bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: 5-FU; 5-FU; 5-FU; Irinotecan; Leucovorin; Leucovorin; Oxaliplatin; bevacizumab [Avastin]
Intervention description: Bolus 400mg/m2, day 1 every 2 weeks; 3200mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks; 2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks; 165mg/m2 1-hour iv infusion, day 1 every 2 weeks; 400mg/m2 2-hour iv infusion, day 1 every 2 weeks; 200mg/m2 2-hour iv infusion, day 1 every 2 weeks; 85mg/m2 2-hour iv infusion, day 1 every 2 weeks; 5mg/kg iv day 1 every 2 weeks
Intervention MeSH terms: Leucovorin; Bevacizumab; Oxaliplatin; Irinotecan; Fluorouracil; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the resection rate of liver metastases and safety of surgery in
      patients with metastatic colorectal cancer and primarily unresectable liver metastases
      receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with
      irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients
      will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of
      these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment
      is until surgery, disease progression, unacceptable toxicity or patient refusal, and the
      target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  unresectable liver metastasis secondary to cancer of colon or rectum;

          -  scheduled for standard first line chemotherapy;

          -  ECOG performance score of 0 or 1;

          -  condition feasible for major abdominal surgery after first line treatment.

        Exclusion Criteria:

          -  diagnosis of metastatic disease >3 months prior to study entry;

          -  evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of
             celiac lymph nodes;

          -  prior systemic or local treatment of metastatic disease;

          -  prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study
             entry;

          -  history or evidence of CNS disease unrelated to cancer.
Field Administration of Stroke Therapy-Blood Pressure Lowering
Condition: Intracerebral Hemorrhage; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Hemorrhage; Hemorrhage
Intervention: Glycerly Trinitrate; Glycerly Trinitrate; Glycerly Trinitrate
Intervention description: 5mg/24hour (0.2mg/hour) transdermal; 10mg/24hour (0.4mg/hour) transdermal; 0.4 mg sublingual single metered spray
Intervention MeSH terms: Nitroglycerin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Stroke; Intracerebral Hemorrhage; Prehospital; Antihypertensive

Summary:

      This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin)
      administered by paramedics in the field within 2 hours of symptom onset to 45 severely
      hypertensive stroke patients. The primary objective of the study is to evaluate the
      feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in
      achieving modest reduction of blood pressure. Patients with acute stroke will be identified
      in the field by paramedics who have received training in basic and advanced cardiac life
      support, stroke recognition, and specific procedures relevant to the proposed study.
      Physician-investigators will obtain informed consent for each subject for study entry after
      cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment
      by applying transdermal GTN patch in the first two dose-tiers, and administering a single
      sublingual GTN metered spray followed by application of the transdermal system in the last
      dose tier. The sites involved in the study will be emergency medical services rescue
      ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Suspected stroke identified with Los Angeles Prehospital Stroke Screen

          2. Age 40-80, inclusive

          3. Last known well time within 2 hours of treatment initiation

          4. Deficit present for > 15 minutes

          5. Systolic blood pressure ≥180

        Exclusion Criteria:

          1. Coma

          2. Rapidly improving neurologic deficit

          3. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound
             the neurological or functional outcome evaluations

          4. Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or > 24)

          5. Major head trauma in the last 24 hours

          6. Recent stroke within prior 30 days

          7. Use of erectile dysfunction therapies in the previous 12 hours

          8. Use of type V phosphodiesterase inhibitors

          9. Patient unable to give informed consent and no available legally authorized
             representative (LAR) to provide informed consent
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Condition: Diarrhoea;Acute
MeSH terms: Diarrhea
Intervention: Carbowhite; Carbowhite placebo
Intervention MeSH terms: Silicon
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Diarrhoea; Carbowhite; Colloidal silicon dioxide

Summary:

      The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon
      dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  signed Informed Consent Form for patient's study participation

          -  male and female patients at the ages from 18 to 55 years

          -  acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or
             less in patients with usually normal stool

