bioihbjkbjnl/mcl2 huggingface dataset:
Alimta Plus Gemcitabine for Advanced Sarcoma
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: Alimta; Gemcitabine
Intervention description: 500 mg/m2 via IV over 10 minutes
A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer.; 1000 mg/m2 via IV over 90 minutes
A nucleoside analog used as chemotherapy.
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In patients with unresectable soft tissue sarcoma, what is the response rate if treated with
      Alimta and gemcitabine?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven soft tissue sarcoma (except the following histologies:
             gastrointestinal stromal tumors (GIST), Kaposi's Sarcoma, mesotheliomas).

          -  Age ≥ 18 years

          -  Recurrent or progressive disease defined as an increase in size of any existing tumor
             mass, or the development of new tumor mass or masses, which is not amenable to
             definitive surgical therapy.

          -  Patients may have had another cancer but there must be convincing clinical evidence
             that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several
             sarcoma patients have had had a prior cancer [Hodgkin's disease or breast cancer]
             treated years previously and then developed a clinically active sarcoma.)

          -  Patients may have received no prior chemotherapy, or may have failed 0-2 prior
             cytotoxic regimens.

          -  Measurable disease defined as lesions that can be measured in at least one dimension
             by physical examination or by means of medical imaging techniques. Ascites and pleural
             effusions will not be considered measurable disease.

          -  Karnofsky performance status of greater than or equal to 60%.

          -  At least 3 weeks since prior chemotherapy or at least 6 weeks since prior radiation
             therapy.

        Exclusion Criteria:

          -  Soft tissue sarcomas with the following histologies: gastrointestinal stromal tumors
             (GIST), Kaposi's sarcoma, mesotheliomas.

          -  Active or uncontrolled infection

          -  Prior treatment with gemcitabine or Alimta

          -  Pregnant or lactating women

          -  Uncontrolled central nervous system metastases

          -  Inability to stop treatment with NSAIDs
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Febuxostat; Placebo
Intervention description: Febuxostat capsules; Febuxostat placebo-matching capsules
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gout; physiology; Hyperuricemia; Uric Acid; Drug Therapy

Summary:

      The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice
      daily (BID), on renal function in gout patients with elevated serum urate levels and who have
      moderate to severe renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a serum urate greater than 7 mg/dL and a serum creatinine greater than or
             equal to 1.5 mg at Day -21

          -  Must have a history or presence of gout defined as having one or more of the American
             Rheumatism Association criteria for the diagnosis of gout (the criteria related to
             tophi have been excluded for the purpose of the study)

          -  Must have an estimated Glomerular Filtration Rate (eGFR) of 15 or greater, or less
             than or equal to 50 mL/min, AND a serum creatinine greater than 1.5 mg/dL at Screening
             Visit Day -21

        Exclusion Criteria:

          -  Has secondary hyperuricemia (eg, due to myeloproliferative disorder, or organ
             transplant)

          -  Has tophaceous gout

          -  Has a history of xanthinuria

          -  Has received aspirin greater than 325 mg/day within 35 days prior to Day
             1/Randomization Visit

          -  Has known hypersensitivity or allergy to allopurinol or any component in its
             formulation

          -  Has known hypersensitivity to febuxostat or colchicine or any components in their
             formulation

          -  Has myocardial infarction or stroke within the 90 days prior to the Screening Visit

          -  Has alanine aminotransferase and/or aspartate aminotransferase values greater than 2.0
             times the upper limit of normal

          -  Has end stage renal disease or is likely to be a candidate for dialysis over the 1
             year study period

          -  Has a serum creatinine less than or equal to 1.5 mg/dL, or an estimated Glomerular
             Filtration Rate at Day -21 Screening Visit less than 15 mL/min or greater than 50
             mL/min as calculated by the central laboratory

          -  Is required to take excluded medications
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Intervention: EDP-938 Dose 1; EDP-938 Dose 2; Placebo; EDP-938 Dose 3; EDP-938 Dose 4; Placebo
Intervention description: Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: challenge study; RSV; antiviral; RSV-A Memphis 37b

Summary:

      A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety,
      pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in
      healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the
      antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus
      challenge model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An informed consent document signed and dated by the subject

          -  Age 18 to 55 years, inclusive

          -  In good health with no history of major medical conditions

          -  A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2

        Exclusion Criteria:

