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Myocardial Infarction Stabilization

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3101. Additional molsidomine in refractory unstable angina pectoris. (Abstract)

myocardial infarction (n = 3). Two patients had angiographically documented severe coronary spasms. Patients entered the study if coronary bypass surgery or PTCA could not be performed within 3 days after angiography (n = 9) or was not feasible due to anatomical or technical reasons (n = 6), concomitant malignant disease (n = 2), or age greater than 75 years (n = 3). All patients received molsidomine orally 12 to 24 mg/day. In 15 of the 20 patients molsidomine was given i.v. initially, starting with 20 (...) mg i.v., followed by infusion of 1 to 4 mg/hour. Heart rate and blood pressure did not change significantly, and eight patients had a slight decrease of systolic and diastolic blood pressure. Severe adverse effects did not occur, and moderate headaches were reported by five patients. In 13 patients, unstable angina could be stabilized, and they remained free of resting angina; five had a marked reduction of the frequency of anginal attacks. In two patients, molsidomine was without demonstrable

1991 Cardiovascular drugs and therapy / sponsored by the International Society of Cardiovascular Pharmacotherapy

3102. [Effects of prostacyclin (PGI2) on tachycardic heart arrhythmias following aortocoronary venous bypass operations]. (Abstract)

and/or by an antiarrhythmic effect on the myocardium. Whether the antiarrhythmic effect of PGI2 on the myocardium is indirect (reduction of microcirculatory disorders produced by inhibition of platelet aggregation) or direct (electrical stabilization of the myocardial cell membrane), is the subject of further investigations. (...) [Effects of prostacyclin (PGI2) on tachycardic heart arrhythmias following aortocoronary venous bypass operations]. In a prospective double-blind study of 40 male patients requiring aorto-coronary bypass surgery, a dose of 8 ng/kg/min of PGI2 was infused throughout extracorporeal circulation (ECC) (control group: glycine buffer). Between the two treatment groups there was no difference in preoperative hemodynamic parameters, number of preoperative infarctions, or number of implantated aorto

1986 Herz

3103. p53 Vaccine for Ovarian Cancer

negative pregnancy test and must use adequate contraception. Patients with active ischemic heart disease (i.e. Class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy. Second malignancy (within the past 2 years) other than curatively treated carcinoma in-situ of cervix or basal cell carcinoma of the skin. These patients (...) mutated gene in human cancers; it has been found to be mutated in almost 50% of ovarian cancers. Genetic mutation of p53 results in stabilization and increase in the level of the protein. In some cases, overexpression of p53 protein could also occur in tumors without detectable mutation in the open reading frame. Therefore, p53 could function as an antigen through two different mechanisms, as a mutant "foreign" protein and as a selfoverexpressed protein. The p53:264 - 272 wild type peptide has been

1999 Clinical Trials

3104. Study of DT388GMCSF Fusion Protein in Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML)

infections are eligible only if evidence of response to antifungal medications is documented and fever does not exceed 38C for at least 2 days. Inability to give informed consent because of psychiatric problems or other serious medical problems. Pregnant or nursing women. Patients with documented CNS leukemia or leukemia with CNS symptoms. Patients who have had a myocardial infarction within the past six months. Patients with severe penicillin allergy (anaphylaxis). Not fully recovered from toxic effects (...) to initiating the treatment. The WBC count must be stabilized below this level for at least three days by leukopheresis or hydroxyurea. Hydroxyurea must be discontinued one day prior to initiation of DT388GMCSF treatment. Patients must have creatinine < 1.6 times ULN: bilirubin <1.6 times ULN; SGPT < 2.6 x ULN; albumin > 3 gm/dl; adequate cardiac function (EF >44%), oxygen saturation > 92% without exogenous oxygen administered. Patients must be willing to be treated at M D Anderson Cancer Center. Women

2003 Clinical Trials

3105. Postural Control in the Elderly

CRITERIA: Subjects will be enrolled in this balance study if they are within the range of 20-90 years old; in good health; report no difficulties or need for help in performing self-care or instrumental activities of daily living; and are able to walk for at least 400 meters. EXCLUSION CRITERIA: We will be unable to study people who have substantial congitive impairment based on mental status screening tests; history of cardiovascular disease (including angina, myocardial infarction, congestive heart (...) and backward directions. When the subject recognizes an unstable position in the movements, he or she presses a computer mouse. An EEG records brain activity during the task, which lasts up to 2 hours. Condition or disease Musculoskeletal Physiology Healthy Detailed Description: A number of studies have explored the role of visual, vestibular and somatosensory systems in the control of upright posture. However, the cortical control of postural stability, in general, and the role of higher cognitive

