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Myocardial Infarction Stabilization

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3121. Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy

during the study is permitted. Allergy to sulpha-containing compounds, NSAIDs, or demonstration o the aspiring triad. History of kidney disease (creatinine level greater than 2.5 dL, need for dialysis, or microalbuminurea). Liver disease. Concurrent use of warfarinor known bleeding diathesis. History of inflammatory bowel disease. Concurrent use of lithium. History of peptic ulcer within 1 year prior to enrollment. History of myocardial infarction 2 years prior to enrollment. Contacts and Locations (...) provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can help stabilize or improve vision in patients with age-related macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair

2002 Clinical Trials

3122. Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer

or coagulopathy or need for full-dose anticoagulation Hepatic Bilirubin less than 3 times upper limit of normal (ULN) Alkaline phosphatase less than 3 times ULN Renal Creatinine less than 2 times ULN Protein < 0.5 g/24 hr urine collection if proteinuria positive by dipstick Cardiovascular No uncontrolled congestive heart failure No uncontrolled angina pectoris No uncontrolled hypertension No uncontrolled arrhythmia No myocardial infarction within the past 12 months No cerebrovascular accident or transient (...) Chemotherapy No prior chemotherapy except for metastatic disease confined to the liver Prior fluorouracil, leucovorin calcium, and oxaliplatin allowed if administered for at least 3 courses (2 weeks each) but no longer than 3 months with at least stabilization of disease achieved Prior adjuvant chemotherapy for primary cancer allowed except for patients who received oxaliplatin and have been diagnosed with metastatic disease within 12 months after completion of adjuvant treatment Endocrine therapy

2002 Clinical Trials

3123. Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers

, digitoxin); have a medically unstable condition or had a major health event in the past 6 months (e.g., myocardial infarct or major surgery); have CBC values more than 10% outside the normal limits, or liver enzymes exceeding 40% of the upper limit of normal; have a history of severe allergies, multiple adverse drug reactions or known allergy to fluoxetine; are actively abusing alcohol or drugs or received inpatient treatment for substance abuse within the past year; are using nicotine replacements (...) possess the diathesis for depression. Over period of four years, the study hopes to randomize 120 smokers with a history of depression and 120 smokers who lack such a history to double-blind treatment with either 60 mg fluoxetine or placebo, while they undergo group cognitive behavioral treatment to quit smoking. To allow plasma drug levels to stabilize before quitting smoking, drug or placebo treatment begins 3 weeks before quitting smoking and continues for an additional 8 weeks following the quit

2001 Clinical Trials

3124. Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test (...) . Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients

2001 Clinical Trials

3125. Vaccine Therapy Plus Chemotherapy in Treating Patients With Metastatic or Locally Recurrent Stomach Cancer or Esophageal Cancer

> Grade 2 NCI-CTC, Version 2.0 criteria Severe hearing disorder > Grade 2 NCI-CTC, Version 2.0 criteria Known dihydropyrimidine dehydrogenase deficiency Any other sever condition as defined by the following: unstable cardiac disease despite treatment; myocardial infarction within 6 months before study entry; history of significant neurologic or psychiatric disorders including dementia or seizures; active uncontrolled infection; active disseminated intravascular coagulation; or any other serious (...) and fluorouracil in patients with chemotherapy-naive metastatic or locally recurrent gastric or gastroesophageal cancer. II. Determine the safety profile and tolerability of this regimen in these patients. III. Determine the tumor response rate, disease stabilization, best overall response, time to progression, time to treatment failure, and overall survival in patients treated with this regimen. IV. Determine the correlation of immunological response with clinical efficacy and benefit in patients treated

2001 Clinical Trials

3126. Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times upper limit of normal Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other (...) a pharmacokinetic or pharmacodynamic-mediated drug interaction in patients treated with this regimen. V. Determine the objective response rate and stabilization rate in patients treated with this regimen at the MTD. VI. Determine the acute and long-term toxic effects of this regimen at the MTD in these patients. VII. Determine the time to tumor progression and survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients are stratified according to age (under 50 vs 50

2001 Clinical Trials

3127. Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer

: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 4 times upper limit of normal (ULN) PT/PTT less than 1.5 times ULN Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No evidence of congestive heart failure No serious cardiac dysrhythmia No evidence of recent prior myocardial infarction on EKG No clinical coronary artery (...) : Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases. Determine the safety profile of this regimen in these patients. Determine the clinical activity of this regimen, in terms of inflammation at injection site(s) and disease regression or stabilization, in these patients. OUTLINE: This is a dose-escalation study. Patients receive

