subtle effects on the activity rate of the autonomic nervous
      system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > 18 and < 66 years of age,

          -  Body Mass Index (BMI) <40

          -  Generally in good health as determined by the Principal Investigator based on prior
             medical history

          -  Normal blood pressure and resting heart rate without medication

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®

          -  Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the
             Principal Investigator, would place the subject at increased risk

          -  Women who are pregnant (positive result for serum pregnancy test at screening visit),

          -  Women who are currently nursing or lactating, women that have been pregnant within 2
             years.

          -  Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain
             medications on a daily basis.

          -  Previous eye surgery, eye medications, cataracts
Intravenous Exenatide in Patients With Acute Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Intervention: Exenatide
Intervention description: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the feasibility of exenatide infusion for the
      treatment of high blood sugars following acute brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥18 years

          -  Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for
             an anticipated length of stay >48 hours

          -  Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL

          -  Informed consent obtained via proxy

        Exclusion Criteria:

          -  Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of
             infusion) or lactating females

          -  Type 1 diabetes mellitus

          -  History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse,
             gall stones)

          -  Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min

          -  Known history of gastroparesis

          -  History of surgery on stomach, esophagus or duodenum

          -  Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome

          -  Concurrent steroid use or planned post-operative steroid use

          -  History of organ transplantation

          -  Brain death or suspected imminent brain death within the next 72 hours

          -  Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg
             for greater than 15 minutes and refractory to medical intervention

          -  Currently enrolled in another investigational drug or device protocol

          -  Insulin infusion within 3 hours of study drug administration or confirmed long acting
             insulin or sulfonylurea use prior to admission within 24 hours of study drug
             administration

          -  Known allergy to exenatide
Intranasal Bevacizumab for HHT-Related Epistaxis
Condition: HHT; Hereditary Hemorrhagic Telangiectasia; Epistaxis; Nose Bleeds; Nasal Bleeding
MeSH terms: Epistaxis; Telangiectasis; Telangiectasia, Hereditary Hemorrhagic; Hemorrhage
Intervention: Bevacizumab; Placebo (Saline)
Intervention description: Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose; 4mL of saline will be mixed by the Stanford Hospital Pharmacy as a control
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HHT; Hereditary Hemorrhagic Telangiectasia; epistaxis; nose bleeds; nasal bleeding; Avastin; bevacizumab

Summary:

      This is a randomized, controlled, double-blind, placebo-controlled trial of intranasal
      Avastin (bevacizumab) injection versus saline control for control of HHT-related epistaxis
      when used in conjunction with bipolar electrocautery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient carries a diagnosis of hereditary hemorrhagic telangiectasia (HHT)

          2. The patient is to undergo treatment with electrocautery in the operating room under
             endoscopic visualization

          3. The patient is able to give informed consent

          4. The patient is at least 18 years old

        Exclusion Criteria:

          1. The patient has had prior treatment with systemic or nasal bevacizumab within the past
             year

          2. The patient has undergone electrocautery for epistaxis within the 6 months prior to
             study enrollment

          3. The patient is a minor

          4. The patient is pregnant

          5. The patient is incapable of understanding the consent process

          6. The patient has a history of HIV or another known cause of immunosuppression, or is
             actively taking immunosuppressive medications due to organ transplantation, rheumatoid
             disease, or other medical conditions.
Success of External Cephalic Version Study
Condition: External Cephalic Version
Intervention: Bupivacaine; Terbutaline
Intervention description: intrathecal bupivacaine 7.5 mg; 0.25 mg Terbutaline subcutaneously
Intervention MeSH terms: Bupivacaine; Terbutaline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: External Cephalic Version; neuraxial analgesia

Summary:

      The purpose of this study is to determine the best way to optimize the success of external
      cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is
      recommended because it may decrease the risk of needing a cesarean section for abnormal
      presentation. While the study team knows that this procedure can be effective, the study team
      still has some un-answered questions as to the best way to perform this procedure to increase
      the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of
      medication placed in your back to numb and relax the abdomen) can increase the success rate
      of a version. This ultimately has led to the finding that using this anesthesia can decrease
      the rate of cesarean section. However, there have been only a small number of studies
      assessing the success rate if spinal anesthesia is used only in the event that without it
      fails. Therefore the study team is going to compare patients who receive spinal anesthesia
      with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails
      without it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients included are those with singleton pregnancies of at least 37 weeks gestation
             in nonvertex presentation with no contraindication for a vaginal delivery.

          -  Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress
             test.

        Exclusion Criteria:

          -  All patients with a contraindication for a vaginal delivery will be excluded from the
             study.

          -  Patients with gross fetal anomalies or uterine malformations.

          -  Patients with contraindications to neuraxial anesthesia or allergies to any of the
             study medications will also be excluded.
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features
Condition: Pre-Eclampsia; HELLP Syndrome; Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia; HELLP Syndrome
Intervention: Acetaminophen; Ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      NSAIDs, specifically cyclo-oxygenase (COX) inhibitors, are known to increase blood pressure
      over time in non-pregnant adults, but the effect of COX-inhibitors on blood pressure in the
      setting of preeclampsia have not been well studied. This study aims to assess the effect of
      avoiding COX-inhibitors on postpartum blood pressure control among women diagnosed with
      preeclampsia with severe features. Eligible women will be randomized to receive either
      acetaminophen or ibuprofen for postpartum pain control. Both agents are first line therapies
      for pain control although ibuprofen has better pain control than acetaminophen. The primary
      outcome will be duration of postpartum severe-range hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ability to give informed consent

          -  diagnosis of a "severe" hypertensive disorder of pregnancy:

