bioihbjkbjnl/mcl2 huggingface dataset:
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Condition: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Erlotinib; Pemetrexed; Erlotinib
Intervention description: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity; 150 mg given orally (po), daily (QD), starting on the first day of the first cycle; 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity; 150 mg given po, QD, starting on the first day of the first cycle
Intervention MeSH terms: Pemetrexed; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nonsquamous

Summary:

      This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect
      of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line
      setting (such as progression-free survival [PFS], disease control rate, best response rate,
      time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared
      to pemetrexed plus erlotinib combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is
             of nonsquamous histology and not amenable to curative therapy.

          -  Failure of previous treatment with one prior platinum-based chemotherapy regimen.

          -  Good performance status.

          -  Adequate bone marrow reserve, renal and hepatic functions.

        Exclusion Criteria:

          -  Serious concomitant systemic disease.

          -  Inability to take oral medication.

          -  Inability or unwillingness to take vitamin supplementation and corticosteroids.

          -  Pregnancy / Breast-feeding.

          -  Treatment with certain medicines that prevent blood from clotting.
Burn Healing and Analgesia With Propranolol
Condition: Burns; Pain
MeSH terms: Burns
Intervention: Propranolol; Placebo; Propanolol
Intervention description: 40 mg; sugar pill; 120 mg twice per day
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No
Keywords: Burns; Pain

Summary:

      The purpose of this study is to investigate the ability of propranolol to decrease pain and
      improve recovery in burn patients with a common genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Thermal burn

          -  Greater than or equal to 18 years of age

          -  Less than 60 years of age

          -  Able to speak and read English

        Exclusion Criteria:

          -  Intubated

          -  Clinically unstable

          -  Other substantial comorbid injury (e.g. long bone fracture)

          -  Heart block greater than first degree (EKG)

          -  History of coronary artery disease

          -  History of congestive heart failure

          -  Asthma (within past 10 years, induced by a beta-blocker, or receiving current
             treatment)

          -  Pregnant

          -  Prisoner

          -  Psychotic, suicidal, or homicidal

          -  Diabetic

          -  Hepatic failure (acute or chronic)

          -  Renal failure (acute or chronic)

          -  History of hyperthyroidism unless taking synthroid or other thyroid hormone
             replacement

          -  Exceeds daily acceptable chronic opioid use prior to burn

          -  Interacting medication

          -  Received propranolol within the last 6 months

          -  Multiple severe allergic reactions

          -  On daily methylphenidate or similar stimulant medication

          -  Unwilling to use medically acceptable birth control (if childbearing potential)

          -  Breastfeeding

          -  Severe peripheral vascular disease or vasospastic disorder

          -  Bradycardia that in the opinion of the investigator would constitute too great a risk
             when considered in the context of the patient's medical comorbidities and health
             history

          -  Other criteria that in investigator's opinion makes participant poor candidate for the
             trial

          -  Cancer (except basal cell cancer)
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Cariprazine; Risperidone
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied in capsules; Risperidone was supplied in capsules
Intervention MeSH terms: Risperidone; Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 732.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188)
      relative to placebo in adult patients (18-60 years of age) with acute exacerbation of
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 60 years of age.

          -  Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
             criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or
             undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).

          -  Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.

          -  Diagnosis of schizophrenia for at least 1 year.

        Exclusion Criteria:

          -  Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or
             clinical laboratory values.

          -  First episode of psychosis.
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Condition: Pandemic; Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: MF59-eH5N1; eTIV_a; MF59-eH5N1 + eTIV_a
Intervention MeSH terms: MF59 oil emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bird flu; influenza vaccine; Seasonal influenza vaccine; Prepandemic vaccine

Summary:

      This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a
      seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007
      influenza season in the Southern Hemisphere.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects
A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
Condition: Alzheimer Disease (AD)
MeSH terms: Alzheimer Disease
Intervention: Zagotenemab; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Memory problems; Cognitive impairment; PERISCOPE-ALZ; Dementia; Tauopathy; Neurofibrillary tangles

Summary:

      The purpose of this study is to evaluate the safety and efficacy of a study drug that targets
      an abnormal protein in the brain found in people with Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have gradual and progressive change in memory function for >6
             months.

          -  Participants must have a family member or close friend who is with you at least 10
             hours per week and can attend study appointments.

