bioihbjkbjnl/mcl2 huggingface dataset:
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Condition: Methicillin Resistant Staphylococcus Aureus (MRSA)
MeSH terms: Pneumonia; Staphylococcal Infections; Healthcare-Associated Pneumonia
Intervention: linezolid (Zyvox); vancomycin
Intervention description: Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.; Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Intervention MeSH terms: Vancomycin; Linezolid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Staphylococcal pneumonia; Methicillin-resistant staphylococcal pneumonia; healthcare-associated pneumonia

Summary:

      To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired
      in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult
      subjects. Subjects entered in to the study will have proven healthcare-associated
      methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either
      linezolid or vancomycin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized male and female subjects with clinically documented nosocomial pneumonia
             proven to be due to methicillin-resistant staphylococcus aureus.

          -  Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the
             diagnosis of pneumonia.

          -  Suitable sputum specimen defined as having less than 10 squamous epithelial cells and
             greater or equal 25 leukocytes or have a culture taken by an invasive technique within
             24 hours of study entry.

        Exclusion Criteria:

          -  Subjects who were treated with a previous antibiotic with MRSA activity (other than
             linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment
             failure (72 hours of treatment and not responding).

          -  Subjects with severe neutropenia (<500 cells/mm3)

          -  Subjects with hypersensitivity to oxazolidinones or vancomycin.
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
Condition: Acute Liver Failure; Fulminant Hepatic Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
Intervention: N-acetylcysteine
Intervention description: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.
NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.
i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour
ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours
iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours
iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Open label-comparator is historical data.
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Liver disease

Summary:

      This proposed study is a multi-center open label study to determine if N-acetylcysteine has
      any survival benefits in patients with acute liver failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written Informed consent from patient's next of kin

          -  Altered mentation of any degree (encephalopathy)

          -  Evidence of moderately severe clotting abnormalities (international normalized ratio ≥
             1.5)

          -  A presumed acute illness onset of less than 26 weeks

          -  Admitted to study site hospital intensive care units with acute liver failure and who
             can be evaluated and started on treatment within the first 24 hours of hospitalization

          -  All subjects will be between 18 and 70 years

          -  The NIH guidelines on the inclusion of women and minorities as subjects will be
             observed

        Exclusion Criteria:

          -  Patients less than age 18 or over 70 years of age

          -  Acetaminophen or mushroom poisoning induced liver failure

          -  Patients with a diagnosis of shock liver (ischemic hepatopathy)

          -  Acute liver failure of pregnancy

          -  Acute liver failure thought secondary to intra-hepatic malignancy

          -  Cerebral herniation

          -  Intractable arterial hypotension

          -  Severe sepsis (temperature >39º C and/or significant bacteremia) present at the time
             of enrollment
Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
Condition: Chronic Obstructive Pulmonary Disease, COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Symbicort (budesonide/formoterol turbuhaler 320/9ug); Spiriva (tiotropium bromide 18ug)
Intervention description: Symbicort (budesonide/formoterol turbuhaler 320/9ug); Spiriva (tiotropium bromide 18ug)
Intervention MeSH terms: Budesonide; Bromides; Formoterol Fumarate; Tiotropium Bromide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 660.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to investigate the effect of combined treatment with Symbicort
      and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in
      patients with severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1
             <=50% of PN

        Exclusion Criteria:

          -  Current respiratory tract disorder other than COPD, history of asthma or rhinitis,
             significant or unstable cardiovascular disorder
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
Condition: Bariatric Surgery Candidate; Glucose Intolerance; Insulin Resistance
MeSH terms: Insulin Resistance; Glucose Intolerance
Intervention: Dexmedetomidine; 0.9% Sodium-chloride; Fentanyl; Morphine Sulfate
Intervention description: A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.; The same infusion rate used in the dexmedetomidine group.; Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).; Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Impaired Glucose Tolerance; Obese patients; Dexmedetomidine

Summary:

      This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patient (BMI>30)

          -  American Society of Anesthesiologists grades II or III

          -  Diagnosis of impaired glucose tolerance

          -  Undergoing sleeve gastrectomy

        Exclusion Criteria:

          -  Baseline glucose > 200mg/dl

          -  Diagnosis of Diabetes

          -  Under corticosteroids treatment

          -  Oral hypoglycemic medication within 7 days previous surgery

          -  Use of insulin within 24h previous surgery

          -  Allergy to any drug used in the study
Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)
Condition: Acne Vulgaris; Post Inflammatory Hyperpigmentation
MeSH terms: Acne Vulgaris; Hyperpigmentation
Intervention: Azelaic acid
Intervention description: Apply sparingly to the face twice a day (morning and night). Massage gently into the skin until vanishing. Approximately 0.5g (2.5cm strip) is sufficient for the entire facial area.
Intervention MeSH terms: Azelaic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with
      skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related
      to acne vulgaris. However, it has not been clinically tested for this purpose. The current
      study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris
      and PIH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 12 years of age

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             Baseline

          -  Fitzpatrick skin type IV to VI

          -  Acne IGA (Investigator Global Assessment) score of 2 or 3

          -  Inflammatory lesions of 15-60 (with no more than 2 nodules)

          -  Non-inflammatory lesions of 20-100

          -  Post Inflammatory Hyperpigmentation Investigator Global Assessment (PIH IGA) score of
             3,4 or 5

          -  Able to understand the requirements of the study and sign Informed Consent/HIPAA
             forms. Subjects under the legal age of consent must have the written informed consent
             of a parent or legal guardian

        Exclusion Criteria:

          -  Female subjects who are pregnant, breast-feeding or who are of childbearing potential
             and not practicing a reliable method of birth control

          -  Allergy or sensitivity to any component of the test medication

          -  Subjects who have not complied with the wash out periods for prohibited medications

          -  Medical condition that contraindicates participation

          -  Skin disease/disorder that might interfere with the diagnosis of acne vulgaris or PIH

          -  Evidence of recent alcohol or drug abuse

          -  History of poor cooperation, non-compliance or unreliability

          -  Exposure to an investigational drug study within 30 day of Baseline visit
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a; Ribavirin; Ribavirin
Intervention description: 180 µg subcutaneously weekly for 48 weeks; 800 mg orally daily for 48 weeks; 1000 mg or 1200 mg (based on patient weight of < 75 kg or ≥ 75 kg, respectively) orally daily for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study will compare the efficacy and safety of treatment with Pegasys (180 µg
      weekly) plus Copegus (800 mg daily) and Pegasys (180 µg weekly) plus Copegus (1000-1200 mg
      daily) in interferon-naive patients with CHC genotype 1 co-infected with HIV-1. Treatment
      will be administered for 48 weeks, and this will be followed by 24 treatment-free weeks. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥18 years of age

          -  CHC genotype 1

          -  Stable HIV-1 infection

        Exclusion Criteria:

          -  Previous treatment with an alpha interferon, ribavirin, viramidine, levovirin,
             amantadine or investigational HCV protease or polymerase inhibitors

          -  Medical condition associated with liver disease other than CHC infection
An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Risperidone long acting injectables; Risperidone tablets
Intervention description: Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.; Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Risperidone; Risperdal

Summary:

      The purpose of this study is to evaluate the efficacy and safety of long acting injectable
      (LAI) risperidone and oral risperidone treatment on participants with schizophrenia
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often
      with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder
      (a mixed psychiatric disorder relating to a complex psychotic state that has features of both
      schizophrenia and a mood disorder such as bipolar disorder).
    

Eligibility criteria:

        Inclusion Criteria: - Participants who will understand the objectives and necessary
        procedures of the study and have signed the informed consent form which specified that they
        were willing to participate in the study - Participants with schizophrenia or
        schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with
        pre-morbid global assessment of functioning score of 71 or higher at Screening -
        Participants who do not present clinically significant abnormality in biochemistry and
        electrocardiography - Participants who will be compliant with the study requirements (that
        is, filling in the questionnaire by themselves) and who are capable of actually performing
        and willing to implementing them

        Exclusion Criteria: - Participants who had taken clozapine for the past three months -
        Participants with mental retardation (Intelligence Quotient less than 70 at the screening)
        - Participants with history of or currently with a serious disease (cardiovascular,
        respiratory, neurological [including seizures or significant cerebrovascular], renal,
        hepatic, hematologic, endocrine, immunologic or other systemic disease) including
        clinically relevant abnormal level - Participants who have an allergic or hypersensitive
        reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating
        female participants
Tobacco and Socioeconomic Disadvantage
Condition: Tobacco Smoking
Intervention: Motivational Interviewing; Nicotine Replacement Therapy Sampling; Referral Only
Intervention description: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a written referral for tobacco dependence treatment.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial in which participants are randomized to one of three groups.
Masking: Single (Outcomes Assessor)
Masking description: The individual conducting the outcomes assessment is blind to study condition.
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco; smoking; cigarette

