bioihbjkbjnl/mcl2 huggingface dataset:
Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy
Condition: Benign Disease Where Total Hysterectomy is Indicated
Intervention: Harmonic ACE®+7 Shears
Intervention description: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a prospective, non-randomized, single arm, multicenter, study to assess the initial
      clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total
      laparoscopic hysterectomy. The study will not modify or influence current surgeon technique.
      Investigators will perform each procedure using the device in compliance with their standard
      surgical approach and product labeling.

      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in
      accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,
      calibrated, and/or used in accordance with manufacturer design specifications, product
      instructions and guidelines
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects satisfying all of the following criteria will be considered the screening
        population and will be eligible for participation in this study:

          1. Indicated for elective total laparoscopic hysterectomy

          2. Age >=40 years and no future desire for fertility

        Exclusion Criteria:

        Subjects with any of the following criteria will be excluded from the study:

        Preoperative exclusion criteria:

          1. Known or suspected uncontrolled bleeding disorders

          2. Subjects unlikely to comply with protocol procedures or adhere to the study visit
             schedule

          3. Any condition rendering a subject unable to understand the nature, scope, and possible
             consequences of the study or study procedures

          4. Any Subject unwilling to sign the study informed consent document

          5. Any suspected malignancy

          6. Any Subject of childbearing potential with a positive or serum pregnancy test within
             24 hours prior to surgery

             Intra-operative exclusion criteria:

          7. Any intra-operative findings identified by the surgeon that may preclude conduct of
             the study procedure
A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; placebo; non-biological DMARDs
Intervention description: 8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks; iv every 4 weeks for 24 weeks; stable dose at investigator's prescription
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging
      (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with
      moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological
      DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg
      (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their
      stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and
      target sample size is <100.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  moderate to severe rheumatoid arthritis of >/=6 months duration

          -  synovitis (swollen and tender joint) in the wrist of the dominant hand

          -  non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline

          -  oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA

          -  history of or current inflammatory joint disease other than RA

          -  functional class IV (ACR classification)

          -  intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

          -  previous treatment with a biologic agent for RA
Postoperative Pain Control Following Vitreoretinal Surgery
Condition: Retinal Detachment; Proliferative Vitreoretinopathy; Retinoschisis
MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Retinoschisis; Pain, Postoperative
Intervention: Triamcinolone; Bupivicaine Hydrochloride
Intervention description: Retrobulbar anesthesia; Retrobulbar anesthesia
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Bupivacaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Retina; Vitreoretinal; Surgery

Summary:

      The aim of this study is to evaluate if patients receiving a steroid (triamcinolone
      acetonide) combined with local anesthesia and antibiotic following retina surgery have better
      postoperative pain control those receiving local anesthesia and antibiotic alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery
             Center and Emory University Hospital by retina attending faculty surgeons

        Exclusion Criteria:

          -  Unable to verbalize level of pain control

          -  Pediatric patients (<18 years old)

          -  Glaucoma, ocular hypertension, or glaucoma suspects

          -  Allergy to local anesthetic

          -  Pre-existing chronic pain requiring narcotic pain medication

          -  Drug addiction

          -  Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)
Etomidate vs. Midazolam for Sedation During ERCP
Condition: Choledocholithiasis; Cholangiocarcinoma; Pancreatitis; Pancreatic Cancer
MeSH terms: Cholangiocarcinoma; Pancreatitis; Choledocholithiasis
Intervention: Etomidate; Midazolam; Meperidine
Intervention description: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.; This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.; Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
Intervention MeSH terms: Midazolam; Meperidine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 20 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Endoscopic Retrograde Cholangiopancreatography (ERCP); Conscious Sedation; etomidate; midazolam

Summary:

      Recently up-coming drug, etomidate which is a modulator of GABA(gamma-Aminobutyric acid)-A
      receptor has been known that it maintains the appropriate sedative levels and affects little
      effects on respiratory system.

      The investigators are now trying to investigate that etomidate with meperidine combination
      regimen is superior to the midazolam with meperidine more effective and less harm on sedation
      during the ERCP procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who are scheduled diagnositic or therapeutic ERCP.

