bioihbjkbjnl/mcl2 huggingface dataset:
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Condition: Type 2 Diabetes; Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: vildagliptin and metformin (combination); glimepiride; Metformin
Intervention description: vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
Intervention MeSH terms: Metformin; Glimepiride; Vildagliptin
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: 18 Years
Healthy volunteers: No
Keywords: diabetes; hypoglycemia; glycemic variability; vildagliptin; glimepiride

Summary:

      The purpose of this study was to compare the effect of a fixed dose combination of
      vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in
      glycemic variability in patients with type 2 diabetes who have not achieved adequate control
      of their disease prior to treatment with metformin monotherapy in optimal doses.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit
             1

        Key Exclusion Criteria:

          -  Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea,
             glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
Condition: CML in Chronic Phase
MeSH terms: Philadelphia Chromosome
Intervention: Nilotinib
Intervention description: Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1090.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; myeloid; myelogenous; chronic BCR-ABL positive; Nilotinib; Philadelphia chromosome; CML in chronic phase

Summary:

      This study will assess the efficacy and safety of nilotinib in adult patients with newly
      diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in
      chronic phase. The aim of the study is to confirm the rates of complete molecular remission
      (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population
      using the EUTOS standardized laboratories.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph)
             chromosome

          -  Ph negative cases or patients with variant translocations who are BCR-ABL positive in
             multiplex PCR are also eligible

          -  WHO performance status 0-2

          -  Laboratory assessments within normal limits

          -  Written informed consent prior to any study procedures being performed

        Exclusion Criteria:

          -  Known impaired cardiac function

          -  History of acute or chronic pancreatitis

          -  Impaired gastrointestinal function or disease that may alter the absorption of study
             drug

          -  Concomitant medications with potential QT prolongation, or known to interact with
             CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)

          -  Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or
             who have not recovered from side effects of such therapy

          -  Patients who are pregnant or breast feeding, or females of reproductive potential not
             employing an effective method of birth control. Female patients must agree to employ
             an effective barrier method of birth control throughout the study and for up to 3
             months following discontinuation of study drug

        Other protocol-defined inclusion/exclusion criteria may apply
The Impact of Grapefruit Juice on the Response to Clopidogrel
Condition: Healthy
Intervention: Grapefruit juice; Clopidogrel 75 mg/day; Clopidogrel 300 mg
Intervention description: Participants received grapefruit juice during 1 of the 2 periods.
Intervention MeSH terms: Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 19 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Platelet Aggregation Inhibition

Summary:

      This study will measure the percentage of platelet aggregation inhibition with a loading dose
      of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank
      11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation
      inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay
      System in healthy volunteers who have drank 11 oz grapefruit juice daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 19-40

          -  Health status confirmed by medical history and physical examination and laboratory
             analysis

        Exclusion Criteria:

          -  Pregnancy

          -  Taking routine prescription or over-the-counter prescriptions

          -  Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of
             study participation

          -  Recently had grapefruit juice or regularly drinks grapefruit juice
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Condition: Hyperglycemia; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Hyperglycemia
Intervention: Glargine insulin; Lispro insulin; NPH Insulin
Intervention description: In both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.; In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm.; NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: glucocorticoids; hyperglycemia; diabetes mellitus

Summary:

      The investigators hypothesize that includes patient weight and glucocorticoid dose can be
      used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be
      treated with pharmacological doses of glucocorticoids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

          -  Treatment with pharmacological doses of glucocorticoids (GCs) ≥10 mg of prednisone or
             its equivalent if they are not on maintenance dose of GCs in the outpatient settings.

          -  Treatment with pharmacological doses of GCs ≥10 mg of prednisone or its equivalent
             above their maintenance dose of GCs in the outpatient settings.

          -  Have either a previous diagnosis of diabetes mellitus which has been treated with diet
             or medications, hemoglobin A1c ≥6.5%, or confirmed inpatient hyperglycemia defined as
             a fasting laboratory glucose or finger stick reading ≥126 mg/dL or random glucose
             reading ≥200 mg/dL on two or more determinations.

        Exclusion Criteria:

        Unwilling to sign informed consent.
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Condition: Pneumonia, Bacterial; Community-acquired
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Ceftaroline; Levofloxacin
Intervention description: 600 mg Q12h; 750 mg QD
Intervention MeSH terms: Levofloxacin; Ceftaroline fosamil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pneumonia; ceftaroline; community-aquired

Summary:

      This study will further analyze the use of ceftaroline for CABP and compare its potential to
      eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of
      ceftaroline compared to levofloxacin may be further highlighted from this investigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for
             parenteral antibiotic therapy.

          -  All patients will have a creatinine clearance (CrCl) >50 ml/min.

        Exclusion Criteria:

          -  pregnant or nursing patients,

          -  allergy to penicillin/cephalosporin antibiotics,

          -  allergy to fluoroquinolones,

          -  renal or hepatic failure, or have received an antimicrobial in past 96h.

