bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Condition: Chronic Hepatitis; Chronic Hepatitis C; Chronic Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Hepatitis, Alcoholic
Intervention: High dose vitamin C
Intervention description: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Intervention MeSH terms: Vitamins; Ascorbic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis
      patients whose serum liver enzymes are elevated more than upper limit.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic hepatitis C patients

               -  positive anti-HCV antibody more than 6 months

               -  serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

               -  not indicated for antiviral therapy with interferon and ribavirin

          2. Chronic alcoholic hepatitis

               -  significant alcohol drinking history and no other cause of chronic hepatitis

               -  serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

        Exclusion Criteria:

          -  Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's
             disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or
             alcoholic hepatitis

          -  decompensated liver cirrhosis

          -  platelet < 50,000/uL or white blood cell < 1,500/uL

          -  need and willing for antiviral therapy

          -  significant renal dysfunction (GFR < 30 mL/min/kg) or history of renal stone

          -  hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks

          -  pregnancy, lactating woman
A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Pharmacist based QI program; Usual Care
Intervention description: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.; Patients in the control arm will continue to receive "usual care" from their VA providers.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2199.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality
      improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2)
      adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based
      quality improvement program for patients with CKD and assess potential mechanisms for the
      intervention's effect.

      Hypothesis: Implementing a CCM based quality improvement program including system level
      support in the form of collaborative care, a CKD registry, and provider education will 1)
      reduce systolic BP in patients with poorly controlled hypertension, 2) increase the
      percentage of patients appropriately monitored for metabolic complications, and 3) decrease
      the rate of catheter use in patients initiating dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  receipt of primary care at a VISN 10 Northeast Ohio CBOC

          -  GFR (calculated according to the 4 variable Modification of Diet in Renal Disease
             study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least
             90 to 730 days prior to the index GFR (26); and

          -  at least one primary care visit in the year prior to study initiation.

        Exclusion Criteria:

          -  ESRD as defined by chronic renal replacement therapy,

          -  receipt of a renal transplant,

          -  hospice care, and

          -  age greater than 85 years or less than 18 years at the time of study initiation.
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Condition: Asthma
MeSH terms: Asthma
Intervention: Dulera
Intervention description: Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adherence monitoring; Motivational Interviewing Adherence strategies

Summary:

      40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20,
      will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3
      months. These intervention subjects will receive medication use feedback at each visit, while
      the control group will receive the standard of asthma care. Those interventional subjects
      with Dulera adherence<60% will receive feedback based on an asthma adherence disease
      management model protocol, Asthma Adherence Pathway. Intervention clinicians will been
      trained in Motivational Interviewing to reduce subject ambivalence about medication use. The
      primary hypothesis is that subjects who receive medication monitoring and Motivational
      Interviewing adherence strategies will have better asthma control, as measured by the Asthma
      Control Questionnaire, than the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Physician diagnosis of asthma of moderate severity

          2. Subjects ≥ 18 years of age

          3. Currently receiving an inhaled corticosteroid medication and being prescribed Dulera
             100/5 as part of standard of care based upon asthma severity and dosing guidelines

          4. Asthma Control Questionnaire (ACQ) result > 1.0 at entry

          5. Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)

          6. History of reversible airway obstruction documented by treating physician Exclusion
             Criteria: intermittent asthma; emphysema, chronic obstructive pulmonary disease;
             chronic bronchitis; cystic fibrosis; medication that may have a drug interaction with
             Dulera

        Exclusion Criteria

          1. Intermittent asthma (asthma exacerbations or symptoms < 3 days/week)

          2. Diagnosis of emphysema in prior year

          3. Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic
             bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis,
             pulmonary hypertension or lung cancer

          4. On any medication documented to have a drug interaction with Dulera
Anti-HIV Medications for People Recently Infected With HIV
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Highly active antiretroviral therapy (HAART)
Intervention description: Regimens will be assigned by investigators
Intervention MeSH terms: Anti-Retroviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Acute/Early Seroconverters; Acute Infection; Treatment Naive; Primary HIV Infection

Summary:

      It is not known if anti-HIV treatment for recently infected patients improves long-term
      patient prognosis. The purpose of this study is to determine if a one year course of anti-HIV
      medications slows progression of HIV disease in adults recently infected with HIV.

      Study hypothesis: A one-year course of HAART administered during acute or early
      seroconversion may slow the progression of HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented acute or recent HIV infection (infected in the past 12 months) as defined
             in the study protocol

          -  Antiretroviral naive. Participants who have taken antiretrovirals for postexposure
             prophylaxis are eligible for this study.

          -  Able to swallow tablets or capsules

          -  Willing to use acceptable forms of contraception

        Exclusion Criteria:

          -  Physician unable to design a potentially effective HAART regimen based on results of
             genotypic resistance testing

          -  Two CD4 counts of less than 350 cells/mm3 obtained at least 7 days apart within 30
             days of study entry

          -  Viral load less than 5,000 copies/ml within 30 days of study entry in participants who
             have been infected with HIV-1 for more than six months prior to study entry

          -  Use of systemic cancer chemotherapy, systemic investigational agents, specific
             antiretroviral medications, or immunomodulators (growth factors, systemic
             corticosteroids, HIV vaccines, immune globulin, interleukins, interferons) within 30
             days prior to study entry

          -  Current alcohol or drug use that, in the opinion of the investigator, would interfere
             with the study

          -  Serious illness requiring systemic treatment or hospitalization until participant
             either completes therapy or is clinically stable on therapy for at least 7 days prior
             to study entry

          -  Currently involuntarily incarcerated for treatment of either a psychiatric or physical
             (e.g., infectious disease) illness

          -  Pregnancy or breastfeeding
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab; Adalimumab; Placebo to tocilizumab; Placebo to adalimumab
Intervention description: The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Intervention MeSH terms: Adalimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab
      (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis
      who are intolerant of methotrexate or where continued treatment with methotrexate was
      considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg
      intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or
      adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to
      last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of
      the treatment administration, but the investigator and the patient remained blinded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Rheumatoid arthritis of > 6 months duration.

