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Congenital Heart Disease Imaging in Adults

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3801. Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

of the study or could put the subject at unacceptable risk. Right-to-left, bidirectional, or transient right-to-left cardiac shunts. Subjects with a history of acute cerebral infarction or transient ischemic attack within 90 days prior to Study Day 1. Acute myocardial infarction or acute coronary syndromes less than one year prior to enrollment. Serious ventricular arrythmias or high risk for arrhythmias due to prolongation of the QT interval. Subjects who experienced a major surgery, radiotherapy (...) hypertension due to compromised pulmonary arterial vasculature. Subjects with Raynaud's syndrome. Subjects with a serious co-morbid medical condition. If female, subject is pregnant and/or breastfeeding. Any subject with congenital or acquired methemoglobinemia. Any subject with a history of inherited anemia or hemoglobinopathy including but not limited to hereditary spherocytosis, hereditary elliptocytosis, hereditary ovalocytosis, Contacts and Locations Go to Information from the National Library

2011 Clinical Trials

3802. 12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)

uncontrolled glaucoma (intraocular pressure > 25 mmHg) despite treatment with anti-glaucoma medication. A known, positive test for Hepatitis B surface antigen or Hepatitis C antibody within 3 months of screening Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Active bleeding disorder or a history of hemoptysis, cerebral or clinically significant gastrointestinal hemorrhage within 6 months (...) Posted : September 21, 2017 Sponsor: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline Study Details Study Description Go to Brief Summary: The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD. Condition or disease Intervention/treatment Phase Macular Degeneration Drug: pazopanib eye drops Phase 2 Detailed Description: MD7114987 is a Phase 2a study designed to determine

2011 Clinical Trials

3803. Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients

-up visits after the end of the study chemotherapy. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Carfilzomib Drug: Lenalidomide Drug: Dexamethasone Phase 2 Detailed Description: Background: Multiple myeloma (MM) is an incurable plasma cell neoplasm with a median survival of 3-4 years. Novel agent combinations with proteasome inhibitors demonstrate improved response rates while increasing survival in MM patients. A common debilitating side effect of the proteasome (...) 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 to 99 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA: Newly diagnosed patients with histologically confirmed multiple myeloma (MM) based on the following criteria: Clonal plasma cells in the bone marrow Measurable disease within the past 4 weeks defined by any

2011 Clinical Trials

3804. Safety and Tolerability Study of RAD001 and LBH589 in All Solid Tumors With Enrichment for EBV Driven Tumors

; Patients with uncontrolled diabetes (fasting glucose > 2x ULN); History of uncontrolled heart disease (unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality such as second and third degree heart block, congenital long QT syndrome, obligate use of a cardiac pacemaker. Patients with QTc at screening > 450 ms. Subjects taking medications known to have a risk of causing causing QTc prolongation and Torsades de (...) effects. Condition or disease Intervention/treatment Phase Nasopharyngeal Carcinoma, Lymphomas, Any EBV+ Solid Tumour Drug: LBH589 and RAD001 Phase 1 Detailed Description: Dose escalation phase 1B of the study will evaluate the safety and tolerability of RAD001 in combination with LBH589 in all solid tumors, lymphomas; and enriched for EBV driven tumors. The phase 2 component will be a single arm, non-randomized study restricted to nasopharyngeal carinoma only (endemic type). A "3+3" dose escalation

2011 Clinical Trials

3805. Long-Term Safety and Efficacy Study of Peginterferon Beta-1a

Week 96 in Study 105MS301 (NCT00906399). Key Exclusion Criteria: Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399). Subjects with any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease Pregnant or nursing women. NOTE: Other protocol-defined Inclusion/Exclusion criteria may (...) Study Description Go to Brief Summary: The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. Condition

2011 Clinical Trials

3806. Assessmet of Patients With PAH Right Ventricular Volume

, myeloproliferative disorders or splenectomy Any subjects with congenital heart disease other than the simple congenital to systemic shunts specified in the inclusion criteria PAH associated with significant venous or capillary involvement (PCWP ˃ 15 mmHg), known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis Clinically significant cardiac ischemic disease Systemic hypertension defined as SBP ˃ 160 mmHg and/or DBP ˃ 95 mmHg (treated or untreated) Moderate or severe hepatic impairment (...) as appropriate) Other forms of PH not included in inclusion criteria Left heart disease including clinically significant valvular disease, ,i.e. moderate or greater mitral regurgitation or stenosis or mild or greater aortic insufficiency or stenosis, pericardial disease, LV systolic dysfunction, i.e. LVEF <40% or LVSF <22%, and/or clinically significant LVDD Known/detected arrhythmia that interferes with image acquisition Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic

