bioihbjkbjnl/mcl2 huggingface dataset:
Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cetuximab
Intervention description: Given intravenously once per week.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cetuximab; tyrosine kinase inhibitor

Summary:

      The purpose of this research study is to find out how well cetuximab works in treating NSCLC
      in patients who have been previously treated with a class of drug called tyrosine kinase
      inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells
      called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC

          -  Patients must have progressed while receiving treatment with a tyrosine kinase
             inhibitor targeting the EGFR pathway

          -  Measurable disease, as defined by RECIST criteria

          -  Patients must have a suitable frozen or paraffin-embedded tissue sample available for
             EGFR mutational analysis. Prior EGFR mutational analyses are allowable

          -  Patients with asymptomatic brain metastasis are eligible; however, they must have
             completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be
             clinically stable

          -  ECOG Performance Status 0-2

          -  18 years of age or older

          -  Negative pregnancy test within 7 days of treatment or be categorized as not of
             child-bearing potential

          -  Bone marrow function, renal function, hepatic function as outlined in protocol

        Exclusion Criteria:

          -  Women who are pregnant of breastfeeding

          -  Active concurrent malignancy

          -  Major thoracic or abdominal surgery within 30 days prior to the first infusion of
             cetuximab

          -  Significant history of uncontrolled cardiac disease

          -  Uncontrolled seizure disorder, or active neurological disease

          -  Prior severe infusion reactions to a monoclonal antibody

          -  Prior chemotherapy regimen within 21 days prior to study entry

          -  Any EGFR tyrosine kinase inhibitor within 14 days of study entry

          -  Radiation therapy within 14 days prior to the first infusion of cetuximab

          -  Acute hepatitis or known HIV

          -  Active or uncontrolled infection

          -  Any concurrent chemotherapy or any other investigational agent(s)
Glutamine for the Treatment of Patients With Irritable Bowel Syndrome
Condition: Diarrhea-Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Glutamine
Intervention description: Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Glutamine; Intestinal Permeability

Summary:

      New and effective treatments are needed for patients with post-infectious irritable bowel
      syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy
      and safety of glutamine, an abundant amino acid in the body and the principal fuel for
      enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with
      increased intestinal permeability following an enteric infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and women age 18-72 years old who developed post-infectious diarrhea-predominant
             IBS (D-IBS)

          -  increased intestinal permeability on Lactulose/Mannitol permeability test

          -  able and willing to cooperate with the study

          -  *absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and
             throughout the study duration

        Exclusion Criteria:

          -  current participation in another research protocol or unable to give informed consent

          -  women with a positive urine pregnancy test or breastfeeding

          -  history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue

          -  + hydrogen breath test for bacterial overgrowth

          -  + antiendomysial antibody titer

          -  use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study

          -  known allergy to glutamine

          -  abdominal surgery except for removal of gallbladder, uterus, or appendix

          -  Abnormal blood urea nitrogen(BUN) and/or creatinine
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: ocriplasmin; Sham injection
Intervention description: Intravitreal injection, single administration; Sham intravitreal injection
Intervention MeSH terms: Plasminogen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; PVD; DME; Diabetic Retinopathy

Summary:

      A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical
      PVD induction for treatment of patients with DME.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  patients >18 years of age with Diabetic Macular Edema

        Exclusion Criteria include:

          -  PVD present at baseline

          -  Vitreous hemorrhage

          -  Certain vitreoretinal conditions including proliferative disease, rhegmatogenous
             retinal detachment, and proliferative vitreoretinopathy (PVR)

          -  Patients who have had a vitrectomy in the study eye at any time
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: PL3994; Placebo
Intervention description: Study drug; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypertension; controlled hypertension; hypertensives

Summary:

      The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension.
      Including in this evaluation is the effect PL3994 has on blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have had a diagnosis of essential hypertension for at least 1 year, per
             subject verbal history

          -  Subject must be on a stable dose of at least one, but not more than 3 antihypertensive
             medications for at least 3 months, per subject verbal history.

