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4361. Lansoprazole to Treat Children With Asthma

or behavioral disorder (excluding mild attention deficit hyperactivity disorder), or other condition that would interfere with participation in the study History of phenylketonuria Medications for treatment of GI symptoms (e.g., proton pump inhibitors, H2 blockers, bethanechol, metoclopramide) in the month prior to study entry (intermittent anti-acids are allowed) Use of theophylline preparations, azoles, anti-coagulants, insulin for Type I diabetes, digitalis, or oral iron supplements when administered

2007 Clinical Trials

4362. The Effects Of GW679769 (Casopitant) On The Pharmacokinetics Of Docetaxel In Subjects With Cancer

with the P-glycoprotein pathway within 14 days prior to the first dose of study medication until 14 days after the last dose of docetaxel including digoxin. Use of drugs with a narrow therapeutic index that are metabolized by CYP2C8 within 14 days prior to the first dose of study medication including repaglinide and torsemide. Disease that will significantly affect absorption of oral medications. Inadequate venous access for pharmacokinetic sampling. Unresolved Grade 2 or worse toxicity from prior (...) be repeated once if subject did not abstain from red meat for the previous three days. Pepsinogen level below the lower limit of laboratory reference range (LLRR). Troponin level above 10% of the coefficient of variation of the assay as determined by the laboratory performing the test. Calculated QT interval (QTc) > 480 msecs. Clinically significant cardiac disease that would interfere with participation in the study as determined by the investigator. Known or suspected iron deficiency. Use of NSAIDS

2007 Clinical Trials

4363. Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

of Tamsulosin hydrochloride and other alpha blockers. Use of Antiarrhythmic drugs, including digoxin. History of MI or cardiovascular attack (CVA) within the preceding 6 months. History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin Pregnant or nursing (lactating) women Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact

2007 Clinical Trials

4364. Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

intravenous catheter Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month. Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump. Exclusion Criteria: nursing or pregnant woman received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month. Had any PAH

2007 Clinical Trials

4365. Effect of Fluvastatin on Biomarkers in Women Who Are Undergoing Surgery for Ductal Carcinoma In Situ or Stage I Breast Cancer

to tolerate statins Willing to undergo 2 blood draws (separated by approximately 3-4 weeks) during study participation (control arm) PRIOR CONCURRENT THERAPY: No other concurrent statins No concurrent chemotherapy No concurrent administration of any of the following: Niacin Propranolol Cholestyramine Cyclosporine Digoxin Erythromycin Itraconazole Gemfibrozil Phenytoin Diclofenac Tolbutamide Glyburide Losartan Cimetidine Ranitidine Omeprazole Rifampin Warfarin No initiation of new hormonal therapy during

2006 Clinical Trials

4366. Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

x ULN unless on anti-coagulant therapy PTT < 1.5 x ULN unless on anti-coagulant therapy Hepatic: Bilirubin ≤ 1.5 x ULN ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) Renal: Creatinine < 1.5 X upper limit of normal (ULN) Cardiovascular: No significant history of cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began (...) therapy. No use inhibitors or inducers of the cytochrome p450 system CYP3A4 enzyme or other medications such as aprepitant, ketoconazole, itraconazole, quinidine, digoxin, cyclosporine, ritonavir, grapefruit products, St. John's Wort, rifampin (rifampicin), carbamazepine, phenytoin, dexamethasone, and phenobarbital. No evidence or history of bleeding diathesis or coagulopathy. No serious non-healing wound, ulcer, or bone fracture. No known or suspected allergy to sorafenib. No uncontrolled

2006 Clinical Trials

4367. 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men

for the past 3 months. Exclusion criteria: Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition. Are diabetic with an HbA1c >= 8. Are taking any androgens, such as testosterone, saw palmetto. Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements. Would donate more than 500 ML of blood over a 2

2006 Clinical Trials

4368. Vaccine Therapy and GM-CSF in Treating Patients With Recurrent or Metastatic Melanoma

blood clotting Bleeding diathesis No ongoing transfusion requirement No underlying cardiac disease associated with known myocardial dysfunction No unstable angina related to atherosclerotic cardiovascular disease No known autoimmune disease Negative pregnancy test PRIOR CONCURRENT THERAPY: Prior surgery, radiotherapy, chemotherapy, biological therapy (including sargramostim [GM-CSF]), or vaccine therapy allowed No concurrent anticancer therapy (e.g., hormone therapy for prostate or breast cancer (...) ) No concurrent digoxin or other medications for the treatment of heart failure No concurrent immunosuppressive therapy 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 ClinicalTrials.gov identifier (NCT number): NCT00436930 Locations Layout table for location information United States, California Hoag

2007 Clinical Trials

4369. Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Cardiac Toxicity Biological: trastuzumab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lapatinib ditosylate Drug: paclitaxel Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: fluorophotometry Other: laboratory biomarker analysis Other: mass spectrometry Procedure: adjuvant therapy Procedure: quality-of-life assessment Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual (...) Enrollment : 122 participants Allocation: Randomized Primary Purpose: Treatment Official Title: Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 + Breast Cancer Actual Study Start Date : March 16, 2007 Actual Primary Completion Date : April 2009 Resource links provided by the National Library of Medicine related topics: related topics: available for: resources: Arms and Interventions Go to Outcome Measures Go