          -  preeclampsia with severe features

          -  chronic hypertension with superimposed preeclampsia with severe features

          -  HELLP syndrome: hemolysis, elevated liver function tests, low platelets

          -  eclampsia

          -  not yet delivered or less than 6 hours after delivery

        Exclusion Criteria:

          -  current incarceration

          -  serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury

          -  AST (aspartate aminotransferase) >200 unit/L

          -  ALT (alanine aminotransferase) > 200 unit/L

          -  known allergy or sensitivity to NSAIDs or acetaminophen

          -  delivery > 6 hours prior to enrollment

          -  chronic kidney disease

          -  chronic liver disease

          -  prior liver transplant

          -  chronic infectious hepatitis

          -  gastritis

          -  gastro-esophageal reflux disease (GERD)

          -  peptic ulcer disease

          -  bleeding disorder

          -  provider feels that participation is not in the best interest of the patient
The Use of Paravertebral Block for Cardiac Surgery
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Intervention: Paravertebral Block; Placebo Comparator
Intervention description: Paravertebral nerve block injection; No block
Patients who did not receive PVB
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Pain after robotic cardiac surgery is a known problem and is often difficult to manage.
      Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A
      paravertebral block has been shown to provide good pain relief with minimal side effects,
      however, paravertebral blocks for robotic surgery have not been well studied. Currently the
      investigators routinely perform PVB on this patient population (of 50 MV robotic cases done
      between January and October 2012, 36 received paravertebral blocks with no adverse events
      noted). The investigators believe this should be studied further and that paravertebral
      blocks will reduce the amount of additional pain medication patients require in the first 24
      hours after surgery, decrease intubation time and improve PACU and hospital discharge times.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients over the age of 18 years of age undergoing robotic mitral valve surgery.

          -  have capacity to understand and sign consent form

        Exclusion Criteria:

          -  patients that are not candidates for paravertebral block as per ASRA guidelines
             (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking
             specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or
             low molecular weight heparin, or patients with an INR of greater than 1.5. -patients
             with a history of COPD or other respiratory diseases that would confound data on time
             to extubated will be excluded.

          -  Patients that with a diagnosis of chronic pain, or patients currently taking narcotics
             are excluded, as this would confound data on postoperative narcotic requirements.
Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
Condition: Prostate Infections
Intervention: Ciprofloxacin hydrochloride; Placebo
Intervention description: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days; Placebo twice a day for 14 days
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: Male
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Prostate Specific Antigen (PSA); Elevated Prostate Specific Antigen (PSA)

Summary:

      Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for
      the treatment of mild to moderate infections, including prostate infections. It has been
      suggested that antibiotic treatment influences PSA levels due to the fact that an increase in
      PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to
      treat such inflammatory conditions. However, it has not been proven that antibiotics can be
      used to lower PSA. This research is being done to see if treatment with the antibiotic
      Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This
      study may also help doctors in deciding which patients need a prostate biopsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a patient of Johns Hopkins Urology Outpatient Clinic

          -  Must have an elevated PSA (> 2.5 ng/mL) and be selected on the basis of a serum PSA
             evaluation for Transrectal Ultrasound (TRUS)/biopsy

          -  Must be able to understand and willing to adhere to the study protocol

          -  Must be willing to take the antibiotic or placebo for two weeks prior to the biopsy
             and agree to have the biopsy regardless of the change in PSA

        Exclusion Criteria:

          -  Abnormal digital rectal examination

          -  Anyone currently being treated or who have been treated for any prostatic diseases
             (prostatitis, prostate Benign Prostatic Hyperplasia (BPH) surgery, prostate cancer) or
             urinary tract infection in the past

          -  Anyone taking medications that are likely to alter serum PSA concentration
             (specifically, androgen steroid hormones, antiandrogens, finasteride, Leutinizing
             Hormone Releasing Hormone (LHRH) analogues)

          -  Anyone unwilling to sign the informed consent or who are unlikely to adhere to the
             study protocol

          -  Anyone with a known allergy to fluoroquinolone antibiotics

          -  Anyone on blood thinning medication (Coumadin)

          -  Anyone taking Tizanidine

          -  Anyone with a history of seizures or cerebral arteriosclerosis

          -  Anyone who has taken an antibiotic medication within the past two weeks
Immune Monitoring to Facilitate Belatacept Monotherapy
Condition: Kidney Transplant Rejection; Immunosuppression
Intervention: Allosure; Immunosuppression reduction; Trugraf
Intervention description: Monthly monitoring of dd-cfDNA levels in blood; Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results; Monthly monitoring of Trugraf result
Intervention MeSH terms: Sirolimus; Prednisone; Everolimus; Abatacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Prospective single-center, single-arm pilot study
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      -  To determine the utility of novel blood-based immune monitoring tools (Allosure and
           Trugraf) to facilitate belatacept monotherapy.

        -  To determine the percent of belatacept-treated renal transplant patients that can be
           safely converted to belatacept monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age minimum 18 years

          -  Written informed consent

          -  Single kidney transplant recipient (i.e. no combined organ transplants)

          -  Treated with de novo belatacept since transplantation (i.e. no previous use of
             calcineurin inhibitor or mTOR inhibitor for the current transplant)

          -  At least 1 year after transplantation or after initiation of belatacept

          -  Stable renal function (eGFR > 40 ml/min continuously during previous 6 months)

          -  Blood biomarkers indicate immune quiescence (for Allosure this corresponds to dd-cfDNA
             < 1%; for Trugraf this corresponds to "TX" signature)

          -  No history of BK viremia in current allograft

        Exclusion Criteria:

          -  History of biopsy-proven acute rejection

          -  Presence of donor-specific antibodies (at any MFI)

          -  Spot urine protein/creatinine ratio > 0.5 g/g