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NCT ID: NCT00679380 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

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

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

NCT ID: NCT00678665 Not yet recruiting - Pain Clinical Trials

Changes in Heart Rate in Response to Heat Pressure and Neural Stimulation

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

Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an important factor in patients' recovery and quality of life. Pain is charted today as one of the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score (facial or numerical), by which the patient himself indicates the level of the pain he or she endures. It has been found that the correlation between the reported pain by the patient and the assessed pain by the caregivers or the medical personnel becomes poor as pain intensifies. Objective assessment of anesthesia using the heart rate and its spectral analyses was done in the past. By using this modality, works on neonatal pain were conducted. In adults, works have shown that there is possibility to assess pain using this modality, though no repeated proof for its ability to detect pain was published. We know that physiological signals such as ECG consist of mixtures of variety of patterns and phenomena accruing at different patterns and time points. Traditional analysis methods are designed and optimized to handle signals that include a single class of patterns such as pure harmonics or piece-wise constant functions. However, such basic operations that use a single representation method usually yield mediocre results when applied to real complex biological signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very low. Recent trends in digital signal processing (DSP) use the novel idea of merging several different representation methods to create a so called over-complete dictionary, examples of this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We intend to develop and apply the novel signal processing tools to the ECG signals for the first time. We believe that such tools have the potential to provide much better insight of the signal basic components and their relation to pain.

NCT ID: NCT00678535 Completed - Gastric Cancer Clinical Trials

Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer

EXPAND
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS). Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

NCT ID: NCT00678262 Completed - Pain Clinical Trials

Changes in Heart Rate in Response to Cold Pressor Test

HRVW1
Start date: May 2008
Phase: N/A
Study type: Observational

Abstract: Pain, a subjective sensation, has been increasingly studied, as it has been recognized as an important factor in patients' recovery and quality of life. Pain is charted today as one of the vital signs. For standardization, pain is charted by a number from 0 to 10 indicating its level. The most common practiced pain assessment tool today is the VAS- Visual Analog Score (facial or numerical), by which the patient himself indicates the level of the pain he or she endures. It has been found that the correlation between the reported pain by the patient and the assessed pain by the caregivers or the medical personnel becomes poor as pain intensifies. Objective assessment of anesthesia using the heart rate and its spectral analyses was done in the past. By using this modality, works on neonatal pain were conducted. In adults, works have shown that there is possibility to assess pain using this modality, though no repeated proof for its ability to detect pain was published. We know that physiological signals such as ECG consist of mixtures of variety of patterns and phenomena accruing at different patterns and time points. Traditional analysis methods are designed and optimized to handle signals that include a single class of patterns such as pure harmonics or piece-wise constant functions. However, such basic operations that use a single representation method usually yield mediocre results when applied to real complex biological signals as ECG and EEG especially in the case where the Signal to Noise Ratio (SNR) is very low. Recent trends in digital signal processing (DSP) use the novel idea of merging several different representation methods to create a so called over-complete dictionary, examples of this approach include the Matching Pursuit algorithm and the Basis Pursuit algorithm. We intend to develop and apply the novel signal processing tools to the ECG signals during painful experience for the first time. We believe that such tools have the potential to provide much better insight of the signal basic components and their relation to pain.

NCT ID: NCT00678028 Completed - Clinical trials for Recurrent Urinary Tract Infections

Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection

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

Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity and there are proofs of relation between patients with recurrent infections and lack of MBL, we decided to explore a possible relation between low levels of MBL and different genotypes of MBL in young women and the risk to develop recurrent UTI.

NCT ID: NCT00676650 Terminated - Prostatic Neoplasms Clinical Trials

Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

SUN 1120
Start date: July 2008
Phase: Phase 3
Study type: Interventional

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

NCT ID: NCT00676338 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

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

This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.

NCT ID: NCT00675142 Completed - Infertility Clinical Trials

Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists

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

The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.

NCT ID: NCT00674141 Withdrawn - Clinical trials for MS Patient With Relpasing Remitting Attacks

Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) Treatment

Start date: July 2008
Phase: Phase 1
Study type: Interventional

The study aims to assess the safety and efficacy of nasale administration of Dexamethasone in relapsing MS patients

NCT ID: NCT00673699 Not yet recruiting - Dyspepsia Clinical Trials

The Role of Narrow-Band Imaging Endoscopy in Diagnosing Gastric Intestinal Metaplasia

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

The purpose of this study is to determine if endoscope with NBI(narrow banding imaging)can detect intestinal metaplasia( consider pre malignant condition) and use a targeting biopsy in case of suspected intestinal metaplasia