2007 Clinical Trials

4370. A Phase I/II Trial of Romidepsin (Depsipeptide) and Bortezomib in Patients With Relapsed Myeloma

). Patients with dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above). Patients with uncontrolled hypertension, i.e. SBP ≥ 160 mm Hg or DBP ≥ 95 mm Hg. Patients with cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker. Patients in whom digitalis cannot be discontinued are excluded from study. Patients with Mobitz II second degree heart block, that do not have (...) . Exclusion Criteria: Prior severe allergic reactions to bortezomib (Velcade), romidepsin, boron or mannitol Neuropathy > Grade 3 or Neuropathy of Grade 2 with pain > Grade 1 by NCI-CTCAE criteria (v3.0). Patients with the following cardiac risk factors will be excluded from the study (as per the previous NCI trials): Congenital long QT syndrome QTc interval > 480 milliseconds Patients who have had a myocardial infarction within 12 months of study entry. Patients who have active coronary artery disease

2007 Clinical Trials

4371. Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Who Are Not Infected With P. Aeruginosa

of screening Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir Investigational drug use within 30 days of screening Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization History

2007 Clinical Trials

4372. Doxorubicin Hydrochloride, Cyclophosphamide, and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery

of Adriamycin, Taxol or Herceptin are not eligible; this includes: Angina pectoris that requires the use of antianginal medication Cardiac arrhythmia requiring medication Severe conduction abnormality Clinically significant valvular disease Cardiomegaly on chest x-ray Ventricular hypertrophy on EKG Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg) Current use of digitalis or beta blockers for CHF Clinically significant pericardial effusion Myocardial infarction documented (...) that is HER-2/neu positive OR >= 2.0 cm tumor size HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have

2006 Clinical Trials

4373. Combined CABG and Stem-Cell Transplantation for Heart Failure

will be collected for assessment of autologous cardiac stem cells. Also sample of pericardial fluid will be collected for measures of growth factors. Comparisons: Preoperatively, patients will be imagined by cardiac ultrasound, cardiac MRI, cardiac PET and SPECT. Serum pro-BNB samples will be collected. Postoperatively at 3 months and 6 months pro-BNB and cardiac ultrasound will be evaluated. At one year cardiac ultrasound, cardiac MRI, cardiac PET and SPECT will be reassessed. Heart failure and coronary artery (...) operation is performed via sternotomy during cardiac arrest. Other Name: CABG Procedure: Bone marrow aspiration (crista iliaca) The bone marrow is aspirated from the iliac crest (100ml). During the operation the aspirate is transported to the stem cell laboratory, where the sample is centrifugated through Ficoll(Registered Trademark). Other Name: Stem cell harvest Biological: Intramyocardial mesenchymal stem cell transplantation During the cardiac arrest, stem cells are directly injected to myocardium

2007 Clinical Trials

4374. Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes

: Subjects with mild diabetes without prior medications or impaired glucose tolerance Exclusion Criteria: Pregnancy Recent major cardiac, renal and hepatic disease Intolerance to alcohol Allergy to acarbose treatment 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 ClinicalTrials.gov identifier (NCT (...) terms Diabetes Mellitus Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia Acarbose Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs

2007 Clinical Trials

4375. Trial of Adjunctive Vitamin D in Tuberculosis Treatment

in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy. Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol. Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy Infection with rifampicin-resistant organism

2007 Clinical Trials

4376. St. John's Wort And Kava In The Treatment Of Major Depressive Disorder With Comorbid Anxiety

or < 1 month of synthetic antidepressants or benzodiazepines Previous reaction to kava or St. John's wort Medications that maybe pharmacokinetically altered via St. John's wort including: Amitriptyline anti-coagulants e.g. phenprocoumon, warfarin, Anti-fugals e.g. voriconazole, Anti-histamines e.g. fexofenadine, Benzodiazepines e.g. alprazolam, Chemotherapeutics e.g. irinotecan, digoxin, HIV medication (anti-retrovirals), * Immunosuppressants e.g. cyclosporine, methadone, OCP, Statins e.g

2007 Clinical Trials

4377. Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension

doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 3 Years to 18 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male or female, age 3-18 years Diagnosis of PAH due to IPAH, connective tissue disease, or congenital heart disease Pulmonary arterial hypertension confirmed by a cardiac catheterization, with mPAP > 25 mmHg (...) Investigator) If receiving therapy for PAH, on a stable dose and regimen for at least 3 months prior to the screening visit If receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit Must demonstrate the ability to appropriately use the nebulizer device as part of the screening process Exclusion Criteria: Prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening Portal hypertension or clinically relevant

2007 Clinical Trials

4378. HSP-glomerulonephritis Trial: MP vs CyA

Inclusion Criteria: On the basis of a renal biopsy, the patient has been diagnosed for crescentic HSP glomerulonephritis of ISKDC grade III or IV or HSP glomerulonephritis of ISKDC grade II + a definite nephrotic syndrome (proteinuria > 40 mg/m2/h). Exclusion Criteria: The child is on regular medication known to interact with cyclosporine. Such medication includes cisapride, phenytoin, phenobarbital, carbamazepine, digoxin and anti-inflammatory pain medication. Contacts and Locations Go to Information

2007 Clinical Trials

4379. Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

, angina or congestive heart failure (e.g., digitalis, beta-blockers, calcium channel-blockers), that alter cardiac conduction, unless the medications were administered for other reasons (e.g., hypertension) Had other serious illness or medical conditions including History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that prohibited the understanding and giving of informed consent Active uncontrolled infection Active peptic ulcer Unstable (...) Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer. The primary objective of this study was to evaluate the cardiac safety, and the secondary objectives were to evaluate safety and toxicity of participants treated with bevacizumab ± trastuzumab administered with 2 different docetaxel-based combination regimens. This study was originally designed to also evaluate disease-free survival (DFS) and overall survival

2007 Clinical Trials

4380. Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

(RECIST criteria for visceral disease patients OR 2 or more lesions on a whole body bone scan) Exclusion Criteria: Cardiac disease: Congestive heart failure > class II New York Heart Association 9NYHA). Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months. Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (...) . Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B

2006 Clinical Trials

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