bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Dexmedetomidine and Remifentanil on Carotid Patients
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Intervention: Remifentanil; Dexmedetomidine
Intervention description: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical; Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Carotid Endarterectomy patients

Summary:

      We propose to test whether intraoperative administration of dexmedetomidine will reduce
      hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic
      requirements in patients undergoing carotid endarterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consenting adult patients (age >50 years) undergoing carotid endarterectomy with
             general anesthesia.

        Exclusion Criteria:

          -  Receiving another alpha 2-adrenoreceptor agonist;

          -  Contraindication to dexmedetomidine, including allergy;

          -  Current hepatic disease (liver function tests > twice upper limit of normal);

          -  Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;

          -  Mentally impairment, including dementia or delirium;

          -  Heart block ;

          -  Sick sinus syndrome;

          -  Atrial fibrillation with a low ventricular response (< 50 bpm);

          -  Absolute or relative hypovolemia;

          -  Prior stroke;

          -  Severe left-ventricular dysfunction
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Educational handout; Verbal script; Hyaluronic Acid
Intervention description: The educational handout will include information on self-management strategies.; The verbal script will include details on self-management strategies that will be reviewed with the patient.; All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence,
      and even safety of the individuals who suffer from it. One of the most powerful tools for
      these patients can be education on self-care and self-management strategies that can be
      taught to a patient by a physician, physical or occupational therapist, or a nurse. These
      self-management strategies can help patients treat daily stiffness through exercise or manage
      flares of osteoarthritis. There is a lack of consensus on the best teaching methods to
      accomplish the goal of educating our patients. Feedback from both patients and providers
      regarding teaching methods is needed. This study will evaluate teaching methods on
      self-management strategies for patients who are undergoing hyaluronic acid injections for
      knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of co-investigator physicians

          -  Age 18+ years

          -  Diagnosis of symptomatic knee osteoarthritis

          -  Scheduled for a hyaluronic acid injection into the knee

          -  Provider is available to administer teaching method

        Exclusion Criteria:

          -  Patients who are already enrolled in the study

          -  Non-English speaking
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Plant sterols esters; placebo
Intervention description: 1.6g phytosterols and 1.3g omega-3 fatty acids per day; 4 gr of corn oil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hypercholesterolemia; Hypertriglyceridemia; Plant sterol; Cholesterol; Fish oil

Summary:

      The purpose of this study is to determine whether plant sterols esterified to fish oil fatty
      acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG
      concentrations in healthy hyperlipidemic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, >18 years old and ≤ 70 years old, capable and willing to give written
             informed consent.

          -  Subject must have hyperlipidemia at the screening visit and at the end of the run-in
             period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl,
             LDL-cholesterol > 130 mg/dl and < 190 mg/dl.

          -  Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.

          -  Female patient who is of reproductive potential agree to use acceptable methods of
             birth control

          -  Female patient who is currently receiving hormone replacement therapy continuously 12
             weeks before visit 1 (on stable dose) and will agree to do so during the study.

        Exclusion Criteria:

          -  Receiving medications or supplements known to affect lipid metabolism.

          -  Uncontrolled hypertension or thyroid disease.

          -  Consume unusual diets - will be determined at the discretion of the investigator.

          -  Gained or lost more than 3 kg during the run-in period.

          -  Patient has history of malignancy ≤ 5 years.

          -  Patients with clinical ischemic CV disease on treatment

          -  Consume 200 grams fish x 2 a week.

          -  Gastrointestinal disease or any disease that the investigator feels would compromise
             the patient safety or limit his/her successful participation to the study.

          -  Patient has type 1 or type 2 diabetes mellitus.

          -  Patient has uncontrolled endocrine or metabolic disease known to influence serum
             lipids or lipoproteins

          -  Patient has had active peptic ulcer disease within 3 months of visit 1.

          -  Woman patient is pregnant or breast-feeding or expecting to conceive during the study.

