bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Perampanel on Neurophysiology Test Perimeters
Condition: Healthy
Intervention: Perampanel 6 MG
Intervention description: Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: 12 healthy males will undergo testing, then receive the drug intervention, followed by blood draw and testing again
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to evaluate the effects of perampanel, a FDA approved drug for epilepsy, on
      commonly performed neurophysiology tests: electroencephalogram (EEG), somatosensory evoked
      potential (SEP), brainstem auditory evoked potential (BAEP), and visual evoked potential
      (VEP). Many other drugs used in the treatment of epilepsy have been shown to affect the
      results of these test but no one has yet examined if perampanel affects these tests. The
      investigators plan to recruit 12 healthy normal male subjects. All subjects will have VEP,
      SSEP, EEG, and BAER performed before and 1 hour (when Cmax is reached) after receiving 6mg of
      oral perampanel. Subjects will also receive a blood draw 1 hour after ingestion of perampanel
      for serum perampanel level. In a previous study done at another institution, healthy
      volunteers have tolerated a single dose of perampanel at 6 mg quite well. There is no placebo
      nor randomization. Subject's participation concludes after completion of post-perampanel
      ingestion neurophysiology tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects between the ages of 18 to 50 years old with a body mass index of
             19-29 kg/m2 will be recruited.

        Exclusion Criteria:

          -  Subjects would be excluded if they use recreational drugs and have any neurologic
             disease, psychiatric condition or any other condition that may affect outcome and risk
             subject safety. Furthermore, anyone that would not be able to participate in
             neurophysiology tests will also be excluded. Subject will also be excluded should they
             take any over the counter medication or consume caffeine or alcohol 12 hours prior to
             the study.
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Condition: ALLERGIC ASTHMA
MeSH terms: Asthma
Intervention: ANTI-IGE THERAPY (XOLAIR)
Intervention description: Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The researcher proposes to assess levels of sputum inflammatory markers (eosinophils,
      eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in
      a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma
      symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).

      Associations will be assessed between the types of sputum inflammatory markers and the
      patient's atopic status and level of asthma control as indicated by the following measures:

        1. pulmonary function test (PFT)

        2. asthma symptoms based on the Asthma Control Test (ACT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe allergic asthma, uncontrolled on conventional therapy

        Exclusion Criteria:

          -  History of systemic illness, currently on other immune modulators like immunotherapy,
             IVIg

          -  Pregnancy

          -  IgE level >1300
Shoulder Contraceptive Implant Study
Condition: Contraception
Intervention: Etonogestrel implant
Intervention description: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Intervention MeSH terms: Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will be the first to establish pharmacokinetic curves for the etonogestrel
      contraceptive implant with scapular subdermal insertion. By obtaining this pharmacokinetic
      data, the investigators can compare this data to already published pharmacokinetic data with
      conventional implant insertion. This comparison can provide some reassurance that the
      absorption and distribution of etonogestrel from the contraceptive implant with scapular
      insertion is similar to that found with conventional insertion. With similar pharmacokinetic
      properties, the investigators would expect scapular insertion of the implant to maintain
      similar contraceptive efficacy for the populations of women that may benefit from this
      alternative insertion site. Preliminary safety data will also enrich the understanding of any
      potential insertion site side effects with subdermal scapular implant insertion, as the
      investigators currently only have a single case report with side effect outcomes. The
      investigators can then use this pilot data to support future larger investigations on
      subdermal scapular implant insertion given its complete avoidance of the neurovascular
      complications associated with arm insertion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women

        Exclusion Criteria:

          -  Any contraindications to etonogestrel implant use based on the US Medical Eligibility
             Criteria for Contraceptive use (defined as class 3 or 4 recommendation)18

          -  Any known liver conditions that could affect drug metabolism (e.g. cirrhosis,
             hepatitis)

          -  Currently taking any medications or supplements known to be CYP3A4
             inducers/inhibitors19

