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NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

NCT ID: NCT01023087 Completed - Sepsis Clinical Trials

Renal Impairment Associated With Colistin Levels

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

Colistin is a relatively old antibiotic drug which its use has been abandoned through the 1970s because it was considered nephrotoxic. Recently ( the last decade) it has been reappraised because multidrug resistant Gram negative bacteria have emerged causing life threatening infections with no other good enough treatment. Moreover, more controlled studies from the recent years show less toxic effect of the drug. The investigators' study is a prospective study comparing renal function in a group of hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin (antibiotics) with a control group which its patients receive other non nephrotoxic antibiotics. The investigators' study hypothesis is that patients receiving Colistin would have renal function decline in higher rates than those seen usually in hospitalized patients in the Internal medicine wards with sepsis. Another goal of the study is to find correlation between Colistin levels in the plasma (after Colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.

NCT ID: NCT01022814 Not yet recruiting - Clinical trials for Color Reaction With Amniotic Fluid

Development of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine

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

In the final months of pregnancy, women need to know whether their 'water is broken' necessitating a race to the delivery room, or whether pressure of the foetus on their bladder has caused them merely to pass urine. They may also have faced the same dilemma on many occasions much earlier in the pregnancy. With this development the investigators will provide them with an immediate answer to this critical question.

NCT ID: NCT01022619 Not yet recruiting - Clinical trials for Gestational Diabetes

The Association Between High Risk Pregnancy and Sleep-disordered Breathing

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

The aim of the present study is to establish, using polysomnographic criteria and prospective nature, whether sleep apnea in pregnancy is more prevalent in women with high risk pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with high risk pregnancy compared to those with uncomplicated pregnancy.

NCT ID: NCT01022385 Not yet recruiting - Clinical trials for Gastrointestinal Complaints

The Effect of a Very Low-residual Diet on the Preparation Before Capsule Endoscopy

Start date: December 2009
Phase: N/A
Study type: Interventional

The aim of the proposed study is to compare prospectively two methods of small bowel preparation prior capsule endoscopy study, the effect on the cleanliness and the quality of visualization after two protocols of preparation: a 12 hour fast only versus 24 hour of a very low residual diet (ENSURE, Abbott Laboratories, Israel) + 12 hour fast.

NCT ID: NCT01021982 Completed - Glaucoma Clinical Trials

Evaluation of Objective Perimetry Using Pupillometer

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

Objective perimetry can better monitor visual field defects in RP and Glaucoma patients than conventional subjective perimetry.The PLR ( Pupil Light Reflex ) of the short and long wave ratio should be significantly higher in areas of visual field defects in RP and Glaucoma patients.

NCT ID: NCT01021423 Terminated - Clinical trials for Non-Hodgkin's Lymphoma

A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

RENEW
Start date: April 1, 2010
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.

NCT ID: NCT01021280 Not yet recruiting - Hypocalcemia Clinical Trials

Parathyroid Hormone (PTH) Homeostasis in Bartter Syndrome

Start date: January 2013
Phase: N/A
Study type: Observational

Parathyroid hormone (PTH) gland calcium sensing receptor (CASR) regulates PTH secretion. CASR is also expressed in nephron thick ascending limb (TAL). Bartter syndrome (BS), a normotensive hypokalemic tubulopathy, may be due to mutations in different TAL channels, including the potassium channel ROMK. Mutations in CASR may also cause BS through its effects on ROMK function. However, it is unknown whether ROMK mutations exert any effects on CASR function and PTH physiology. Preliminary data from our center shows that PTH levels were specifically elevated in type II (where ROMK is mutated) and not in type IV (where another gene, Barttin is defective) BS, without a common explanation. We assume that the mutation in ROMK may cause a dysregulation of PTH secretion via possible interaction with CASR. The purpose of this study is: to investigate the PT-gland function and regulation in BS. Methods: Patients with BS type II and IV and normal controls will undergo a standard protocol of controlled ionic hypo- and hypercalcemia, during which PTH secretion, phosphate balance and calcium excretion will be followed. Calcium Vs PTH response curves will be generated and compared. Expected impact and benefit: the results of this study will help understand the mechanisms of PTH regulation beyond CASR.

NCT ID: NCT01020695 Completed - Clinical trials for Post-Traumatic Stress Disorder

Quantitative Electroencephalography (QEEG) and Low-resolution Electromagnetic Tomography (LORETA) Analysis in Post Traumatic Stress Disorder (PTSD) Patients

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

In this study the Quantitative Electroencephalography and low resolution topographic analysis of chronic Post-traumatic stress disorder and normal subjects will be compared.

NCT ID: NCT01020383 Completed - Unstable Angina Clinical Trials

Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients

Start date: September 2009
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).