bioihbjkbjnl/mcl2 huggingface dataset:
Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
Condition: Stomach Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Intervention: Rebamipide
Intervention MeSH terms: Rebamipide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 301.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To examine the efficacy of continued administration of rebamipide following bacteria
      eradication therapy in patients with H. pylori-positive active gastric ulcer in a
      placebo-controlled, double-blind study
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients aged 20 years or older at time of consent

          2. H. pylori-positive patients meeting both of the following criteria:• Assessed as H.
             pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study
             examination, • Assessed as H. pylori-antibody-positive by urine-based test after
             obtaining informed consent

          3. Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:•
             Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal
             diameter: ->5 mm

          4. Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or
             antiprotozoal agents within 1 week prior to endoscopy

        Exclusion Criteria:

          1. Patients who have previously received H. pylori eradication therapy

          2. Patients with acute gastric ulcer

          3. Patients with linear ulcer

          4. Patients with complication of duodenal ulcer (excluding cicatrix)

          5. Patients who have undergone upper-GI tract or vagal nerve resection

          6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric
             stenosis

          7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with
             obviously exposed blood vessels at lesion sites)

          8. Patients with a history of amoxicillin shock

          9. Patients with infectious mononucleosis

         10. Patients with severe renal disorders

         11. Patients with a history of hypersensitivity to penicillins, clarithromycin,
             lansoprazole, or rebamipide

         12. Patients who have been treated with drugs contraindicated to clarithromycin, such as
             terfenadine, cisapride, and pimozide

         13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become
             pregnant during the study

         14. Patients who are otherwise judged inappropriate for inclusion in the study by the
             investigator or subinvestigator
A Multiple Myeloma Trial in Patients With Bone Metastases
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm Metastasis
Intervention: zoledronic acid
Intervention description: 4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Z-MAX, multiple myeloma, zoledronic acid, bone metastases

Summary:

      The purpose of this trial is to study the safety of treating patients with multiple myeloma
      and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks
      for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older

          -  Confirmed diagnosis of Multiple Myeloma

          -  Stable renal function defined as two serum creatinine determinations of < 3 mg/dL

          -  Calculated creatinine clearance of greater than or equal to 30 mL/min

          -  ECOG Performance Status of 0 or 1

          -  Life expectancy of greater than or equal to 9 months

          -  If the patient is of child-bearing potential, a negative pregnancy test is required at
             screening, while postmenopausal women must be amenorrheic for at least 12 months to be
             considered of non-childbearing potential.

          -  Ability to comply with trial requirements and give informed consent.

        Exclusion Criteria:

          -  IV Bisphosphonate therapy for more than 3 years.

          -  Patients with a diagnosis of amyloidosis.

          -  Known hypersensitivity to zoledronic acid or other bisphosphonates

          -  Pregnant patients or lactating patients.

          -  Women of childbearing potential not on a medically recognized form of contraception

          -  Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes
             mellitus.
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PEG-IFN alfa-2a; Ribavirin
Intervention description: PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.; Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon alpha-2
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 896.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the addition of a higher-dose induction treatment period with
      peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with
      PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive
      participants with CHC, genotype 1 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic CHC, genotype 1

          -  Chronic liver disease consistent with CHC on a biopsy sample obtained within the
             previous 36 months as judged by a local pathologist (all countries except Australia)

          -  Infection with Hepatitis C virus (Australian sites only had to meet Section 100
             criteria for treatment with PEG-IFN alfa-2a plus ribavirin)

          -  Compensated liver disease

          -  Naive to interferon-based therapy for CHC infection

        Exclusion Criteria:

          -  Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of
             study drug

          -  Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus
             (HIV)

          -  Chronic liver disease other than CHC infection
Carbohydrate Consumption as a Factor in Aspart Dosing
Condition: Diabetes
Intervention: aspart; aspart- Insulin
Intervention description: Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate); 0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
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: Single (Participant)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; prandial; insulin; aspart; carbohydrate; inpatient; novolog

Summary:

      Good sugar control in postoperative hospitalized patient has been shown to improve wound
      healing and infection rates. However, sugar control is difficult to achieve and suboptimal
      use of insulin is thought to be a contributory factor. Though it is known that generally the
      consumption of carbohydrates alone raises the blood sugar, the usual practice of dosing
      meal-time insulin is based on the fraction of the total meal-tray eaten which includes
      proteins, fats and carbohydrates. This leads to an overestimation of insulin required for a
      patient who consumes a portion of mainly proteins and fats on their trays or an
      underestimation for those eating mainly the carbohydrates on their tray. Low sugars or high
      blood sugars can follow respectively.

