bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Condition: Cold Sore
MeSH terms: Herpes Labialis
Intervention: Penciclovir; Placebo
Intervention description: Penciclovir every 2 hours during waking hours for 96 hours; Placebo every 2 hous during waking hours for 96 hours
Intervention MeSH terms: Penciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: cold sore

Summary:

      Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours
      in preventing the appearance of classical lesions following prodromal symptoms (tingling or
      burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be known to be a cold sore sufferer and presenting a prodromal stage with pain

          -  Sign the written informed consent form prior to enrolment in the trial;

          -  Be aged 18 to 75 years;

        Exclusion Criteria:

          -  If female, are pregnant, planning pregnancy or lactating;

          -  Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;

          -  Have already ongoing classical cold sore lesions at the baseline visit;

          -  Have taken any cold sore product, analgesic or NSAID in the 24 hours before the
             baseline visit;

          -  Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline
             thermographic assessment;

          -  Are known to be immunosuppressed (acquired, congenital or therapeutic);

          -  Have been involved in any investigational protocol within the 30 days prior to the
             trial;

          -  Have evidence or history of drug or alcohol abuse;
A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Lispro Mix 50/50
Intervention description: Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.
Intervention MeSH terms: Isophane insulin, insulin lispro drug combination 50:50
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c)
      level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day
      (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic
      control on oral antidiabetic drugs (OADs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed as having type 2 Diabetes.

          -  Patients who have not been on insulin treatment within 6 months.

          -  Patients who have been taking OADs for at least 90 days.

          -  Patients with an HbA1c level in the range of 7.5% to 11.0%.

          -  Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

        Exclusion Criteria:

          -  Patients having pre-proliferative or proliferative retinopathy (except for old
             retinopathy with no need for treatment).

          -  Patients having or suspected of having malignancy

          -  Patients having serious complications of the heart, liver, or kidney.

          -  Patients hypersensitive or allergic to insulin or insulin analog preparations or a
             history of it.

          -  Patients receiving systemic steroids.

          -  Are currently enrolled in a clinical trial of a non-approved drug. Or patients who
             participated in other clinical trials including post-marketing clinical trials within
             90 days prior to informed consent being obtained.

          -  Patients of child-bearing potential. Breastfeeding patients. Patients with a positive
             result in a pregnancy test performed for women of child-bearing potential.
S. Aureus Screening and Decolonization
Condition: Wound Infection Due to Staphylococcus Aureus; MRSA Infection of Postoperative Wound
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Intervention: antiseptic bundle; standard of care
Intervention description: Chlorhexidine gluconate liquid soap for bathing daily.
Chlorhexidine gluconate mouthrinse to use twice daily.
Nasal mupirocin to apply twice daily.; Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
Intervention MeSH terms: Anti-Infective Agents, Local
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staphylococcus aureus infection; Decolonization; Surgical site infection

Summary:

      Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity
      and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year
      over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such
      infections double the length of hospitalization and risk of dying, and increase U.S. health
      care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by
      either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers
      of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA
      SSI. A potential prevention approach is routine pre-operative screening of patients, followed
      by decolonization of identified SA carriers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patient who are 18 years and older, able to give informed consent and willing to
             complete the study decolonization protocol.

          -  Surgery must be scheduled 2 weeks in the future to allow completion of the study
             protocol prior to the scheduled operation.

          -  Patients will be admitted from home the day of the surgery or have the surgery done on
             an outpatient basis.

        Exclusion Criteria:

          -  Currently on antibiotic therapy, allergy to mupirocin or CHG.
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Olopatadine 0.6% / Azelastine 137 mcg
Intervention description: single dose; 2 sprays per nostril
Intervention MeSH terms: Azelastine; Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rhinitis

Summary:

      To compare patient perceptions of the sensory attributes, including taste and aftertaste, of
      Olopatadine relative to azelastine when administered as a single dose in patients with
      allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time
             of enrollment

          2. 18 yrs of age or older

          3. Read and sign informed consent

          4. Females of childbearing potential may participate if: are non-breast feeding, have
             negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon
             exiting study, do not intend to become pregnant during the study, are using adequate
             methods of birth control.

        Exclusion Criteria:

          1. History of intolerance or hypersensitivity to any component of the study medications,
             including benzalkonium chloride.

          2. Any disease or systemic disorder that may complicate or interfere with investigation
             or evaluation of the study medications (including but not limited to): Rhinitis
             medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal
             septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal
             drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper
             or lower respiratory infection.

