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Cerebrovascular Accident Risk in Women

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1581. Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants

diabetes with documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident, or any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol Signs of colon cancer or dysplasia Signs of severe or unstable renal, hepatic, gastrointestinal, cardiovascular, respiratory, neurological (...) to sign informed consent If female of childbearing age, be post-menopausal, surgically sterile, or willing to use a reliable form of birth control for the duration of the study (such as physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device)and for at least five months after the last adalimumab treatment. Able to comply with the requirements of the study. CDAI score ≤ 220. Calprotectin > or = 250µg/g and/or hsCRP > or = 5mg/L. Significant

2012 Clinical Trials

1582. Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

approved form of contraception from screening until after the psilocybin administration sessions; Having a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions; and Able to provide adequate locator information. Exclusion Criteria: Exclusionary medical conditions (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, uncontrolled hypertension, history of cerebrovascular accident, severe obesity (BMI (...) and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Males and females age 25-65 with SCID diagnosis of alcohol dependence; Concerned about their drinking

2012 Clinical Trials

1583. Effect of Aged Garlic Extract on Atherosclerosis

to 65 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria Age 40-65 years Framingham risk score 6-20%, and at least 2 components of the metabolic syndrome as defined by ATP III Clinical Identification of the Metabolic Syndrome (including impaired fasting glucose > 110 mg/dl, treated hypertension or SBP > 130 or DBP > 85 mm Hg, plasma triglycerides > 150 mg/dl, HDL cholesterol < 35 mg/dl for men or < 40 mg/dl for women, abdominal (...) -platelet agents) Renal failure History of hypertensive encephalopathy or cerebrovascular accident Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI 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 by the sponsor. Please refer to this study

2012 Clinical Trials

1584. Atrial Fibrillation Progression Trial

fibrillation/ atrial flutter. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery. Pulmonary embolism or recent atrial embolism/thrombosis. Hypertrophic obstructive cardiomyopathy. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation). Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation. Heritable arrhythmias (...) or increased risk for torsade de pointes with class I or III Drugs. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure. Prior AV nodal ablation. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications. Medical conditions limiting expected survival to <3

2012 Clinical Trials

1585. AMG 386 and Abiraterone for Advanced Prostate Cancer

cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication or placement of percutaneous transluminal coronary angioplasty/stent. Major surgery within 28 days prior to enrollment or still recovering from prior surgery. Minor surgical procedures, placement (...) or equal to 1.5 times upper limits of normal (ULN) per institutional laboratory range and international normalized ratio (INR) less than or equal to 5 Creatinine less than or equal to 1.5 times institutional upper limits of normal OR Creatinine clearance of >40 mL/min per 24 h urine collection or calculated according to the Cockcroft-Gault formula ---Creatinine clearance (CrCl) (mL/min) = (((140-age) times actual body weight (kg))/(72 x serum creatinine (mg/dL)))*(x 0.85 for females) Urinary protein

2012 Clinical Trials

1586. Vascular Inflammation in Psoriasis Trial (The VIP Trial)

condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study. History of diabetes mellitus, type 1 or type 2 - note that patients with type 2 diabetes may be enrolled if the duration of diabetes is <10 years and HbA1c is <7.0%) Uncontrolled hypertension, with measured (...) of Pennsylvania Study Details Study Description Go to Brief Summary: The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo (an inactive substance that may resemble an active substance but has no medical value) injection. The study will compare the effects of each on systemic inflammation and cardiovascular disease risk factors in subjects diagnosed with moderate to severe psoriasis. This study will look

2012 Clinical Trials

1587. A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors

, or angioplasty Pulmonary hemorrhage or gross hemoptysis within 12 months Known arterial or venous thrombosis or pulmonary embolism within 2 years Concurrent use of systemic low molecular weight heparin or low dose warfarin Presence of brain metastases Cerebrovascular accident or transient ischemic attack within 2 years Cardiovascular events, such as myocardial infarction, unstable/severe angina, coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring medication, congestive heart (...) administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years. ] A serious AE (SAE) is any AE that results in death (refers to an event, which risk

