bioihbjkbjnl/mcl2 huggingface dataset:
Skeletal Muscle and Adipose Tissue Study
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Intervention: Bolus dose of Cefazolin; Continuous Cefazolin drip; Paraspinal muscle microdialysis catheters; Subcutaneous microdialysis catheters
Intervention description: Mode of Cefazolin administration will be a intermittent bolus; Mode of Cefazolin administration will be a continuous drip; Two dialysis probes will be inserted into a paraspinal muscle; Two dialysis probes will be inserted into a paraspinal subcutaneous region
Intervention MeSH terms: Cefazolin; Dialysis Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: tissue microdialysis; spinal fusion; surgical site infection

Summary:

      The purpose of this research study is to compare the current standard of care for
      prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of
      Cefazolin during pediatric spinal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic scoliosis

          -  Planned posterior spinal fusion surgery (PSFS)

          -  Age: 12-20 years old

          -  American Society of Anesthesiology status I or II undergoing posterior spinal fusion
             for at least 6 levels

          -  No known allergy to cefazolin

        Exclusion Criteria:

          -  Known allergy to cefazolin

          -  Anatomical or other abnormalities that precluded insertion of a microdialysis catheter
             into the selected paraspinal muscle

          -  Known renal or hepatic insufficiency or failure
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Condition: Hyperopia; Myopia
MeSH terms: Hyperopia
Intervention: Lotrafilcon B; lotrafilcon B with Hydraluxe
Intervention description: commercially available contact lens; commercially available contact lens
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The current study aims to systematically investigate the diurnal variation in the optical
      quality of soft contact lenses on eye throughout the day. Subject reported quality of vision
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Habitual prescription +5.00 D to -6.00 D

          -  18-35 years of age

          -  The subject must appear able and willing to adhere to the instructions set forth in
             this clinical protocol.

          -  Vertex corrected refractive cylinder must be -0.75 or less.

          -  Visual acuity best correctable to 20/25 or better for each eye

          -  The subject must read and sign the Informed Consent form.

          -  Mesopic pupil size >5.00 mm.

        Exclusion Criteria:

          -  active condition that would prevent contact lens wear

          -  history of issues of eye alignment or binocularity by self-report

          -  doctor diagnosed, self-reported accommodative or binocular vision issues

          -  doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular,
             ongoing treatment
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Topicort® (desoximetasone) Topical Spray, 0.25%
Intervention description: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Intervention MeSH terms: Desoximetasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the potential of Topicort® (desoximetasone)
      Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary
      objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event
      profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 7 years and older must have provided written assent accompanied by
             written informed consent from patient's representative

          -  Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface
             area (excluding face and scalp)

          -  Physicians Global Assessment score of 3 or 4 at baseline

        Exclusion Criteria:

          -  Has other dermatological conditions that may interfere with clinical assessments

          -  Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance
             that would compromise patient safety or study results

          -  History of an adverse reaction to Cortrosyn™ or similar test reagents

          -  Chronic infectious disease, system or organ disorder or other medical condition that
             would place patient at undue risk by study participation
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: Netarsudil Ophthalmic Solution 0.02%
Intervention description: 1 drop in each eye once daily in the evening
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 261.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as
      monotherapy or when used concomitantly with other IOP-lowering agents in subjects with
      elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical
      setting. The study is an open-label design. The patients will receive treatment for 12 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female subjects (aged 18 or older)

          2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by
             the treating physician to require additional intraocular pressure (IOP)-lowering
             treatment with netarsudil 0.02%.

          3. Willingness to follow protocol requirements, including signed informed consent,
             routine follow-up schedule, completing questionnaires and completing laboratory tests

        Key Exclusion Criteria:

          1. Have any active ocular disease other than glaucoma or ocular hypertension that would
             interfere with study interpretation

          2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and
             not using a medically acceptable form of birth control. Male subjects with a female
             partner of childbearing potential must have had a prior vasectomy or agree to use an
             effective method of birth control during the treatment period and for 3 months after
             the subject has completed the study.

