bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery
Condition: Postoperative Complications
MeSH terms: Hyperglycemia; Postoperative Complications
Intervention: Control-saline; Dexamethasone 4 mg; Dexamethasone 8 mg; Control saline; Dexamethasone 4 mg; Dexamethasone 8 mg
Intervention description: Patients are randomized to receive saline 2 cc; Patients randomized to receive dexamethasone 4mg and 1 cc saline; Patients randomized to receive dexamethasone 8mg; Patients are randomized to receive saline 2 cc; Patients are randomized to receive dexamethasone 4 mg and saline 1 cc; Patients are randomized to receive dexamethasone 8 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: dexamethasone; hyperglycemia; gynecologic surgery

Summary:

      The question of a possible hyperglycemic effect from single-dose dexamethasone is an
      important issue for clinicians managing patients in the intraoperative and postoperative
      periods. Recent evidence suggests that even moderate elevations in blood glucose levels may
      be associated with adverse events.

      The aim of this clinical investigation is to determine whether standard clinical doses of
      dexamethasone produce hyperglycemia in the perioperative period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting for elective gynecologic surgery

        Exclusion Criteria:

          -  Age < 18 or > 90, patients receiving chronic or preoperative steroids,or allergy to
             dexamethasone.
Relapse Prevention With Varenicline
Condition: Recurrence; Smoking Cessation; Substance-Related Disorders
MeSH terms: Recurrence; Substance-Related Disorders
Intervention: Varenicline; Placebo
Intervention description: Varenicline given twice a day or five weeks.; Placebo given twice a day or five weeks.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Relapse; Smoking Cessation; Substance Abuse

Summary:

      This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation
      aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the
      laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking
      and will delay or prevent relapse compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years old

          -  Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests
             positive for nicotine metabolites at intake

          -  Contemplating a smoking cessation attempt in the near future

          -  Willing to engage in a practice quit attempt during which they will be asked to smoke
             on one occasion

          -  Able to give informed consent

        Exclusion Criteria:

          -  Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression,
             bi-polar disorder, or schizophrenia

          -  History of attempted suicide or expresses any current suicidal ideation

          -  Pregnant, breast feeding, or planning to become pregnant within the next 3 months

          -  Reports desire for immediate treatment of tobacco/nicotine dependence

          -  Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less
             than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma
             creatinine adjusted by weight, gender, and age)
STOP Study: Effectiveness of Zyban in a Clinical Population
Condition: Cigarette Smoking; Nicotine Addiction; Smoking Cessation
MeSH terms: Tobacco Use Disorder; Behavior, Addictive
Intervention: bupropion HCl
Intervention description: 150mg BID for up to 8 weeks + counseling
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: smoking cessation; nicotine addiction; Zyban; bupropion hydrochloride

Summary:

      Despite the significant health, social and economic costs of cigarette smoking, 17% of
      Ontarians still currently smoke. Use of smoking cessation pharmacotherapy such as Zyban
      (bupropion HCl) has been shown to double quit rates but such medications are under-utilized
      by smokers attempting to quit. It has been suggested that the high price of pharmacotherapy
      may act as a barrier to accessing such treatment.The main objective of this study is to
      evaluate the methods and effectiveness of providing smokers who want to quit with 8 weeks of
      free Zyban in combination with smoking cessation counselling through family health teams and
      community health centres across the province.

      Hypothesis: Ontario smokers who receive 8-weeks of free bupropion in combination with brief
      counselling will have higher smoking cessation rates than the standard population cessation
      rates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ontario resident

          -  18 years of age or older

          -  Current daily cigarette smoker who smokes 10 or more cigarettes per day and has smoked
             > 100 cigarettes in their lifetime

          -  Want to quit smoking cigarettes within 30 days of assessment

          -  Willingness and capacity to give written informed consent and to comply with study
             protocol

        Exclusion Criteria:

          -  Enrollment in any of the STOP Study NRT models in the past 6 months

          -  Currently receiving Wellbutrin SR or any medication containing bupropion hydrochloride

          -  Current seizure disorder or history of seizures

          -  Current or prior diagnosis of bulimia or anorexia nervosa

          -  Current diagnosis of bipolar disorder

          -  History of head trauma

          -  Allergy or sensitivity to Zyban, Wellbutrin or bupropion

          -  Undergoing abrupt withdrawal from alcohol, benzodiazepines or other sedatives

          -  Currently taking monoamine oxidase (MAO) inhibitors, or thioridazine

          -  Pregnant or breastfeeding or at risk of becoming pregnant

          -  Central nervous system (CNS) tumor

          -  Severe hepatic impairment
Hypoxic Pulmonary Vasoconstriction Pilot Study
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Intervention: Sildenafil study group
Intervention description: One dose of 20 mg Sildenafil will be given one hour before CT imaging.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if the events leading to smoking-associated
      centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent
      mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be between the ages of 30 and 60.

