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NCT ID: NCT01205438 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

NCT ID: NCT01205087 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

NCT ID: NCT01205074 Active, not recruiting - Healthy Subjects Clinical Trials

¹³C-Methacetin Breath Test (MBT) Methodology Study

Start date: September 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Several factors will be tested to see if they have an influence on the methacetin breath test results. Each one of the factors has been raised as a possible source of distortion of the MBT result. I. Variability between same tests on same subject MBT. Repeatability will be tested in both healthy individuals and patients with chronic liver disease. II. COPD - Chronic obstructive pulmonary disease is a leading cause of death worldwide, and can potentially have an effect on the MBT since the breath test is based on CO2 production and these subjects may have abnormal CO2 production. III. Smoking- 13C Methacetin is metabolized by healthy hepatocytes reflecting hepatic microsomal function of CYP1A2, and smoking may cause induction of CYP1A2. Furthermore, internal preliminary data has shown signs that there is an influence of smoking on the MBT ranges. IV. Age- Empirical data on several hundred subjects with chronic liver disease has shown that age is a significant factor in determining the probability of disease severity and preliminary data in normal subjects have shown changes in MBT with age.. Therefore, the effect of age has to be elucidated in an orderly fashion. V. CYP450 1A2 Inhibitors- Several drugs and food items inhibit CYP450 1A2 and may affect the MBT. VI. Alcohol - Alcohol ingestion leads to induction of hepatic CYP and at a later stage to inhibition due to liver damage. Acute alcohol ingestion may therefore effect MBT results. VII. Beta-blockers - beta blocker are affecting portal hypertension and may affect hepatic blood flow and thereby the outcome of the methacetin breath test.

NCT ID: NCT01205009 Not yet recruiting - Infertility Clinical Trials

Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders

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

In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.

NCT ID: NCT01204827 Withdrawn - Chronic Hepatitis B Clinical Trials

Follow Up of Patients Chronic Hepatitis B (CHB) Treated With Sebivo Using the 13C Methacetin Breath Test

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

Patients with HBeAg negative chronic HBV and evidence of hepatic disease (elevated liver enzymes or evidence of cirrhosis) who have significant viremia are treated with anti HBV therapy. Currently the key goals of anti HBV therapy are profound and prolonged viral suppression and treatment efficacy is assessed by monitoring viral load and liver enzymes. However these do not always reflect the degree of liver impairment or the degree of improvement in response to therapy. Sebivo has been accepted in Israel as a first line therapy for HBeAg negative and HBeAg positive chronic HBV with evidence of liver damage. Viral load should decrease by 1 log every 3 months, otherwise patients should be offered add-on or alternative therapy. As the majority of patients in Israel are HBeAg negative chronic HBV and in order to have homogenous population we will select for our study only patients with HBeAg negative chronic HBV. The 13C Methacetin breath test, assess liver function and specifically the function of the microsomal CYP4501A2. It has been shown to correlate with the degree of liver impairment and with clinical outcomes in both acute and chronic liver disease. The aim of this study is to determine the utility of the 13C Methacetin Breath Test to follow up patients with HBeAg negative chronic HBV receiving anti viral therapy.

NCT ID: NCT01204749 Completed - Ovarian Cancer Clinical Trials

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

NCT ID: NCT01203865 Recruiting - Fibromyalgia Clinical Trials

Prevalence of Fibromyalgia in Israel

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

The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.

NCT ID: NCT01203800 Completed - Clinical trials for A Positive or a Negative Brain SPECT

Evaluation of Blood Brain Barrier Permeability in Chronic Stroke

Start date: September 2009
Phase: N/A
Study type: Observational

In this study the investigators intend to explore the long term significance of BBB disruption on the clinical course and the rate of significant recurrent ischemic events in patients with a chronic stroke.

NCT ID: NCT01203761 Not yet recruiting - Depression Clinical Trials

The Experience of Loneliness Among Patients During the Perioperative Period

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

The experience of illness and hospitalization exerts a great deal of psychological distress, one of the most distressful events people might experience throughout their life times. Surgery and anesthesia with their accompanying loss of control, fear of being unconscious and invaded, and expectation of postoperative pain adds appreciably to that stress and anxiety. Current psycho-physiological research has provided evidence on the alarming possibility of the aversive affects of hospitalization stress on the patients' already deteriorated physical health and marked interference with their recovery. As an additional stressor, which may partly be related to the hospital staff, and partly to the person's illness and expected surgery is loneliness. Loneliness is a painful experience that is, commonly, not embraced and which has consequences that are detrimental to one's emotional, physical and spiritual well being. The present study explores the qualitative aspects of loneliness (via questionnaires) in two patient populations: (1) patients facing surgery, and (2) patients who have already undergone surgery. In addition, family members [i.e. those waiting outside of the operating room] will be given a questionnaire, and these three groups will be compared to the general population.

NCT ID: NCT01203735 Recruiting - Clinical trials for Locally Advanced Inoperable Non-small-lung Cancer

Valproic Acid With Chemoradiotherapy for Non-Small-Cell Lung Cancer

Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This is non-randomized phase 2 study to evaluate toxicity and efficacy of VA with concurrent chemoradiotherapy (CCRT) containing weekly vinorelbine and cisplatin in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC).All patients will be planned for three-dimensional conformal RT (3-DCRT). Concurrent weekly vinorelbine and cisplatin and oral valproic acid (VA)will be started at the first day of RT. Follow up will be conducted every 3 months after completion of the study treatment. Toxicity will be assessed using CTCAE, based on clinical examination and laboratory tests during the study treatment and at follow up visits. Response to treatment will be evaluated using RECIST criteria. Overall and progression free survival (OS and PFS) will be estimated using the Kaplan-Meier method.