bioihbjkbjnl/mcl2 huggingface dataset:
Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
Condition: Neuritis; Radiofrequency Ablation
MeSH terms: Neuritis
Intervention: Dexamethasone 4 mg/ml; Normal saline
Intervention description: dexamethasone 4 milligram given post-ablation at each lesion site; Placebo, normal saline administered post-ablation at each lesion site
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient serves as his or her own control. Investigators are recruiting patients who are undergoing bilateral procedures. Each patient will receive dexamethasone at each lesion site post-ablation on one side, and placebo (saline) on the other.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The patient, care providers, and principle investigator will be blinded.
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      Chronic neck and back pain has become one of the leading causes of disability and loss of
      productivity. For many patients with facet or sacroiliac joint mediated pain who have
      responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the
      joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe
      procedure with minimal risk of adverse events. However, with any procedure involving damage
      to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The
      investigators will test the hypothesis that dexamethasone injection delivered at the time of
      lesion effectively prevents the development of post-ablation neuritis through a
      placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic,
      lumbar, and sacroiliac joint radiofrequency denervations
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac
             joint pain who have responded to medial branch blocks and are already scheduled for
             bilateral radiofrequency ablations

          -  age greater than 18 years old

          -  English speaking

        Exclusion Criteria:

          -  patient not previously scheduled for radiofrequency ablation of the cervical,
             thoracic, or lumbar facets, or sacroiliac joints

          -  on anticoagulation

          -  have a pacemaker

          -  age less than 18 years old

          -  non-English speaking
Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: N1539
Intervention description: Once daily
Intervention MeSH terms: Meloxicam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: meloxicam; pediatric

Summary:

      This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539
      in postoperative Pediatric subjects aged 2 to <17 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 2 to <17 years of age before dosing on Day 1

          -  Eligible for elective surgery that will be performed according to standard surgical
             technique under appropriate anesthesia

          -  Be premenarche or have confirmed negative urine pregnancy testing before surgery on
             Day 1, if an adolescent female of childbearing potential

          -  Willing and able to cooperate with all the requirements of the study; including
             providing appropriate informed consent/assent

        Exclusion Criteria:

          -  Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal
             anti-inflammatory drugs (NSAIDs), or any excipient of N1539

          -  Have a known bleeding disorder that may be worsened with the administration of an
             NSAID

          -  Be undergoing cardiothoracic surgery

          -  Has used meloxicam within 7 days before the surgical procedure on Day 1

          -  Has any clinically significant medical history or clinical manifestations of
             significant disease or any other condition that increases the risk associated with the
             subject's participation in the study or compromises the scientific objectives of the
             study.
Geriatric Ketamine for Pain Management Study
Condition: Pain
Intervention: Morphine; Ketamine
Intervention description: intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.; Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
Intervention MeSH terms: Ketamine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 65 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Geriatric, Pain, Ketamine, Emergency Medicine

Summary:

      This research project is geared towards geriatric analgesia in the Emergency Department (ED)
      with a goal of reducing the administration of opioid pain medications to elderly patients,
      thereby avoiding the commonly occurring, severe side effects associated with such
      medications, including hypotension, respiratory depression, altered mental status, delirium,
      as well as nausea/vomiting and constipation.

      The primary outcome of the study will be difference in pain score from baseline to 30 minutes
      post-medication administration.

      This project has the potential to change and modify the ED approach to geriatric analgesia by
      virtue of minimizing the use of opioid administration in elderly patients. T
    

Eligibility criteria:

        Inclusion Criteria:

          -  ED patients; 65 years of age and older; abdominal, flank, back, traumatic chest, neck
             or musculoskeletal pain; capacity to give verbal or written consent.

        Exclusion Criteria:

          -  ED patients <65 years old; altered mental status; presenting with headache,
             non-traumatic chest pain; allergy to morphine or ketamine; weight <40kg or >115kg,
             unstable vital signs (systolic blood pressure <90 or >180 mmHg; heart rate <5 or >150
             beats per minute; and respirations <8 or >30 per minute), and past medical history of
             severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness;
             Patients with BMI>40; severe COPD
Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema
Condition: Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy
Intervention: ranibizumab 0.5 mg
Intervention description: intravitreal injection
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; Visual impairment

Summary:

      The purpose of this study was to demonstrate that the change of best corrected visual acuity
      (BCVA) was comparable in patients treated with ranibizumab at the discretion of the
      investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c)
             ≤ 12.0%