      Hypothesis: The purpose of this study is to see if dosing meal-time insulin based on grams of
      carbohydrates consumed will result in better sugar control compared to the usual practice of
      dosing meal-time insulin based on percent of total meal consumed in hospitalized patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged > or = to 18 admitted to general surgical floors, excluding the ICU, at
             Rush University Medical Center, regardless of race, ethnicity, gender

          -  Clinical diagnoses of type 2 diabetes for more than 6 months prior to admission

          -  Treated with insulin and/or 2 or more oral diabetic agents

          -  Estimated length of stay 3 days or more

          -  Postoperative point of care blood glucose of > 180 mg/dL

        Exclusion Criteria:

          -  Glomerular Filtration Rate < 60 based on MDRD equation

          -  Pregnant patients

          -  Receiving parenteral or enteral nutrition

          -  Patients with an admitting diagnosis of hypoglycemia

          -  Outpatient insulin < 0.5 units/kg/day

          -  Inability to give consent

          -  Severe liver disease

          -  Known hypopituitarism or adrenal insufficiency

          -  Treatment with Prednisone at dose > 5 mg daily or its equivalent
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
Condition: Fungal Infection
MeSH terms: Mycoses
Intervention: Posaconazole; Calogen®
Intervention MeSH terms: Posaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single site study will examine plasma and alveolar compartment (AC) levels of
      posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant
      recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal
      infection rates will be assessed following transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo lung transplantation

          -  Able to take oral/nasogastric medication

          -  Females of childbearing potential, males, and the sexual partners of males must use an
             effective method of birth control during this study and for 6 weeks after completing
             the study.

        Exclusion Criteria:

          -  Severe liver disease

          -  Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine,
             astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before
             transplant

          -  Treatment with posaconazole within 14 days before transplant

          -  Breastfeeding
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Intervention: Liposome Bupivacaine; Bupivacaine HCl
Intervention description: Administered via local tissue infiltration around the knee joint; Administered via CFNB
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing
      total knee replacement (TKR). However the resulting motor blockade can lead to decreased
      quadriceps muscle strength and delayed functional recovery.The purpose of this study is to
      compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control
      and functional recovery
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA Status I-III

          -  Scheduled to undergo primary unilateral total knee arthroplasty

        Exclusion Criteria:

          -  Patients who are pregnant or nursing

          -  Alcohol or narcotic dependence within the last 2 years

          -  Condition requiring regular use of analgesia that may confound post surgical
             assessments as determined by principle investigator

          -  BMI > 40kg/m2

          -  Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or
             pathological conditions potentially aggravated by epinephrine

          -  Allergies to amide-type local anesthetics

          -  Any disease condition or lab result that could complicate a patients postoperative
             recovery

          -  History of hypotension

          -  Abnormal liver, renal or cardiac function

          -  Other physical, mental or medical conditions that, in the opinion of the investigator,
             make study participation inadvisable.
Scoring Clinical Index For Onychomycosis in Toenail Onychomycosis Treating With Itraconazole Capsules
Condition: Onychomycosis, Toe
MeSH terms: Onychomycosis
Intervention: Itraconazole
Intervention description: Itraconazole (ICZ) capsule will be administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle will consist of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment will be 49 weeks.
Intervention MeSH terms: Itraconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Onychomycosis, Toe; Itraconazole; Sporanox

Summary:

      The purpose of this study is to evaluate the participants with toenail onychomycosis (fungal
      infection of the nail) confirmed positive by potassium hydroxide (KOH) and bacterial
      identification test after administration of itraconazole (ICZ) capsule, to identify the
      change in Scoring Clinical Index for Onychomycosis (SCIO) score and to determine the
      relationship between the change of SCIO score and mycological cure rate and clinical
      improvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Onychomycosis participants whose etiologic agent is identified by potassium hydroxide
             (KOH) smear and bacterial identification test

          -  Participants with Scoring Clinical Index for Onychomycosis (SCIO) greater than or
             equal to 9

          -  Participants who are healthy in general in following items: medical and medication
             history, physical examination before administration time, vital signs (blood pressure
             and pulse) and clinical laboratory tests (clinical test results [liver function and
             renal function] are within 2 times the normal range)

          -  Female participants of child-bearing age who use acceptable contraceptives

          -  Participants who can understand features of clinical study and signed informed consent
             form

        Exclusion Criteria:

          -  Participants with psoriasis (scaly skin rash)

