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NCT ID: NCT00529334 Withdrawn - Breast Cancer Clinical Trials

A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

CK-PBI
Start date: September 2007
Phase: N/A
Study type: Interventional

This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience. Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.

NCT ID: NCT00529074 Withdrawn - Analgesia Clinical Trials

Epidural Anesthesia /Analgesia Versus PCA for Laparoscopic Complex Ventral Hernia Repair: A Randomized Controlled Trial

Start date: February 2006
Phase: N/A
Study type: Interventional

We plan to demonstrate the superiority of epidural anaesthesia/analgesia in repairs of large ventral hernias as compared with a conventional narcotic analgesia regimen. We hypothesize that: 1. Primary outcome measures will improve. Patients will have a shorter length of stay (1 day less) with pre and post-operative epidural analgesia. 2. Secondary outcome measures will also improve. Among them will be VAS pain scores, time to first flatus and bowel movement as well as major and minor complications.

NCT ID: NCT00528827 Withdrawn - Hypertension Clinical Trials

A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

Start date: September 2007
Phase: Phase 2
Study type: Interventional

To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.

NCT ID: NCT00528255 Withdrawn - Induction of Labor Clinical Trials

Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

Miso-Obs-203
Start date: n/a
Phase: Phase 2
Study type: Interventional

This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

NCT ID: NCT00527709 Withdrawn - Hypotension Clinical Trials

Hold Parameters on Likely Cardiovascular Depressant Medications

Start date: August 2006
Phase:
Study type: Observational

This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient. There are general rules about when it would be appropriate for these types of medications not to be given. However, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent. Research Question: Can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?

NCT ID: NCT00525941 Withdrawn - Insomnia Clinical Trials

An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

Start date: September 2007
Phase: Phase 3
Study type: Interventional

NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.

NCT ID: NCT00525928 Withdrawn - Smoking Clinical Trials

Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Start date: October 2007
Phase: N/A
Study type: Interventional

This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely. This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.

NCT ID: NCT00519402 Withdrawn - Clinical trials for Obstructive Sleep Disordered Breathing

Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered Breathing

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

Introduction: There is currently no long-term study, which compares the outcomes of partial tonsillectomy to conventional tonsillectomy. We hypothesize that there will be little significant tonsillar regrowth with partial tonsillectomy. Background and Significance: Tonsillectomy is the most common major surgical procedure performed on children in the United States with nearly 300,000 procedures performed each year, primarily for the indication of obstructive sleep disordered breathing (OSDB). Conventional (total) tonsillectomy removes the tonsillar capsule, and partial tonsillectomy preserves the capsule by shaving away the tonsils using an endoscopic microdebrider. Partial tonsillectomy results in less pain, fewer days to normal activity and diet, and fewer days of analgesics than total tonsillectomy. There are no significant differences between the techniques in blood loss or postoperative life improved Historical evidence suggests that eventually there will be tonsillar regrowth with partial tonsillectomy. However, in a 2003 follow-up report of 243 children undergoing partial tonsillectomy and 107 undergoing complete tonsillectomy from 1998 through 2002 for OSDB there was no evidence of significant tonsillar regrowth. (1) We will follow-up children undergoing partial or complete tonsillectomies at the Cleveland Clinic from 1998 through 2002. There will be standardized tonsillar examinations by two observers, with a third observer in cases of significant disagreement, and questionnaires evaluating sleep apnea and daytime sleepiness, and number of tonsillar infections. If there are a large number of children with recurrent tonsillar symptoms post partial tonsillectomy, the procedure should be abandoned. However, if follow-up reveals comparable tonsillar symptoms for partial and the total tonsillectomy, perhaps the partial procedure should replace the total tonsillectomy as the standard operation to relieve tonsillar OSDB. This could eventually result in millions of less lost days of work and school in the United States.

NCT ID: NCT00518635 Withdrawn - Clinical trials for Polycystic Ovary Syndrome

Low Dose Growth Hormone in Obese PCOS Women

Start date: October 2010
Phase: N/A
Study type: Interventional

Study hypothesis: Growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of women with polycystic ovary syndrome. Study aims: To determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and testosterone (male hormones) in obese women with polycystic ovary syndrome. Study design: Obese women with polycystic ovary syndrome, but not recently been on GH treatment, and presently attending Outpatients Clinic will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participating in the study. If suitable, an equal number of women will be randomized to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.

NCT ID: NCT00517972 Withdrawn - Depression Clinical Trials

Omacor for Perimenopausal Depression

Start date: n/a
Phase: Phase 2
Study type: Interventional

Recently, antidepressants and other similar acting agents have been explored as a class of medications to treat major depressive disorder (MDD) in the context of perimenopause, as well as the somatic symptoms of perimenopause (such as hot flashes). Omega-3 fatty acids, which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are nutritional compounds with widely established health benefits and which occur naturally in fish and marine sources. Results of previous mood disorder studies have indicated that omega-3 fatty acids may be of help in the treatment of depression. Therefore, the current study is designed to examine the effectiveness and tolerability of the study drug, Omacor, (omega-3 fatty acid ethyl esters), in the treatment of major depressive disorder in perimenopausal women.