bioihbjkbjnl/mcl2 huggingface dataset:
Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks
Condition: Total Knee Arthroplasty; Knee Pain
Intervention: 0.1% and 0.4% perineural ropivicaine
Intervention description: Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TKA; Bilateral; Cleveland Clinic; UCSD; Catheter; Nerve block; Postoperative pain; Femoral Catheter; Bilateral Total Knee Arthroplasty; Bilateral Femoral Catheter

Summary:

      This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing
      bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one
      of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4%. The
      contralateral side will receive the other possible ropivacaine concentration of 0.1% or 0.4%.
      The basal rate and patient-controlled bolus volume will depend upon the treatment group, but
      the total dose of local anesthetic is the same for each. For the duration of the study, all
      patients will receive the current usual and customary analgesics for bilateral TKA patients.
      All patients will receive a ropivacaine perineural infusions initiated in the operating room
      and continued until at least the afternoon of postoperative day (POD) 2, as well as oral
      acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of
      administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with
      0 equal to no pain and 10 being the worst imaginable pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary, bilateral TKA

          -  Age 18 years or older

          -  Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

        Exclusion Criteria:

          -  Chronic, high-dose opioid use

          -  History of opioid abuse

          -  Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

          -  Pregnancy

          -  Incarceration
Adult Growth Hormone Deficiency and Cardiovascular Risk
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Intervention: Blood draws; growth hormone releasing hormone (GHRH) & arginine; Carotid ultrasound; MRI; Endothelial cell biopsy
Intervention description: Subjects will have serum cardiovascular markers assessed; Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.; Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.; Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.; Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Growth hormone

Summary:

      This protocol will assess the cardiovascular risk associated with growth hormone deficiency
      in adults. We will use multiple modalities to assess risk for heart attacks or strokes
      including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are
      growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize
      that adults with growth hormone deficiency will have results suggestive of an increased risk
      for cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 19 years or older who have undergone transsphenoidal surgery for a clinically
             non-secreting pituitary adenoma

        Exclusion Criteria:

          -  Currently taking growth hormone, radiation therapy in the past 5 years, changes in
             dose of other pituitary hormone replacement therapy in past 3 months, taking
             hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women
24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E
Condition: Abortion, Second Trimester
Intervention: Vaginal Misoprostol; Buccal Misoprostol
Intervention description: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E; Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Computer-generated randomization will be utilized to assign treatment arms and the vaginal misoprostol and buccal placebo and buccal misoprostol and vaginal placebo will be prepared according to randomization scheme by the research pharmacy in opaque-sealed envelopes as to blind participants and providers.
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: D&E; dilation and evacuation; abortion; second trimester; mifepristone; misoprostol

Summary:

      This study aims to compare mifepristone and buccal misoprostol to mifepristone and vaginal
      misoprostol for cervical preparation for second trimester dilation and evacuation (D&E).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The study will enroll healthy English or Spanish-speaking women, over 18 years of age,
             eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by
             sonogram, and willing/able to undergo informed consent.

        Exclusion Criteria:

          -  Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy,
             intolerance, allergy or contraindication to mifepristone or misoprostol
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Condition: Infections, Herpesviridae
MeSH terms: Herpesviridae Infections
Intervention: Valaciclovir; Placebo
Intervention description: Valtrex 1g once daily; placebo
Intervention MeSH terms: Valacyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: viral shedding; Recurrent; herpes; genital herpes

Summary:

      Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for
      60 days in a two-way crossover study with a washout period of 7 days between treatment
      periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In overall general good health.

          -  HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

        Exclusion criteria:

          -  have active lesions consistent with genital herpes.

          -  previous history of symptomatic genital herpes.

          -  history of recurrent, undiagnosed symptoms consistent with genital herpes.
Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years
Condition: Turner's Syndrome
MeSH terms: Dwarfism; Turner Syndrome; Gonadal Dysgenesis; Syndrome
Intervention: r-hGH
Intervention description: Subcutaneous administration.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: Female
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Growth hormone; Turner syndrome; r-hGH; early treatment

Summary:

      The objective of this study is to evaluate the efficacy and safety of recombinant human
      growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years.
      After 4 years of treatment, height in these girls will be compared with an historical control
      group of untreated girls with Turner Syndrome, matched for age and height at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Young girls with turner syndrome proved by karyotype

          -  Growth hormone secretion confirmed with ornithin stimulation test

          -  Normal glucidic metabolism confirmed by assessment of HbA1c

          -  None associated severe pathology which could have impact on growth (i.e. renal
             insufficiency, decompensated heart failure)

          -  No previous or associated treatment with anabolic or sexual steroids

          -  Known parental height

        Exclusion Criteria:

          -  Severe associated pathology with impact on growth

          -  Concomitant treatment with impact on growth

          -  Previous or associated treatment with anabolic steroids

          -  Associated growth hormone deficiency
A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Condition: Glaucoma; Cataract
MeSH terms: Glaucoma; Cataract
Intervention: Pred Forte; EconoPred Plus; Prednisolone Acetate
Intervention description: Four drops daily decreasing to once daily over four weeks.; Prednisolone Acetate four times daily decreasing to once daily over four weeks.; Dosed four times daily decreasing to once daily over four weeks.
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Cataract

Summary:

      Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be willing and able to provide written informed consent.

          -  Be able and willing to follow instructions on the use of the study medication and
             likely to complete the entire course of the study.

          -  Be male or female of any race at least 18 years of age.