2012 Clinical Trials

1588. Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

History of cerebrovascular accident Transient ischemic attack within two years Cerebral aneurysm Dementia Parkinson's disease Huntington's chorea Multiple sclerosis Current History of substance abuse including alcoholism or history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine). Inadequate communication with the patient. Under custodial care. Participation currently in another clinical study or enrolled in another clinical study within 30 days prior (...) depression (BP1 or BP2) according to DSM IV, with the additional requirement of duration for the current episode ≥ 4 weeks and CGI ≥ 4. Men and Women Ages 22-68 years. Negative answers on safety screening questionnaire for transcranial magnetic stimulation. Taking mood stabilizing medication (e.g., Lithium, Lamictal, Tegretol, Topamax, etc.) at a therapeutic dose or atypical antipsychotic medication which was prescribed as mood stabilizers by their treating physician, except for Leponex (Clozapine

2012 Clinical Trials

1589. Second-line Pazopanib Renal Cell Carcinoma (RCC) Study. ICORG 10-01, V5

/ALT above 1.0 x ULN (upper limit of normal) are not permitted. If UPC > or = 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value <1 g to be eligible. A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: A hysterectomy A bilateral oophorectomy (ovariectomy) A bilateral tubal ligation Is post-menopausal Subjects (...) Childbearing potential, including any female who has had a negative serum or urine pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants

2012 Clinical Trials

1590. Imaging Study of the Lungs During an Allergic Asthma Attack

infection within the previous 6 weeks. Participation in research study involving a drug or biologic during the 30 days prior to the study. Intolerance to albuterol, atropine, or lidocaine. Antihistamines within 7 days of the screening visit. Known exposure to agents that are associated with pulmonary disease (i.e. asbestos, silica). Presence of other known pulmonary disease, coronary disease, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure (...) allergen and demonstrated skin reactivity Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years Willing and able to give informed consent Expressed the desire to participate in an interview with the principal investigator Exclusion Criteria: Women of childbearing potential who are documented to be pregnant (based on blood testing) or who are nursing. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract

2012 Clinical Trials

1591. Trebananib And Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

>= grade 2 in severity except alopecia Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or TEK tyrosine kinase, endothelial (Tie2) receptor Clinically significant cardiovascular disease within 12 months prior to enrollment/randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient (...) that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with AMG 386; these potential risks may also apply to temsirolimus Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible Patients with pre-existing clinically significant pulmonary infiltrates of unknown origin Patients with an indwelling peritoneal or pleural catheter that is used to manage

2012 Clinical Trials

1592. Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

of > or = 140 mmHg or diastolic blood pressure > or = 90 mmHg]. History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep vein thrombosis within the past 6 months. Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. Evidence of active bleeding or bleeding diathesis. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase (...) have documented disease progression within the past 6 months. Adequate organ system function determined within 14 days prior to first dose of study treatment. Left ventricular ejection fraction (LVEF) > 50% of the institutional LLN within 28 days prior to the first dose of study treatment. Females must be of either non-child bearing potential or have a negative pregnancy test within 7 days prior to the first dose of study treatment. Exclusion Criteria: Well differentiated liposarcoma. Prior

2012 Clinical Trials

1593. Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma

aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets) Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets) Valid written informed consent signed by the patient prior to any study-specific procedures. Exclusion Criteria: Women who are pregnant or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. A negative pregnancy test is required within 24 hours of administration (...) of radiotracer and study initiation for women of childbearing age and potential. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. Prior treatment with a VEGF receptor TKI within a time period equivalent to 5 half

2012 Clinical Trials

1594. Vandetanib With Everolimus

) or presence of stroke/cerebrovascular accident. Congenital long QT syndrome. QTcF interval greater than 500 ms that is not correctable to less than 500ms such as with cessation of a causative medication, etc. History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the Investigator, increases the risk of ventricular arrhythmia. Presence of a symptomatic bradyarrhythmia or uncompensated heart failure. Contacts and Locations Go to Information from the National (...) for ventilatory support. Pregnant or lactating women. History of hypersensitivity to vandetanib, lactose, murine products, or any component of the formulation. History of hypersensitivity to sirolimus, temsirolimus, everolimus. History of hypersensitivity to any component of the formulation. Patients unwilling or unable to sign informed consent document. Presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. History (within the last 3 months