          -  Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).

          -  Must have pulmonary function test (PFT) results that meet the following:

          -  Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) > 70%

          -  Forced Expiratory Flow at 25-75% (FEF25-75) > 79% of predicted

          -  FVC greater than 80% of predicted

          -  Must be able to give informed consent for self.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Body Mass Index (BMI) greater than 32.

          -  Weight of greater than 220 pounds (100 kg).

          -  Allergies to shell fish, seafood, eggs or iodine.

          -  Heart disease, kidney disease or diabetes.

          -  Diagnosis of asthma.

          -  Usage of any medications that are known to affect the heart or lungs (contraceptives,
             anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for
             osteoporosis and gastrointestinal diseases will be allowed).

          -  Any metal in or on the body between the nose and the abdomen.

          -  Any major organ system disease (by judgment of study medical team).

        For the subjects that will receive Sildenafil as part of the study, additional exclusion
        criteria are as follows:

          -  Nitroglycerin usage.

          -  Prior history of hypersensitivity to Sildenafil.
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Condition: Tibial Tubercle Osteotomy
MeSH terms: Hemarthrosis
Intervention: Tranexamic Acid (TXA)
Intervention description: One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Tibial Tubercle Osteotomy; Tranexamic Acid

Summary:

      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle
      osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and
      swelling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing TTO

          -  Age 18-60

          -  Willing and able to provide consent

        Exclusion Criteria:

          -  Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects,
             dementia, etc.)

          -  Younger than 18 years of age

          -  Older than 60 years of age

          -  Any patient considered a vulnerable subject

          -  Have bleeding or clotting disorder

          -  Preoperative anticoagulation therapy

          -  Abnormal coagulation profile

          -  Renal disorder or insufficiency

          -  Sickle cell disease
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
Condition: Short Stature Born Small for Gestational Age (SGA)
MeSH terms: Dwarfism
Intervention: Genotropin (somatropin)
Intervention description: Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Genotropin(somatropin); SGA; Short Stature; Long-term; Safety

Summary:

      To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA)
      without epiphyseal closing.
    

Eligibility criteria:

        Inclusion Criteria:

        Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

        Exclusion Criteria:

          -  Children who have any chronic disease requiring treatment with steroid hormone that
             may affect growth promotion including estrogen, androgen, anabolic hormone, and
             corticosteroids (except those for external use), and have received the treatment.

          -  Children who have received radiotherapy or chemotherapy.

          -  Children who have serious cardiac disease, renal disease, or hepatic disease.

          -  Children who have diabetes mellitus with a manifestation of abnormal glucose
             metabolism.

          -  Children who have serious chronic disease.

          -  Children who have malignant tumor.

          -  Children who are allergic to m-cresol.
Trial of Levomilnacipran in Geriatric Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: levomilnacipran; Placebo
Intervention description: antidepressant; an inactive drug
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: depressed; older adults; antidepressants; depression; MDD

Summary:

      The purpose of this study is to examine the effects of levomilnacipran (FETZIMA) compared to
      placebo for the treatment of depression in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  The presence of a major depressive disorder diagnosed according to the Diagnostic and
             Statistical Manual and Mental Disorders, 5th edition (DSM-V) criteria

          -  A 24-item Hamilton Rating Scale for Depression (HAMD) score of 16 or higher at
             baseline

          -  Mini-Mental State Exam (MMSE) score > 24.

        Exclusion Criteria:

        Subjects will be excluded if they had 1) any current and/or lifetime history of other
        psychiatric disorders (except unipolar depression with or without comorbid generalized
        anxiety disorder), or 2) recent unstable medical or neurological disorders; 3) any
        disabilities preventing participation in the study or in the MRI; 4) diagnosis of dementia;
        5) acute suicidality; 6) subjects with known allergic reactions to milnacipran,
        uncontrolled narrow angle glaucoma, seizures, poorly-controlled hypertension or ischemic
        changes on ECG, serotonin syndrome, or the recently used monoamine oxidase inhibitors
        (MAOIs) within last 4 weeks; 7) ineligible for MRI (e.g., metal in the body or
        claustrophobia)
Feasibility of Vaginal Progesterone to Reduce HIV-Associated Preterm Birth
Condition: PreTerm Birth
MeSH terms: Premature Birth
Intervention: Vaginal Progesterone; Placebo
Intervention description: 200 mg micronized vaginal progesterone suppository; Indistinguishable placebo vaginal suppository
Intervention MeSH terms: Progesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PreTerm Birth; HIV; Vaginal Progesterone; ART; Adherence; Feasibility

