bioihbjkbjnl/mcl2 huggingface dataset:
Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane
Condition: Colorectal Disorders
Intervention: Exparel; IV Lidocaine
Intervention description: 2. Liposomal bupivacaine TAP block (experimental arm)
Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
Adhesive tapes will be applied at the level of the TAP block puncture sites.; 1. Intravenous Lidocaine infusion (control arm, current standard of care)
100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To compare the analgesic impact of intravenous perioperative lidocaine infusion with
      preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated
      into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary
      endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative
      morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include
      date of ambulation, return of bowel function (first flatus), tolerance of goal diet,
      incidence of post-operative nausea and vomiting during hospital stay, length of stay
      (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and
      surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and
      quality of life on follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years

          -  Elective laparoscopic colorectal surgery

          -  ASA I-III

        Exclusion Criteria:

          -  Contraindication to Na Channel Blocker

          -  Chronic Opioid use

          -  Liver dysfunction

          -  Renal insufficiency

          -  Epilepsy

          -  Psychomotor retardation

          -  BMI >40

          -  Sleep Apnea

          -  Cardiac Rhythm Disorders

          -  Planned open or concomitant procedure
Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™
Condition: Herpes Zoster; Fibrosis
MeSH terms: Herpes Zoster
Intervention: Zostavax; Placebo
Intervention description: Vaccination with one dose of Zostavax per Zostavax package insert; Injection of 0.65 mL of sterile normal saline
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 50 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study Design:

      Double-blinded, placebo controlled study of the efficacy of Zostavax in cirrhosis.

      Subjects will receive either Zostavax or placebo and will be followed for four months.

      Hypothesis:

      The investigators hypothesize Zostavax would induce cell-based immunity in cirrhotic patients
      like that seen in elderly patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cirrhosis of any etiology diagnosed clinically by labs and imaging or by liver biopsy

          -  Male or Female age 50 to 70

        Exclusion Criteria:

          -  Active or history of Herpes Zoster

          -  Anaphylactic allergy to neomycin or gelatin

          -  Immunosuppressive medication use

          -  Antiviral medication use

          -  Known history of HIV

          -  Known immune deficiency disease

          -  Active on a liver transplant list

          -  Known malignancy other than non-melanomatous skin cancer within the past five years.

          -  History of vaccination with varicella or zoster vaccine

          -  Pregnant or lactating women

          -  Prisoners

          -  Post-transplant patient

          -  Acute illness
Skin and Soft Tissue Infection (SSTI) Study
Condition: Skin Diseases, Infectious; Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Skin Diseases, Infectious; Skin Diseases
Intervention: Provodine; Incision and Drainage
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abscess; Antiseptic; Provodine; Povidone-Iodine

Summary:

      The purpose of this study is to determine if the use Provodine as an antiseptic and hand wash
      once daily for at least 7 days will have better healing, better health outcomes, fewer
      treatment failures and fewer infections themselves and among their household contacts than
      those who do not use Provodine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skin abscess

          -  Treatment requiring incision and drainage

        Exclusion Criteria:

          -  Unable or unwilling to provide informed consent

          -  Homeless, incarcerated, or living in a group home

          -  Abscess on the face or breast

          -  Abscess requiring surgical drainage in the operating room or requiring admission to
             the hospital

          -  Intravenous drug users

          -  Previous enrollment in this study

          -  Documented history of iodine sensitivity
Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation
Condition: Type 2 Diabetes; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Diabetes Mellitus
Intervention: Placebo; Sitagliptin
Intervention description: Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.; Active drug dose will be 100 mg per day for estimated GFR above 50 ml/min. The dose will be decreased to 50 mg per day for estimated GFR 30-50 ml/min. The dose will be decreased further to 25 mg for those with estimated GFR below 30 ml/min or on dialysis.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes; Kidney Transplant; Sitagliptin

Summary:

      This study is designed to see if the use of the drug Sitagliptin (used to reduce insulin
      resistance) will delay or prevent kidney transplant patients from getting diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a kidney transplant at UNMC, including cadaveric or living donor
             transplant.

        Exclusion Criteria:

          -  A previous diagnosis of diabetes or previous criteria for diabetes, according to the
             American Diabetes Association, not previously recognized as diabetes.