          -  Have visually significant cataract or medically uncontrolled glaucoma for which they
             have elected to undergo surgery.

        Exclusion Criteria:

          -  Contraindication to use of corticosteroids.

          -  Ocular disease other than glaucoma or ocular hypertension that would interfere with
             study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects
             with mild chronic blepharitis, age-related macular degeneration and background
             diabetic retinopathy may be enrolled at the discretion of the investigator.

          -  Laser or any other intraocular surgery within the past three months.

          -  Require use of ocular NSAID or systemic steroids.

          -  Have known allergy or sensitivity to the study medications or their components

          -  Have corneal abnormalities that would interfere with the ability to obtain an adequate
             laser flare measurement.

          -  Be concurrently enrolled in an investigational drug or device study or participation
             within the last 30 days in any investigational drug or device study.

          -  Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not
             using a reliable form of contraception (a woman is considered of childbearing
             potential unless she is postmenopausal, has had a uterus and/or both ovaries removed,
             or has had a bilateral tubal ligation).

          -  Have a situation or condition that in the investigator's opinion may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with participation in the study
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
Condition: End Stage Renal Disease; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: 300mg glecaprevir/pibrentasivir 120mg
Intervention description: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      In this study, individuals without hepatitis C infection who are on the kidney transplant
      waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be
      treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg /
      pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant
      procedure and continued for 4 weeks post-renal transplant.
    

Eligibility criteria:

        Recipient Inclusion Criteria

          -  Participants ≥ 40 years old

          -  On the deceased donor kidney waitlist at Johns Hopkins Hospital

          -  Awaiting a first or second kidney transplant

          -  No available living kidney donors

          -  On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a
             glomerular filtration rate <15 ml/min for ≥ past 90 days

          -  HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors
             for contracting HCV other than being on hemodialysis

          -  Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 80%

        Recipient Exclusion Criteria

          -  Plan to receive a multi-organ transplant

          -  Plan to receive a dual kidney transplant (including en bloc)

          -  Prior solid organ transplant

          -  Participating in another study that involves an intervention or investigational
             product

          -  Plan to receive a blood type incompatible kidney

          -  History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B
             (HBV) infection, defined as being on active antiviral treatment for HBV, detectable
             hepatitis B surface Ag or detectable hepatitis B DNA

          -  Unable to safely substitute or discontinue a medication that is contraindicated with
             the study medication

          -  Psychiatric or physical illness that in the opinion of the investigator would make it
             unsafe to proceed with transplantation or interfere with the ability of the subject to
             participate in the study
Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: alefacept; Narrow Band UVB Phototherapy
Intervention description: IM; UVB Phototherapy
Intervention MeSH terms: Alefacept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; alefacept; Amevive; narrow band ultraviolet B; phototherapy

Summary:

      Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic
      plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic
      subjects as both modalities have an effect on T cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has given written informed consent

          -  Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10%
             with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline

          -  Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal

          -  Male and female subjects must use an adequate means of contraception from screening to
             end of study.

        Exclusion Criteria:

          -  Subject who received alefacept in the past

          -  Subject who has shown no improvement following an adequate course of nbUVB in the past

          -  Subject who has been treated in the past with either therapy or cyclosporine

          -  Subject with any active cancer, including skin cancer at Baseline

          -  Subject with erythrodermic, pustular or predominantly guttate psoriasis

          -  Subject who has used treatment for psoriasis prior to Baseline as follows:

               -  Topical treatment within 14 days

               -  Oral treatment within 28 days

               -  Broad band UVB (bbUVB) or nbUVB treatment within 56 days

               -  Biological treatment within 84 days

          -  Serious local infection or serious systemic infection within the 3 months prior to the
             first dose of study drug

          -  Subject with a history of drug or alcohol abuse within the past 2 years

          -  Subject that is known to be infected with the AIDS virus

          -  Subject with any other skin disease or other disease that might interfere with
             psoriasis status assessments

          -  Female subject who is nursing, pregnant or planning to become pregnant while in this
             study

          -  Subject who is currently enrolled in any other investigational drug or device study
Brain Imaging of Lidoderm for Chronic Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: lidocaine; placebo
Intervention description: 5% lidoderm patch; placebo
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: chronic back pain; placebo; fmri; brain imaging

Summary:

      The investigators tested whether pain decrease can be observed centrally with non-invasive
      brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of
      5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of
      Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before
      treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double
      blind, placebo controlled trial, where participants either received Lidoderm or placebo
      patches, without cross over.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female 18 years or older of age

          2. Pain in the location of the lower back

          3. Pain duration for a minimum of 6 months on a continuous basis

          4. Pain intensity of at least 3 out of 10 on most days of the week over the past six
             months

          5. Manifestations of radicular element of pain: radiation below knee (examples towards
             thigh, buttocks).

          6. Right handedness

        Exclusion Criteria:

          1. Applying for or currently receiving workers' compensation or disability status.

          2. Back pain secondary to spinal cord injury

          3. Back pain secondary to any systemic condition (e.g ankylosing spondylitis0

          4. Diabetes mellitus

          5. Back pain secondary to tumors.

          6. Standard MRI criteria re: claustrophobia, metal objects etc.

          7. Subjects with cognitive deficits such as dementia, psychiatric illness including
             depression with a BDI score of more than 19 (moderate to severe depression), history
             of brain injury, history of chronic disease

          8. Pregnant and/or lactating women

          9. Left handedness

         10. Active cancer

         11. Other serious painful condition (e.g., arthritis)