Summary:

      More than 1.5 million HIV-infected women become pregnant each year. Approximately half have
      access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB).
      Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that
      should be studied in this high-risk population. This pilot study will provide critical
      insight into the feasibility of a phase III trial by determining whether women are willing to
      participate, to adhere to study drug, and to complete follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. viable intrauterine pregnancy confirmed by ultrasound

          3. presentation to antenatal care prior to 24 weeks gestation

          4. antibody-confirmed HIV-1 infection

          5. initiating or continuing ART treatment in pregnancy

          6. ability and willingness to provide written informed consent

          7. willing to adhere to study visit schedule

        Exclusion Criteria:

          1. multiple gestation

          2. non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or
             cervical length <20mm on screening ultrasound)

          3. planned or in situ cervical cerclage

          4. evidence of threatened abortion, preterm labor, or ruptured membranes

          5. major fetal anomaly detected on screening ultrasound

          6. known uterine anomaly

          7. known or suspected allergy or contraindication to VP or placebo components
The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery
Condition: Neuromuscular Blockade
Intervention: sugammadex
Intervention description: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neuromuscular blockade; Sugammadex; Laparoscopic surgery; Intra abdominal pressure alarm

Summary:

      This study is a randomized, controlled, double-blinded, and parallel design study. A total 96
      patients were randomized to receive a deep block or a moderate block scheduled for elective
      laparoscopic colorectal surgery. Investigators estimated the proportion of intra-abdominal
      pressure(IAP) alarm and surgical rating score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists grade 1 or 2

          -  Scheduled for elective laparoscopic Colorectal surgery

        Exclusion Criteria:

          -  Severe respiratory or cardiac disease

          -  Severe hepatic or renal function impairment

          -  On medications affecting neuromuscular function

          -  Known allergy to the drugs to be used

          -  Pregnant

          -  Malignant hyperthernia
TissueLink Versus SEAMGUARD After Distal Pancreatectomy
Condition: Distal Pancreatectomy
Intervention: SEAMGUARD with bioabsorbable staple; TissueLink with radiofrequency ablation
Intervention description: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.; After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find a lowest leak rate following a distal
      pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to
      have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the
      pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and
      prevent leaks at the end of the pancreas.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age equal or above 18 years

          2. Accepted for elective distal pancreatectomy for any indication

        Exclusion from randomization process:

          -  Thickness of pancreas on preoperative CT scan images > 2.5 cm at the site of expected
             transection in anterior-posterior diameter. This will be reviewed by the surgeon the
             day before the surgeon sees the patient to predetermine the appropriateness of the
             patient for the study.

        General study exclusion criteria:

          1. Current immunosuppressive therapy

          2. Chemotherapy within 2 weeks before operation

          3. Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation

          4. Radiotherapy before operation

          5. Inability to follow the instructions given by the investigator

          6. Lack of compliance

          7. Persons unable or unwilling to give informed consent to participate in this study

          8. Pregnant women

          9. Prisoners

         10. Institutionalized individuals
Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Condition: Localized Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Intervention: β-1,3/1,6-D-glucan; Placebo
Intervention description: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.; 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.
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: 20 Years
Maximum age: 27 Years
Healthy volunteers: No

Summary:

      combining the non-surgical therapy with a well-tolerated substance that can stimulate
      protective immune responses like B-glucan, might effectively mount resolution pathways
      contributing to resolving of the chronic lesion observed in aggressive forms of periodontal
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Except for periodontitis, patients were systemically healthy as evaluated by modified
             Cornell medical index.

          -  No more than two teeth other than first molars and incisors, with probing depth (PD) ≥
             5mm, bleeding on probing (BOP), and clinical attachment level (CAL) ≥ 5mm.

          -  Rapid rate of attachment loss and bone destruction.

          -  A radiographic examination revealing an evidence of moderate to severe vertical bone
             loss around permanent incisors and first molar teeth.

          -  Every patient should have at least 20 teeth excluding third (3rd) molars, and at least
             an extraction-indicated tooth for a dento-periodontal affection.

          -  Familial aggregation.

        Exclusion Criteria:

          -  Previous subgingival scaling and root planing, allergy to β-glucan, smoking, former
             smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic
             therapy in the previous 6 months and allergy to chlorhexidine.