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NCT ID: NCT00503087 Recruiting - Healthy Clinical Trials

Evaluation of Pain Reduction in the Administration of Saline Injections by the Usage of Pneumatic Skin Flattening

Start date: August 2007
Phase: Phase 1
Study type: Interventional

Each participant will be administered 2 injections of saline - the first in the right gluteal area and the second in the left gluteal area. Both injections will be administered intra-muscularly by the same clinician. One injection will be given with vacuum (Pneumatic Skin Flattening or PSF Machine) and the other without vacuum. The order of the injections will be randomly assigned. Each subject will serve as a control for himself. Between injections a 30 min pause will be given to minimize pain sensation bias of the previous injection. Immediately after each injection the pain level will be assessed by the VAS scale. The researcher assessing the pain will be blinded for the type of injection given. The evaluation of the pain reduction will be made by comparison of the pain level with and without the application of the PSF. Hypothesis: PSF Technique will reduce the pain associated with saline injections.

NCT ID: NCT00502918 Terminated - Labor Clinical Trials

Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

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

The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

NCT ID: NCT00502684 Recruiting - Clinical trials for Primary Operable Breast Cancer

Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery

Start date: June 2014
Phase: N/A
Study type: Interventional

Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.

NCT ID: NCT00502606 Active, not recruiting - Periodontitis Clinical Trials

a Clinical Study.the Effect of Addition of Insoluble Antibacterial Nanoparticles(IABN) in Resin Base Provisional Cement

IABN
Start date: February 2007
Phase: N/A
Study type: Observational

The effect of Antibacterial Nanoparticles, Incorporated in cement, on S.mutans in the margins of provisional restorations is going to be examined clinically by using two kinds of provisional cement 1. cement with out antibacterial nanoparticles. 2.cement with small addition of IABN. after one week in the mouth the crowns are to be removed and examined for the presence and quantity of s. mutans. in vitro tests of the same has shown significant reduction in bacterial population around the provisional cement as compared to the regular cement.

NCT ID: NCT00502450 Withdrawn - Acute Otitis Media Clinical Trials

Is There Hearing Loss After Acute Mastoiditis

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

Following acute mastoiditis there is a possible risk to develop hearing loss. The cause could be either possible involvement of the inner ear, or in cases that underwent surgery, secondary to the effect of the drill's noise. Extended hearing test will be performed for 25 children that suffered acute mastoiditis that resolved with conservative treatment and compared with 25 children that needed surgical intervention.

NCT ID: NCT00502437 Not yet recruiting - Antiemetic Clinical Trials

The Antigagging Effect of Granisetron (Kytril), an Antiemetic Drug, in Dental Situations

Start date: n/a
Phase: N/A
Study type: Interventional

Antigagging effect of kytril (granisetron) an antiemetic drug in dental situations Gagging in dental situations can be a problem to the patient and the operating dentist. There are not proven methods of eliminating this reflex which sometimes will not allow routine quality dental care. Pharmacological and behavioral approaches to eliminate this reflex have been tried with limited success. This suggested study will test a potent antiemetic drug used in other clinical situations such as antineoplastic treatment. Granisetron is a potential antagonist for the 5-hydroxytryptamine3-receptor - 5HT(3), The drug binds to the receptor and blocks the effect of nausea and vomiting. Kytril mechanism of action was successfully proven for various medical situations as a potential antiemetic agent. Our Center for dental sedation and anesthesia in the oral medicine department have received approval to use Granisetron as an antigagging drug in dental situations based on several pilot studies conducted in other medical centers in different clinical situations such as strabismus corrections, post hysterectomy and others. Our preliminary clinical impression is that pre-emptive IV administration of this drug to patients with increased gag reflex is beneficial. In our research we try to investigate the possibility of using kytril in dental situations. In the first stage of this research we will study the INTRAVENOUS use of this drug and its effects On normal subjects compare them to themselves with placebo. According to the results of this study we will go on to the second stage of the research and try the same drug under oral administration. The purpose of this study is to test the antigagging effect of this drug in a controlled manner in dental situations. Our working hypothesis is that administration of this drug in dental situations with success, will allow many patients to receive good dental care

NCT ID: NCT00502398 Recruiting - Clinical trials for Pulmonary Artery Hypertension

Is There Intravascular Hemolysis in Patients With Pulmonary Hypertension?

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

Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their contents released into the circulation. It is thought that these red-cell contents cause constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible that patients with pulmonary hypertension have hemolysis. In this study we will be drawing blood from a range of patients and normal controls for a panel of blood tests related to hemolysis.

NCT ID: NCT00502242 Completed - Kidney Transplant Clinical Trials

Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

Start date: December 2007
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.

NCT ID: NCT00501969 Completed - Clinical trials for Advanced Stage Parkinson's Disease

An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

Start date: August 2004
Phase: Phase 3
Study type: Interventional

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

NCT ID: NCT00501774 Completed - Vulvodynia Clinical Trials

A Search for Helicobacter Pylori in Localized Vulvodynia

Start date: May 2004
Phase: N/A
Study type: Observational

Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.