          -  Pregnant or nursing females

          -  Acute or chronic medical illness

          -  Abnormal lung function

          -  Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test

          -  Nose or nasopharynx abnormalities

          -  Receipt of any investigational drug within 3 months prior to the planned date of viral
             challenge/first dose of study drug
Study of the Medication Prazosin for Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Prazosin medication; Placebo medication
Intervention description: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg; Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
Intervention MeSH terms: Prazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Abuse; Use; Disorder; Dependence; Symptoms; Alcoholic; Alcoholism; Prazosin; Drug; Medicine; Medication; Treatment; Study; Placebo; Medical; Management; Craving; Consumption; Binge; Drinking; Drink; Heavy

Summary:

      The purpose of this study is to determine whether the drug prazosin is effective for the
      treatment of alcohol dependency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary DSM-IV diagnosis of alcohol dependence(AD)

          -  Heavy drinking in the last 30 days

          -  At least 18 years of age

          -  Good general medical health (see Exclusion Criteria below)

          -  Capacity to provide informed consent

          -  English fluency and literacy

        Exclusion Criteria:

          -  Psychiatric/behavioral: current post-traumatic stress disorder(PTSD); psychiatric
             disorder requiring any medication other than anti-depressants; currently taking
             disulfiram, acamprosate, or naltrexone or planning to take any of these medications
             during the 12-week medication phase of the study; current dependence on any other
             psychoactive substance other than nicotine or cannabis; a current diagnosis of opioid
             abuse, use of any opioid- containing medications or benzodiazepines during the
             previous month, or UDA positive for opioids, benzodiazepines, or sedative hypnotics.

          -  Medical: significant acute or chronic medical illness; women who are pregnant, nursing
             infant(s), or of childbearing potential and not using a contraceptive method judged by
             the study physician or PA to be effective; signs or symptoms of alcohol withdrawal at
             the time of initial consent

          -  Legal involvement that could interfere with study treatment. Individuals court ordered
             for treatment will not be eligible to participate in this study.
Rho Kinase (ROCK) Inhibition in Carotid Atherosclerosis
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis
Intervention: Fasudil Hydrochloride; Placebo Oral Tablet
Intervention description: Fasudil 40 mg three times a day x 14 days; Placebo oral tablet manufactured to mimic fasudil three times a day x 14 days
Intervention MeSH terms: Fasudil
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled, parallel arm design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients scheduled for elective carotid endarterectomy

Summary:

      To evaluate the causal relationship between Rho/Rho kinase overactivity and mechanisms of
      vascular dysfunction in patients with atherosclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with >= 70% carotid stenosis (unilateral or bilateral) who are scheduled to
             undergo elective carotid endarterectomy

          -  Age >= 18 years

          -  Agreement of the operating surgeon for patient to participate

        Exclusion Criteria:

          -  Surgery scheduled < 14 days after randomization

          -  Pregnancy

          -  ALT, GGT > 3x upper limit of normal (ULN)

          -  Creatinine > 3.5 mg/dL

          -  Prior intolerance to statins

          -  Reluctance to add or change dosage of statin therapy during study
Intravenous Phenoxybenzamine Use in Pediatric Patients Undergoing Open-Heart Surgery
Condition: Open-heart Surgery; Cardiopulmonary Bypass
Intervention: Phenoxybenzamine
Intervention description: 0.125 to 1 mg/kg given i.v. over 15 to 45 minutes in preparation for cardiopulmonary bypass; may be continued at 0.125 mg/kg/day in ICU
Intervention MeSH terms: Phenoxybenzamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 785.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Cardiopulmonary bypass is done with a machine that does the work of the heart and lungs
      during open-heart surgery. This study is to determine if intravenous (i.v.) phenoxybenzamine
      is safe. This drug lowers the blood pressure, making it easier for the cardiopulmonary bypass
      machine to deliver blood and oxygen to all of the organs and tissues.
    

Eligibility criteria:

        Inclusion Criteria:

          -  0-18 years of age

          -  weight of less than or equal to 20 kilograms

        Exclusion Criteria:

          -  Parental refusal to give informed consent
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
Condition: Critically Ill; Hypoglycemia
MeSH terms: Hypoglycemia; Critical Illness
Intervention: Glucagon-Like Peptide-1; Saline
Intervention description: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.; 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Intensive insulin therapy (IIT); Insulin infusion; Tight glycemic control; Intensive Care Units

Summary:

      The goal of this present proposal is to examine the efficacy of GLP-1 administered to control
      blood glucose in critically ill patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women age > 21 to 75 years of age.

          -  All subjects who meet ICU specific criteria for inclusion in their glucose protocol
             and placed on insulin infusion protocol as standard of care.

          -  Able to obtain patient or proxy consent.

        Exclusion Criteria:

          -  Current diagnosis of malignancy.

          -  Type 1 diabetes.

          -  Inability to obtain informed consent.