        Exclusion Criteria:

          -  Participants must not have significant neurological disease affecting the nervous
             system, other than AD, that affects cognition or may affect completion of the study.

          -  Participants must not have serious or unstable illness that could interfere with the
             analysis of the study or has a life expectancy <24 months.

          -  Participants must not have history of cancer within the last 5 years with the
             exception of certain types of skin, cervical, prostate, and other cancers that are not
             likely to recur or spread.

          -  Participants must not have serious risk for suicide.

          -  Participants must not have history of drug or alcohol use disorder within the last 2
             years.

          -  Participants must not have multiple severe drug allergies

          -  Participants must not have HIV, Hepatitis B or Hepatitis C

          -  Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin
             (IVIG) therapy
Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Condition: Cancer; Head and Neck Cancer; Oncology; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Panitumumab; Cisplatin
Intervention description: Arm 2 consists of panitmumab plus RT; Cisplatin
Intervention MeSH terms: Cisplatin; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: head and neck; squamous cell carcinoma; radiotherapy; chemoradiotherapy; panitumumab; locally advanced head & neck cancer; EGFr; epidermal growth factor receptor; SCCHN; locally advanced SCCHN; HNC; epidermal growth factor

Summary:

      The purpose of this study is to estimate, with pre-specified precision, the difference in
      local-regional control (LRC) rate at 2 years in subjects receiving chemoradiotherapy (CRT) or
      panitumumab plus radiotherapy (PRT) as first line treatment for locally advanced squamous
      cell carcinoma for the head and neck (SCCHN). A formal hypothesis will not be tested in this
      trial; however, the treatment arm difference in LRC rates at 2 years will be estimated.
    

Eligibility criteria:

        Inclusion Criteria:

        Histologically or cytologically confirmed SCC of the oral cavity, oropharynx, hypopharynx
        or larynx Stage III or Stage IVa-b (M0) disease according to the American Joint Committee
        on Cancer staging manual 6th edition (locally advanced) ECOG performance status of 0 or 1
        Bidimensionally measurable disease >/= 10 mm in at least 1 dimension

        Exclusion Criteria:

        NO Primary tumor of the nasopharynx, sinuses, salivary gland, or skin NO Subjects requiring
        prophylactic tracheostomy NO Prior (or concomitant) malignancy (except non-melanomatous
        skin cancer or in situ cervical cancer), other than the study disease (SCCHN), unless
        treated with curative intent with no evidence of disease for >/= 3 years NO Prior treatment
        for locally advanced SSCHN NO Prior surgery for SCCHN (except nodal sampling or biopsy for
        study disease) NO Major surgery </= 28 days before randomization or minor surgery </= 14
        days before randomization with the exception of feeding tube placement, dental extractions,
        central venous catheter placement, biopsies and nodal sampling
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer; Locally Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Bevacizumab
Intervention description: Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.; Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event [AE], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.)
Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
Intervention MeSH terms: Bevacizumab; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Neoplasm

Summary:

      To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in
      patients with advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be female and greater than or equal to 18 yrs of age

          -  Participants must have confirmed cancer with measurable or evaluable, locally
             recurrent or metastatic disease.

          -  Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy

          -  Participants may have received prior hormone therapy for locally recurrent or
             metastatic disease

        Exclusion Criteria:

          -  Participants with breast cancer overexpressing Human Epidermal growth factor Receptor
             2 (HER2) gene amplification

          -  Prior chemotherapy or targeted therapy for metastatic breast cancer

          -  Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting

          -  History of, or active brain mets

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to treatment, or anticipation of need for major surgical procedure during course
             of study

          -  Prior history of high blood pressure crisis

          -  Have a serious, nonhealing wound, ulcer, or bone fracture
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Inactive Marijuana (0% THC); Active Marijuana (5.5% THC); Active Marijuana (6.2% THC); Naltrexone; Placebo naltrexone
Intervention description: Marijuana cigarette containing 0% THC; Marijuana cigarette containing 5.5% THC; Marijuana cigarette containing 6.2% THC; Naltrexone (12mg/70kg); Naltrexone (0mg)
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind, placebo-controlled
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: naltrexone; smoked marijuana; marijuana use

Summary:

      In heavy marijuana smokers, opioid receptor blockade increases the subjective and
      cardiovascular effects of marijuana. The current study was designed to clarify
      opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function
      for marijuana-elicited effects in heavy marijuana smokers. For this within-subject,
      double-blind study, a marijuana smoking procedure was designed to characterize a
      dose-response relationship for marijuana's subjective and cardiovascular effects under
      blinded conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use

