bioihbjkbjnl/mcl2 huggingface dataset:
Nutrition and Pharmacological Algorithm for Oncology Patients Study
Condition: Oncologic Complications; Quality of Life; Nutrition Poor; Head and Neck Cancer; Lung Cancer; Pancreatic Cancer
MeSH terms: Malnutrition
Intervention: Dexamethasone; Dronabinol; Mirtazapine; Nutrition Intervention
Intervention description: If the patient's prognosis is extremely poor (less than 12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning.; If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (which is FDA approved) 2.5mg, twice daily before meals.; If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.; Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve "purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status
Intervention MeSH terms: Dexamethasone; Dronabinol; Mirtazapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Loss of appetite is a common symptom of patients with cancer and can cause distress which
      impacts patients and caregivers. Patients diagnosed with head/neck, lung or pancreatic cancer
      will be recruited for this study to decrease the suffering and distress associated with
      eating during cancer treatment and improve the quality of life of patients by implementing an
      algorithm utilizing nutrition intervention and appetite stimulants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a diagnosis of head/neck, lung, pancreatic cancer, or metastatic cancer
             from any solid tumor

          2. Planned, ongoing, or recently treated patient (within the past 30 days) with
             chemotherapy, immunotherapy, and/or intravenous targeted biologic therapy

          3. No previous use of appetite stimulants

          4. All patients must sign study specific informed consent prior to being included in the
             study

          5. No contraindication to appetite stimulants

        Exclusion Criteria:

          1. Patient <18 years old

          2. Contraindication to appetite stimulants
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
Condition: Irritable Bowel Syndrome; Generalized Anxiety Disorder
MeSH terms: Irritable Bowel Syndrome; Syndrome; Anxiety Disorders
Intervention: Duloxetine
Intervention description: All subjects will receive single-blind placebo for the first two weeks, and then duloxetine for the next 12 weeks, followed by an up to 2 week taper off of the duloxetine. After 2 weeks of placebo daily, subjects will receive 30 mg per day of duloxetine for two weeks, then titrated up to 60 mg per day of duloxetine at week 2. A dosage decrease to 30 mg daily is permittable after week 2. This will be a flexible dose study with doses of duloxetine progressively increasing at weeks 4 (90 mg daily) and 6 (120 mg daily) in conjunction with CGI-I scores, to reach 120 mg daily or the maximum tolerated dose, if less than 120 mg daily at Week 12. There will be a post-taper follow up appointment at Week 14. Of Note: Amendment IRB Approved 6/14/11 Study Ending at Week 12 with removal of Week 14 visit as part of study.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: IBS; Irritable Bowel Syndrome; GAD; Generalized Anxiety Disorder

Summary:

      The investigators propose to evaluate the effectiveness of duloxetine in treating subjects
      with both Irritable Bowel Syndrome (IBS) and Generalized Anxiety Disorder (GAD). The
      investigators hypothesize that duloxetine as a single therapeutic agent will effectively
      target pain and other core symptoms of IBS as well as GAD in this patient population with
      both conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years of age

          -  Active IBS diagnosis by a gastroenterologist

          -  Generalized Anxiety Disorder diagnosed by DSM-IV TR criteria and the Mini
             International Neuropsychiatric Interview for the DSM-IV (Mini)

          -  No changes in any non study medication once starting the study

        Exclusion Criteria:

          -  Current diagnoses of Major Depressive Disorder, Panic Disorder, Social Phobia, Post
             Traumatic Stress Disorder, Obsessive Compulsive Disorders, Eating Disorders,
             Somatoform Disorders, Drug or alcohol abuse or dependence, or severe personality
             disorder

          -  Lifetime history of any Bipolar Disorder or Psychotic Disorder

          -  Concurrent GI disorders falling outside of Rome III Functional GI disorders

          -  Pregnant women or sexually active female subjects not using medically acceptable
             method of contraception

          -  Current suicidal ideation

          -  Unstable medical condition
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: lumbar decompression
Intervention description: The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal Stenosis; Lumbar Spinal Stenosis

Summary:

      This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar
      Decompression with the Mild® devices in patients with symptomatic central canal spinal
      stenosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element
             hypertrophy.