2001 Clinical Trials

3128. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

upper limit of normal 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: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No unstable medical conditions No severe concurrent disease or infection that would preclude study No intestinal obstruction (...) cancer, fallopian tube cancer, or primary peritoneal cancer. Condition or disease Intervention/treatment Phase Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: canfosfamide hydrochloride Phase 2 Detailed Description: OBJECTIVES: I. Determine the objective response rate and disease stabilization rate in patients with platinum-resistant advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated with TLK286. II. Determine the safety

2001 Clinical Trials

3129. [Self-care in the prevention of sudden cardiac death]. (Abstract)

[Self-care in the prevention of sudden cardiac death]. In acute myocardial infarction a third up to half of death registered within the first month occur in the first hour of the onset of attack most frequently because of ventricular fibrillation. Immediate self administration of drugs stabilizing electrically the heart may prevent it. On the basis of experiments in dogs and in rats flunitrazepam (Rohypnol tabl. 1 mg), tramadol (Tramal caps. 50 mg) and the beta blocker metipranolol (Trimepranol (...) sleepy. There were no undesirable changes in the heart rate or blood pressure. In the three drug combination with metripranolol, the decrease in the heart rate was more marked. The tests in volunteers were without any undesirable effects and both combinations may, therefore, be given to selected high risk subjects, e g. convalescents from myocardial infarction. Randomized trial to prove the preventive effect already started.

1992 Vnitr̆ní lékar̆ství

3130. [A comparison of the clinical efficacy of enalapril maleate analogs in patients with heart failure and ischemic heart disease]. (Abstract)

[A comparison of the clinical efficacy of enalapril maleate analogs in patients with heart failure and ischemic heart disease]. The authors examined 68 patients aged from 42 to 68 years with ischemic heart disease without a history of myocardial infarction and with angina pectoris of exertion functional class 2-3 and circulatory insufficiency class 2 (according to NYHA criteria). The criteria serving as the reason for relating patients to the follow-up group were left-ventricular end-diastolic (...) volume > 160 ml, ejection fraction < 30%, cardiothoracic index > 0.55, threshold power of endured loads within a range of 71.5 +/- 2.30 watt. After stabilization of the clinical status by means of basic therapy (nitrates, blockers of slow calcium channels, diuretics, antiaggregants), all patients were divided into two follow-up groups. The first group consisted of 36 patients who received renitec (10 mg/24 h), patients of group 2 were given enap in the same dose. The course of treatment lasted 12

1998 Eksperimental'naia i klinicheskaia farmakologiia

3131. A comparison of the efficacy of sotalol and nadolol in the suppression of ventricular ectopic beats. (Abstract)

and no membrane-stabilizing action. Twenty-two patients with stable chronic ventricular arrhythmias after myocardial infarction were studied; to qualify for entry they had to exhibit a minimum frequency of 30 ventricular ectopic beats per hour over a 24-hour Holter monitoring period. The study was of single-blind, cross-over format with placebo periods before active drug administration and during the cross-over periods. Nadolol 80 and 160 mg and sotalol 160 and 320 mg were administered for 7-day periods

1983 South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde Controlled trial quality: uncertain

3132. Ibopamine as a substitute for digitalis in patients with congestive heart failure on chronic digoxin therapy. Smith Kline and French Ibopamine Group. (Abstract)

with ibopamine in any measured parameter. There were two deaths during the study: a sudden death and one following an acute myocardial infarction. Both patients were on digoxin. This study suggests that in patients with mild-to-moderate congestive heart failure, ibopamine therapy may effectively and safely substitute digoxin therapy for up to four weeks, representing an option for patients requiring inotropic support but are at risk for potential digoxin toxicity. (...) Ibopamine as a substitute for digitalis in patients with congestive heart failure on chronic digoxin therapy. Smith Kline and French Ibopamine Group. The substitution of digoxin with ibopamine, a new inotropic and vasodilating agent, was evaluated in a multicenter study in 58 patients with mild-to-moderate congestive heart failure, stabilized on diuretics, and digoxin therapy. The study was a parallel, double-blind, randomized trial of four weeks duration in which half of the group continued

1989 International journal of cardiology Controlled trial quality: uncertain

3133. Doxazosin for the treatment of chronic congestive heart failure: results of a randomized double-blind and placebo-controlled study. (Abstract)

of worsening heart failure severe enough to prompt discontinuation of the study, myocardial infarction, and death). Doxazosin was well tolerated, producing no major side effects and only a slightly higher frequency of minor treatment-related side effects compared with placebo (p = NS).(ABSTRACT TRUNCATED AT 250 WORDS) (...) Doxazosin for the treatment of chronic congestive heart failure: results of a randomized double-blind and placebo-controlled study. In this study we evaluated the effects of once-daily administration of oral doxazosin in patients with chronic congestive heart failure (CHF). After a stabilization period of at least 2 weeks with digitalis and diuretics, 73 patients with chronic CHF were randomized to receive additionally either doxazosin or placebo in double-blind fashion. Patients underwent