          -  Simultaneous transplant of another solid organ, such liver or heart.

          -  Patient unable to take oral medication.

          -  Patient unable to give informed consent.

          -  Hypersensitivity to sitagliptin.
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Brimonidine 0.33% gel (Br); CD07805/47 (Br) placebo gel; Ivermectin 1% cream (IVM); CD5024 (IVM) placebo cream
Intervention MeSH terms: Ivermectin; Brimonidine Tartrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM)
      associated with Brimonidine 0.33% gel (Br) compared with the association of their respective
      vehicles in the treatment of moderate to severe rosacea.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Male or female subjects age 18 years or older;

          2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and
             pustules) of rosacea on the face;

          3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored
             3 or 4 according to Clinician's Erythema Assessment [CEA]);

          4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to
             the Investigator's Global Assessment [IGA]);

          5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

          6. Female subjects of childbearing potential must practice a highly effective method of
             contraception during the study;

          7. Females subjects of non-childbearing potential;

        Main Exclusion Criteria:

          1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that
             may be confounded with rosacea;

          2. Subjects with more than 2 nodules of rosacea on the face;

          3. Subjects with any uncontrolled chronic or serious disease or medical condition that
             may either interfere with the interpretation of the clinical trial results, or with
             optimal participation in the study or would present a significant risk to the subject;

          4. Subjects with known or suspected allergies or sensitivities to any component of the
             investigational and non-investigational products, including the active ingredients
             brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis
Condition: Cardiac Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: 68Ga-DOTATATE PET/CT; 18FDG PET/CT scan; 13NH3 PET/CT scan
Intervention description: 5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.; This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.; This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Researchers are trying to determine if 68Ga-DOTATATE PET/CT imaging will have a similar
      accuracy as 18FDG PET/CT in diagnosing cardiac sarcoidosis and if it will be able to do so
      without the need for complex patient dietary preparation that is required with 18FDG PET/CT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Referred for clinically indicated 18FDG PET/CT scan for cardiac sarcoidosis (CS)

        Exclusion Criteria:

          -  Pregnant

          -  Unable or unwilling to give consent for 68Ga-DOTATATE PET/CT scan
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: standard dose amoxicillin/clavulanate; high dose amoxicillin/clavulanate
Intervention description: amoxicillin/clavulanate 875/125 + placebo bid x 7 days; Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acute sinusitis; amoxicillin/clavulanate; adults; outcomes

Summary:

      The aim is to determine if high-dose amoxicillin/clavulanate is more effective than
      standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at
      a primary care office.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult 18 or over

          2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

          3. Clinician and participant chose to start antibiotic treatment

        Exclusion Criteria:

          1. Previously enrolled in the study

          2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate

          3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking
             allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash
             with amoxicillin); chronic kidney disease with glomerular filtration rate < 30;
             significant hepatic impairment; history of antibiotic-associated colitis

          4. Cognitive impairment so that unable to give informed consent or give reliable
             assessment of improvement

          5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin
             within the past month (risk of penicillin-resistant pneumococci), very ill patient
             (though not ill enough to send to hospital); immunocompromise

          6. Need to hospitalize the patient
Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery
Condition: Blood Pressure
Intervention: Gabapentin1200 mg; bisoprolol 2.5mg; placebo
Intervention description: patients received 1200mg gabapentin 2 hrs preoperative; patients received 2.5mg bisoprolol 2 hrs preoperative; patients received oral placebo 2 hrs preoperative
Intervention MeSH terms: Bisoprolol; Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: gabapentin; bisoprolol; hemodynamic; surgical field

Summary:

      the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of
      intraoperative bleeding, improving the operative's field visibility and increase the surgeon
      satisfaction via optimization of blood pressure and heart rate .

      A prospective randomized double blinded controlled study. Eligible patients were randomized
      according to random list generated software and allocated into 3 equal and matched groups (15
      patients in each group):-

        -  Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200
           mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of
           anesthesia.

        -  Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5
           mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of
           anesthesia.