          -  Age : more than 20 and less than 90 years old

          -  ASA(American Society of Anesthesiologists) classificiation : I, II, III

        Exclusion Criteria:Patients following

          -  Refuse to be enrolled

          -  ASA American Society of Anesthesiologists)classification IV, V

          -  Breast feeder

          -  The mentally ill

          -  Drug abuser

          -  Hypersensitivity to sedative or opioids

          -  Alcohol intoxication or dependency

          -  Body mass index (BMI) 36kg/m2 or more

          -  Unstable vital sign

               1. tachypnea, respiration rate more than 25/min or less than 10/min

               2. Oxygen saturation : 90% or less

               3. Systolic blood pressure : less than 90 mmHg or more than 180 mmHg

               4. Diastolic blood pressure : less than 50 mmHg or more than 100 mmHg

               5. Heart rate : more than 120 beat/min or less than 50 beat/min.
Bioequivalence of Ethylenediamine Dihydrochloride Study
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Intervention: Ethylenediamine dihydrochloride allergen patch
Intervention description: 1 allergen panel containing 2 allergen and 2 control patches
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: ethylenediamine dihydrochloride

Summary:

      The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when
      prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or previous symptoms and/or history consistent with allergic contact
             dermatitis, and positive patch test (within the past 10 years) to ethylenediamine
             dihydrochloride

          -  18 years of age or older, otherwise in good health

          -  Female subjects of childbearing potential must consent to a urine pregnancy test;
             results must be negative for study inclusion.

          -  Informed consent signed and understood by each subject.

        Exclusion Criteria:

          -  Subjects unable to meet inclusion requirements

          -  Women who are breastfeeding or pregnant

          -  Topical treatment during the last 7 days with corticosteroids or other
             immunosuppressive agents on or near the test area

          -  Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg
             prednisone) or other immunosuppressive agents

          -  Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks

          -  Acute dermatitis outbreak or dermatitis on or near the test area on the back

          -  Subjects unable to comply with patch test study requirements including multiple return
             visits and activity restrictions (e.g., protecting test panels from excess moisture
             due to showering or vigorous activity)

          -  Subject participation in clinical trials of investigational drugs, treatments, or
             devices, other than T.R.U.E. TEST, during this study or 3 weeks prior to inclusion in
             this study
Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention
Condition: Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketamine
Intervention description: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ketamine; Thoracotomy; VATS; Pain

Summary:

      This study will test the null hypothesis that low-dose ketamine given peri-operatively will
      have no effect on the development of chronic post-surgical pain, in patients undergoing
      thoracotomy or video assisted thoracic surgery (VATS) procedures

      A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis.
      Potential participants due to undergo either thoracotomy or video assisted thoracic surgery
      (VATS) will be identified by the collaborating thoracic surgeons in the out-patient
      department. Patients will be sent information about the study by post, prior to admission for
      surgery. If they are willing to participate, written consent will be sought on the ward
      preoperatively, where they will complete baseline measures of pain.

      Patients will be randomised to receive an intravenous infusion of placebo (saline) or
      ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and
      continuing for the first three postoperative days (96 hours in total). Prior to starting the
      infusion a loading dose of ketamine (0.1 mg per kg) will be administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients (18 years and above) who are undergoing either thoracotomy or video
             assisted thoracic surgery (VATS).

          -  Participants must be able to understand English.

        Exclusion Criteria:

          -  Patient refusal

          -  History of previous chronic thoracic pain

          -  Neuropathic pain (whatever the site), existing at time of recruitment

          -  Pre-operative analgesic treatments which include the following medications: strong
             opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin,
             pregabalin, duloxetine, clonazepam or carbamazepine.

          -  Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Condition: HIV Infection; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Antiretroviral therapy (ART); raltegravir; Emtricitabine and tenofovir disoproxil fumarate
Intervention description: Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.; raltegravir is an HIV medication given 400 mg twice daily by mouth; Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: HIV; Human immunodeficiency virus; Acquired Immune Deficiency Syndrome Virus; AIDS Virus; Immunodeficiency Virus, Human; Virus, Human Immunodeficiency; Hepatitis C; Hepatitis C, chronic; Hepatitis C virus; Hepatitis C antibodies; Hepatitis C antigens

Summary:

      The chief purpose of this research is to evaluate interferon alpha sensitivity and cell type
      specific levels of interferon receptor and interferon stimulated genes and proteins in HIV/
      HCV (hepatitis C virus) coinfected persons before and after administration of HIV medications
      (antiretroviral therapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Human

