L-Citrulline malate,1gr,twice a day,2weeks

Coronary Heart Disease

L-Citrulline malate as a 1gr powder agent, twice a day, for 2 weeks and placebo as a 1gr powder agent of O.R.S, twice a day,for 2 weeks

L-Citrulline malate

National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital

The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease

Phase 0 Study of The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease According to Their Smoking History

Brachial Index according to the smoking history

Brachial Index according to coronary heart disease

babak sharif kashani

Head of Cardiology Department

Masih Daneshvari Hospital

Shahid Beheshti University of Medical Sciences

Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy

Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8
Cisplatin: Cisplatin (70 mg/m2) IV day 1
Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14
Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

CGS + Radical Cystectomy

Sex: Female, Male

Region of Enrollment

Pathological Complete Response (pCR) Rate.

Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC

Safety Profile

To determine the objective response rate for patients with measurable disease according to RECIST.

Objective Response Rate

Progression Free Survival

To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.

Correlate Biomarker Expression

Overall Study

Clinical Data Coordinator

Transitional Cell Carcinoma of the Bladder

Gemcitabine ( 1000 mg/m2) IV days 1 and 8

Gemcitabine

Cisplatin

Sunitinib malate (37.5 mg) oral daily for days 1-14

Sunitinib Malate

Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Radical Cystectomy

University of Florida

Indiana University Simon Cancer Center

Northern Indiana Cancer Research Consortium

Baylor College of Medicine

St. Bartholomew's Hospital (Barts)

Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123

Noah Hahn, M.D.

Sponsor-Investigator

Pfizer

Hoosier Cancer Research Network

Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
Sunitinib malate 37.5 mg orally, daily. After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.

Paclitaxel and Sutinib Malate

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:

Eastern Cooperative Oncology Group (ECOG) Performance Status

Tumor Site

Histology

Prior Treatment

To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Progression Free Survival Rate at 24 Weeks

To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

Response Rate

To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma

Overall Survival

To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.

Progression-Free Survival

Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.

Toxicity Profile

Nasser Hanna, M.D.

Esophageal Cancer

Sunitinib malate

Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

Paclitaxel

Northwestern University Feinberg School of Medicine

Rush-Presbyterian St. Luke's Medical Center

Medical & Surgical Specialists, LLC

Cancer Care Center of Southern Indiana

Oncology Hematology Associates of SW Indiana

Fort Wayne Oncology & Hematology, Inc

IN Onc/Hem Associates

Arnett Cancer Care

Horizon Oncology Center

Medical Consultants, P.C.

Monroe Medical Associates

Providence Medical Group

Ireland Cancer Center - University Hospitals of Cleveland

Sutent + Taxol for Advanced Esophageal Cancer

A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer

Professor, IU School of Medicine

Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

Intravenous Glutamate

Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

Saline Infusion

Total

Race and Ethnicity Not Collected

Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality

p-CK-MB postoperative day 1, p-troponin-T postoperative day 3

Degree of Perioperative Myocardial Injury

Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU

Postoperative Hemodynamic State

Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40)

Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40)

maximum p-creatinine value recorded postoperatively < 30 days

Postoperative Renal Function

Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan

Number of Participants With Postoperative Stroke < 24 Hours

ICU Stay

Number of patients with atrial fibrillation recorded postoperatively

Atrial Fibrillation

Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients

Severe Circulatory Failure in CCS Class IV Patients

Late mortality - related to biochemical markers (troponin-T, mixed venous oxygen saturation, NT-proBNP) and intervention

Long-term Survival

Rolf Svedjeholm

Coronary Artery Bypass

Myocardial Ischemia

Myocardial Infarction

Coronary Artery Disease

Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.

malate/infarkt

The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease

Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

Sutent + Taxol for Advanced Esophageal Cancer

Glutamate for Metabolic Intervention in Coronary Surgery

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