          -  Patients with visual impairment due to DME in at least one eye

          -  BCVA ≥ 24 and ≤ 78 letters in the study eye

        Exclusion Criteria:

          -  Active intraocular inflammation

          -  Any active infection in either eye at the

          -  Structural damage within 0.5 disc diameter of the center of the macula in the study
             eye

          -  Uncontrolled glaucoma in either eye at screening

        Other protocol-defined inclusion/exclusion criteria may apply.
Antibiotic Elution in Total Knee Arthroplasty
Condition: Total Knee Replacement
Intervention: hand mixed vancomycin; hand mixed tobramycin; pre-mixed tobramycin
Intervention description: hand mixed vancomycin powder into cement; hand mixed tobramycin into cement; this cement is already pre-mixed with tobramycin
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin; Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Masking description: patient will not know which antibiotic cement group they are in
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to characterize and quantify the level of antibiotics eluted from
      antibiotic laden cement after primary cemented total knee arthroplasty.

      Patients will be identified by medical record review to make sure they meet inclusion and
      exclusion criteria.

      Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups
      which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed
      tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group.
      Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the
      knee postoperatively will be collected as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age over 18

          -  Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

          -  Primary diagnosis of knee osteoarthritis

               -  Exclusion Criteria:

          -  Diminished mental capacity

          -  Vancomycin allergy

          -  Tobramycin allergy

          -  Patient history requiring IV administration of vancomycin or tobramycin
             perioperatively

          -  Chronic kidney disease stage III and stage IV
ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Ketorolac and Ropivacaine
Intervention description: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day; Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      After surgery it is normal to experience some pain at the site of operation. In order to
      reduce the pain, medication such as Morphine is injected into a vein using a Patient
      Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient
      when needed. However, Morphine is an opioid drug, which can cause side effects such as
      sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid
      drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs
      (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects
      of morphine. Recently a portable device called ON-Q pump has been developed to continuously
      infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q
      Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses
      the drug through the catheters by elastic force. This pump is very safe and is attached to a
      bedside pole or the patient's hospital gown. This pump has already been approved by the FDA
      for clinical use, and has been reported to provide effective pain management after some
      surgical procedures.

      The primary aim of the present study is to evaluate the relative efficacy of the drugs
      Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following
      gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used
      for post operative pain relief. Our hypothesis is that these two drugs in combination will
      provide better analgesia than Ketorolac alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients belonging to ASA class I to II classification who are undergoing abdominal
             gynecologic surgery will be included in the study.

        Exclusion Criteria:

          -  Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer,
             sepsis, or coagulation problems will be excluded from the study.
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Intervention: Pro Root MTA®; EBRRM®
Intervention description: Patients in this group will receive the pulpotomy with Pro Root MTA®.; Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Minimum age: 10 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Although many pulpotomy agents are commercially available, there is a dearth of clinical
      research comparing the efficacy of these agents in treating individuals with irreversible
      pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished
      from MTA by its superior chemical, physical, and biological properties. This study aims to
      address this knowledge deficit by assessing the performance of biocompatible materials in
      pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep
      caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis
      without apical periodontitis, this research will compare the success rates of MTA and EBRRM
      pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the
      treatment of this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with diagnosis of irreversible pulpitis without apical periodontitis

          2. Either gender

          3. Lower Age 10 Years - Upper Age 40 Years

        Exclusion Criteria:

          -  Teeth displaying indications of resorption.

          -  Teeth that have not fully developed, characterized by open apices.

          -  Canals that are calcified or obstructed.

          -  Perforations that were caused by the dentist.

          -  Fractures in the root

          -  Teeth that cannot be restored

          -  • Teeth that are unable to withstand frigid temperatures, have a sinus infection, or
             have swelling around them.

          -  There has been no pulp exposure despite the removal of carious lesion.

          -  Ten minutes after a pulpotomy, hemorrhage could not be stopped.

          -  Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
The Effect of Selenium Supplementation Among Pediatric Patients With Burns
Condition: Burns
MeSH terms: Burns
Intervention: Selenium1; Selenium2; Placebo
Intervention description: 2 ug/kg; 4 ug/kg; IV saline as placebo
Intervention MeSH terms: Selenium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The selenium status of children with major burns is suboptimal which may increase the
      incidence of infection. Se requirements during critical illness are not known. Results from
      this investigation may provide a tool for recommending Se supplements during burn injury.

