bioihbjkbjnl/mcl2 huggingface dataset:
Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Condition: Arteriosclerosis of Coronary Artery Bypass Graft
MeSH terms: Arteriosclerosis
Intervention: Minimally invasive coronary artery bypass graft surgery
Intervention description: The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Minimally invasive coronary surgery; Coronary artery bypass grafting; MICS CABG

Summary:

      This clinical study has been developed to evaluate the clinical outcomes in patients
      undergoing coronary artery bypass grafting via Minimally Invasive Coronary Surgery (MICS); a
      minimally invasive coronary bypass procedure that is done on a beating heart via a smaller
      chest incision, thus avoiding the invasiveness of the standard procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > or equal to 18 and < or equal to 80 years of age

          -  Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first
             time, single or multivessel coronary artery bypass grafting (on pump or off pump)

          -  Left ventricle ejection fraction >30%

          -  Willing and able to provide written informed consent and comply with study
             requirements

        Exclusion Criteria:

          -  Severe cerebrovascular disease within 90 days of surgery including history of prior
             stroke.

          -  Previous cardiac surgery procedures such as CABG revisions, surgical ablations or
             valve replacements

          -  Congestive heart failure with a New York Heart Association (NYHA) Class IV

          -  History of renal insufficiency (i.e. prior serum creatinine of >2mg/dl) and/or
             requiring dialysis

          -  Uncontrolled diabetes (i.e. >2 serum glucose concentrations of >350 mg/dl)

          -  Severe uncontrolled systemic hypertension (i.e. systolic pressure >160 mmHg)

          -  Peripheral/systemic active infection excluding the patient from cardiac surgery

          -  Life expectancy of less than 1 year due to other illness such as cancer or pulmonary,
             hepatic or renal disease

          -  Participation in another investigational protocol that may confound the results of
             this study

          -  Female of child bearing potential and lactating or intends to become pregnant during
             the study

          -  Severe distal disease and small posterior lateral targets
Management of Postoperative Pain After Total Knee Replacement.
Condition: Postoperative Pain; Knee Replacement Arthroplasty
MeSH terms: Pain, Postoperative
Intervention: Nerve Block; Periarticular Injection
Intervention description: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.; Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two methods of postoperative pain management in
      patients undergoing total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral primary total knee replacement.

          -  Weight 50-125 kg.

          -  Age 18-79 years.

          -  Intact neurological exam to the surgical lower extremity.

          -  Cognitively intact with ability to sign informed consent.

        Exclusion Criteria:

          -  Renal insufficiency with creatinine >1.5 mg/dL.

          -  Allergy to medication used in the study.

          -  Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7
             days.)

          -  Prior open knee surgery with regional anesthesia or periarticular injection for
             post-operative pain management.
Mechanisms of Weight Loss With SGLT2 Inhibition
Condition: Type 2 Diabetes; Overweight; Obesity
MeSH terms: Overweight; Weight Loss
Intervention: Canagliflozin; Placebo
Intervention description: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.; Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Canagliflozin; Obesity; Weight Loss; Body Weight; Body Weight Changes; Overweight; Sodium-glucose transporter subtype 2 inhibitor

Summary:

      The purpose of this study is to investigate the effect of canagliflozin, a medication
      approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in
      people with type 2 diabetes who are overweight or obese.

      Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than
      absorb, glucose. Canagliflozin is also often associated with weight loss.

      The study population will generally be type 2 diabetics, ages 18-75 years old, who are
      overweight or obese.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 2 diabetes

          2. BMI 25-45 kg/m2

          3. Hemoglobin A1C > 6.5% but < 9%

          4. Normal renal function (GFR > 60)

          5. Age 18-75

        Exclusion Criteria:

          1. Type 1 diabetes

          2. History of recurrent UTI or mycotic genital infections

          3. Treatment with insulin or a GLP1 agent

          4. Pregnant or breastfeeding
A Comparison of One-site and Two-site Peribulbar Anaesthesia for Cataract Surgery at Kaduna, Nigeria
Condition: Anaesthesia; Cataract
MeSH terms: Cataract
Intervention: One-site peribulbar injection; Two- site peribulbar injection
Intervention description: injection into the inferior medial orbital compartment; Two injections into the infero-temporal and supero-nasal orbital compartments
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ophthalmic surgery, peribulbar local anaesthesia

Summary:

      The aim of the study was to compare the efficacy and safety of single injection peribulbar
      anaesthesia against the classic double injection technique.