          -  Intolerant of methotrexate or continued treatment with methotrexate is considered
             inappropriate.

          -  All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to
             receiving study drug.

          -  Weight ≤ 150 kg.

        Exclusion Criteria:

          -  Major surgery (including joint surgery) within 12 weeks prior to baseline or planned
             major surgery within 6 months after baseline.

          -  History of or current inflammatory joint disease other than rheumatoid arthritis (RA).

          -  Treatment with a biologic agent at any time prior to baseline.

          -  Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.

          -  Active current infection or history of recurrent bacterial, viral, fungal or
             mycobacterial infection.
Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Condition: Multiple Sclerosis; Urinary Bladder Diseases
MeSH terms: Multiple Sclerosis; Urinary Bladder Diseases; Sclerosis
Intervention: Systematic Screening and Education Regimen
Intervention description: Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the impact of a systematic bladder health screening and disease
      education regimen as well as the implementation of a referral process on the quality of life
      of multiple sclerosis patients with bladder dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by
             study doctor

        Exclusion Criteria:

          -  Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing
             multiple sclerosis
Insulin Glulisine in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Glimepiride; Insulin Glulisine; Metformin
Intervention description: One daily injection at bedtime; At same dosage as during the run-in period; One bolus given before the main meal; At same dosage as during the run-in period
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of a single injection of glulisine before the main meal added to
      insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs
      in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus, Type 2

          -  25 < BMI < 45 kg/m²

          -  7,5% < HbA1c < 9%

          -  Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir),
             and at least 1g metformin daily, for more than 3 months

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Treatment with OADs only

          -  Treatment with thiazolidinediones, with exenatide or with pramlintide

          -  Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting
             insulin analogue)

          -  Active proliferative diabetic retinopathy,

          -  Pregnancy (women of childbearing potential must have a negative pregnancy test at
             study entry and effective contraception)

          -  Breast-feeding

          -  History of hypersensitivity to the study drugs or to drugs with a similar chemical
             structure.

          -  Treatment with systemic corticosteroids in the 3 months prior to study entry

          -  Treatment with any investigational product in the 2 months prior to study entry

          -  Previous treatment with insulin glulisine

          -  Likelihood of requiring treatment during the study period with drugs not permitted by
             the clinical study protocol

          -  Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major
             disease making implementation of the protocol or interpretation of the study results
             difficult

          -  Impaired hepatic function

          -  Impaired renal function

          -  History of drug or alcohol abuse

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Escitalopram
Intervention description: Once daily by mouth
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: women; postpartum depression; anxiety

Summary:

      The purpose of this study is to determine whether women with postpartum major depressive
      disorder (MDD) will experience a significant decrease in depressive symptoms from baseline
      over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine
      whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ages 18 to 45 years old

          -  Subjects must meet criteria for a major depressive episode with symptoms developing
             within three month of live childbirth

          -  Subjects must present within six months of childbirth

          -  MADRS score >15

          -  BAI score >10

          -  Subjects will be able to be treated on an outpatient basis

          -  Subjects will be able to provide written informed consent

        Exclusion Criteria:

          -  Subjects who have taken any psychotropic medication, including antidepressants and
             anti-anxiety medication, within the past two weeks (with the exception of
             non-benzodiazepine medications used for sleep, including trazodone, zolpidem,
             eszopiclone, etc)

          -  Suicidal ideation with active plan or intent, as determined by the investigator

          -  Presence of psychotic symptoms or homicidal ideation

          -  History of mania or hypomania

          -  Pregnant or breastfeeding

          -  Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety
             disorders, as determined by investigator

          -  Active alcohol/substance abuse currently or within the past year

          -  Abnormal TSH, severe anemia, or uncontrolled hypertension
Preventing Cardiovascular collaPse With Administration of Fluid Resuscitation Before Endotracheal Intubation
Condition: Acute Respiratory Failure; Intubation Complication
MeSH terms: Respiratory Insufficiency; Shock
Intervention: intravenous crystalloid fluid, 500 mL
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 337.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Endotracheal intubation is common in the care of critically ill patients. Complications of
      airway management in this setting are frequently encountered and may be associated with an
      increased risk of death. The prevention of complications during urgent and emergent
      endotracheal intubation is a key focus for airway management research. Post-intubation
      hypotension (PIH), a common complication of endotracheal intubation in the critically ill,
      may be prevented by a bolus of intravenous fluid prior to the start of the procedure, but
      this approach has not been examined in a prospective trial. There are no randomized trials of
      intravenous fluid administration to prevent PIH in critically ill adults. The investigators
      propose a randomized trial of fluid loading to prevent PIH in critically ill adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is admitted to participating study unit

          -  Planned procedure is endotracheal intubation and planned operator is a provider
             expected to routinely perform endotracheal intubation in the participating unit

          -  Administration of sedation with or without neuromuscular blockade is planned

          -  Age ≥ 18 years old

        Exclusion Criteria:

          -  Operator believes fluid loading to be absolutely indicated or contraindicated for the
             safe care of the patient

          -  Urgency of intubation precludes safe performance of study procedures

          -  Pregnancy

          -  Prisoners

          -  Age < 18 years old