          -  Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and
             diastolic blood pressure must not exceed 105 mmHg.

        Exclusion Criteria:

          -  Subject weight greater than 100 kg or less than 50 kg.

          -  Any significant medical condition or abnormal safety laboratory results which, in the
             judgement of the Investigator would place the subject at significant risk.
Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia
Intervention: Furosemide Cohort 1; Furosemide Cohort 2; Furosemide Cohort 3; Placebo
Intervention description: furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.; Sugar water will be administered in a equivalent volume as drug intervention.
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 7 Days
Maximum age: 28 Days
Healthy volunteers: No

Summary:

      This study will describe the safety of furosemide in premature infants at risk of
      bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics
      (PK) of furosemide. Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          1. Receiving positive airway pressure (nasal continuous airway pressure, nasal
             intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or
             mechanical ventilation (high frequency or conventional)

          2. < 29 weeks gestational age at birth

          3. 7-28 days postnatal age at time of first study dose

        Exclusion Criteria:

          1. Exposure to any diuretic ≤ 72 hours prior to first study dose

          2. Previous enrollment and dosing in current study, "Safety of Furosemide in Premature
             Infants at Risk of Bronchopulmonary Dysplasia"

          3. Hemodynamically significant patent ductus arteriosus, as determined by the
             investigator

          4. Major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary
             adenomatoid malformation)

          5. Meconium aspiration syndrome

          6. Known allergy to any diuretic

          7. Serum creatinine >1.7 mg/dL < 24 hours prior to first study dose

          8. BUN >50 mg/dL < 24 hours prior to first study dose

          9. Na <125 mmol/L < 24 hours prior to first study dose

         10. K ≤2.5 mmol/L < 24 hours prior to first study dose

         11. Ca ≤ 6 mg/dL < 24 hours prior to first study dose

         12. Indirect bilirubin >10 mg/dL < 24 hours prior to first study dose

         13. Any condition which would make the participant, in the opinion of the investigator,
             unsuitable for the study
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Intervention: Placebo; Sodium Zirconium Cyclosilicate(ZS); Insulin; Glucose; Insulin; Glucose
Intervention description: Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).; Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.; Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.; Glucose 25g administered IV <15 minutes before the insulin.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      The study is designed to determine if ZS 10g administered up to three times over 10h added to
      insulin and glucose in patients presenting with hyperkalemia will prove tolerable and
      efficacious. Patients will receive ZS or Placebo on top of standard of care treatment with
      insulin and glucose.
    

Eligibility criteria:

        Inclusion Criteria:

        ≥ 18 years of age

        Potassium ≥5.8 mmol/L

        Exclusion Criteria:

        Possible pseudohyperkalaemia

        Hyperkalaemia caused by any condition for which a therapy directed against the underlying
        cause of hyperkalaemia would be a better treatment option than treatment with insulin and
        glucose.

        Dialysis session expected within 4h after randomization

        Treated with any therapy intended to lower S-K between arriving at the hospital and
        randomization during Visit 1.
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Moderate to Severe COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD1981; Placebo
Intervention description: Oral tablet, twice daily; Placebo Oral tablet, twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic
      Obstructive Pulmonary Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2
             and 3)

          -  Clinical diagnosis of COPD

        Exclusion Criteria:

          -  Other clinically relevant disease or disorders

          -  Exacerbation of COPD within 30 days
A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: vemurafenib
Intervention description: 960 mg b.i.d. continuous oral dosing
Intervention MeSH terms: Vemurafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label single arm study will assess the efficacy, safety and tolerability of
      Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive
      oral Vemurafenib [RG7204; PLEXXIKON: PLX4032] at a dose of 960 mg b.i.d. continuously until
      disease progression or withdrawal from study and will be assessed at regular intervals for
      tumour response and tolerability. Target sample size is <100 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >/=18 years of age

          -  histologically confirmed metastatic melanoma (Stage IV, AJCC)

          -  patients must have completed and failed at least one prior standard of care regimen
             (e.g. DTIC, temozolomide, etc.)