      This was a double blind randomized controlled trial involving two groups of consenting, adult
      Nigerian subjects with operable age-related cataract. An anaesthetic nurse who allocated the
      subjects to the two groups administered all the injections. The same surgeon operated on all
      the subjects while the principal investigator and a research assistant measured the outcome
      variables. All others were blinded as to subject allocation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 50 years and above

          -  Diagnosed with uncomplicated senile cataract

          -  Visual acuity of <3/60

        Exclusion Criteria:

          -  Impaired mental status

          -  Difficulty in speaking

          -  Known allergy to amide-type local anaesthetic agents and/ or hyaluronidase

          -  Previous surgery in the same eye

          -  Glaucoma

          -  Impaired ocular motility

          -  Eyelid abnormalities

          -  Patients with only one eye
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Lactobacillus plantarum 299v; Placebo comparator; Run in period; Wash - out period
Intervention description: two capsules of 5 X 10 ^9 c.f.u each; Micro-crystalline cellulose powder, identical taste, texture and appearance; Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo; Wash - out period following treatment phase of eight weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: only constipation and diarrhea predominant; no mixed or alternating types

Summary:

      In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy
      and will the probiotic influence gut microflora and thus improve clinical outcomes, as
      compared to no intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  fulfillment of the Rome II criteria for IBS,

          -  availability of at least one colonoscopy within the last three years,

          -  aged 18 or older at the time of screening,

          -  provision of written informed consent,

          -  commitment of availability throughout the 12 week study period.

        Exclusion Criteria:

          -  major abdominal surgery in the past other than other than appendectomy, caesarean
             section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and
             hysterectomy,

          -  current use of antibiotics,

          -  history of organic intestinal disease,

          -  pregnant or breastfeeding mothers,

          -  chronic infectious disease like HIV or tuberculosis, and

          -  unable to understand English or Afrikaans.
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Condition: Well-differentiated Pancreatic Neuroendocrine Tumor
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Intervention: sunitinib
Intervention description: Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.
Intervention MeSH terms: Sunitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuroendocrine tumors; adenoma islet cells; carcinoma islet cells; pancreatic neoplasms; angiogenesis inhibitors; sunitinib; neoplasms; carcinoma; adenoma

Summary:

      The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with
      unresectable pancreatic neuroendocrine tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven diagnosis of well-differentiated pancreatic
             neuroendocrine tumor (according to World Health Organization [WHO 2000]
             classification).

          -  Disease progression within 12 months prior to study enrollment.

          -  Disease that is not amenable to surgery, radiation, or combined modality therapy with
             curative intent.

        Exclusion Criteria:

          -  Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO
             2000 classification).

          -  Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth
             factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or
             mammalian target of rapamycin (mTOR) inhibitors.
Rehabilitation of the Stroke Hand at Home
Condition: Stroke
MeSH terms: Stroke
Intervention: Hand Mentor (TM) robotic stroke therapy device; Home Therapy Program
Intervention description: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.; Subjects in the control group will be instructed in a self administered home therapy program
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Stroke Rehabilitation; Home rehabilitation; robotic therapy

Summary:

      The purpose of this research is to evaluate a therapy delivery system for stroke patients
      that provide accessible, affordable stroke care. User-friendly home therapy robots and a
      telerehabilitation system are combined to monitor and provide therapy that is accessible for
      patients in rural and underserved locations. The robotic-based home therapy intervention will
      produce significantly greater improvement in upper extremity motor function than Usual and
      Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation
      program at the end of 8 weeks of home therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral ischemic or hemorrhagic stroke

          -  within 6 months of admission to in-patient rehabilitation

          -  Persistent hemiparesis

          -  Proximal Upper Extremity voluntary activity

          -  Preserved cognitive function

          -  Difficult access to an organized stroke rehabilitation program

        Exclusion Criteria:

          -  Not independent before stroke

          -  Hemispatial neglect

          -  Significant other illnesses
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Metvix PDT
Intervention description: Methyl aminolevulinate cream will be applied for 3 hours on the whole target field.
The target field will then be exposed to red light using Aktilite 128 lamp.
Intervention MeSH terms: Methyl 5-aminolevulinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal transplant patients; Actinic Keratoses; Metvix PDT; Field cancerisation; Gene expression

Summary:

      The aim of this study is to determine possible molecular changes on large scale gene
      expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic
      keratoses (AK) and cancerised field in renal transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal transplant with an history of immunosuppression from 5 to 15 years,

          -  Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the
             scalp, forearms or the chest.