          3. Impairment of sense of tast or smell (self reported)

          4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)

          5. Congestion, that in the opinion of the investigator, that would interfere with
             successful nasal drug administration/absorption

          6. Patients w/a severe impairment of nasal breathing

          7. Anatomic abnormalities of as identified by nasal examination

          8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or
             other disease/illness that could interfere w/study.

          9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte
             abnormalities.
Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy
Condition: Shoulder Arthroscopy; Pain
Intervention: IV Saline; IV Dexamethasone 4mg; IV Dexamethasone 6mg; IV Dexamethasone 8mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks.
      However, these studies only used fixed doses of IV dexamethasone at relatively high doses,
      which could potentially lead to increased glucose levels, delayed wound healing, and
      unintended side effects. There remains a paucity of research on the effective dose range of
      IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV
      dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular
      blocks in shoulder surgery has yet to be delineated.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients undergoing shoulder arthroscopy under regional anesthesia

        Exclusion Criteria:

          -  General anesthesia

          -  Contraindication to regional anesthesia

          -  Pre-existing neuropathy in the surgical limb

          -  Diabetes Mellitus

          -  History of postoperative nausea and vomiting &/ or motion sickness

          -  Procedures involving biceps tenotomy

          -  Peri-articular cocktail injections given intraoperatively to augment pain relief

          -  Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)

          -  Open surgical procedures

          -  Corticosteroid injection within 1 month

          -  Patients on systemic oral or IV steroid therapy within 6 months
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Condition: Intervertebral Disk Degeneration; Intervertebral Disk Displacement; Ossification of Posterior Longitudinal Ligament
MeSH terms: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Ossification of Posterior Longitudinal Ligament
Intervention: Cervios ChronOs; Bonion
Intervention description: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.; The ACDF surgery will be carried out with Bonion after randomization procedure.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 85.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: anterior cervical discectomy and fusion; bone graft substitute; PEEK cage; hydroxyapatite; demineralized bone matrix; b-tricalcium phosphate; Bonion; Cervios ChronOs

Summary:

      Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety
      of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic
      radiculopathy (CSR) and cervical spondylotic myelopathy (CSM). ACDF using autogenous iliac
      bone graft is gold standard, however, it may lead to donor-site morbidities. Preventing these
      complications, some authors have tried to use alterative bone graft substitutes. Among these
      alternatives, Cervios ChronOs™ which is the polyetheretherketone (PEEK) cage with
      b-tricalcium phosphate (TCP) has become popular and shown good clinical results. However,
      b-TCP has only osteoconduction ability of three osteogenic properties.

      Recently, Bonion™ which is the PEEK cage filled with hydroxyapatite (HA) / demineralized bone
      matrix (DBM) is introduced. HA/DBM mixture has abilities of osteoconduction and
      osteoinduction, therefore this alternative is expected to show superior bone fusion
      capability to PEEK cage with b-TCP. However, there has been no comparison study between the
      PEEK cage with b-TCP and the PEEK cage with HA/DBM. The purpose of this study is to evaluate
      bone fusion rate between these cervical spine cages using postoperative computed tomography
      (CT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of cervical HIVD, CSR, CSM or OPLL

          -  The patient who is expected to receive anterior cervical discectomy and fusion
             operation.

          -  Volunteer for this study with written consent.

        Exclusion Criteria:

          -  Patient with cervical spine fracture, infection.

          -  Below -3.5 T-score by DEXA bone densitometry

          -  Patient with hemorrhagic diseases

          -  Patient with malignancy

          -  Patient who is not suitable for this study judged by principal investigator
Enteral Versus Parenteral Glutamine Supplement
Condition: Critically Ill
MeSH terms: Critical Illness
Intervention: parenteral glutamine; enteral glutamine
Intervention description: Dipeptiven, Fresenius Kabi, Graz, Austria was given intravenously through central venous line in a dose up to 30 g per day; Alitraq, Abbott Laboratories, B.W. Zwolle, the Netherlands was given via nasogastric tube as continuous infusion of enteral diet, dose up to 30 g per day
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: enteral; parenteral; glutamine; intestinal permeability; infection

Summary:

      Glutamine is a major fuel for the intestinal tract and immune cells and therefore affects the
      intestinal permeability (IP) and infection rate at critically ill patients. The preferential
      route of glutamine supplementation at critically ill patients still remains open. Therefore
      the researchers will investigate IP, infection rate and treatment outcome at patients
      supplemented with either parenteral or enteral glutamine.

