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NCT ID: NCT02054663 Completed - Clinical trials for Acute Coronary Syndrome

Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not?

Start date: December 2013
Phase: Phase 4
Study type: Interventional

After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in some, because of increased risk of bleeding or intolerance. These patients need to be transitioned to another agent, such as Clopidogrel. At present, there is no clinical consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no evidence regarding the benefits or potential complications associated with each strategy. The present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet function testing. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy.

NCT ID: NCT02054611 Completed - ARDS Clinical Trials

The Educational ARDS Diagnosis Study

READS
Start date: February 2014
Phase: N/A
Study type: Interventional

Without rigorous, high-quality training materials, the results of the LUNG-SAFE study examining the global incidence and outcomes of severe lung failure (acute respiratory distress syndrome [ARDS]) could be confused by either under-recognition of patients with, or misclassification of patients without, ARDS. This problem has been previously identified with the use of the prior ARDS definitions, particularly in patients with milder severity of illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only moderate reliability when applied by experts, although this can be improved through the use of training radiographs (as will be used in this educational module). The investigators hypothesize that the training from the educational module will allow more accurate diagnosis of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.

NCT ID: NCT02054481 Completed - Psoriasis Clinical Trials

BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

NCT ID: NCT02053909 Completed - Clinical trials for Saphenous Vein Graft Disease

Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

TARGET
Start date: September 2014
Phase: Phase 4
Study type: Interventional

Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more pronounced platelet inhibition, and may substantially improve graft patency following CABG compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on saphenous vein graft patency following CABG. In this context, the investigators seek to compare vein graft patency between patients randomized to receive aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the early postoperative period, and continuing for 2 years after CABG.

NCT ID: NCT02053792 Completed - Hemophilia B Clinical Trials

A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

Start date: February 6, 2014
Phase: Phase 3
Study type: Interventional

This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.

NCT ID: NCT02053636 Completed - Breast Cancer Clinical Trials

A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

FINESSE
Start date: December 2013
Phase: Phase 2
Study type: Interventional

The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.

NCT ID: NCT02053610 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)

Start date: December 31, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

NCT ID: NCT02053480 Completed - Clinical trials for Pyruvate Kinase Deficiency

Pyruvate Kinase Deficiency Natural History Study

PKD NHS
Start date: December 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to describe the range and incidence of symptoms, treatments, and complications related to pyruvate kinase deficiency (PKD). Eligible patients are those of all ages with known PKD or with a hemolytic anemia and a family member with PKD. The study will collect retrospective medical history, routine clinical care data, and quality of life measures at baseline and annually for patients with PKD.

NCT ID: NCT02053467 Completed - Clinical trials for Health Services Research

Building Capacity for Specialized Services Through eConsultation

eConsult
Start date: January 1, 2014
Phase: N/A
Study type: Interventional

The consultation-referral process is complex, involving several steps including 1) the PCP recognizing the need for specialist advice/intervention, 2) patient agreement on seeing the specialist, 3) referral letter and information sent to specialist, 4) appointment booked and communicated, 5) patient visit(s) with the specialist and 6) communication back to the PCP. There are many factors during this process which limit the effectiveness and efficiency of patient care. These include inequitable access for patients and providers, long wait times before specialist advice received/implemented, delayed communication and mismatched consult expectations. These gaps result in significant breakdowns in transitions of care, inappropriate treatment, patient dissatisfaction and potential harm. Moreover, not all individuals are willing or able to travel to see specialists in a large academic medical centre even when recommended by the PCP. Electronic consultation (eConsult) service is a form of asynchronous communication whereby primary care providers (PCP) and specialists can communicate directly about a patient through a secure web-based application. eConsult has the potential for improving transitions in care through improved communication ensuring that patients are seen by the right specialist, when necessary, with the right information and in a timely manner. The goal of this project is to evaluate the impact of eConsult on specialist referral rates using health administrative data.

NCT ID: NCT02053428 Completed - Clinical trials for Cancer of Head and Neck

Comparison of Percutaneous Image-guided Gastrostomies

Start date: June 2013
Phase: N/A
Study type: Interventional

Percutaneous image-guided gastrostomy (PIG) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. Large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at Interventional Radiology for PIG at our institution. To date, there is no guideline for PIG and no direct comparison of two PIG techniques. The proposed pilot study is to compare the two different types of PIG techniques in head and neck cancer patients who require prophylactic enteral feeding by PIG. The purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two PIG techniques.