2003 Clinical Trials

3106. Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer

or fungal infections requiring treatment. Patients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol. Use of any investigational agent within four weeks of study treatment. Prior gene therapy. History of myocardial infarction within 6 months, angina within the past 6 months, or a history of arrhythmias on active therapy (...) of normal. FEV1 and corrected DLCO of >/= 40% of predicted. Patients with asymptomatic brain metastases that have been treated are eligible if the following criteria are met: No history of seizures in the preceding 6 months. Definitive treatment must have been completed ≥4weeks prior to registration. Subjects must be off steroids that were being administered because of brain metastases or related symptoms for ≥2 weeks. Post-treatment imaging within 2 weeks of registration must demonstrate stability

2003 Clinical Trials

3107. TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer

no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No gross hematuria Cardiovascular: No uncontrolled cardiac arrhythmia No myocardial infarction within the past 6 months Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No severe concurrent disease, infection, or comorbidity (...) the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286. II. Determine the overall survival of patients treated with this drug. III. Determine the objective response rate, duration of objective response, time to tumor progression, and disease stabilization in patients treated with this drug. IV. Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 21

2002 Clinical Trials

3108. Solitary Islet Transplantation for Type 1 Diabetes Mellitus Using Steroid Sparing Immunosuppression

diabetic complications but which have not progressed to end-stage renal failure Failure of intensive insulin management, as judged by an endocrinologist independent of study investigators EXCLUSION CRITERIA: Significant cardiac disease as defined by: a) a history of a myocardial infarction with the past 6 months or b) coronary angiographic evidence of non-correctable arteriopathy, or c) evidence of ischemia on a functional cardiac examination Active alcoholism or other substance abuse (including (...) , with the dosages adjusted to account for the transplanted islets. They will take Daclizumab every 2 weeks, and FK506 and rapamycin daily. Blood tests to follow how much of these drugs are in the blood stream will be performed daily at first and then weekly after blood levels of these drugs stabilize. They will be given antibiotics to prevent infections. The arginine test will be repeated 2 weeks after the transplant and periodically thereafter. Blood will be drawn weekly to check drug levels, and monthly

2000 Clinical Trials

3109. Children's Activity and Nutrition III

for blood pressure (BP) control within the context of ethnicity and family history of early myocardial infarction (MI), defined as having a parent or grandparent with an MI at less than 55 years of age and a family history. Blacks have a higher mortality rate through middle adulthood than whites from coronary heart disease (CHD), the leading causes of death in the United States. Blacks have been found to exhibit greater cardiovascular (CV) response to stress (i.e., reactivity), a potential risk factor (...) artery wall elasticity and endothelial dependent arterial dilation up to 11 years later after controlling for other expected predictors (i.e., age, gender, ethnicity, resting BP, adiposity, ambulatory BP); 2) the influence of ethnicity, family history and a select group of moderator variables (i.e., environmental stress, anger and John Henryism coping styles, aerobic fitness on youth's cardiovascular (CV) reactivity; and 3) the stability of CV reactivity and a 24- hour ambulatory BP from childhood

2000 Clinical Trials

3110. Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina, symptomatic congestive heart failure, or serious cardiac arrhythmia No New York Heart Association class III or IV heart disease No history of cardiac toxicities with prior fluorouracil and leucovorin calcium No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must (...) symptomatic worsening, time to disease progression, onset and duration of complete and partial responses, and duration of disease stabilization in patients treated with these regimens. III. Determine the safety profile of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN

2001 Clinical Trials

3111. Warfarin and Antiplatelet Therapy in Chronic Heart Failure

myocardial infarction and nonfatal stroke [ Time Frame: 30 months intake; 12-42 months follow-up ] The primary safety end point was major bleeding episodes, defined as bleeding episodes leading to death or disability (including loss of neurological or special senses function), requiring surgical intervention, or associated with an acute decline of hemoglobin 2gm/dl or transfusion of >1 U packed red cells or whole blood. Eligibility Criteria Go to Information from the National Library of Medicine Choosing (...) , monitored by measurements at 6 week intervals after initial titration and stabilization. Active Comparator: 2 Aspirin 182 mg Drug: Aspirin an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner. Active Comparator: 3 Clopidogrel 75 mg Drug: Clopidogrel 75 (an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner) Outcome Measures Go to Primary Outcome Measures : acomposite of mortality, nonfatal