          -  Body-mass index less than 18.5kg/m2 or greater than 30kg/m2

          -  Currently pregnant or planning to become pregnant in the next 12 months
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Condition: Leukemia-Lymphoma
Intervention: EMLA; Lidocaine
Intervention description: EMLA cream (lidocaine 2.5% and prilocaine 2.5%); lidocaine 1%
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in
      which a needle is inserted into the spinal canal. In this population, LPs are most commonly
      performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal
      cord) for diagnostic testing, and to inject medications including chemotherapy. Local
      analgesic (pain control medicine) during pediatric LP procedures is underutilized and not
      standardized. The first local analgesic routinely used for LP procedures was lidocaine
      injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved
      by the FDA for local skin use in pediatric patients, has provided an additional option for
      local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain
      control in the pediatric population has not been performed. Pediatric oncology patients often
      require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of
      standardization of LP analgesia in this population, the investigators have designed a
      prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine
      injection in reducing pain associated with LP in children being treated for leukemia or
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric cancer patients (aged 3-18) with a diagnosis of leukemia or lymphoma

          -  Patients are expected to receive serial (i.e. > 1) LP as outpatients in Charleston
             Area Medical Center Children's Cancer Center in the course of 12 months for diagnostic
             and/or treatment purposes

        Exclusion Criteria:

          -  Patients not in the age range

          -  Non-cancer patients

          -  Allergy to amide anesthetics

          -  Patients treated with class I and III anti-arrhythmic drugs (eg, amiodarone,
             bretylium, sotalol, dofetilide)

          -  Patients with congenital or idiopathic methemoglobinemia
Preoperative Antibiotics for Carpal Tunnel Release Surgery
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Intervention: Vancomycin; Cefazolin; Saline Solution
Intervention description: Vancomycin - 1-gram dosing; 2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater; Placebo
Intervention MeSH terms: Vancomycin; Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Principal investigator, co-investigators, and participants are blinded to study intervention
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Endoscopic Carpal Tunnel Release; Prophylactic Antibiotics

Summary:

      This is a clinical trial to determine how effective antibiotics administered prior to
      endoscopic carpal tunnel release surgery are in preventing surgical site infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High probability (>12 points) on the Carpal Tunnel-6 diagnostic aide

          -  Recommendation for carpal tunnel release

          -  Capable of providing informed consent/LAR to act on subject's behalf

        Exclusion Criteria:

          -  Patients allergic to both penicillin/cephalosporins and vancomycin

          -  Patient immobilized with splint or cast

          -  Unwilling unable to provide informed consent

          -  Children under the age of 18
Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery
Condition: Post Operative Pain; Nausea
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone 8mg iv x1; placebo
Intervention description: Dexamethasone 8mg iv x1; 2 ml normal saline IV x1
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine the opiate sparing effects of intravenously
      administered dexamethasone in outpatient knee surgery. Dexamethasone is a glucocorticoid with
      well known antiemetic effects. However, the analgesic effects of dexamethasone have not been
      adequately researched. Following surgery, patients are typically discharged home with PO
      opiates to manage post-operative pain. The investigators believe that by using VAS (Visual
      Analog Scale) for Pain the investigators can show that a single dose of dexamethasone can
      reduce pain scales and opiate consumption post-operatively, on Post Operative Day (POD 1)
      when compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients undergoing ambulatory knee arthroscopy surgery

          -  Must provide phone contact number and agree to phone followup on post operative day 1

        Exclusion Criteria:

          -  Patients with major systemic disease

          -  Allergy or intolerance to study drug
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Condition: Hemorrhoid
MeSH terms: Hemorrhoids
Intervention: Exparel; Bupivacaine HCl with Epinephrine; Normal Saline
Intervention description: 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL); 75mg/30mL 0.25% Bupivacaine HCl with epinephrine; 30mL Normal Saline
Intervention MeSH terms: Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liposomal Bupivacaine; Exparel

Summary:

      The purpose of this study is to compare the quality and duration of pain relief after a
      hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine
      hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more
      effective postoperative pain relief than both bupivacaine hcl and the control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are
             English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30

        Exclusion Criteria:

          -  contraindications to administration of local anesthesia (e.g., local anesthetic
             allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders,
             pregnancy , and history of substance abuse or chronic opioid use
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Condition: Heart Disease
MeSH terms: Heart Diseases
Intervention: Dexmedetomidine; Placebo
Intervention description: Dexmedetomidine; Normal saline administration matching dexmedetomidine rate of infusion
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 798.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-85 years old;

