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NCT ID: NCT00741910 Completed - Crohn's Disease Clinical Trials

Extension Study of Semapimod 60 mg IV x 3 Days

CD06
Start date: July 2003
Phase: Phase 2
Study type: Interventional

Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.

NCT ID: NCT00741624 Completed - Pain Clinical Trials

Pain Reduce Following Refractive Surgery

Start date: September 2008
Phase: Phase 2
Study type: Interventional

applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

NCT ID: NCT00741299 Completed - Bipolar Disorder Clinical Trials

A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder

Start date: August 2007
Phase: N/A
Study type: Observational

The purpose of this study is to examine whether tobacco smoking is associated with bipolar affective disorder (severity of depressive and manic symptoms, presence of psychotic symptoms, history of a suicide attempts and other clinical features.)

NCT ID: NCT00740831 Completed - Uterine Myomas Clinical Trials

PGL4001 Versus GnRH-agonist in Uterine Myomas

PEARLII
Start date: August 2008
Phase: Phase 3
Study type: Interventional

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

NCT ID: NCT00740103 Completed - Crohn's Disease Clinical Trials

Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

CD05
Start date: December 2002
Phase: Phase 2
Study type: Interventional

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).

NCT ID: NCT00739986 Completed - Crohn's Disease Clinical Trials

Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

CD04
Start date: October 2002
Phase: Phase 2
Study type: Interventional

Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).

NCT ID: NCT00739817 Not yet recruiting - Clinical trials for Primary Ciliary Dyskinesia

Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

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

Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. Undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. In addition, the gene responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic counseling. Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which discriminates between PCD patients, PCD carriers and healthy controls at high rate of specificity and sensitivity. Testing is simple and last approximately one minute. We have recently identified a unique isolated Druze population with high prevalence of PCD. The high frequency of disease places this closed community at a high risk of undiagnosed PCD. The aim of this project is to use nasal NO measurement as a screening tool to identify possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.

NCT ID: NCT00739466 Completed - Clinical trials for Coronary Artery Stenosis

Biorest Liposomal Alendronate With Stenting sTudy (BLAST)

BLAST
Start date: September 2008
Phase: Phase 2
Study type: Interventional

The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare metal stent. Study hypothesis: Liposomal Alendronate will reduce in-stent restenosis as compared to placebo.

NCT ID: NCT00739375 Completed - Clinical trials for Pulmonary Hypertension

The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension.

Start date: September 2011
Phase: Phase 1
Study type: Interventional

Pulmonary hypertension (PHT) is an elevation of pulmonary arterial pressure (PAP) that can be the result of heart, lung or systemic disease. PHT also complicates chronic hemodialysis (HD) therapy immediately after the creation of an arteriovenous (AV) access, even before starting HD therapy. It tends to regress after temporary AV access closure and after successful kidney transplantation. Affected patients have significantly higher cardiac output. This syndrome is associated with a statistically significant survival disadvantage. The laboratory hallmark of this syndrome is reduced basal and stimulatory nitric oxide (NO) levels. It appears that patients with end-stage renal disease (ESRD) acquire endothelial dysfunction that reduces the ability of their pulmonary vessels to accommodate the AV access-mediated elevated cardiac output, exacerbating the PHT. Doppler echocardiographic screening of ESRD patients scheduled for HD therapy for the occurrence of PH is indicated. Early diagnosis enables timely intervention, currently limited to changing dialysis modality such as peritoneal dialysis or referring for kidney transplantation.An echocardiographic diagnosis of pulmonary hypertension (PHT) is made when the systolic pulmonary arterial pressure (PAP) exceeds normal values (30 mmHg). In mild PHT, PAP values range up to 45 mmHg, in moderate PHT, PAP is between 45 and 65 mmHg, and in severe PHT, PAP values are greater than 65 mmHg. Systolic PAP equals cardiac output times pulmonary vascular resistance (PVR), (i.e., PAP = cardiac output × PVR). Increased cardiac output by itself does not cause PH because of the enormous capacity of the pulmonary circulation to accommodate the increase in blood flow. Therefore development of PHT requires pathologic, marked elevation of pulmonary vascular resistance. The presence of PH may reflect serious pulmonary vascular disease, which can be progressive and fatal. Consequently, an accurate diagnosis of the cause of PHT is essential in order to establish an effective treatment program. Pulmonary hypertension can occur from diverse etiologies. In 1996 we first noted unexplained PH in some long-term hemodialysis (HD) patients during an epidemiologic study of this disorder (Nakhoul F and Yigla M Rambam Medical Cemter-Haifa). It was assumed that their PHT was related to end-stage renal disease (ESRD) or to long-term HD therapy via an arteriovenous (AV) access. There are several potential explanations for the development of PHT in patients with ESRD. Hormonal and metabolic derangement associated with ESRD might lead to vasoconstriction of pulmonary vessels and increased pulmonary vascular resistance. Values of PAP may be further increased by high cardiac output resulting from the AV access itself, worsened by commonly occurring anemia and fluid overload. Despite almost five decades of HD therapy via a surgically created, often large, hemodynamically significant AV access the long-term impact of this intervention on the pulmonary circulation has received little attention. RD versus AV HD via AV access Proposed Mechanisms: 1. Elevated Parathyroid hormone 2. Metastatic Calcification due to the increase of the calcium-phosphor multiple 3. High cardiac output 4. Nitric oxide-endothelin metabolism 5. A-v Access flow These observations indicate a role for AV access-mediated elevations in cardiac output in the pathogenesis of PH. The correlation between access flow and PAP values has not yet been studied. Since patients undergoing HD therapy via AV access had PH that reversed after successful kidney transplantation and after short AV access compression, we concluded that both ESRD and AV access-mediated elevated cardiac output are required for the development PH. From a physiologic point of view, due to the enormous capacity of the pulmonary microcirculation, increased cardiac output by itself cannot cause PH. It is the inability of the pulmonary circulation of some ESRD patients to accommodate the AV access-mediated elevated cardiac output that leads to the development of PH.

NCT ID: NCT00739284 Recruiting - Kidney Disease Clinical Trials

A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney

JJVsPCN08
Start date: August 2008
Phase: N/A
Study type: Interventional

Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.