          -  On any Phase 1 trial.
Effect of Fenofibrate on Sleep Apnea Syndrome
Condition: Dyslipidemia; Sleep Apnea Syndrome; Overweight; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Overweight; Dyslipidemias; Syndrome
Intervention: Placebo; Fenofibrate
Intervention description: Fenofibrate-matching placebo tablet; 145 mg NanoCrystal tablet
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Dyslipidemia; Sleep Apnea Syndromes; Fenofibrate; Obese; Overweight or obese patients

Summary:

      Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological
      changes associated with sleep apnea syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway
             Pressure (CPAP) or presenting clinical symptoms of sleep apnea

          -  Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².

          -  Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0
             mmol/L within 3 months before the inclusion.

        Exclusion Criteria:

          -  indication for immediate CPAP

          -  other known endocrine disease, except treated and adequately controlled hypothyroidism

          -  renal failure or plasma creatinine level >130 µmol/L

          -  current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper
             normal limit (UNL)

          -  symptomatic gallbladder disease

          -  known muscular disease or creatine phosphokinase (CK) > 3 times UNL.
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
Condition: Emphysema; Alpha 1-antitrypsin Deficiency (AATD)
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Intervention: Prolastin-C, 60 mg/kg; Prolastin-C, 120 mg/kg
Intervention description: 60 mg/kg weekly infusion of Prolastin-C for 8 weeks; 120 mg/kg weekly infusion of Prolastin-C for 8 weeks
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: emphysema; alpha 1-antitrypsin; alpha 1-antitrypsin deficiency (AATD); alpha 1-proteinase inhibitor (Alpha-1 PI)

Summary:

      This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of
      Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions
      of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between 18 and 70 years of age

          -  Have a documented diagnosis of congenital AATD

          -  Have a post-bronchodilator Forced Expired Volume in 1 second (FEV1) of ≥30% and <80%
             and FEV1/forced vital capacity (FVC) <70%

          -  If receiving alpha-1 PI augmentation therapy, be willing to discontinue the treatment
             for the duration of the study

        Exclusion Criteria:

          -  Had a moderate or severe pulmonary exacerbation during the 4 weeks before the study

          -  History of lung or liver transplant

          -  Any lung surgery during the past 2 years

          -  Confirmed liver cirrhosis

          -  Elevated liver enzymes

          -  Severe concurrent disease

          -  Females who are pregnant or breast-feeding or unwilling to practice effective
             contraception during the study

          -  Infection with hepatitis A, B, or C, human immunodeficiency or parvovirus B19

          -  Smoking during the past 6 months

          -  Use of systemic steroids within 4 weeks of the study

          -  Use of antibiotics for an exacerbation within 4 weeks of the study
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
Condition: Triple Negative Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ixabepilone; ixabepilone + cetuximab
Intervention description: injection, intravenous (IV), until unacceptable toxicity or progression or 15 months after the Last Subject First Visit (LSFV), whichever comes first.
Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant met the re-treatment criteria.; Ixabepilone: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
Ixabepilone 40 mg/m^2 was administered as a 3-hour IV continuous infusion on Day 1 in a 21-day cycle provided the participant meets the re-treatment criteria.
Cetuximab: injection, IV, until unacceptable toxicity or progression or 15 months after the LSFV, whichever comes first.
Cetuximab 400 mg/m^2 was administered as a 2-hour IV loading dose via in-line filtration with an infusion pump, gravity drip, or a syringe pump on Day 1 of first cycle then 250 mg/m^2 1-hour IV once a week, i.e. on Days 1, 8, and 15 of each cycle provided the participant meets the re-treatment criteria.
Intervention MeSH terms: Cetuximab; Epothilones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and
      the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with
      triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth
      Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced
             non-resectable and/or metastatic breast cancer

          -  Prior adjuvant or neoadjuvant anthracycline-based chemotherapy

        Exclusion Criteria:

          -  Tumors that are fluorescence in situ hybridization test (FISH) positive or
             immunohistochemistry (IHC) 3+

          -  Neuropathy > Grade 1

          -  Prior systemic therapy for metastatic disease
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
Intervention: Sunitinib
Intervention description: Sunitinib 37.5 mg daily by oral capsule in a continuous regimen until progression or unacceptable toxicity
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: brain metastases; Sunitinib; Phase 2

Summary:

      This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with
      non-small cell lung cancer with brain metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with radiologically proven brain metastases secondary to non-small cell lung
             cancer

          -  Received previous whole brain radiation therapy and none, 1 or 2 prior systemic
             therapy for the treatment of advanced/metastatic non-small cell lung cancer

        Exclusion Criteria:

          -  Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or
             leptomeningeal disease.

          -  Brain metastases >4 cm in any linear direction

          -  Intracranial or intratumoral hemorrhage