2000 Clinical Trials

3112. Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer

), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test) Serious, non-healing wound, ulcer, or bone fracture Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to day 0 Gastrointestinal tract disease resulting (...) -774 Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study Patients with recent (within 6 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, myocardial infarction (MI), or clinically significant peripheral artery disease Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor

2003 Clinical Trials

3113. Phase II Bevacizumab + Tax In Advanced Breast Cancer

disease No arterial thromboembolic event within the past 6 months including the following: Transient ischemic attack Cerebrovascular accident Myocardial infarction Other: No other prior or concurrent malignancy within the past 10 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix No other uncontrolled concurrent illness No ongoing or active infection No non-healing wounds No psychiatric illness or social situation that would preclude study participation No prior allergic (...) Radiation: radiation therapy Phase 2 Detailed Description: OBJECTIVES: Determine the effect of bevacizumab and docetaxel on reduction of microvessel density and induction of apoptosis of endothelial and tumor cells in patients with locally advanced breast cancer. Determine the safety profile of this regimen in these patients. Compare the effect of docetaxel and bevacizumab, in terms of objective response, stabilization of disease, and progression-free survival, in these patients. OUTLINE

2001 Clinical Trials

3114. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma

No history deep vein thrombosis No myocardial ischemia or infarction within the past 6 months No uncompensated coronary artery disease within the past 6 months No uncontrolled hypertension No symptomatic congestive heart failure No unstable angina pectoris within the past 6 months No cardiac arrhythmia No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months No clinically significant (...) and corresponding 95% confidence intervals will be derived using the method described in Brookmeyer and Crowley. Secondary Outcome Measures : Complete response rate [ Time Frame: Up to 6 months ] Will be compared between groups using chi-square or Fisher exact tests, as appropriate. Objective response rate (complete and partial response) [ Time Frame: Up to 6 months ] Will be compared between groups using chi-square or Fisher exact tests, as appropriate. Rate of disease stabilization [ Time Frame: Up to 6

2001 Clinical Trials

3115. SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated

no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within past 3 months No pulmonary embolism within past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective (...) biomarker analysis Phase 2 Detailed Description: PRIMARY OBJECTIVES: I. Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416. II. Determine the toxicity of SU5416 in this patient population. III. Determine the median and overall survival and time to progression in these patients receiving this treatment. OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks

2000 Clinical Trials

3116. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

expectancy: At least 12 weeks WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within (...) the objective response rate and disease stabilization rates of patients with previously treated metastatic or locally recurrent colorectal cancer treated with SU5416. II. Determine the median and overall survival and time to progression in this patient population receiving this treatment. III. Determine the toxicity of SU5416 in these patients. OUTLINE: This is a multicenter study. Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses

2000 Clinical Trials

3117. Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes

of insulin provision. B. Secondary Aims The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative (...) , Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers Outcome Measures Go to Primary Outcome Measures : Number of Participants With All-Cause Mortality [ Time Frame: five years ] Secondary Outcome Measures : Number of Participants With Death, Myocardial Infarction, or Stroke [ Time Frame: five years ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members

2000 Clinical Trials

3118. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

OR Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 1.25 times upper limit of normal Renal: Glomerular filtration rate at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmias No congestive heart failure even if stabilized on medication No New York Heart Association class III or IV heart disease No myocardial infarction

2002 Clinical Trials

3119. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)

Congestive Heart Failure Coronary Artery Disease Myocardial Infarction Drug: MyoCell™ Device: MyoCath™ Phase 1 Detailed Description: A very promising approach to reversal or stabilization of the post-infarct remodeling process is the direct injection of regenerative cells into the myocardial infarct scar. Such cell-based therapy for cardiac repair is called "cellular cardiomyoplasty". The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension (...) . Information provided by: Bioheart, Inc. Study Details Study Description Go to Brief Summary: The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial

2003 Clinical Trials

3120. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

times ULN (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No New York Heart Association class III or IV congestive heart failure No serious cardiac arrhythmia No history of cardiac toxicity from fluorouracil/leucovorin calcium No myocardial infarction within past 6 months Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No uncontrolled predisposing colonic (...) metastatic colorectal cancer. Condition or disease Intervention/treatment Phase Colorectal Cancer Drug: irinotecan hydrochloride Drug: oxaliplatin Phase 3 Detailed Description: OBJECTIVES: Compare the overall survival of patients with metastatic colorectal cancer treated with irinotecan with or without oxaliplatin. Compare the response rate, time to tumor-related worsening of symptoms, time to disease progression, onset and duration of responses, and duration of disease stabilization in these patients

2001 Clinical Trials

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