      A prospective randomized single blind study is performed at mechanically ventilated. Patients
      were randomly assigned to either parenteral (group P) or enteral (group E) glutamine
      supplemented group. Early enteral feeding is started in both groups. Patients are/will be
      treated with glutamine for five days. IP will be measured using lactulose/mannitol test (L/M)
      on the fourth day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  mechanically ventilated critically-ill patients

          -  older than 18 years

          -  staying in intensive care unit for at least 4 days

        Exclusion Criteria:

          -  anuria

          -  intestinal insufficiency (obstruction, discontinuation of intestine or severe ileus)
Treatment of Upper Extremity Deep-Vein Thrombosis
Condition: Deep-Vein Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis; Upper Extremity Deep Vein Thrombosis
Intervention: Dalteparin sodium injection; Warfarin
Intervention description: 200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin.; Titrated to INR 2-3 through study month 3
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight; Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Upper Extremity Deep-Vein Thrombosis; DVT; Fragmin; Deep-Vein Thrombosis; Thrombosis

Summary:

      The purpose of this study is to document the long-term outcome or prognosis of patients
      diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin
      sodium injection) for three months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with confirmed upper extremity DVT diagnosed by ultrasound imaging or
             venogram

        Exclusion Criteria:

          -  Active, clinically significant bleeding

          -  Known hypersensitivity to heparin or low-molecular weight heparin

          -  Currently pregnant or less than 1 week post-partum

          -  Acquired bleeding diathesis

          -  Known inherited bleeding disorder

          -  Renal failure

          -  Extremes of weight

          -  Poor performance status

          -  Unable to return for repeat diagnostic testing or follow-up visits
Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Metoprolol succinate
Intervention description: Nebivolol 2.5 mg once daily; Metoprolol succinate 50 mg once daily
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 1.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hypertension, Left Ventricular Mass

Summary:

      The purpose of this study is to evaluate if a drug called nebivolol can reverse inappropriate
      left ventricular mass (LVM) when compared to the standard of care drug metoprolol.
    

Eligibility criteria:

        All candidates must have previously untreated hypertension. The candidates will be picked
        from patients with stage-1 hypertension (systolic BP 140-159 mm Hg or diastolic BP 90-99 mm
        Hg) and those with stage-2 hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100),
        based on the seventh report of the Joint National Committee on Prevention, Detection,
        Evaluation, and Treatment of High Blood Pressure guidelines (JNC-7).

        Inclusion Criteria:

          -  Presence of inappropriate LVM.

          -  Presence of phenotype of inappropriate LVM.

        Exclusion Criteria:

        The criteria will assure that only patients with hypertension are enrolled, that is,
        excluded will be subjects with systolic BP < 140 or diastolic BP < 90 (ie, prehypertension
        or normal BP), but without complications or any indication (or suspicion) of end-organ
        damage based on a physical exam, clinical history, or laboratory tests.

        Specific exclusion criteria are:

          -  Reactive airways disease including asthma.

          -  Diabetes mellitus or hypoglycemia; thyrotoxicosis.

          -  LV dysfunction (ejection fraction < 50%) or heart failure.

          -  Present or previously documented coronary heart disease or angina.

          -  Acute myocardial infarction, or history of myocardial infarction.

          -  Severe bradycardia, heart block greater than first degree or sick sinus syndrome
             (unless a permanent pacemaker is in place).

          -  Hepatic insufficiency or history of cirrhosis.

          -  Chronic renal failure or renovascular dysfunction.

          -  Cerebrovascular dysfunction.

          -  Peripheral vascular disease.

          -  Pregnant or nursing women; women of childbearing age will be required to take a
             pregnancy test at the time of enrollment and use an acceptable method of birth
             control.

          -  Poor echo image quality.
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
Condition: Kidney Transplantation
Intervention: basiliximab; rabbit anti-thymocyte globulin; tacrolimus; alemtuzumab; mycophenolate mofetil; steroids
Intervention description: IV; IV; oral; Intravenous (IV); oral; IV and/or oral
Intervention MeSH terms: Mycophenolic Acid; Alemtuzumab; Tacrolimus; Thymoglobulin; Antilymphocyte Serum; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Effectiveness; Treatment Efficacy; Anti-rejection therapy; Immunosuppression; Therapy, antirejection; Renal Transplantation; Transplantation, Kidney; Transplantation, Renal; Grafting, Kidney

Summary:

      The purpose of this study is to compare the safety and efficacy of different induction agents
      (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients
      treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient of a primary or re-transplanted deceased donor kidney or a primary or
             re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA
             identical or 0 antigen mismatch deceased donor kidneys are allowed).

        Exclusion Criteria:

          -  Patient has previously received an organ transplant other than a kidney

          -  Patient receiving chronic steroid therapy at time of transplant