bioihbjkbjnl/mcl2 huggingface dataset:
Prandial Insulin Dosing in Hospitalized Patients
Condition: Diabetes; Admitting Hospital; Non-critically Ill
MeSH terms: Diabetes Mellitus
Intervention: Aspart fixed dose; Aspart flexible dose
Intervention description: fixed dose; dose based upon carbohydrate intake and total daily requirements
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: diabetes; glucose; hospital

Summary:

      The purpose of this study is to determine whether mealtime insulin results in better control
      of blood sugar than a fixed meal dose in hospitalized patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  general medical or minor surgical hospitalized patients

          -  type 2 diabetes

          -  blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20
             units of insulin/day in the 24 hours prior to enrollment

        Exclusion Criteria:

          -  • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of
             study entry, including cardiothoracic, neurosurgical, and open intra-abdominal
             procedures (in particular, any surgery lasting over 2 hours).

               -  Patients receiving glucocorticoids, total parental nutrition (TPN), or tube
                  feeds.

               -  Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on
                  pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause
                  will undergo pregnancy testing.

               -  Patients currently on IV insulin (must wait to enroll) or with planned surgical
                  procedures in the next 72 hours for whom intravenous insulin will be likely

               -  Prolonged (>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small
                  bowl obstruction). Liquid or modified consistency diets are acceptable.

               -  Patients for whom expected length of stay will be less than 48 hours

               -  Patients using subcutaneous insulin pumps

               -  Diabetic ketoacidosis

               -  End-stage renal disease on dialysis

               -  End-stage liver disease with cirrhosis

               -  Mental conditions precluding informed consent

               -  Potentially sensitive admissions: prisoners, HIV, suicidality

               -  Unable to give consent in English
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Condition: Bipolar I Disorder
Intervention: olanzapine; placebo; divalproex
Intervention description: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).; placebo, capsules, by mouth every evening, daily, for 6 weeks.; dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
Intervention MeSH terms: Valproic Acid; Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Mixed episode associated with Bipolar I

Summary:

      Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of
      both mania and depression more than treatment with mood stabilizer alone, in patients with a
      mixed episode of bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a mixed episode of bipolar I disorder.

          -  Have had at least one previous manic or mixed episode associated with bipolar disorder

          -  You must be between 18 and 60 years old.

          -  You must be able to visit the doctor's office three times in the first week and then
             once every week for the next five weeks.

          -  If you are a female, you must have a negative pregnancy test and be using an effective
             method of contraception.

        Exclusion Criteria:

          -  You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or
             dependence.

          -  You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine
             systems, or blood.

          -  Have required a recent thyroid hormone supplement to treat hypothyroidism (must have
             been on a stable dose of the medication for at least 2 months prior to Visit 3).

          -  You are allergic to any of the medications involved in this study.
Harmonic ACE®+7 Shears in Laparoscopic Colectomy
Condition: Benign or Malignant Disease Indicated for Colectomy
Intervention: Harmonic ACE®+7 Shears
Intervention description: Vessel sealing performance assessed for transection and sealing of the following named vessels:
Inferior mesenteric artery (IMA)
Inferior mesenteric vein (IMV) (if identified)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemostasis; Harmonic ACE®+7 Shears; Laparoscopic; Inferior mesenteric artery; Inferior mesenteric vein; Observational

Summary:

      This is a prospective, non-randomized, single arm, multicenter, observational study to assess
      the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing
      during laparoscopic colectomy. The study will not modify or influence current surgeon
      technique. Investigators will perform each procedure using the device in compliance with
      their standard surgical approach and product labeling.

      The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in
      accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,
      calibrated, and/or used in accordance with manufacturer design specifications, product
      instructions and guidelines.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Indicated for elective laparoscopic colectomy

          2. Planned dissection and transection of the IMA

          3. Age: equal to or more than18 years

        Exclusion Criteria:

        Preoperative exclusion criteria:

          1. Known or suspected uncontrolled bleeding disorders

          2. Subjects unlikely to comply with protocol procedures or adhere to the study visit
             schedule

          3. Any condition rendering a subject unable to understand the nature, scope, and possible
             consequences of the study or study procedures, or

          4. Any Subject unwilling to sign the study informed consent document

             Intra-operative exclusion criteria:

          5. Prior to transection of the IMA, the investigator prospectively concludes the
             inability to safely isolate and transect the IMA with exclusive use of study device
             while adhering to the instructions for use, or

          6. Any intra-operative findings identified by the surgeon that may preclude conduct of
             the study procedure
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Dexmedetomidine; Placebo Saline
Intervention description: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.; Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, prospective, double-blind , placebo-controlled trial examining the
      effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar
      spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects,
      over the age of 18, undergoing lumbar spinal fusion will be considered eligible for
      enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal
      saline infusion. They will be followed for approximately six weeks postoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults who will undergo lumbar spinal fusion, including surgeries extending into
             thoracic and sacral segments

          -  Subject is non-lactating and is either:

          -  Not of childbearing potential

          -  Of childbearing potential but is not pregnant at time of surgery as determined by
             pre-surgical pregnancy testing

          -  Subject is ASA physical status 1, 2, or 3.

        Exclusion Criteria:

          -  Subject is pregnant or breastfeeding

          -  Any subject whom the investigators deem unable to complete any/all research related
             tasks

          -  Subjects who are cognitively impaired (by history)

          -  Subject requires antipsychotic medications

          -  Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks
             prior to surgery

          -  Subject has known allergy to dexmedetomidine

          -  Subjects with impaired renal or hepatic function

          -  Subjects with advanced heart block

          -  Subjects with severe ventricular dysfunction
HPV Vaccination Study in Postpartum Women
Condition: HPV; Immunization; Human Papilloma Virus
MeSH terms: Papilloma
Intervention: Gardasil9
Intervention description: Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papilloma Virus; HPV; Immunization

Summary:

      The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the
      United States (U.S.) and is responsible for a wide range of conditions, including cancers
      within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that
      HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical
      cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum
      care at Johns Hopkins University. The investigators will measure the immunogenicity and
      acceptability of the vaccine in the postpartum setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants biologically born as females between the ages of 15 through 45 who have
             delivered a live born baby within the past 72 hours.

        Exclusion Criteria:

          -  Pregnancy

          -  Severe allergic reaction to vaccine components

          -  Prior receipt of an HPV vaccine dose

          -  Fetal demise or stillbirth

          -  Allergy to latex or yeast

          -  Moderate or severe acute illness (deemed by the investigator to exclude)

          -  Immunosuppression (e.g., HIV, solid organ transplant).
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Condition: Chronic Foot Ulcers
MeSH terms: Foot Ulcer; Diabetes Mellitus, Type 2; Ulcer
Intervention: Placebo; vildagliptin
Intervention description: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea; 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea
Intervention MeSH terms: Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: type 2 diabetes; healing; foot ulcers; vildagliptin

Summary:

      A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4
      months of vildagliptin on healing of chronic ulcers in type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Oral hypoglycemic agents treatment

          -  Chronic foot ulcers

          -  Adequate blood circulation (perfusion) was assessed by a dorsum transcutaneous oxygen
             test >30 -mmHg, anklebrachial index values > 0.7 and < 1.2 with toe pressure > 30
             mmHg, or Doppler arterial aveforms that were triphasic or biphasic at the ankle of the
             affected leg

          -  Written consensus

        Exclusion Criteria:

          -  Active Charcot disease

          -  Ulcers resulting from electrical, chemical, or radiation burns

          -  Collagen vascular disease

          -  Ulcer malignancy

          -  Untreated osteomyelitis, or cellulitis

          -  Ulcer treatment with normothermic or hyperbaric oxygen therapy

          -  Concomitant medications such as corticosteroids, immunosuppressive medications, or
             -chemotherapy

          -  Recombinant or autologous growth factor products

          -  Skin and dermal substitutes within 30 days of study start

          -  Use of any enzymatic debridement treatments

          -  Pregnant or nursing mothers
Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Intervention: Non invasive cardiac imaging
Intervention description: Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 697.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IHD; CAD; Non invasive imaging; SPECT; PET; CMR; Echocardiography

Summary:

      Main purpose of the study:

      To comparatively assess the diagnostic performance of non invasive anatomical and functional
      imaging modalities to detect significant obstructive coronary artery disease as demonstrated
      at invasive coronary angiography and functional evaluation of coronary lesions (fractional
      flow reserve).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with intermediate (>20%, <90%) risk of IHD based on age,gender,symptoms and
             exercise stress test results

        Exclusion Criteria:

