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NCT ID: NCT01855685 Active, not recruiting - Clinical trials for X-Linked Chronic Granulomatous Disease

Gene Therapy for X-linked Chronic Granulomatous Disease (X-CGD)

CGD
Start date: June 24, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

X-linked chronic granulomatous disease (X-CGD) is a rare genetic disorder, which affects boys. It is caused by an error in a gene that makes part of the immune system. The basic defect lies in specialised white blood cells called phagocytic cells (or phagocytes), which are responsible for protection against infection by destroying invading bacteria and fungi. They do this by pouring large amounts of substances similar to bleach onto these organisms. In CGD, there is a defect in the system that makes the bleach, called the NADPH-oxidase. In X-CGD (which accounts for two thirds of patients), the defect lies in a gene which makes up a critical part of the NADPH-oxidase (known as gp91-phox), and the cells cannot make bleach-like substances. Therefore they kill bacteria and fungi poorly, and the patients suffer from severe and recurrent infections. This also results in inflammation which can damage parts of the body such as the lung and gut. In many cases, patients can be adequately protected from infection by constant intake of antibiotics. However, in others, severe life-threatening infections break through. In some cases, inflammation in the bowel or urinary systems results in blockages which cannot be treated with antibiotics, and which may require the use of other drugs such as steroids. Development of curative treatments for CGD is therefore of great importance.

NCT ID: NCT01850108 Active, not recruiting - Sickle Cell Disease Clinical Trials

Non-Myeloablative Conditioning and Bone Marrow Transplantation

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

Allogeneic blood or marrow transplantation (alloBMT) is a curative therapy for a variety of hematologic disorders, including sickle cell disease and thalassemia. Even when it is clear that alloBMT can give to these patients an improvement in their disease, myeloablative transplants have important toxicities and mortalities associated. The lack of suitable donors continues to be a limit to access to transplantation. Substantial progress has been made recently in the development of pre-treatment regimens that facilitate the sustained engraftment of donor marrow with reduced toxicity. Most of these regimens incorporate highly immunosuppressive drugs, which allow the reduction or elimination of myeloablative agents or total body irradiation without endangering the sustained engraftment of HLA-identical allogeneic stem cells. Preliminary results of non-myeloablative allogeneic stem cell transplantation suggest that the procedure can be performed in patients who are ineligible for myeloablative alloBMT, and that sustained remissions of several hematologic malignancies can be obtained.

NCT ID: NCT01848561 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: April 29, 2013
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

NCT ID: NCT01844986 Active, not recruiting - Clinical trials for Advanced Ovarian Cancer

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

SOLO-1
Start date: August 26, 2013
Phase: Phase 3
Study type: Interventional

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

NCT ID: NCT01844505 Active, not recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

Start date: June 11, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

NCT ID: NCT01843374 Active, not recruiting - Clinical trials for Unresectable Pleural or Peritoneal Malignant Mesothelioma

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

Tremelimumab
Start date: May 17, 2013
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

NCT ID: NCT01843075 Active, not recruiting - Alzheimer's Disease Clinical Trials

Evaluating Liraglutide in Alzheimer's Disease

ELAD
Start date: January 2014
Phase: Phase 2
Study type: Interventional

This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.

NCT ID: NCT01842568 Active, not recruiting - Stroke Clinical Trials

Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Start date: May 2013
Phase:
Study type: Observational

Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications. This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.

NCT ID: NCT01842438 Active, not recruiting - Prostate Cancer Clinical Trials

A Couple Support Intervention for Prostate Cancer

Start date: October 2012
Phase: Phase 1
Study type: Interventional

Even with careful prostate surgery, men find it difficult to have an erection. Our previous research shows that couples are not often supported to cope with the effects of surgery on their sexual relationships. In this study, the investigators will design a way of supporting couples, and test how well it works. The investigators will decide what the support should include (e.g. duration, frequency and timing of the support). The investigators will do this by looking at available literature on the subject. The investigators will recruit 68 couples to the study, half will receive standard care and the other half will be invited to attend six sessions of psychosexual support with specially trained professionals (trained by men affected by prostate conditions and a cancer/couple support specialist). Before and after the support, men and their partners will be asked to complete questionnaires which measure quality-of-life, emotional needs, and their relationship. The investigators will ask the couples to fill out the questionnaires again six-months later to see if the support has long-term benefits. At the end of the study the investigators will also interview 10 couples to find out their views of the support, and another 10 couples about standard treatment. When the investigators have tested this support, they expect to see men and their partners tell us that their quality of life has improved, and they have higher satisfaction with their relationship. The investigators will calculate the overall cost of providing this support, and the benefits it has on reducing the need for other health-care services (like GP use).

NCT ID: NCT01838577 Active, not recruiting - Clinical trials for EGFR Mutation Positive Non Small Cell Lung Cancer

Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

GEM
Start date: September 2013
Phase:
Study type: Observational [Patient Registry]

The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC. The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.