          -  BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)

          -  measurable disease by RECIST criteria

          -  negative pregnancy test and, for fertile men and women, effective contraception during
             treatment and for 6 months after completion

        Exclusion Criteria:

          -  active CNS metastases on CT/MRI within 28 days prior to enrollment

          -  history of or known carcinomatous meningitis

          -  previous treatment with BRAF (sorafenib allowed) or MEK inhibitor

          -  cardiac dysrhythmias >2 NCI CTCAE or treatment with drugs with dysrhythmic potential

          -  uncontrolled hypertension(>150/100mmHg) despite optimal medical therapy

          -  infectious disease including HIV, HBV and HCV
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults
Condition: Cannabis Dependence; Cannabis Withdrawal
MeSH terms: Marijuana Abuse
Intervention: rimonabant; placebo
Intervention description: double blind, placebo controlled, single 90 mg dose; matched placebo
Intervention MeSH terms: Rimonabant
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 21 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cannabis Dependence; Marijuana Dependence; Cannabis Withdrawal; Rimonabant; cannabinoid receptor type 1 (CB1) inverse agonist; Neuropsychology; functional magnetic resonance imaging (fMRI); Endocannabinoids; Cortisol

Summary:

      The purpose of this study is to find out more about cognitive functioning in people who are
      cannabis dependent, relative to people who do not use cannabis, and how their brains process
      information after one month of not using cannabis. An additional goal is to characterize the
      severity of cannabis dependence using precipitated and naturalistic withdrawal with a double
      blind, placebo controlled, single administration of rimonabant. Research assessments occur
      bi-weekly throughout this 28 day study.
    

Eligibility criteria:

        Cannabis Dependent Subjects:

        Inclusion Criteria:

          -  males or females 21-30 years of age

          -  meets Diagnostic and Statistical Manual (DSM-IV) diagnosis of Cannabis Dependence

          -  willing to be abstinent for 28 days during study

          -  smokes < 10 cigarettes per day

          -  drinks < 1 (female) or < 2 (male) per day

        Exclusion Criteria:

          -  active suicide ideation

          -  meets DSM-IV diagnosis for dependence on other substances other than cannabis

          -  significant medical disorders

          -  pregnant women

          -  meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence

          -  currently taking psychoactive medication
Celebrex (Celecoxib) Treatment of Laryngeal Papilloma
Condition: Laryngeal Papilloma
MeSH terms: Papilloma; Laryngeal Neoplasms
Intervention: Celebrex; PDL; CO2 laser or microsurgery
Intervention description: oral taking of Celebrex (100 mg, BID) for 9 months; once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J; once-time surgery to remove laryngeal papilloma
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Papilloma; pulsed dye laser; Celebrex; voice

Summary:

      Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical
      removal is the current management for RRP, but it is a very traumatic procedure, and often
      leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP
      treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly
      developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on
      RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this
      proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will
      deliver long-term efficacy in managing RRP.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 64 years of age

          2. with laryngeal papillomas requiring surgical treatment

          3. willingness to participate in the study

          4. a signed informed consent form

        Exclusion Criteria:

          1. age less than 18 years

          2. evidence of mental impairment so that the patient can not understand or sign the
             consent form

          3. malignant diseases such as laryngeal cancer

          4. established coronary heart and artery disorder, cerebrovascular disease, and other
             cardiovascular diseases

          5. established diabetes, which requires (1) insulin treatment; or (2) more than 2 oral
             agents of medication; or (3) to have a baseline HgbA1c >8.0

          6. hypertension, with ongoing blood pressure > 150 mg Hg systolic or to require
             medication

          7. family history with serious cardiovascular events and problems

          8. any sign and evidence which in the opinion of cardiovascular physician warrants
             exclusion of subject