2011 Clinical Trials

3807. Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation

coronary syndrome, angina or active myocardial ischemia diagnosed by ECG, or other imaging within 6 months of screening History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest History of clinically significant congenital heart disease Presence of severe aortic or mitral stenosis, aortic or mitral regurgitation, atrial septal defect, or other conditions leading to AF Diagnosis of heart failure NYHA Class II-IV or with an ejection fraction <40% (Part 1 only) Diagnosis of heart (...) ) or sick sinus syndrome, unless controlled by a pacemaker Current reversible cause of AF Wolff-Parkinson-White syndrome Any congenital abnormality, severe valve disease Subjects who have taken another investigational product within 30 days of dosing 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 by its

2011 Clinical Trials

3808. Tecemotide (L-BLP25) in Prostate Cancer

Subjects should have no autoimmune diseases that have required treatment as specified in the protocol History of immunodeficiency diseases, hereditary or congenital immunodeficiencies Serious intercurrent medical illness A clinically significant cardiac disease Subjects who have received any prior therapy for prostate cancer Subjects who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis Subjects receiving any other investigational agents Contraindication (...) to biopsy such as bleeding disorders, ratio of prothrombin time to partial thromboplastin time (PT/PTT) >=1.5 times the upper limit of normal, artificial heart valve Contraindication to MRI such as subjects weighing >136 kilograms, allergy to magnetic resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices Contraindication to radiation therapy such as pre-existing and active prostatitis or proctitis, inflammatory bowel disease

2011 Clinical Trials

3809. Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

of the protocol. Patients must not have a serious intercurrent illness including, but not limited to: Ongoing or active infection requiring parental antibiotics on Day 1 A history of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib. History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 History of congenital long QT syndrome or mean corrected QTc interval > 450 msec at baseline Clinically significant (...) cardiovascular disease, defined as any of the following conditions: i. Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) ii. Prior history of hypertensive crisis or hypertensive encephalopathy iii. Myocardial infarction within 6 months iv. Unstable angina v. New York heart association grade II or greater congestive heart failure (Appendix C) vi. Serious cardiac arrhythmia requiring medication vii. LVEF < 50% or below institutional limit

2011 Clinical Trials

3810. Myocardial Perfusion MRI

block (LBBB) Known congenital long QT syndrome or a family history of congenital long QT syndrome Known previous arrhythmias on drugs that prolong cardiac repolarization Uncorrected hypokalemia Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg) Baseline hypotension (e.g. mean arterial pressure <60 mm Hg) Ejection fraction below 35% Cardiomyopathy, congenital heart defect or higher degree valvular pathology Coronary artery stent placement within 4 (...) . The total imaging time is about 45 min. Condition or disease Intervention/treatment Phase Myocardial Perfusion Imaging Magnetic Resonance Imaging Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875) Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 232 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic Official Title

2011 Clinical Trials

3811. Prevalence and Long-term Impact of Non-atherosclerotic CAD

vascular territory, and to evaluate the long-term outcome of young women with NACAD in comparison to those with atherosclerotic CAD over a 5-year follow-up. Condition or disease Myocardial Infarction Detailed Description: All women aged 55 or younger having a coronary angiogram for acute coronary syndrome (ACS) will be approached prior to their procedure. A pregnancy test will be performed (standard for pre-menopausal women due to potential radiation exposure). If the cause of the heart attack (...) , 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: 19 Years to 55 Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Women aged 55 or younger with a troponin positive acute coronary syndrome (ST and non-ST elevation myocardial infarction or Acute Coronary Syndrome (ACS)) having

2011 Clinical Trials

3812. Effects of Weight Loss on Cardio-respiratory Function

increases the risk for heart disease independent of other known risk factors such as coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea. Obesity also causes significant changes in pulmonary function, including a decrease in expiratory reserve volume and functional residual capacity and closure of peripheral airways. The exact mechanisms for the development of cardiopulmonary disease are not well understood - the pathophysiology is complex and likely multifactorial (...) planes. Adenosine stress MRI will be performed for evaluation of underlying coronary artery or microvascular disease. Condition or disease Obesity Cardiovascular Abnormalities Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 150 participants Observational Model: Case-Only Time Perspective: Prospective Official Title: Effects of Weight Loss on Cardio-respiratory Function and Patient-centered Outcomes in an Underserved, Minority Population

2011 Clinical Trials

3813. REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE

). Patient is not likely to be compliant with the protocol, in the opinion of the Investigator. Currently hospitalized. Current use of an intravenous inotrope. Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival. Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment. Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant (...) are related to prognosis. Condition or disease Intervention/treatment Congestive Heart Failure Other: No Intervention Detailed Description: REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis. Within