          -  Able to provide written informed consent

          -  HIV antibody positive

          -  HIV viral load positive

          -  HIV treatment naive

          -  Hepatitis C antibody positive

          -  Hepatitis C viral load positive

          -  Hepatitis C treatment naive

          -  Approved to take HIV medications for minimum 9 months

          -  Willing to use contraception, Life expectancy greater than 2 years

        Exclusion Criteria:

          -  Significant opportunistic infections within 12 month

          -  Hepatitis B positive

          -  Evidence of liver cirrhosis

          -  Decompensated liver disease

          -  Chronic alcohol abuse

          -  Allergy to raltegravir, tenofovir, and/or emtricitabine

          -  Active or suspected malignancy

          -  Sarcoidosis

          -  Active TB

          -  Coronary artery disease

          -  Uncontrolled seizures

          -  Untreated thyroid disease

          -  Untreated diabetes

          -  Weight greater than 125 kg

          -  Severe depression or severe psychiatric disorder

          -  Ongoing alcohol or illicit drug use

          -  Pregnant, nursing, pr planning to become pregnant

          -  Allergy to interferon
Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients
Condition: Opioid Use; Pain, Postoperative; Colectomy; Colorectal Surgery
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; Bupivacaine liposome
Intervention description: Abdominal injection of bupivacaine into fascial layer.; Abdominal injection of bupivacaine liposome into fascial layer.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking: Double (Participant, Outcomes Assessor)
Masking description: The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bupivacaine; Exparel; TAP Block; Opioids; Narcotics; ERAS

Summary:

      The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get
      abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is
      to compare pain medication usage after surgery between two different types of local
      anesthetic: liposomal bupivacaine and standard bupivacaine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

        Exclusion Criteria:

          -  Allergic to local anesthetics

          -  Unable to provide consent

          -  Pregnant

          -  On opioids at home chronically (Patients previously on a regular opioid regimen would
             need to be opioid-free for a period of 1 year for inclusion in the study)

          -  Undergoing emergent operations

          -  Undergoing loop ileostomy reversal

          -  Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal
             prolapse repairs
Comparative Performance of PureVision, Acuvue Oasys and O2Optix
Condition: Myopia
MeSH terms: Myopia
Intervention: PureVision Contact Lens; Acuvue Oasys Contact Lens; O2Optix Contact lens
Intervention description: contact lens for daily wear; contact lens for daily wear; contact lens for daily wear
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 510.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the performance of the PureVision Contact Lens
      compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear
      basis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is myopic

          -  VA correctable to 0.3 LogMAR or better (driving vision)

          -  Clear central cornea

          -  Subject uses a lens care system on a regular basis

        Exclusion Criteria:

          -  Systemic disease affecting ocular health

          -  Using systemic or topical medications

          -  Wear monovision, multifocal or toric contact lenses

          -  Any grade 2 or greater slit lamp findings
Antifungal Activity of Loceryl Nail Lacquer in Combination With a Cosmetic Varnish
Condition: Foot Dermatoses
MeSH terms: Skin Diseases; Foot Dermatoses
Intervention: Loceryl NL + Cosmetic varnish; Loceryl NL 12 weeks; Loceryl NL 15 months
Intervention description: Loceryl NL + Cosmetic varnish once/week for 12 weeks; Loceryl NL once/week for 12 weeks; Loceryl once/week for additional 15 months
Intervention MeSH terms: Amorolfine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Masking description: Only 12 first weeks of treatment with Loceryl NL and/or Loceryl alone were investigator masked and randomized.
15 months of treatment with Loceryl NL alone had an open study design
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis; antifungal

Summary:

      The main objective is to compare efficacy, in terms of antifungal activity of Loceryl Nail
      Lacquer associated with a Cosmetic Varnish and Loceryl Nail Lacquer alone, in the treatment
      of mild to moderate toenail Distal Subungual Onychomycosis.

      The second objective of this study will be photographic follow-up of clinical improvement and
      cure after the initial treatment period of 12 weeks, for 15 additional months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1
             great toenail chosen as a Target nail

          -  Subjects must have maximum of 50% of nail distal edge involved

          -  Subjects with positive mycological results (direct microscopy and culture) of the
             Target nail for dermatophytes or Yeast (including Candida) at Screening

        Exclusion Criteria:

          -  Subjects with clinically important abnormal physical findings at the
             Screening/Baseline visit

          -  Subjects with Lichen planus, eczema, psoriasis, or other abnormalities of the nail
             unit

          -  Subjects with known immunodeficiencies, radiation therapy, immune suppressive drugs