          -  Age < 30 Yrs or > 75 yrs

          -  Pregnancy (suspected or ascertained)

          -  LV Dysfunction (LVEF < 35% by Echo or other method)

          -  Low (< =20%) or high (>=90%) probability of CAD

          -  Acute Coronary Syndrome

          -  Prolonged (> 20 minutes) chest pain

          -  De novo or accelerated angina

          -  Hemodynamic or electrical instability

          -  Recent ST-T segment or T wave changes of ischemic nature

          -  Acute myocardial infarction with or without ST segment elevation

          -  Elevated serum cardiac markers of necrosis

          -  Known diagnosis of CAD

          -  Previously known myocardial infarction

          -  Previous PCI

          -  Previous CABG

          -  Persistent atrial fibrillation or advanced AV Block

          -  Asthma or chronic treatment with aminophylline

          -  Recent (<6 months) cerebral ischemic attack

          -  Known significant carotid stenosis or vascular aneurisms

          -  Asthma or chronic treatment with aminophylline

          -  Active cancer

          -  Severe hypertension. Patients cannot withdraw therapy for 12 hours.

          -  Congenital heart disease

          -  Significant valvular disease

          -  Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis)

          -  Inability to provide an informed consent
A Study of LUMIGAN® RC in the Clinical Setting
Condition: Glaucoma, Primary Open Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: Bimatoprost 0.01%
Intervention description: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Intervention MeSH terms: Bimatoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated
      intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension
      (OHT) in a clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

          -  Determined by the treating physician to require treatment with LUMIGAN® RC

        Exclusion Criteria:

          -  None
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
Condition: Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis
Intervention: TIS or TIP
Intervention description: 300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis, Pseudomonas aeruginosa, Lung Clearance Index, Multiple Breath Washout, Inhaled Tobramycin, Inhaled Antibiotics.

Summary:

      The purpose of the study was to evaluate lung clearance index (LCI) by a standardized
      procedure in a well characterized study setting and to assess feasibility of LCI as a more
      sensitive method than forced expiratory volume at 1 second (FEV1) to measure effectiveness of
      antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF

          -  Patients with elevated LCI of ≥ 7.5 at screening

          -  Patients with FEV1 of ≥ 50% predicted at screening

          -  Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before
             screening

          -  chronic lung Infection with Pseudomonas aeruginosa

        Exclusion Criteria:

          -  Patients who are regularly receiving more than one class of inhaled anti-pseudomonal
             antibiotic

          -  Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days
             prior to on-phase of study drug

          -  Pregnant or nursing (lactating) women

          -  Change in dose, formulation or strength of the study drug in the past treatment cycle
             before screening

          -  History of hearing loss or chronic tinnitus

          -  Infection with Burkholderia cenocepacia complex

        Other protocol-defined inclusion/exclusion criteria may apply
A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: boceprevir; PegIFN-2b; RBV
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is being done to find out if the addition of boceprevir to standard of care (SOC)
      treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for
      participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not
      successfully treated by previous SOC. All participants will receive treatment with SOC alone
      for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional
      weeks of combined treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Weight between 40 kg and 125 kg

          -  Documented CHC genotype 1 infection

          -  Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented
             non-response

          -  Documented diagnosis of cirrhosis

          -  No evidence of hepatocellular carcinoma (HCC) by ultrasound

          -  Participant and partner of participant must agree to use 2 effective contraceptives as
             specified for at least 2 weeks prior to Day 1 of treatment and continue until at least
             6 months after last dose of study drug (7 months for male participants)

        Exclusion criteria:

          -  Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus

          -  Use of any investigational drugs within 30 days prior to study enrollment

          -  Participation in any other clinical trial within 30 days of study enrollment or
             intention to participate in another clinical trial during this study

          -  Evidence of present or previous decompensated liver disease including, but not limited
             to, a history or presence of clinical ascites or hepatic encephalopathy. Only
             participants with large (F3) esophageal varices, as determined in an
             esophagogastroduodenoscopy (EGD) performed within the past 12 months according to
             international guidelines will be excluded.

          -  Clinically significant ocular examination findings

          -  Pre-existing significant psychiatric condition(s)

          -  Clinical diagnosis of active or recent substance abuse

          -  Evidence of active or suspected malignancy, or a history of malignancy, within the
             last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of
             the skin)