          -  Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or
             soy.
VANOS Cream and Skin Barrier Function
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Fluocinonide
Intervention description: Fluocinonide 0.1% cream topical daily for two weeks
Intervention MeSH terms: Fluocinonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Skin barrier; Atopic Dermatitis; Corticosteroid; Effects on skin severity and barrier function

Summary:

      The purpose of this study is to determine the effect of short-term therapy using "VANOS
      Cream," a super-potent topical steroid cream on skin barrier function in patients with atopic
      dermatitis. This cream is already approved for this indication, but the investigators will
      further examine its effects on the skin barrier. This cream is a novel formulation of
      fluocinonide designed to enhance compliance with a cream base, but have the skin barrier
      repair properties of an ointment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD according to Hanifin-Rajka criteria (see Appendix B)

          -  Age 12 years or older

          -  Must have an Investigator's Global Assessment (IGA) Score of Moderate, Severe, or Very
             Severe (See Appendix C)

          -  Must have failed to achieve adequate disease despite adequate topical or systemic
             therapy

          -  Must be a candidate, according to the principal investigator and standard of care, for
             a super-potent topical steroid course. Subjects that are candidates for super-potent
             topical steroids are defined as subjects whose disease is not adequately controlled
             with medium-potency topical steroids or systemic therapy, including phototherapy.

        Exclusion Criteria:

          -  Active skin infection

          -  Hypersensitivity to any ingredients in Vanos cream

          -  Previous use of super-potent topical steroids within 2 weeks of starting study (Class
             I steroid).
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Endoscopically Guided Ablation
Intervention description: Visually Guided Ablation using EAS-AC
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to confirm the safety and effectiveness of the CardioFocus
      Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic, Paroxysmal Atrial Fibrillation (AF)

          -  18 to 70 Years of age

          -  Others

        Exclusion Criteria:

          -  Generally good overall health as determined by multiple criteria

          -  Willing to participate in a study

          -  Others
The Use of Antibiotic Sinonasal Rinse After Sinus Surgery
Condition: Chronic Rhinosinusitis
Intervention: Mupirocin; Placebo
Intervention MeSH terms: Mupirocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Double blind placebo controlled trial to evaluate whether the routine use of nasal irrigation
      with mupirocin is more effective than saline irrigations alone in reducing symptoms of
      chronic rhinosinusitis in the early postoperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Rhinosinusitis

          -  Undergoing endoscopic sinus surgery

        Exclusion Criteria:

          -  Age under 18

          -  Documented adverse reaction to mupirocin
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; sitagliptin
Intervention description: Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.; Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 368.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and
      safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese
      subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible
      subjects will continue their metformin background treatment during the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years and below 80 years at the time of signing
             informed consent

          -  Subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at
             a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to
             1000 mg daily for at least 60 days prior to screening

          -  HbA1c 7.0-10.0% (both inclusive)

          -  Body mass index below or equal to 45.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
             in a period of 60 days prior to screening. An exception is short-term treatment (below
             or equal to 7 days in total) with insulin in connection with intercurrent illness

          -  History of chronic pancreatitis or idiopathic acute pancreatitis

          -  Any chronic disorder or severe disease which at the discretion of the investigator
             might jeopardise subject's safety or compliance with the protocol

          -  Screening calcitonin value above or equal to 50 ng/l

          -  Personal or family history of medullary thyroid carcinoma or multiple endocrine
             neoplasia syndrome type 2

          -  Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
             or squamous cell skin cancer)

          -  Any contraindications to liraglutide, sitagliptin or metformin according to local
             labelling
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
Condition: Hypertriglyceridemia; HIV Infection
MeSH terms: Hypertriglyceridemia
Intervention: Lovaza; fosamprenavir/ritonavir
Intervention description: Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks; Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day
Intervention MeSH terms: Ritonavir; Fosamprenavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; triglycerides; fosamprenavir

Summary:

      In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a
      switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result
      in 30% of patients achieving a reduction in fasting triglycerides < 200 mg /dL while
      maintaining virologic suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  fasting triglycerides >= 200 mg/dL but <1,200 mg/dL