        -  Group C: control group in which Patients were premedicated with oral placebo with sips
           of water, 2 hours before induction of anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who underwent functional endoscopic sinus surgery

          -  ability to swallow tablets

        Exclusion Criteria:

          -  suspected difficult airway

          -  basal HR <60/min.

          -  chronic cardiovascular or cerebrovascular disease

          -  bronchial asthma or COPD

          -  DM

          -  bleeding disorders

          -  anemia (Hb level< 10 gm/dl)

          -  renal or hepatic insufficiency

          -  psychiatric disorders

          -  chronic treatment by BBs, gabapentin or drugs that affect coagulation

          -  acute nasal infection

          -  allergy/contraindications to any of the study's drugs.
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Condition: Prevention of New Onset Diabetes Among Kidney Transplant Patients
MeSH terms: Diabetes Mellitus
Intervention: Insulin treatment for hyperglycemia
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney transplant; New onset diabetes; Prevention; Insulin

Summary:

      Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in
      decreasing the incidence of NODAT among de novo kidney transplant patients with manifested
      post-transplant hyperglycemia during the first week after transplantation.

      Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress
      related to the surgery and use of higher doses of immunosuppressive medications, and leads to
      lower incidence of NODAT at 1 and 2 years.

      Specific Aim 2: To determine the improvement in overall glycemic control with the early
      initiation of insulin therapy.

      Hypothesis 2: Early initiation of insulin therapy results in greater overall control of
      glycemia compared to standard care of dietary counseling, life-style modification, oral
      hypoglycemic agents and/or insulin as needed at 1 year.

      Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to
      the early initiation of insulin therapy at one year post-transplantation.

      Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of
      post-transplant hyperglycemia and preserves better beta-cell function at 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney
             transplantation;

          2. Standard triple immunosuppressive medications following kidney transplantation
             including tacrolimus, mycophenolate mofetil and corticosteroids;

          3. Capable to understand the study protocol and to give informed consent;

        Exclusion Criteria:

        1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
Human Urinary Kallidinogenase Improve Short Term Motor Functional Outcome of Acute Ischemia Stroke Patients
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Intervention: Kallikrein
Intervention description: HUK has been approved by China's State Food and Drug Administration as a state category I new drug for the treatment of stroke patients. Based on the available evidence, HUK injection ameliorates neurological deficits and improves long-term outcomes.
Intervention MeSH terms: Kallikreins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Acute cerebral infarction is a common type of ischemic stroke, causing brain dysfunction in
      patients with high morbidity and disability. With the changes in people's diet, lifestyle
      patterns and population aging, the incidence of acute cerebral infarction has increased year
      by year, which has become an important cause of disability and death in middle-aged and
      elderly patients. The human urinary kallidinogenase (HUK) was used in China in the management
      of acute ischemic stroke (AIS) in recent years. However, the mechanism of HUK on AIS has not
      been systematically investigated. This study aimed to assess the effect of HUK on motor
      functional outcome and relative corticospinal tract recovery in the patients with AIS.
      Diffusion tensor imaging(DTI) and diffusion tensor tractography(DTT) have all been used to
      observe features of cerebral white matter fibrous structures. In addition, diffusion tensor
      tractography which is used to trace fiber bundle and evaluate white matter fiber bundle
      integrity and direction is the only non-invasive imaging method to display the corticospinal
      tract in vivo.
    

Eligibility criteria:

        Inclusion Criteria:

        18 years old ≤ age <80 years old; Within 72 hours of onset; Diagnosed as acute cerebral
        infarction, and confirmed by magnetic resonance imaging as an acute infarct in the
        unilateral corticospinal tract; The patient's onset muscle strength grade <4; No history of
        cerebral infarction or residual physical activity disorder; No other intracranial lesions;
        Patients or their legal representatives voluntarily Sign the informed consent form;

        Exclusion Criteria:

        Intracranial hemorrhagic disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
        Transient ischemic attack; Intravenous thrombolysis and interventional thrombectomy;
        Serious physical illness affects limb movement before enrollment ; Apply other drugs with
        nutritional nerves and regeneration during the study period; Unstable vital signs, severe
        liver and kidney diseases or malignant tumors; Incomprehensible or incapable of obeying the
        research procedure or being unable to follow up due to mental illness, cognitive or
        emotional disorders;