Summary:

      Randomized clinical trial comparing 3 brief interventions designed to increase motivation to
      quit smoking in socioeconomically disadvantaged smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be between the age of 19 and 65

          -  Participants must self-report being a daily smoker and provide biochemical
             verification of smoking status (expired breath carbon monoxide reading >5)

          -  Participants must be at socioeconomic disadvantage, defined as receiving services at a
             New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick
             Housing Authority-run public housing units or requesting social services from the
             community social service agency, "Elijah's Promise")

          -  Participants must be able to speak and read English.

        Exclusion Criteria:

          -  Participants may not be taking FDA approved smoking cessation or anti-psychotic
             medications

          -  Participants may not reported medical issues of potential concern to nicotine
             replacement users (e.g., unstable angina pectoris, myocardial infarction, or
             significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)

          -  Participants may not report pending legal issues with potential to result in
             incarceration.

          -  Participants may not be pregnant or nursing, planning on becoming pregnant in the next
             two months, and must be using effective birth control.
Assessing Pyridium for Post-Sling Urinary Retention
Condition: Urinary Retention
MeSH terms: Urinary Retention
Intervention: Phenazopyridine
Intervention description: to be given preoperatively
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Midurethral sling; Pyridium

Summary:

      There has been preliminary data showing that pyridium can decrease the risk of difficulty
      urinating after midurethral sling. This study is designed to have two groups of patients. One
      group will receive pyridium pre-operatively, while the other group will have routine
      preoperative care. Both groups will have their bladder tested prior to going home. It will be
      evaluated if there is a difference in the difficulty to urinate post-operatively in both
      groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any female patient undergoing a midurethral sling surgery, regardless of concomitant
             pelvic reconstructive or gynecological surgery

        Exclusion Criteria:

          -  Patients with complications from surgery requiring indwelling catheter,
             bladder/urethral perforation requiring indwelling catheter

          -  Acute bleeding requiring indwelling catheter for accurate urine output calculation

          -  Patients undergoing concomitant surgery other than gynecological, preoperative voiding
             dysfunction defined as postvoid residual >150cc, or spinal anesthesia

          -  Women who are pregnant, including women of childbearing age who test positive on
             preoperative urine pregnancy test
Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
Condition: Asthma
MeSH terms: Asthma
Intervention: Ciclesonide; Usual Care Inhaled Glucocorticosteroids
Intervention description: Asthma Care with Alvesco; Usual asthma care and dosage as chosen by the Primary Care Physician including inhaled steroid treatment
Intervention MeSH terms: Ciclesonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Alvesco®; Ciclesonide

Summary:

      The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide)
      compared with usual asthma care in the primary care setting. Patients with a history of
      asthma for at least 6 months and who, in the opinion of the physician, meet the clinical
      requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either
      receive Alvesco® or usual care.
    

Eligibility criteria:

        Main inclusion criteria:

          -  Written informed consent

          -  18 years or older with diagnosis of asthma for at least 6 months

          -  Clinically stable asthma at the time of study enrollment

          -  Clinical requirements for treatment with ICS as outlined in the Canadian Asthma
             Consensus Guidelines

          -  If patients are currently on ICS, the dose must be stable for 3 months and they must
             be willing to switch

        Main exclusion criteria:

          -  On combination therapy (ICS + long acting beta-2-agonist) for asthma in the past 3
             months or require combination therapy

          -  Severe asthma, one or more asthma exacerbations in the last 3 months requiring
             hospitalization or emergency room visit, or patients who have used systemic steroids
             more than 3 times in the past 6 months or who are currently using systemic steroids

          -  Mild asthma requiring short acting beta-2-agonists only

          -  Patients with a contraindication to ICS therapy

          -  Any other disease or medical condition requiring further clinical evaluation, which in
             the opinion of the Primary Care Practitioner may interfere with the clinical study or
             interfere with the diagnosis of asthma.

          -  Pregnancy, breast feeding, intention to become pregnant during the course of the study
             or lack of safe contraception in pre-menopausal women