          -  body temperature of ≤ 38 °C

          -  patient's ability to adequately cooperate in the process of study

        Exclusion Criteria:

          -  aged of <18 or >55 years;

          -  blood or pus in stool;

          -  body temperature of >38 °C;

          -  episodes of acute diarrhea for the last 30 days;

          -  administration of antidiarrheal products for the last 24 hours;

          -  salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi;
             ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii;
             ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which
             require administration of antimicrobial products;

          -  pregnancy, lactation;

          -  concomitant decompensated diseases or acute conditions which, according to an
             investigator, may affect study results

          -  alcoholism and drug abuse;

          -  participation in any other clinical study.
IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis
MeSH terms: Pancreatitis
Intervention: Ibuprofen; placebo
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: post-ERCP pancreatitis; pediatric; ibuprofen

Summary:

      Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique
      utilized to diagnose and treat pathologic conditions involving the ducts draining the liver
      and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and
      occurs in approximately 11% of children undergoing the procedure. By definition it leads to
      prolongation of hospital stay or delays in care and rarely can result in long-term morbidity
      or even death. Recent adult trials have demonstrated prevention of PEP with administration of
      rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed
      in children thus no "gold standard" or even commonly accepted method of preventing PEP in the
      pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages
      over rectally administered NSAIDs in the pediatric population in that it would allow for more
      consistent weight based dosing and would have more predictable absorption compared to
      suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV
      ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is
      a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls
      (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical
      Center Dallas over a two-year period. The primary outcome measurement will be development of
      PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be
      measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease
      rates of post-ERCP pancreatitis in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age<=18 years

          -  Undergoing ERCP (defined as cannulation of the major or minor papilla) for any
             indication

        Exclusion Criteria:

          -  Age>18

          -  Pancreatitis within the 72 hours preceding ERCP

          -  Allergy or hypersensitivity to Aspirin or NSAID medications

          -  Pregnancy or breastfeeding mother

          -  Cr >1.4

          -  Gastrointestinal hemorrhage in preceding 72 hours

          -  Heart disease reliant upon a patient ductus arteriosis

          -  History of sickle cell disease
Clinical Trial to Evaluate the Chronic Efficacy of OC-01 Nasal Spray on Signs of Dry Eye Disease (The MYSTIC Study)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 0.1% 0.6 mg/ml; OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); placebo comparator
Intervention description: OC-01 (varenicline) nasal spray: 0.1 % (0.6 mg/ml); OC-01 (varenicline) nasal spray: 0.2 % (1.2 mg/ml); vehicle control
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the chronic safety and effectiveness of OC-01
      Nasal Spray as compared to placebo on signs of dry eye disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to us an artificial tear substitute for dry eye symptoms
             within 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery (e.g.
             laser-assisted in-situ keratomileusis, laser epithelial keratomileusis,
             photorefractive keratectomy or corneal implant) within twelve months of Visit 1

          -  Have a history or presence of an ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis
Condition: Cellulitis
MeSH terms: Cellulitis
Intervention: IV cefazolin plus oral probenecid and placebo cephalexin; Oral cephalexin and saline IV plus probenecid placebo
Intervention description: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.; Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
Intervention MeSH terms: Cefazolin; Cephalexin; Probenecid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Cellulitis; Emergency Department; Cefazolin; Probenecid; Cephalexin

Summary:

      The purpose of this study is to determine whether oral cephalexin is equivalent to
      intravenous cefazolin plus oral probenecid for the treatment of uncomplicated skin and soft
      tissue infections in patients that present to the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the emergency department with a presumed diagnosis of mild to
             moderate skin and soft tissue infection

          -  Deemed well enough to be treated as an outpatient

          -  19 years of age or older

        Exclusion Criteria:

          -  known allergy to study drugs

          -  known chronic kidney disease with a creatinine clearance <30 mL/min

          -  known previous methicillin-resistant staphylococcus aureus (MRSA) infection

          -  use of antibiotics for greater than 24 hours in the past 7 days

          -  wound/abscess requiring operative debridement or incision and drainage

          -  suspected necrotizing fasciitis, osteomyelitis or septic arthritis

          -  febrile neutropenia

          -  concomitant documented bacteremia

          -  Two or more signs of systemic sepsis

          -  new altered mental status

          -  infections at a site involving prosthetic materials

          -  animal or human bite wound infections

          -  post-operative wound infections

          -  known peripheral vascular disease

          -  superficial thrombophlebitis

          -  pregnant/breastfeeding

          -  obesity (BMI > 30 kg/m2)
Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)
Condition: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy
MeSH terms: Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism
Intervention: Theophylline
Intervention description: 24 hour infusion of IV theophylline
Intervention MeSH terms: Theophylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This study will test an investigational drug, theophylline, in children with
      pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt
      Clinical Research Center.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 10 to 21 years old

          2. English proficiency

          3. Clinical and genetic diagnosis of PHP1a

        Exclusion Criteria:

          1. Use of a PDE inhibitor in the past 30 days

          2. History of a seizure disorder unrelated to hypocalcemia

          3. History of a cardiac arrhythmia (not including bradycardia)

          4. History of hepatic insufficiency

          5. AST or ALT >2x upper limit of normal

          6. Total bilirubin >1.5 x upper limit of normal (unless patient has a diagnosis of
             Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified)

          7. Congestive heart failure

          8. Cigarette use in the past 30 days

          9. Alcohol use within the past 24 hours

         10. Current pregnancy

         11. Untreated hypothyroidism (defined as free T4 level < 0.6 ng/dL or TSH >10 mcU/mL)

         12. Active peptic ulcer disease

         13. Fever >101 degrees in the past 24 hours

         14. Current use of medications known to effect theophylline levels (listed below)

         15. Severe sleep apnea requiring BiPAP

        Drugs with clinically significant drug interactions with theophylline:

          -  Allopurinol

          -  Cimetidine

          -  Ciprofloxacin

          -  Clarithromycin

          -  Enoxacin

          -  Ephedrine

          -  Erythromycin

          -  Estrogen

          -  Flurazepam

          -  Fluvoxamine

          -  Lithium

          -  Lorazepam

          -  Methotrexate

          -  Midazolam

          -  Pentoxifylline

          -  Propranolol

          -  Rifampin

          -  Sulfinpyrazone

          -  Tacrine

          -  Thiabendazole

          -  Ticlopidine

          -  Troleandomycin

          -  Verapamil
Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
Condition: Islet Cell Tumor
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Intervention: Everolimus; Pasireotide LAR
Intervention description: Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets; Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).
Intervention MeSH terms: Everolimus; Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic; Neuroendocrine tumors; PNET; Pasireotide; Everolimus; Advanced progressive pancreatic neuroendocrine tumor

Summary:

      This study will estimate the treatment effect of everolimus in combination with pasireotide
      LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced
      progressive PNET.

      A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet
      its primary objective, which was based on progression-free survival (PFS) as per local
      radiology assessment and was prematurely terminated with the last patient last visit on
      19-Feb-2015. However, it is important to note that the data did not reveal any new safety
      concerns. It was decided to stop the study and this decision was shared with the study sites
      on 31-Jul-2014.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor

          -  Progressive disease within the last 12 months

          -  Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT

        Exclusion Criteria:

          -  Patients currently requiring somatostatin analog treatment

          -  Prior therapy with mTOR inhibitors or pasireotide

          -  Patients with more than 2 prior systemic treatment regimens

          -  Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy
             within the last 4 weeks

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Standard chemotherapy; bevacizumab [Avastin]
Intervention description: As prescribed; 7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label two-arm study will assess the safety and efficacy of a combination of
      bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in
      childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma
      soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard
      chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of
      induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1
      of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy
      with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time
      on study treatment is 1-2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  childhood and adolescent patients aged >/=6 months to 18 years of age

          -  metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma

          -  adequate bone marrow function

          -  adequate renal and liver function

          -  adequate blood clotting

        Exclusion Criteria:

          -  previous malignant tumors

          -  tumor invading major blood vessels

          -  prior systemic anti-tumor treatment