          -  Able to perform study procedures

          -  Women practicing an effective form of birth control

        Exclusion Criteria:

          -  Current repeated illicit drug use (other than marijuana)

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular
             disease,hypertension, hepatitis, clinically significant laboratory abnormalities, LFTs
             > 3x upper limit of normal, blood pressure > 140/90
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Capecitabine [Xeloda]; Oxaliplatin; Trastuzumab [Herceptin]
Intervention description: 1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles; 130 mg/m2 intravenous infusion day 1 of every cycle; First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Intervention MeSH terms: Capecitabine; Oxaliplatin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the disease free survival rate of a combination of capecitabine
      [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable
      gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and
      Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle)
      will be administered for three cycles prior to surgery to resect the tumor. If complete
      resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three
      cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin
      alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in
      every cycle. The anticipated time on study drug will be 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients over 18 years of age

          -  Locally advanced resectable HER2-positive gastric or esophagogastric junction
             adenocarcinoma (Sievert types I, II, III)

          -  Measurable (RECIST criteria) or assessable disease

          -  ECOG performance 0-2

          -  Life expectancy of 12 weeks or more

        Exclusion Criteria:

          -  Immeasurable lesion as the only evidence of disease

          -  Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous
             surgical resection of the tumor (except diagnostic laparoscopy)

          -  Concomitant heart disease
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
Condition: Advanced Cancer
MeSH terms: Body Weight
Intervention: Remeron (mirtazapine)
Intervention description: Mirtazapine 15 mg orally at bed time. Patients with a creatinine clearance < 50% or a bilirubin or transaminases > twice the upper limit of normal will take a 7.5 mg dose.
Drug Administration: Drug will be administered orally, every day for a period of 8 weeks
Dose modifications: None
Intervention MeSH terms: Mirtazapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced cancer; weight loss; Remeron; body weight

Summary:

      The purpose of this study is to find out if remeron, also called mirtazapine, can help you
      prevent weight loss while on treatment for your cancer. Remeron is currently used to treat
      depression and has not been approved by the Food and Drug Administration for use to treat
      weight loss.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients, 18 years of age or older, with advanced cancer are eligible.

          2. Patients must have lost 10% in the last 6 months

          3. Patients must have a life expectancy of at least 12 weeks.

          4. Patients must have a Zubrod performance status of 0-3.

          5. Patients must sign an informed consent.

        Exclusion Criteria:

          1. Patients with symptomatic brain metastases are excluded from this study.

          2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child
             bearing potential must use adequate contraception.

          3. Patients with severe medical problems such as uncontrolled diabetes mellitus or
             cardiovascular disease or active infections are not eligible for this trial.

          4. Patients with head and neck cancers and GI cancers who have functional problems that
             limits food intake or absorption of nutrients such as partial or complete bowel
             obstructions, and patients with skin cancers (except melanoma) are not eligible

          5. Patients who lost weight on a voluntary diet.

          6. Patients who are already taking an appetite stimulant or other anti-depressant, except
             for SSRI taken in the morning.

          7. Patients who had surgery in the last 6 months
Employment-Based Depot Naltrexone Clinical Trial
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: employment-based reinforcement
Intervention description: Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opiate dependence; naltrexone; reinforcement; behavior therapy; cocaine dependence; risk reduction behavior

Summary:

      The purpose of this study is to determine whether employment-based naltrexone treatment
      proves effective in promoting depot naltrexone adherence and drug abstinence.
    

Eligibility criteria:

        Individuals were eligible if they:

          -  met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV)
             criteria for opioid dependence,

          -  reported using heroin on at least 21 of the last 30 days while in community,

          -  were unemployed,

          -  were aged 18-65 years,

          -  were medically approved for naltrexone

          -  lived in or near Baltimore, MD.

        Individuals were excluded if they

          -  had current DSM-IV major Axis I disorders,

          -  had current suicidal or homicidal ideation,

          -  expressed interest in methadone treatment,

          -  were required to use opioids for medical purposes,

          -  earned more than $200 in taxable income over the previous 30 days,

          -  had physical limitations that would prevent them from using a keyboard,

          -  were pregnant or breastfeeding,

          -  had serum aminotransferase levels more than three times over normal.