          -  Patients who require antibiotics other than the study drugs will also be excluded.
The Effect of Tamsulosin on Postoperative Urinary Retention
Condition: Urinary Retention
MeSH terms: Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: Oral drug: 10 days of 0.4 mg of oral Tamsulosin; Oral drug: 10 days of identical-appearing placebo
Intervention MeSH terms: Tamsulosin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: Female
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Postoperative care; Urinary tract infection; Female pelvic reconstructive surgery; Enhanced recovery after surgery; Tamsulosin; Flomax

Summary:

      This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to
      prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing
      same-day discharge with an enhanced recovery after surgery protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage II or greater pelvic organ prolapse in > 1 vaginal compartment

          -  Plan for multicompartment native tissue vaginal repair (which would include any
             combination of uterosacral ligament suspension, sacrospinous ligament suspension,
             cystocele and/or rectocele repair, with or without hysterectomy and with or without
             concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and
             reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health

          -  Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day
             hospital discharge

          -  Willing to remain compliant with Investigation Product (IP)

        Exclusion Criteria:

          -  Intraoperative complication necessitating prolonged bladder drainage or placement of a
             vaginal pack x 24 hours (patients would exit study after randomization and will be
             excluded from the per-protocol analysis)

          -  Patients whose surgical plan would necessitate a voiding trial on postop day >0

          -  Less than 21 years of age

          -  Unable to understand English

          -  Patients who are scheduled to undergo combined colorectal procedures such as
             rectopexy, sphincteroplasty

          -  Patient with known allergy to Tamsulosin or sulfa drugs

          -  Patients with upcoming cataract surgery

          -  Patient with orthostatic hypotension

          -  History of postvoid residual (PVR>150) prior to surgery with prolapse reduction

          -  Patients with hypertension on alpha-blockers

          -  Single compartment prolapse repair (anterior or posterior repair only)

          -  Use of mesh for prolapse repair

          -  High tone pelvic floor dysfunction
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
Condition: Head and Neck Neoplasms
MeSH terms: Head and Neck Neoplasms
Intervention: Neck dissection
Intervention description: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 41.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: LigaSure; Neck dissection; Operative duration; Postoperative drainage; Postoperative pain

Summary:

      The aim of this prospective randomized study was to investigate if the LigaSure vessel
      sealing system can reduce the operation duration and the postoperative drainage amount in
      patients undergoing neck dissection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck
             cancer

        Exclusion Criteria:

          -  history of coagulation disorders

          -  prior radiation to the neck

          -  prior neck dissection

          -  declined to participate
Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Lifestyle counseling; Standard care
Intervention description: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.; In standard care group, counseling sessions are conducted only 6 times for 4 years
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes prevention; Lifestyle modification; Obesity; Impaired glucose tolerance; Diet; Physical activity

Summary:

      This study was conducted to test the possibility of preventing or delaying the development of
      type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma
      glucose concentrations by internet-based diabetes prevention program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 30-69 years

          -  BMI ≥ 20 kg/m2

          -  Impaired glucose tolerance :

             2h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose :
             Fasting plasma glucose 110-125 mg/dl

        Exclusion Criteria:

          -  Diabetes at baseline

          -  Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease

          -  Unable to communicate with clinic staff, Pregnancy and childbearing
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Monovalent Influenza Vaccine; Placebo
Intervention description: A single dose of 10^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy; Monovalent

Summary:

      This prospective annual release study is designed to evaluate the safety of 1 new influenza
      virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza
      season
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent)
             and/or clinically significant respiratory illness (example, cough or sore throat)
             within 14 days prior to randomization

          -  Any known immunosuppressive condition or immune deficiency disease, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barré syndrome
CNS Sarcoidosis and Acthar Gel
Condition: CNS Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: H.P. Acthar Gel
Intervention description: 80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to see if treatment with H.P. Acthar® Gel will result in the
      improvement and long-term stabilization of clinical and radiographic abnormalities that occur
      in patients with CNS sarcoidosis. In addition, it will also look at whether treatment will be
      also associated with improvement in measures of quality of life. The treatment of CNS
      sarcoidosis involves the use of either corticosteroids such as prednisone or potent
      immunosuppressive agents such as methotrexate, both which can induce severe long term side
      effects. The adverse effects of steroids may be avoided by treatment with adrenocorticotropic
      hormone (ACTH), which is available for patient use as H.P. Acthar® Gel. The efficacies of
      H.P. Acthar® Gel in the treatment of CNS sarcoidosis and the impact on quality of life have
      not been previously studied. In addition, little is known regarding the expression of immune
      markers in CNS sarcoidosis and the association of such markers with disease activity and
      response to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A highly probable diagnosis of sarcoidosis, as determined using the World Association
             for Sarcoidosis and Other Granulomatous Disorders (WASOG) Sarcoidosis Organ Assessment
             Instrument (Judson et al., 2014), with involvement not limited to the central nervous
             system.

          -  At the time of enrollment, a history of clinical deterioration based on the
             development of new symptoms or worsening previously present symptoms with confirmation
             by clinical examination and objective clinical testing.

          -  If on steroids, on a stable dose of the medication for at least 3 months.

        Exclusion Criteria:
No Drop Post-Op Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: Omidria
Intervention description: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal
      Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of
      Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post
      operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 55-90 years with visual significant cataracts in one or both eyes.

          -  Healthy individuals able to tolerate outpatient cataract surgery under local
             anesthesia via either phacoemulsification and/or femtosecond assisted cataract
             surgery. Well-controlled diabetes, hypertension will be included.

          -  Females of childbearing potential must agree to use a reliable method of birth control
             while participating in this study. Reliable methods of birth control are: abstinence,
             oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or
             vasectomy of the partner (with confirmed negative sperm counts) in monogamous
             relationship (same partner). An acceptable, although less reliable, method involves
             the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge.
             A pregnancy test is required at least 10 days from the last normal menstrual period,
             if the patient is a sexually active female of childbearing potential.

        Exclusion Criteria:

          -  Allergy to Phenylephrine or NSAIDs.

          -  Inability to sit steady and upright for the Optical Coherence Tomography (OCT).

          -  Complications during surgery, including posterior capsular rupture, vitreous loss,
             zonular dialysis, or iris trauma.

          -  Macular thickness above 300 microns at baseline

          -  Currently taking a prostaglandin analogue

          -  Presence of an epiretinal membrane on the preoperative OCT.

          -  Retained lens fragment post-operatively.

          -  Inability to return for follow appointments

          -  Female patients who are pregnant, lactating or planning to become pregnant during the
             course of treatment.