          -  fasting LDL <= 160 mg/dL

          -  participation in a lipid-lowering diet and exercise program for at least 28 days

          -  treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus
             optimized background ART for at least 3 months

          -  plasma HIV-1 RNA <50 copies/mL

          -  CD4+ cell count >50 cells/mm3

          -  male subjection testosterone replacement therapy with total testosterone level <= 1 x
             upper limit of normal

          -  female study volunteer must use a form of contraception

          -  ability and willing ness to give written informed consent

        Exclusion Criteria:

          -  any Grade 4 laboratory abnormality

          -  currently taking amprenavir or fosamprenavir

          -  required a second RTV-boosted PI for reasons of virologic failure

          -  atherosclerotic disease risk

          -  congestive heart failure (NYHA Class III or IV)

          -  uncontrolled hypertension

          -  history of pancreatitis

          -  active bleeding disorder

          -  recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal
             disease

          -  current diabetes mellitus requiring pharmacological treatment

          -  use of systemic cancer chemotherapy; active cancer

          -  pregnancy or breast-feeding

          -  requirement for any lipid-lowering agent after baseline

          -  use of hormonal anabolic therapies, systemic steroids, immune modulators

          -  use of anticoagulants, investigational antiretroviral drugs

          -  allergy to study drugs

          -  active CDC clinical category C event
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
Condition: Obese; Cigarette-smoking; Schizophrenia
MeSH terms: Schizophrenia
Intervention: Naltrexone; Placebo Naltrexone; Bupropion; Placebo Bupropion
Intervention description: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.; Placebo Naltrexone created and masked by the pharmacy to be used as a control.; 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.; Placebo Bupropion created and masked by the pharmacy to be used as a control.
Intervention MeSH terms: Naltrexone; Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to observe the efficacy of Naltrexone and Bupropion
      combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of schizophrenia by the International Classification of Diseases 10th
             Revision (ICD-10);

          -  age between 18 and 65 years old;

          -  on stable antipsychotic medication treatment for at least one month;

          -  BMI > 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or
             BMI>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over
             90cm;

          -  smoking at least 10 cigarettes daily for one year or longer;

          -  desire to lose weight and quit smoking.

        Exclusion Criteria:

          -  Binge eating or other eating disorders;

          -  Current use of weight loss or antidiabetic medications;

          -  Current substance use (except nicotine or caffeine);

          -  Elevated hepatic transaminase levels (>2.5x normal range);

          -  Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4）
             abnormalities;

          -  History of seizure disorder;

          -  History of unstable cardiac problems or other unstable medication conditions;

          -  Being pregnant or nursing (for women).
Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Condition: Full-thickness Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Intervention: Arthroscopic Rotator Cuff Repair; Ropivacaine; Saline
Intervention description: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.; The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.; The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an
      outpatient basis. Postoperative pain control regimens can include narcotic pain medicine,
      non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene
      block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the
      shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very
      painful when the block wears off. The purpose of this study is to:

        1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during
           the first two days after arthroscopic rotator cuff repair.

        2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and
           placebo catheters after arthroscopic rotator cuff repair.

        3. Evaluate for any continued pain relief benefit of continuous infusion scalene block
           ropivacaine catheters during the three days after the infusion catheters have finished.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be eligible for inclusion in the study if they have a full-thickness
             rotator cuff tear that has been deemed reparable by preoperative MRI. They will be
             included in the study if they are medically stable to undergo the surgery and consent
             to involvement in the study.

        Exclusion Criteria:

          1. Prior surgery on the involved shoulder

          2. Preoperative MRI suggesting that the rotator cuff tear is irreparable

          3. Patients with known allergies to oxycodone, ropivacaine or a similar drug

          4. Workman's compensation patients

          5. Patients who do not fill out their visual analog scores or their medication diaries

          6. Patients with labral or subscapularis tears requiring repair