2011 Clinical Trials

3814. Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

/min) History of coronary artery disease (CAD) (e.g., angina Canadian class II-IV) For any patients in whom there is doubt, a stress-imaging study should be performed and if abnormal, an angiography should also be performed to define whether or not CAD is present An ECG recorded at screening showing significant ST depression (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment at a point 60 msec from the end of the QRS complex) NYHA class II to IV congestive heart failure (CHF (...) contraception device [IUCD], double-barrier method using condoms, or a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter No known cardiac abnormalities, including any of the following: Congenital long QT syndrome QTc interval > 480 msec Myocardial infarction within 12 months prior to study entry Other significant electrocardiogram (ECG) abnormalities, including type II second- or third-degree atrio-ventricular (AV) block, or bradycardia (ventricular rate < 50 beats

2011 Clinical Trials

3815. Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia

; 3) the structure of your face compared to faces of people affected by HED; 4) molds of your teeth to see if and how they are different than people affected by HED. Condition or disease Hypohidrotic Ectodermal Dysplasia Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 27 participants Official Title: Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia Study Start Date : February 2011 (...) test results) Exclusion Criteria: Medically significant condition as determined by the PI Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (e.g. Urecholine, Salagen, Pilocar, Provocholine) Presence of cardiac pacemaker 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 by its

2011 Clinical Trials

3816. Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial

prior to enrollment with the exception of basal cell carcinoma EXCLUSION CRITERIA: Metastatic disease including malignant ascites Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, heart failure Childs B or C cirrhosis or with evidence (...) and imaging studies. Two weeks after the fourth treatment (course 1), participants will have more imaging studies, a physical examination, and blood tests. If the tumor is shrinking, participants will have two more courses of treatment (eight more infusions of gemcitabine). Participants will have followup visits every 3 months for 2 years following the last treatment and then every 6 months. Condition or disease Intervention/treatment Phase Histologically or Cytologically Confirmed Pancreatic Ca

2011 Clinical Trials

3817. Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

cardiovascular disease; this includes: Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications History of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (< 60 beats per minute [bpm]), heart block (excluding 1st degree block being, PR interval prolongation only), congenital long QT syndrome, new ST segment elevation or depression, or new Q waves on electrocardiogram (ECG) Patients with corrected QT (...) , magnetic resonance imaging (MRI) or caliper measurement by clinical exam, or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI Detectable disease in a patient is defined as one who does not have measurable disease but has at least one of the following conditions: Baseline values of CA-125 at least 2 x upper limit of normal (ULN) Ascites and/or pleural effusion attributed to tumor Solid and/or cystic abnormalities on radiographic imaging that do

2011 Clinical Trials

3818. Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas

with any other tyrosine kinase inhibitor Impaired cardiac function including any one of the following: i. Inability to monitor the QT interval on ECG ii. Congenital long QT syndrome or a known family history of long QT syndrome. iii. Clinically significant resting brachycardia (<50 beats per minute) iv. QTc > 450 msec on baseline ECG. If QTc >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc v. Myocardial infarction within (...) known brain metastasis. Non specific CNS changes on MRI characteristic with NF1 are allowed. Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation) Acute or chronic liver disease or severe renal disease considered unrelated to the cancer. History of significant congenital or acquired bleeding disorder unrelated to cancer Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery. Treatment with other investigational

2011 Clinical Trials

3819. Sorafenib and TRC105 in Hepatocellular Cancer

, including tests of kidney function. Participants will have imaging studies after every two cycles to evaluate the results of treatment, and may also provide tumor samples for study. Treatment will continue as long as the tumor does not grow and side effects remain tolerable. Condition or disease Intervention/treatment Phase Hepatoma Liver Neoplasms Adenoma, Liver Cell Carcinoma, Hepatocellular Liver Neoplasms, Experimental Drug: TRC 105 Drug: Sorafenib Phase 1 Phase 2 Study Design Go to Layout table (...) intercurrent illness including, but not limited to, hypertension (systolic blood pressure (BP) greater than 140, diastolic BP greater than 90), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements. No anti-coagulation therapy is allowed with the exception of low-dose aspirin. No bleeding diathesis. Patients with a history of bleeding varices

2011 Clinical Trials

3820. Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction

belinostat once a day for 5 days, and will be asked to keep a medication diary to record any side effects. Participants will have regular clinic visits with blood and urine sample collection and imaging studies to evaluate the cancer's response to treatment. Participants may continue to take belinostat for as long as the cancer responds to the treatment. Condition or disease Intervention/treatment Phase Neoplasms Lymphomas Drug: Belinostat Phase 1 Detailed Description: Background: Belinostat is a histone (...) are ineligible because of the potential for the increased risk of liver dysfunction from the antiretroviral therapies themselves and because of potential pharmacokinetics (PK) interactions with belinostat. Appropriate studies will be undertaken in these groups of patients when indicated. Patients with significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), symptomatic congestive heart failure, myocardial infarction within the past 6 months, unstable angina, unstable

2011 Clinical Trials

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