          3. Known sensitivity or allergy to the study medication or components

          4. Any systemic disease or clinical evidence of any condition which would make the
             subject, in the opinion of the investigator, unsuitable for the study or could
             potentially confound the study results

          5. Concurrent participation or prior participation in any investigational drug or device
             study within the last 30 days prior to the Baseline Visit
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Condition: Tendinopathy; Hip Pain
MeSH terms: Tendinopathy
Intervention: PRP; Whole Blood; Ultrasound
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Gluteus Medius Tendinosis

Summary:

      Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain
      Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by
      side lying, stair climbing, and walking. Treatment is currently limited to lifestyle
      modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical
      repair. Platelet rich plasma (PRP) injections contain important growth factors that are
      essential in the healing and tissue formation processes. However, the extent to which PRP is
      more efficacious than whole blood in tendinopathy remains unclear. In this double-blind
      randomized trial, patients will be allocated to receive either a PRP or whole-blood
      injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months,
      and 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe lateral hip pain for greater than 3 months

          -  Symptoms are refractory to conservative treatment, including at least 8 weeks of
             traditional physical therapy for this condition

          -  Moderate to severe gluteus medius tendinosis with or without partial tear <1 cm

          -  Normal neurologic exam except for hip abductor weakness on the affected side

        Exclusion Criteria:

          -  Severe (Tonnis grade >1) hip osteoarthritis with active synovitis or bone edema

          -  Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal
             distribution

          -  No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on
             MRI

          -  Any condition that requires anti-platelet or anti-coagulation therapy, including
             aspirin therapy for cardiac conditions

          -  Non-English speaking
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Condition: Spinal Anesthesia; Cesarean Section
Intervention: Low-dose epinephrine; High-dose epinephrine; No epinephrine
Intervention description: 0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications; 0.2ml of 1:1000 epinephrine will be added to the standard spinal medications; 0.2ml of preservative-free saline will be added to the standard spinal medications
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: spinal anesthesia; epinephrine; bupivacaine; repeat cesarean

Summary:

      The purpose of this study is to investigate whether the addition of a medication called
      epinephrine to spinal medications prolongs the duration of the anesthesia. The medication
      standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain
      medication (morphine). These medications typically last about 2 hours. The investigators want
      to determine if adding epinephrine to the spinal medications prolongs the anesthetic without
      side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean
      section. Epinephrine is known to prolong the action of some local anesthetics, but the
      investigators want to specifically study combining it with the medications the investigators
      use regularly for cesarean section.

      You may qualify to take part in this research study because you are having a repeat cesarean
      section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want
      to determine if epinephrine will prolong the anesthetic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-emergent repeat cesarean section

          -  Neuraxial anesthesia as the planned primary anesthetic

          -  Informed consent obtained

          -  Females age 18-50

        Exclusion Criteria:

          -  Emergency cesarean section

          -  Anesthetic other than neuraxial

          -  Allergy to local anesthetics, morphine, or epinephrine

          -  Pre-existing sensory/motor deficit
Multi-dose Acetaminophen for Patients Undergoing General Anesthesia
Condition: Recovery Following Cholecystectomy
Intervention: Acetaminophen; normal saline
Intervention description: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.; 100mL of normal saline every 4 hours to a maximum administration of 400mL
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose
      IV acetaminophen on patients' readiness for discharge. In doing so the investigators will
      also investigate the various factors that could potentially contribute to a patient's
      readiness for discharge such as overall opioid consumption, time to rescue medication,
      incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers
      and their overall correlation with IV acetaminophen intake.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing ambulatory laparoscopic cholecystectomy.

          -  American Society of Anesthesiologists physical status 1, 2 or 3.-

        Exclusion Criteria -

          -  Cognitively impaired (by history) and unable or unwilling to consent

          -  Chronic steroid or opioid user (as prescribed for a chronic systemic illness)

          -  Parturient or nursing mother. Patients who have been informed by a physician that they
             have liver or kidney disease
The SLIM Study: Sling and Botox® Injection for Mixed Urinary Incontinence
Condition: Mixed Urinary Incontinence; Stress Urinary Incontinence; Urgency Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: OnabotulinumtoxinA (Botox ®) Injections; Saline Injections
Intervention description: OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.; Saline will be injected into the bladder so that investigators are masked to subject randomization.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
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: No

Summary:

      This double-blind randomized controlled trial seeks to find a better treatment for women with
      mixed urinary incontinence (both stress and urgency incontinence). The primary aim is to
      determine whether midurethral sling surgery combined with injections of onabotulinumtoxinA
      (Botox®) into the detrusor muscle of the bladder improves symptoms of mixed urinary
      incontinence better than sling surgery alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing mid-urethral sling surgery

