Clinical Trials Logo

Filter by:
NCT ID: NCT01346020 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Start date: April 2010
Phase: N/A
Study type: Observational

This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation. 1. Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized. 2. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians. 3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.

NCT ID: NCT01487629 Active, not recruiting - Clinical trials for Diabetic Retinopathy

Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

IBERA-DME
Start date: April 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.

NCT ID: NCT01548352 Active, not recruiting - Syncope Clinical Trials

BAsel Syncope EvaLuation (BASEL IX) Study

Start date: April 2010
Phase:
Study type: Observational

Syncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sudden cardiac death and mortality in patients with syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease have an excellent prognosis. Therefore The investigators test the hypothesis that the use of a meticulous patient history, clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk stratification regarding adverse outcomes. The prospective multicenter cohort study is designed to enroll 720 patients presenting with transient loss of consciousness within the last 12 hours to the ED. Blood samples for the measurement of novel biomarkers will be obtained at presentation. All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse events (death, resuscitation, recurrence of syncope, hospitalization for syncope).

NCT ID: NCT01637584 Active, not recruiting - PTSD Clinical Trials

Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

NOSSTIP
Start date: April 2010
Phase: N/A
Study type: Interventional

The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during REM and NREM sleep relative to wakefulness; 2) To identify the neurobiological underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM sleep, and NREM sleep in OIF/OEF veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also explore the stability of the PET signal by comparing pre- and post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks after the initial PET series. The overarching hypothesis is that PTSD is characterized by neurobiological alterations in the amygdala, mPFC, and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment.

NCT ID: NCT01923077 Active, not recruiting - Clinical trials for Acute Myocardial Infarction

Intensive Statin Therapy in Patients With AMI

INTENSIFY
Start date: April 2010
Phase: Phase 2
Study type: Interventional

Objective: Statins have been shown to have beneficial pleiotropic effects besides being lipid lowering. The investigators hypothesized that early and intensive statin treatment was associated with improved left ventricular (LV) function and with a stabilization of the coronary atherosclerotic plaques in patients with acute myocardial infarction (AMI) Method: In a prospective randomized blinded endpoint trial patients with ST segment elevation or non ST segment elevation AMI were randomized to either intensive statin-therapy (loading dose rosuvastatin 80 mg immediately after randomization followed by 40 mg daily) or usual statin therapy (simvastatin 40 mg daily). Patients were followed 12 month and the investigators performed echocardiography at randomization, after 30 days and after 12 month. The investigators used 2D Speckle Tracking for the assessment of LV-function. Coronary plaque assessment was done with Cardiac-CT (MSCT) at baseline and after 12 month. Primary outcome for this study was assessment of LV function with global and regional myocardial strain. Secondary outcomes can be divided in 4 groups: 1. Additional echocardiographic measurements such as Ejection Fraction, S´, LV-volume, atrial volume, VA-coupling, diastolic function, post systolic strain and strain rate. 2. Biochemical assessment of inflammation and endothelial function: Hs-CRP, ICAM, VCAM, E-selection and Nitrate/Nitrite ratio. 3. Coronary plaque assessment by MSCT: Plaque volume and plaque stability. 4. Long term follow-up: Mortality and cardiovascular events

NCT ID: NCT02097381 Active, not recruiting - HIV Infection Clinical Trials

Study of Recovery of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy

Start date: April 2010
Phase: N/A
Study type: Interventional

HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood. This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.