          2. Scheduled for cardiac surgery with bypass (CABG, valve, or combined);

          3. Able to provide a written informed consent;

          4. Hemodynamically stable (heart rate>= 55).

        Exclusion Criteria:

          1. Sick sinus syndrome or Wolff-Parkinson-White syndrome

          2. Atrio-ventricular block

          3. Hypersensitivity or known allergy to dexmedetomidine

          4. Hepatic disease, e.g. twice the normal level of liver enzymes

          5. Atrial fibrillation within 1 preoperative month;

          6. Permanent pacemaker;

          7. Use of amiodarone or dexmedetomidine within the last 30 days;

          8. Patients with an ejection fraction under 30% or who had severe heart failure

          9. Myocardial infarction in the previ¬ous 7 days;

         10. Body mass index =< 40 (BMI= mass (kg) / height (m)2);

         11. Those taking clonidine within last 48 hours.
Effects of Oral Sildenafil on Mortality in Adults With PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: sildenafil citrate; sildenafil citrate; sildenafil citrate
Intervention description: sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study; sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study; sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: pulmonary arterial hypertension; pulmonary hypertension; PAH; sildenafil; revatio

Summary:

      This is a blinded study in adult patients with PAH evaluating the relative effects of
      sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three
      times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute
      walking distance (6MWD) will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects ≥ 18 <75 years of age with any of the following conditions:

          -  Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)

          -  PAH secondary to connective tissue disease

          -  PAH with surgical repair (at least 5 years previously) of atrial septal defect
             (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and
             aorto-pulmonary window

          -  PAH diagnosis confirmed by right heart catheterization performed within 12 months
             prior to randomization

          -  Functional Class II-IV; Baseline 6MWD ≥ 50 m.

        Exclusion Criteria:

          -  Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary
             regurgitation

          -  History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular
             tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation

          -  History of pulmonary embolism; History of chronic lung disease / restrictive lung
             disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with
             impairment of lung function

          -  No prior long term treatment with PDE-5 inhibitors

          -  Treatment with bosentan OR riociguat within 3 months of randomization

          -  Current treatment with nitrates or nitric oxide
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Platelet Rich Plasma
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PRP; BPTB; VAS; Anterior Knee Pain

Summary:

      The purpose of this research study is to investigate whether or not platelet rich plasma
      (PRP) may help to improve tendon healing and decrease post operative pain in patients
      undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar
      tendons as autografts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary ACL Reconstruction

          -  Outerbridge </= 2

          -  Minimum follow up of two years

          -  No ligamentous secondary injury

          -  Willingness to participate in study

        Exclusion Criteria:

          -  Any previous knee injury

          -  prior history of anterior knee pain

          -  Outerbridge classification 3 or greater

          -  Revision ACL

          -  Diabetic or smoker

          -  Workers compensation patient

          -  pregnant or nursing women

          -  Any patient with limited English Proficiency
Pharmacogenomics and Post-Operative Nausea and Vomiting
Condition: Postoperative Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Granisetron; Ondansetron
Intervention description: Rapid metabolizer will receive 1mg IV Granisetron; Poor or normal metabolizers will receive 4mg Ondansetron IV
Intervention MeSH terms: Ondansetron; Granisetron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacogenetics; CYP2D6; Ondansetron; Granisetron; Bariatric surgery

Summary:

      The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic
      data to guide post-operative nausea and vomiting treatment in the bariatric surgical
      population. The hypothesis is that using genotypic variation in CYP2D6 to select the
      appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in
      the bariatric surgical population.
    

Eligibility criteria:

        Inclusion Criteria

          -  A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including
             Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.

          -  Patient age 18 or above.

          -  Patients must understand and provide written informed consent and HIPAA authorization
             prior to initiation of any study-specific procedures.

          -  Patient is willing to engage in a medication adjustment as part of their clinical
             visit (when needed).

        Exclusion Criteria

          -  Patient with uncontrolled concurrent illness including psychiatric illness, or
             situations that would limit compliance with the study requirements or the ability to
             willingly give written informed consent.

          -  Patients that deny access to their medical records for research purposes will not be
             included in this study. Also any patient who will be unable to have genetic testing at
             minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or
             granisetron.

          -  Any patient with prior genetic testing that is readily available in the medical record
             will be excluded from this study.

          -  Any patient that is pregnant