      The hypothesis of this research is that Se supplementation will restore the depressed Se
      status among children with burn injuries. The secondary hypothesis is that Se status is
      related to the incidence of infection among pediatric patients with burns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 1 and 18 years of age admitted to Shriners Burns Hospital

          -  TBSA burn of > 20%

          -  Existing IV catheter

          -  Enrolled into study within 3 weeks of burn injury

        Exclusion Criteria:

          -  < 1 year or > 18 years of age

          -  < 20% TBSA burn

          -  No existing IV catheter

          -  Pre-existing or acute renal disease (creatine > 1.5 mg/dl)

          -  Pre-existing or acute liver disease (bilirubin > 3)

          -  Pre-existing or acute thyroid disorders

          -  Cancer

          -  AIDS

          -  Pregnancy (as determined by routine admission labs)
Changes in Cerebral Function in Treatment Naive HIV-1 Infected Subjects Commencing Either Boosted Atazanavir With Truvada or Boosted Darunavir With Maraviroc and Kivexa
Condition: HIV; Impaired Cognition
MeSH terms: Cognitive Dysfunction
Intervention: standard care; novel treatment
Intervention description: atazanavir 300 mg daily
ritonavir 100 mg daily
tenofovir 245 mg daily*
emtricitabine 200 mg daily*; darunavir 800 mg daily
ritonavir 100 mg daily
lamivudine 300 mg daily** and abacavir 600mgs daily**
maraviroc 150 mg once daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The purpose of this study is to compare two different combination anti-HIV therapies over 48
      weeks and to assess if differences in improvement in the function of the brain are observed
      over this period.

      The study will compare anti-HIV therapy combinations which are currently in use.

      The patients will not have had any previous treatment for their HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected males or females

          -  signed informed consent

          -  no previous antiretroviral treatment since HIV diagnosis

          -  screening CD4+ lymphocyte count <= 350 cells/ųL

          -  susceptible to all currently licensed (Nucleoside Reverse Transcriptase Inhibitors)
             NRTIs, (Non-Nucleoside Reverse Transcriptase Inhibitors) NNRTIs and PIs based on HIV-1
             genotypic resistance report

          -  CCR5-tropic HIV based on genotypic resistance testing*

        Exclusion Criteria:

          -  • existing neurological disease

               -  hepatitis B or hepatitis C co-infection

               -  age under 18 years

               -  screening laboratory parameters > grade 2 (with the exception of cholesterol and
                  triglycerides)

               -  current history of major depression or psychosis

               -  recent head injury (past three months)

               -  current alcohol abuse or drug dependence

               -  active opportunistic infection or significant co-morbidities

               -  patients who are receiving other concomitant medication which are not permitted,
                  as listed in appendix 2

               -  female patients of child-bearing potential who:

                    -  have a positive serum pregnancy test at screening or during the study

                    -  are breast feeding

                    -  are planning to become pregnant

               -  all participants unwilling to use a barrier method of contraception

               -  patients who in the opinion of the investigator are not candidates for inclusion
                  in the study
Growth and Development Study of Alglucosidase Alfa
Condition: Pompe Disease; Glycogen Storage Disease Type II (GSD-II); Acid Maltase Deficiency Disease
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease; Deficiency Diseases
Intervention: alglucosidase alfa
Intervention description: Dose: 20 mg/kg every 2 weeks; Route of administration: Intravenous infusion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Glycogenesis 2

Summary:

      Pompe disease (also known as glycogen storage disease Type II) is a rare autosomal recessive
      metabolic muscle disease caused by the deficiency of acid α glucosidase (GAA), an enzyme that
      degrades lysosomal glycogen. As opposed to the exclusively cytoplasmic accumulation of
      glycogen that occurs in other glycogen storage disorders, Pompe disease is characterized by
      organelle bound (lysosomal) and extra-lysosomal accumulation of glycogen in many body
      tissues, ultimately leading to multisystemic pathology. The overall objective of this study
      was to evaluate the long-term growth and development of participants with infantile-onset
      Pompe disease with alglucosidase alfa before 1 year of age. Participants were to be followed
      for a 10-year period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant or participant's legal guardian must have provided signed, informed
             consent prior to performing any study-related procedures.

          -  The participant must have had a confirmed diagnosis of Pompe disease as determined by
             deficient endogenous GAA activity or GAA mutation analysis.

          -  The participant must be less than (<) 1 year of age at time of study enrollment (and
             received alglucosidase alfa treatment before 1 year of age), or the participant must
             be between 1 year and 24 months of age and must have had initiated alglucosidase alfa
             treatment prior to turning 1 year of age.

        Exclusion Criteria:

          -  The participant was participating in another clinical study using alglucosidase alfa
             or any investigational therapy.