          -  Prior failure of conservative therapy and Oswestry Disability Index (ODI) score > 20%.

          -  Radiologic evidence of lumbar spinal stenosis (LSS), ligamentum flavum hypertrophy
             (typically > 2.5 mm), confirmed by pre-op MRI and/or CT.

          -  Central canal cross sectional area clearly reduced per MRI/CT report.

          -  If present, anterior listhesis preferred ≤ 5.0mm and deemed stable by Investigator.

          -  Able to walk at least 10 feet unaided before being limited by pain.

          -  Available to complete 26 weeks of follow-up.

          -  A signed Informed Consent Form is obtained from the patient.

          -  Adults at least 18 years of age.

        Exclusion Criteria:

          -  Prior surgery at intended treatment level.

          -  Compound fracture with interspinal retropulsion contributing to spinal stenosis.

          -  Disabling back or leg pain from causes other than LSS (e.g. acute compression
             fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).

          -  Disc protrusion or osteophyte formation severe enough to confound study outcome.

          -  Facet hypertrophy severe enough to confound study outcome.

          -  Bleeding disorders and/or current use of anti-coagulants.

          -  Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID)
             within 5 days of treatment.

          -  Epidural steroid administration within prior three weeks (of procedure).

          -  Inability of the patient to lie prone for any reason with anesthesia support
             (e.g.chronic obstructive pulmonary disease (COPD), obesity, etc.).

          -  Metabolic wound healing pathologies deemed by Investigator to compromise study
             outcomes.

          -  Dementia and/or inability to give informed consent.

          -  Pregnant and/or breastfeeding.

          -  On Workman's Compensation or considering litigation associated with back pain.
Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Condition: AIDS
Intervention: Maraviroc; Vardenafil; Maraviroc; Placebo
Intervention description: Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.; Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
Intervention MeSH terms: Maraviroc; Vardenafil Dihydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacodynamics. maraviroc, vardenafil, blood pressure

Summary:

      The objective of this study was to estimate the effects of a single dose of vardenafil on the
      blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to
      assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects. no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and pulse rate
             measurement, 12-lead electrocardiogram and clinical laboratory tests.

          -  Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
             (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease.

          -  Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP
             of greater than 90 mm Hg, either at Screening or at the predose measurements.
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Condition: Acute Back Strain
MeSH terms: Sprains and Strains
Intervention: FLECTORÂ® Patch (diclofenac epolamine topical patch) 1.3%
Intervention description: One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FLECTORÂ® Patch; acute back strain

Summary:

      Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been
      studied extensively in the setting of acute back strain. This study is being conducted as an
      initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In
      particular, this study is expected to provide information about the amount of improvement in
      back strain among subjects using the FLECTOR Patch, which may then be used to inform
      subsequent studies.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants in the study must:

          1. have acute, non-radicular back strain with onset up to 10 days before the first visit

          2. have intact, non-damaged skin at the proposed patch application site

          3. be untreated or unresponsive to conservative pain treatment regimens and/or opioids

          4. have a minimum pain intensity score of four (4) or more on a scale of 1-10 (a rating
             of zero (0) being "no pain" and a rating of ten (10) being "pain as bad as you can
             imagine")

          5. have a normal neurologic examination

        Exclusion Criteria:

        Participants may not be in the study if they:

          1. have had surgery or other chronic pain condition within 3 months before first
             treatment

          2. have back pain radiating below the knee at time of enrollment

          3. have neuropathic pain or have been treated with gabapentin or pregabalin for
             neuropathy

          4. are being treated for or are known to currently have kidney or liver disease

          5. have certain other diseases or are using certain types of other drugs.
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg daily orally
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib)
      in patients with locally advanced or metastatic non-small cell lung cancer with epidermal
      growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg
      daily orally until disease progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR
             mutations

          -  Measurable disease according to RECIST criteria

          -  ECOG performance status 0-2

          -  Adequate haematological, renal and liver function

        Exclusion Criteria:

          -  Previous chemotherapy or therapy against EGFR for metastatic disease

          -  History of another malignancy, except for in situ carcinoma of the cervix, adequately
             treated basal cell skin carcinoma, or radically treated prostate carcinoma with good
             prognosis

          -  Symptomatic cerebral metastases

          -  Pre-existing parenchymal lung disease such as pulmonary fibrosis

          -  Concomitant use of coumarins
Safety Study of Levocetirizine and Fexofenadine
Condition: Pruritus; Chronic Urticaria; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Pruritus; Urticaria; Chronic Urticaria
Intervention: Levocetirizine Oral Tablet; Fexofenadine 60 Mg Oral Tablet; Placebo Oral Tablet
Intervention MeSH terms: Fexofenadine; Levocetirizine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once
      daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch
      Response.
    

Eligibility criteria:

        Inclusion Criteria:

        Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin,
        will be recruited for this study

        Exclusion Criteria:

          -  None of the subjects will have taken oral antihistamines, antidepressants,
             antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids
             or mast cell stabilizers to the skin for 2 weeks prior to testing.

          -  No subject shall perform physical exercise for 4 hours prior to the skin prick
             testing.

          -  Especially, Bronchial asthma, anaphylactic reactions in the history, use of
             beta-blockers, skin diseases in the test field are exclusion criteria.
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Condition: Drug Induced Liver Injury
MeSH terms: Chemical and Drug Induced Liver Injury
Intervention: acetaminophen
Intervention description: 4 g/day for 10 consecutive days
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: acetaminophen; protein adducts; hepatic function; drug safety; non drinkers

Summary:

      Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by
      processing it in the liver. During the processing, some of the acetaminophen may bind to
      proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large
      acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of
      adducts are formed. However, we have found that lower levels may be formed even when people
      take recommended doses. The purpose of this study is to measure the amount of adducts formed
      when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age 21 years or older

          2. provide written informed consent

          3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months
             and would be considered non-drinkers

        Exclusion Criteria:

          1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days
             preceding study enrollment

          2. Currently taking isoniazid

          3. Consumption of any alcoholic beverage during the run-in period

          4. A detectable serum acetaminophen at baseline

          5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels
             greater than 50 IU/L at the start of the run-in period or at baseline

          6. Platelet count less than 125,000/cc at baseline

          7. Positive pregnancy test at baseline (female participants only)

          8. Currently adheres to a fasting type diet as determined by self report

          9. Currently has anorexia nervosa as determined by self report

         10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give
             informed consent for any reason

         11. Known hypersensitivity to acetaminophen
Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: PEG-3350 and Gatorade; Golytely 4 liters
Intervention description: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.; Golytely 4 liters
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PEG-3350, polyethylene glycol, colonoscopy

Summary:

      A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for
      colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets
      Phosphosoda) are now used on a limited basis because of their known association with renal
      injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely)
      has been used for over two decades for colon cleansing. The mixture is not very palatable due
      to the electrolyte additives which include sodium sulfate.

      To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons
      worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not
      mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade.
      Conservatively, we estimate that 25% of colonoscopies in the US are being done with this
      prep. Anecdotally there have been reports (case series) that it is far more palatable and the
      prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is
      not surprising. The issue at present is that there has never been a blinded study to confirm
      these claims.

      This study will compare the efficacy of the two preps. There is no funding. The investigators
      will charge insurance companies for the prep - this is our current practice. The procedures
      will be done on healthy individuals referred for colon cancer screening and the exam will be
      billed to their insurance. There will be no patient honorarium. The investigators will check
      electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.
    

Eligibility criteria:

        Inclusion Criteria:

        All adults undergoing average risk colon cancer screening (ages 40-75 years old)

        •Able to provide informed consent

        Exclusion Criteria:

          -  A history of constipation

          -  Patients who use medications to assist with a bowel movement such as osmotic,
             stimulant, or cathartic laxatives (including "colon cleansers")

          -  Diabetes or glucose intolerance

          -  Patients with severe underlying renal or hepatic impairment

          -  Pregnant women - pregnancy test performed on all menstruating women before procedure.