        Exclusion Criteria:

          -  At risk in terms of precautions, warnings, and contra-indication referred in the
             package insert of Metvix®,

          -  AK lesions clinically atypical or suspicious for malignancy on the target field,

          -  Any of the following topical treatments within the specified washout period at
             Screening:

               -  5-FU, Imiquimod, Diclofenac sodium: 3 months,

               -  Cryotherapy: 3 months,

               -  PDT: 3 months,

               -  Other less common AK treatments: 3 months.

          -  Systemic retinoids within the last month prior to Screening visit.
Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup
Condition: Asthma; Croup
MeSH terms: Asthma; Croup
Intervention: Dexamethasone IV for PO; Dexamethasone crushed tablets
Intervention description: Common pediatric emergency department practice; Alternative route of administration for patients unable to swallow tablet whole
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      Study of the palatability and acceptability of dexamethasone oral tablets crushed and placed
      in apple sauce or pudding in comparison with the IV solution mixed with sugar syrup and given
      orally. It is hypothesized that dexamethasone tablets crushed and administered in apple sauce
      or pudding will be more palatable and acceptable for pediatric patients receiving
      dexamethasone for an acute asthma exacerbation or croup.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt
             Children's Hospital Emergency Department

          -  Age 1 to 7 years

          -  Dexamethasone treatment indicated

          -  No other acute or chronic process accounting for signs and symptoms (e.g., foreign
             body aspiration, pneumonia, cystic fibrosis)

          -  Have not received systemic corticosteroid for current episode prior to enrollment

        Exclusion Criteria:

          -  Allergy to dexamethasone or apple sauce and pudding

          -  Unable to take medication orally
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
Condition: Atherogenic Dyslipidemia; Obesity Associated Disorder
MeSH terms: Dyslipidemias
Intervention: Therapeutic Lifestyle Changes; Placebo; Fenofibrate; Wax Matrix Extended Release Niacin (WMER Niacin)
Intervention description: Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
Intervention MeSH terms: Niacin; Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 161.0
Sex: Female
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Extended Release Niacin; Fenofibrate; treatment; Obesity; Atherogenic Dyslipidemia

Summary:

      Atherogenic Dyslipidemia (AD) is a risk-conferring lipid/lipoprotein profile that comprises a
      higher proportion of small LDL particles, reduced HDL-C, and increased triglycerides. It is
      characteristically seen in patients with obesity, metabolic syndrome, insulin resistance, and
      type 2 diabetes mellitus and has emerged as an important marker for the increased
      cardiovascular disease (CVD) risk observed in these populations.

      Optimal cardiovascular risk reduction in patients exhibiting the lipid triad of AD requires
      integrated pharmacotherapy to normalize HDL-C, Triglyceride (TG) and LDL-C levels. Recent
      studies have focused on optimizing treatment for AD and compare the efficacy and tolerability
      of combined lipid-altering drug based therapies, however, an optimal pharmacologic approach
      has not yet been established.

      The present study was intended to evaluate the restorative efficacy of Extended Release
      Niacin (ER Niacin) and Fenofibrate as mono and combination therapies , as well as their
      safety and tolerability in females with obesity-induced AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI≥30 kg/m2.

          -  Conventional diagnosis of atherogenic dyslipidemia, confirmed by a fasting serum TG
             more than150 mg/dl coincide with an HDL-C of less than 50 mg/dl.

        Exclusion Criteria:

          -  The use of any antilipidemic medication.

          -  Findings suggestive for renal dysfunction (eGFR˂60ml/min per 1.73 m2).

          -  Findings suggestive for hepatic insufficiency (ALT and/or AST˃2ULN).

          -  Clinical or laboratory findings suggestive for thyroid dysfunction.

          -  Established diagnosis of Diabetes Mellitus.

          -  History of gout, hyperuricemia, or on hypouricemic agents.

          -  Active peptic ulcer.

          -  Pregnancy, or nursing mothers.

          -  Alcohol or tobacco consumption.