2012 Clinical Trials

1595. Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Female patients who are pregnant or lactating. Other severe acute or chronic medical or psychiatric condition, or laboratory (...) Investigator, Dr. Alan L. Ho. Male or female, age > or = to 18 years. ECOG performance status < or = to 2 (Karnofsky > or = to 60%, see Appendix A). Life expectancy of ≥ 12 weeks. Adequate organ function as defined by the following criteria: absolute neutrophil count (ANC) > 1000 cells/mm3 platelets > or = to 75,000 cells/mm3 Hemoglobin > or = to 9.0 g/dL AST and ALT < or = to 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT < 5.0 x ULN Total bilirubin

2012 Clinical Trials

1596. Pilot Immunotherapy Trial for Recurrent Malignant Gliomas

failure, recent major cerebrovascular accident, brittle diabetes, renal dialysis, end stage liver disease, or labile hypertension. Patients who have a history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products. Patients with an abnormal INR (International Normalized Ratio of greater than 1.3), if repeatable and refractory to correction by routine methods. Patients who have documented deep venous thrombosis Contacts and Locations Go to Information from (...) strategies, this treatment marshalls the native immune system (specifically the antigen presenting cells, or dendritic cells) rather than engineering the differentiation of these immune cells and re-injecting them. Compared to traditional treatment alternatives for tumor recurrence, including a boost of further radiation and more chemotherapy, this treatment represents potentially greater benefit with fewer risks. This combination product serves as a therapeutic vaccine with an acceptable safety profile

2012 Clinical Trials

1597. Comparison of TAK-875 to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes

compared to placebo plus metformin and sitagliptin plus metformin on glycemic control as measured by change from baseline in glycosylated hemoglobin (HbA1c) over a 24-week Treatment Period. Participants completing the 24-week Treatment Period may enter an optional 80-week extension period for a total of 104 weeks of treatment. Due to concerns about potential liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda (...) , you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: The participant is male or female and 18 years of age or older with a historical diagnosis of type II diabetes mellitus. The participant meets one of the following criteria: The participant

2012 Clinical Trials

1598. Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes

) > 3500 mg/g during screening; Recently active cardiovascular disease defined as: Unstable angina pectoris within 12 weeks before Study Day -1; Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before Study Day -1; Cerebrovascular accident, including transient ischemic attack within 12 weeks before Study Day -1; Current diagnosis of Class III or IV NYHA congestive heart failure (Appendix C); Clinical diagnosis of severe (...) . For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Screening eGFR ≥ 15.0 and < 45.0 mL/min/1.73 m2. A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age (if diabetes developed at a younger age, a fasting C-peptide level must confirm type 2 diabetes); Male or female patients at least 18 years of age; Body mass

2012 Clinical Trials

1599. Salvage Ovarian FANG Vaccine + Bevacizumab

Association grade II or greater congestive heart failure. Serious cardiac arrhythmia requiring medication. Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit History of cerebrovascular accident within the past 6 months. No significant traumatic injury within the past 28 days. Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (...) /kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. Prior splenectomy. Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. Kaposi's Sarcoma. Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels

2012 Clinical Trials

1600. Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 Diabetes

Day 1; Cerebrovascular accident, including transient ischemic attack within 12 weeks before Study Day 1; Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy; Atrioventricular block, 2o or 3o; Administration of a contrast agent that may induce nephropathy within 30 days prior to Study Day 1 or planned during the study; Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to Study Day 1 or anticipated (...) (if diabetes developed at a younger age, a fasting C-peptide level must be ≥ 0.1 ng/mL to confirm type 2 diabetes); Male or female patients at least 18 years of age; Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 6 weeks prior to Study Day 1. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to and/or during screening (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB

2012 Clinical Trials

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