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NCT ID: NCT00712933 Completed - Clinical trials for Systemic Lupus Erythematosus

A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057

Start date: May 30, 2008
Phase: Phase 3
Study type: Interventional

This is a long-term continuation study to provide continuing treatment to subjects with SLE.

NCT ID: NCT00712361 Completed - Clinical trials for Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters

A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device

Start date: July 2008
Phase: N/A
Study type: Interventional

1. Aim: SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive and non-invasive devices. 2. Hypothesis: Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.

NCT ID: NCT00712348 Completed - Gaucher Disease Clinical Trials

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Start date: December 2008
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.

NCT ID: NCT00711997 Completed - Clinical trials for Pancreatic Neoplasms

Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer

Start date: August 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable, locally advanced pancreatic cancer. Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs). Secondary objectives include determining the adverse events (AEs) profile, effects on clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor resectability after 4 intratumoral administrations of DTA-H19.

NCT ID: NCT00711945 Completed - Crohn's Disease Clinical Trials

Growth Relapse and Outcomes With Therapy 1

GROWTH1
Start date: March 2008
Phase:
Study type: Observational

Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is imperative to be able to evaluate the risk for more severe disease and poorer outcomes when making the decision which therapies to offer our patients. These decisions should be based according to longer-term disease outcomes, such as whether they prevent disease relapse or prolong remission [10-12]. However, for the most part, previous studies were not designed to yield predictive parameters that could allow a clinician to differentiate which patients are at a higher risk for relapse, or more likely to to have serious attacks or complications of the disease or therapy. The ability to predict these risks would impact dramatically the way CD patients are treated, allowing the clinician to tailor therapy, both type and intensity, to each patient's individual risk for relapse and outcomes.In the present first phase of the study , we will attempt to identify factors that predict relapse of the disease, focusing on the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan antibodies, as well as disease severity, site and phenotype.

NCT ID: NCT00711581 Completed - Cholelithiasis Clinical Trials

Evaluation of Laparoscopic Internal Retractor Device

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

The purpose of this study is to determine the safety and efficacy of the Endograb system which is an internal laparoscopic retractor device. This retractor device is inserted into the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal incisions in a laparoscopic operation.

NCT ID: NCT00711399 Completed - Respiratory Sounds Clinical Trials

Assessment of Cough and Wheeze With Breath Sound Documenting Device

Start date: September 2008
Phase: N/A
Study type: Observational

The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.

NCT ID: NCT00709865 Completed - Clinical trials for Congestive Heart Failure

Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

TRIDENT-1
Start date: July 31, 2008
Phase: Phase 3
Study type: Interventional

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

NCT ID: NCT00708396 Recruiting - Schizophrenia Clinical Trials

Tolerability And Efficacy Of High Dose Escitalopram In The Treatment Of Patients Suffering From Schizophrenia And Obsessive-Compulsive Disorder (OCD) - An Open Label Study

Start date: July 2008
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate tolerability and efficacy of escitalopram (Cipralex) treatment in doses beyond 20mg (20-40 mg/d) in patients with OCD and schizophrenia, non responsive or partially responsive to recommended doses (evaluation according to Y-BOCS). An open label, prospective study. The study will include 20 patients recruited from the inpatient wards and from the outpatient clinic who have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and OCD. Before entering the study all patients will be interviewed by 2 senior board certified psychiatrists in order to confirm the diagnosis of schizophrenia or schizoaffective disorder and OCD according to DSM-IV criteria. After confirming the diagnosis of schizophrenia/schizoaffective disorder and OCD each patient will be evaluated by PANSS, Y-BOCS and GCI-S scales. Those patients who score above 12 points on the Y-BOCS will be eligible for the study. Rating scales (PANSS, Y-BOCS, CGI-S, CGI-I) will be completed on a weekly basis during the whole 13 weeks period. In addition patients will be asked to report medication side effects and will also be clinically evaluated for side effects by the physician. Special attention will be paid to worsening of psychosis or OC symptoms. All patients whose mental status will deteriorate or those who cannot tolerate the drug will be dropped-out and intent to treat analysis will be made.

NCT ID: NCT00708136 Completed - Balance Clinical Trials

Effect of Water-Exercise on Balance Function of Healthy Elderly Individuals

EWEB
Start date: January 2006
Phase: N/A
Study type: Interventional

The proposed project is a Randomized Controlled study design. Seniors (age >65) willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. The first 60 subjects who upon questioning were judged to meet the following inclusion criteria: 1. able to stand independently 90 seconds 2. able to walk 10 meters (with cane if necessary) 3. able to understand verbal instructions. The exclusion criteria will be: 1. Serious visual impairment 2. Inability to ambulate independently (cane acceptable, walker not). 3. Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). 4. Persons with impaired communication capabilities. The whole project will be conducted over a period of 24 months. The proposed study is a randomized experimental intervention/ control group design. A total of 60 elderly volunteer subjects will be randomly assigned to two groups, exercise group (30) and control group (30). Twelve training periods will be performed with 8 subjects participating in training during each period (4 exercise groups). The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1. Medical background variables. 2. Berg Balance Scale. 3. Late life Function and Disability Instrument. 4. Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5. Fall Efficacy Scale 6. Fall incidence and fall severity. 7. 6-minute walk test. The control group will not perform any specific balance training during the 12 week period. These individuals from control will participate in a separate exercise program after the training period. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.