          -  Diabetic participants who take an anti-diabetic drug

          -  Pregnant or breast feeding female participants

          -  Participants with clinical evidence of arterial insufficiency or peripheral vascular
             disease and medical history of decreased ventricular function like congestive heart
             failure (heterogeneous condition in which the heart is unable to pump out sufficient
             blood to meet the metabolic need of the body)

          -  Participants who applied a topical antifungal agent (nail lacquer) on target nail
             within 1 month before the study medication administration and who took an oral
             antifungal agent within 3 month before the study medication administration
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.
Condition: Dermatitis, Chronic
MeSH terms: Dermatitis
Intervention: clobetasol propionate 0.05%; Vehicle / Placebo
Intervention description: 2 times a day, 14 total days study treatment; 2 times a day, 14 total days of study treatment
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how clobetasol proprionate foam works against a
      placebo foam in the treatment of hand dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of understanding and willing to provide signed informed consent

          -  Male or female at least 12 years of age at time of consent and at time of first dose.

          -  Able to complete the study and to comply with study instructions.

          -  Moderate to severe hand dermatitis.

          -  Chronic hand dermatitis diagnosis must be at least 6 months

        Exclusion Criteria:

          -  Female who is pregnant, trying to become pregnant, or breast feeding.

          -  Currently diagnosed with allergic contact dermatitis.

          -  Participated in a previous study of the same study product.

          -  Had any major illness within 30 days before the screening/baseline visit.

          -  Considered immunocompromised.

          -  Has a clinically relevant history of or current evidence of abuse of alcohol or other
             drugs.

          -  Considered unable or unlikely to attend the necessary visits.
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine; Placebo
Intervention description: Fesoterodine 4 mg and 8 mg; Placebo sham 4 mg and 8 mg
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 566.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Urgency Urinary Incontinence OAB

Summary:

      This study is designed to assess the efficacy and safety of a flexible dose regimen of
      fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects
      with overactive bladder (OAB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female subjects 65 years of age or older

          -  OAB symptoms for at least 3 months

          -  score 3 or greater on Vulnerable Elderly Survey (VES-13)

          -  adequate mobility for independent toileting

          -  mean number of at least 2 UUI episodes per 24 hours

          -  mean urinary frequency of 8 or more micturitions per 24 hours

          -  able to independently complete the bladder diaries

        Exclusion Criteria:

          -  PVR urinary volume greater than 200 ml

          -  MMSE score less than 20

          -  greater than 15 UUI episodes per 24 hours

          -  creatinine clearance less than 30 ml/min

          -  an average resting heart rate of greater than or equal to 90 beats per minute
Incretins in Impaired Fasting Glucose
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Intervention: Sitagliptin; Placebo
Intervention description: 100 mg once daily; once daily for duration of the study
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      People with high fasting glucose can develop type 2 diabetes with the passage of time. This
      study is being done to determine the effect of a novel medication in people with this
      elevated fasting glucose. Sitagliptin is a substance that raises levels of a hormone normally
      found in the blood. This hormone, called glucagon-like peptide-1 (GLP-1), is normally
      released by the intestine in response to the presence of food. This hormone acts like a
      messenger between the intestine and the pancreas to raise insulin levels, and therefore,
      lower blood sugars. Sitagliptin is effective in people with diabetes, however, this study is
      being done to determine if Sitagliptin is effective in people with high fasting glucose who
      do not yet have diabetes.
    

Eligibility criteria:

        Twenty four participants aged 35 to 70 years with impaired fasting glucose (100mg/dl-125
        mg/dl) will be studied.

        Inclusion Criteria:

          -  Males and females between the ages of 35-70.

          -  Good health as determined by past medical history,physical examination, vital signs,
             electrocardiogram and laboratory tests at the time of screening.

          -  Patients on diuretics or thyroid hormone therapy must be on a stable dose (at least 3
             months prior to screening) and the maintenance dose may not be adjusted during the
             study.

        Exclusion Criteria:

          -  Individuals with a body mass index less than 19 or greater than 40 kg/m^2, or a total
             weight > 130 kg, will be excluded from study.

          -  Subjects less than 35 years will not be studied in order to minimize the possibility
             of studying subjects with type 1 diabetes.

          -  No history of a) significant nephropathy, (i.e., plasma creatinine > 1.4 mg/dl in
             women and 1.5 mg/dl in men, and/or proteinuria); b) clinically significant
             atherosclerotic vascular disease (e.g., history of heart attack or angina); c) a known
             systemic illness.

          -  Pregnant or lactating females.