NCT ID: NCT03168880 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel Versus Weekly Paclitaxel Plus Weekly Carboplatin In Women With Large Operable or Locally Advanced, Triple Negative Breast Cancer

TNBC
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Triple-negative breast cancer is a subtype of breast cancer that is clinically negative for expression of estrogen and progesterone receptors (ER/PR) and HER2 protein. It is characterized by its unique molecular profile, aggressive behavior, distinct patterns of metastasis, and lack of targeted therapies. Although not synonymous, the majority of triple-negative breast cancers carry the "basal-like" molecular profile on gene expression arrays. Although sensitive to chemotherapy, early relapse is common and these cancers show a predilection for visceral metastasis, including brain metastasis. Targeted agents, including epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), and poly (ADP-ribose) polymerase (PARP) inhibitors, are currently in clinical trials and hold promise in the treatment of this aggressive disease. Multiple independent data sets have revealed that the triple negative type of breast cancer carries a poor prognosis. It is unclear whether the poor prognosis of triple negative breast cancer is due to poor therapy options or inherent aggressiveness. Given their triple negative receptor status, these tumors are not amenable to conventional targeted therapies for breast cancer, such as endocrine therapy or trastuzumab, leaving only chemotherapy in the therapeutic armamentarium. Patients on metformin showed a 30-40% protection against all forms of cancer. Recent pilot studies carried out using population registries raise the possibility that metformin may reduce cancer risk and/or improve cancer prognosis. One showed an unexpectedly lower risk of a cancer diagnosis among diabetics using metformin compared with a control group of diabetics using other treatments ; another showed lower cancer-specific mortality among subjects with diabetes using metformin compared with diabetics on other treatments. Metformin is a biguanide known to be an insulin sensitizing agent which promotes reduced circulating insulin and glucose levels in hyper-glycaemic and hyper-insulinaemic patients. Metformin activates the AMP dependent kinase, attenuates insulin and IGF-1 stimulated proliferation in breast cancer cells and a general decrease in protein synthesis in vitro. Western blot analysis indicated that metformin stimulates AMPK phosphorylation in a dose-dependent manner. AMPK activation is associated with decreased phosphorylation of mTOR and S6 kinase. While metformin reduces breast carcinoma cell proliferation both in vitro and in vivo, the activation of AMPK leads to significant VEGF production, angiogenesis and tumor progression. This must be taken into consideration when it is applied in as a therapeutic regimen.

NCT ID: NCT01065142 Active, not recruiting - Heart Failure Clinical Trials

ETIC (Therapeutic Education in Heart Failure)

ETIC
Start date: April 2011
Phase: N/A
Study type: Interventional

Use lay language. Background: Heart failure is an increasingly frequent current pathology due to the population aging and the improvement of acute and chronic heart failure management. Heart failure patients have a poor quality of life because of their symptoms (asthenia, dyspnea…) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year. Previous studies were multidisciplinary interventions and not realistic in a daily practice for a general practitioner. The aim of this project is to integrate therapeutic education for heart failure patients in a current practice. The patient becomes competent to manage his disease and to identify acute heart failure signs. Main objective: Improve therapeutic education efficiency on life quality of heart failure patients in general practice. Second objectives: Describe heart failure patient's hospitalizations. Methods: Cluster randomized controlled clinical trial comparing intervention and control groups with a follow through for 19 months for each patient. A therapeutic education program will be proposed to the heart failure patients in primary care. The intervention group GP will follow a workshop concerning the therapeutic education concepts and the intervention. Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of hospitalizations of patients in each group. Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster randomized surgeries in Auvergne (France). Expected results: The therapeutic education allows the patients to improve their quality of life, to be able to detect their illness signs worsening in a early manner, and to contact their doctor if needed. This would limit the acute heart failure due to treatment adaptation or life habits.

NCT ID: NCT01135420 Active, not recruiting - Clinical trials for Diagnosis, Dual (Psychiatry)

Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

Start date: April 2011
Phase: Phase 2
Study type: Interventional

This research program will improve the care and treatment outcomes of dually diagnosed veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental health services. It will increase the use of substance abuse outpatient care and 12-step groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.

NCT ID: NCT01161628 Active, not recruiting - Clinical trials for Chronic Graft-versus-host Disease

Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)

Start date: April 2011
Phase: Phase 2
Study type: Interventional

Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has significant activity in cGVHD when utilized early in the course of the process. In addition, the investigators hope to show that the early use of Rituximab may allow for the earlier discontinuation of immunosuppression while obviating the need for long courses of systemic corticosteroids, which should translate into reduced treatment-related morbidity and mortality associated with cGVHD.