          -  Have symptoms of both stress and urgency urinary incontinence

          -  Able to consent, fill out study documents, and complete all study procedures and
             follow-up visits

          -  At least 18 years of age

          -  English speaking

          -  Be able and willing to learn clean intermittent self catheterization technique

        Exclusion Criteria:

          -  History of recurrent UTI (defined as three culture proven UTIs within last 12 months)

          -  Systemic neuromuscular disease known to affect the lower urinary tract

          -  Undergoing concomitant prolapse surgery

          -  Previous incontinence surgery

          -  Treatment with anticholinergic medication in the last 2 months

          -  Previous bladder injection with onabotulinumtoxinA

          -  Prisoner Status

          -  Pregnancy
Treatment of Post-dural Puncture Headache in Postpartum Patients: Sphenopalatine Ganglion Block to Epidural Blood Patch.
Condition: Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Intervention: Sphenopalatine ganglion Block; Epidural blood patch
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to compare the effectiveness of a sphenopalatine
      ganglion block to an epidural blood patch for post-dural puncture headache relief in
      randomized postpartum parturients over a 48 hour period.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age 18 years or age or greater

          2. Postpartum obstetric parturient who was previously admitted to UCH.

          3. Diagnosis of post-dural puncture headache based on the International Classification of
             Headache Disorders:

               1. Dural puncture has been performed

               2. Headache has developed within 5 days of the dural puncture

               3. Not better accounted for by another ICHD-3 diagnosis.

               4. Occurring immediately or within seconds of assuming an upright position and
                  resolving quickly (within 1 minute) after lying horizontally.

        Exclusion Criteria

          1. Refusal to participate in the study

          2. Placement of an EBP within the past 5 days

          3. Allergy and/or intolerance to any the study materials

          4. Contraindications to an EBP

          5. Plan for therapeutic anticoagulation post-partum
Pain Perception During Vulvar Biopsy
Condition: Any Condition Requiring Vulvar Biopsy
Intervention: EMLA; Lidocaine
Intervention description: Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.; Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: Female
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: vulvar biopsy

Summary:

      The purpose of this study is to compare pain control during vulvar biopsy following either
      (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and
      prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will
      provide better biopsy analgesia, but the benefit will be offset by the pain of lidocaine
      injection compared to EMLA application, thus there will not be a significant difference in
      highest pain scores between the two groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females above age 18 presenting to Duke Gynecology Oncology clinic for vulvar biopsy

          -  Able to provide informed consent in English and agree to the risks of the study

        Exclusion Criteria:

          -  Not able to provide informed consent

          -  Vulvar biopsy on a hair bearing surface
Steroid Administration for Articular Fractures of the Elbow (SAFE Trial)
Condition: Elbow Fracture
MeSH terms: Fractures, Bone; Elbow Fractures; Intra-Articular Fractures
Intervention: Glucocorticoids; Saline
Intervention description: Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone intraoperatively. Following surgery, the participant will be provided with a six-day oral methylprednisolone taper course.; Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.
Intervention MeSH terms: Dexamethasone; Methylprednisolone; Glucocorticoids
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The treating physician and patient will be blinded to the treatment assignment.
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glucocorticoid Administration

Summary:

      The primary purpose of this study is to determine if perioperative glucocorticoid
      administration (IV intra-operative followed by a post-operative oral taper course) improves
      post-operative range of motion in a patient population that has sustained an intra-articular
      elbow fracture(s) (radial head, proximal ulna, distal humerus, or combined) that required
      operative fixation.
    

Eligibility criteria:

        Inclusion Criteria

        • All adults ≥18 years old with an isolated, intra-articular traumatic elbow fracture to be
        treated at Vanderbilt University Medical Center with operative intervention and a
        standardized post-operative rehab protocol.

          -  Intra-articular elbow fracture defined as:

               -  Distal humerus

               -  Proximal ulna

               -  Radial head fracture

               -  Combination fracture of two or more of the above

          -  Radiographs present confirming intra-articular injury

        Exclusion Criteria

          -  Patients with bilateral elbow fractures

          -  Patients with an altered mental status

          -  Pregnant

          -  Allergy or contra-indication to glucocorticoid administration

          -  Type 1 or Type 2 diabetes

          -  Pre-injury limitation in elbow range or motion (patient reported)

          -  Unable to provide consent for themselves