1991 American heart journal Controlled trial quality: uncertain

3134. Chemotherapy in Treating Women With Metastatic Breast Cancer

than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Neurologic: No history of an existing grade 3-4 peripheral neuropathy of any etiology Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No allergy to camptothecin (...) therapy (e.g., patients with disease that is primarily resistant to hormonal therapy, patients without prior partial response, or stabilization of disease lasting less than 6 months) Patients with new or extensive visceral metastases Patients with rapidly progressive or symptomatic metastases during hormonal therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to greater than 50% of bone marrow No concurrent radiotherapy

2000 Clinical Trials

3135. SU5416 in Treating Patients With Advanced Solid Tumors

: No New York Heart Association class III or IV heart disease No uncompensated coronary artery disease on electrocardiogram or physical exam No myocardial infarction or severe or unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep vein thrombosis or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use (...) tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progression-free survival in this patient population. III. Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population. IV

2000 Clinical Trials

3136. Mitomycin and Mitoxantrone in Treating Patients With Acute Myelogenous Leukemia

and SGPT no greater than 3 x normal Alkaline phosphatase no greater than 3 x normal No active hepatitis Renal: Not specified Cardiovascular: No myocardial infarction within last 6 months No congestive heart failure Ejection fraction greater than 50% (measured by MUGA or 2-D Echo) Pulmonary: No severe chronic obstructive pulmonary disease Other: No active infection or antimicrobiologically stabilized infection Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See

1999 Clinical Trials

3137. A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood

the possibility of premature myocardial infarction has led health care providers and patients to consider treating these lipid metabolism disorders. Statin compounds have beneficial effects as lipid-lowering agents, and thereby reduce the risk of cardiovascular complications. Statin compounds such as pravastatin, simvastatin, and atorvastatin are increasingly being prescribed in persons taking PI-based potent antiretroviral therapy. It is important to determine whether there are significant drug-drug (...) interactions between the statin compounds and PIs. Fourteen healthy participants for each cohort of Arm A are stabilized on a fixed regimen of pravastatin (Arm A1), simvastatin (Arm A2), or atorvastatin (Arm A3) for 4 days. A baseline pharmacokinetic (PK) evaluation is completed on Day 4. Pravastatin (or simvastatin or atorvastatin) dosing stops following the Day 4 dose and PK evaluation. On Day 5, a ritonavir and saquinavir combination regimen is initiated and continued through Day 18 of the study

1999 Clinical Trials

3138. Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals

additional courses those who achieve partial response or stabilization, continue therapy until progression. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A Phase II Trial of Paclitaxel From Baker Norton Pharmaceuticals Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go (...) . Failed at least one systemic chemotherapy regimen. Exclusion Criteria Co-existing Condition: Patients with the following conditions and symptoms are excluded: Less than 2 weeks since major surgery. Serious uncontrolled infection. NOTE: Must be ruled out by thorough work-up in patients with unexplained fevers, night sweats, or involuntary weight loss of more than 10% normal weight. Leukopenia. Thrombocytopenia. Patients with the following prior conditions are excluded: History of angina or myocardial

1999 Clinical Trials

3139. A Study of WF 10 IV Solution in Patients With Advanced HIV Disease

: Neoplasm other than basal cell carcinoma of the skin. Clinically significant cardiac disease. Anemia. Concurrent Medication: Excluded: Cytotoxic chemotherapy. Corticosteroids. Patients with the following prior conditions are excluded: History of myocardial infarction or arrhythmias. Prior Medication: Excluded within 2 weeks prior to study entry: Any antiretroviral agent. Interferon. Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic (...) Concurrent Medication: Allowed: Approved drugs at a stabilized dose except those specifically excluded. Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis. Patients must have: HIV positivity. Absolute CD4 count < 200 cells/mm3. Intolerance to or refusal to take AZT, ddI, ddC, or d4T. No active opportunistic infection requiring ongoing therapy. Life expectancy at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded

1999 Clinical Trials

3140. Lung Health Study II

) < 70 percent Forced expiratory volume at one second (FEV1) 30 to 90 percent predicted. Exclusions: Cancer Recent myocardial infarction Alcoholism Heart Failure Insulin-dependent diabetes mellitus Neuropsychiatric disorders Used bronchodilators or oral or inhaled corticosteroids in previous year Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided (...) in the development of emphysema. On this basis, the rationale for the use of corticosteroids is well justified. There are various published studies suggesting that inhaled steroids reduce bronchial lavage markers of inflammation, variously influence short-term bronchial hyperreactivity, improve lung function acutely or short-term, and slow rate of decline in lung function. Most studies have asked for improvement rather than stability. However, despite the studies which do not support these contentions

1999 Clinical Trials

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