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NCT ID: NCT00888082 Withdrawn - Breast Cancer Clinical Trials

Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

PROOF
Start date: n/a
Phase: Phase 3
Study type: Interventional

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements. The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.

NCT ID: NCT00888680 Withdrawn - Migraine Clinical Trials

Double-blind, Placebo-controlled Study of BGC20-1531 in Migraine

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

The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.

NCT ID: NCT00911131 Withdrawn - Esophageal Varices Clinical Trials

Enhancing Detection of Small Esophageal Varices by PillCam ESO

Start date: n/a
Phase: Phase 3
Study type: Interventional

Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure within smaller esophageal varices which will therefore enhance the ability of capsule endoscopy to detect these varices better. Therefore, the aims of the investigators' study are as follows: 1. To determine if using an abdominal binder to increase IAP can increase the detection rate of small esophageal varices when using capsule endoscopy. 2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a comparable detection rate of small esophageal varices to conventional endoscopy.

NCT ID: NCT00914043 Withdrawn - Breast Cancer Clinical Trials

Studying Biological Markers of Fatigue in Women With Residual Invasive Breast Cancer Enrolled on Clinical Trial NSABP-B-45

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

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. PURPOSE: This research study is looking at biological markers of fatigue in women with residual invasive breast cancer enrolled on clinical trial NSABP-B-45.

NCT ID: NCT00915616 Withdrawn - Clinical trials for Gastroesophageal Reflux Disease

The Potential Therapeutic Effect of Melatonin in Gastro-Esophageal Reflux Disease

Start date: n/a
Phase: Phase 3
Study type: Interventional

Gastro-Esophageal Reflux Disease was defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. Many drugs used for the treatment of GERD such as omeprazole (a proton pump inhibitor) which is widely used anti-ulcer drug and has been demonstrated to protect against esophageal mucosal injury. Melatonin has been found to protect the gastrointestinal mucosa from oxidative damage caused by reactive oxygen species in different experimental ulcer models. The aim of this study is to evaluate the role of exogenous melatonin in the treatment of reflux disease in human either alone and in combination with omeprazole therapy.

NCT ID: NCT00915668 Withdrawn - Healthy Clinical Trials

A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women

Start date: n/a
Phase: Phase 1
Study type: Interventional

The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.

NCT ID: NCT00928460 Withdrawn - Clinical trials for Myocardial Infarction

Efficacy of Preoperative Electrocardiography

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

A preoperative electrocardiogram (ECG) is nearly routinely performed by anesthesiologists in elderly non-cardiac surgery patients as part of pre-anesthesia evaluation. However, the added value of this routine ECG beyond patient history and physical examination is questionable. The ECGtrial will investigate the efficacy of routine preoperative electrocardiography in patients undergoing non-cardiac surgery.

NCT ID: NCT00930995 Withdrawn - Hepatitis C Clinical Trials

Angiotensin Receptor Blockade as an Anti-Fibrotic Intervention in Patients With Chronic Hepatitis C

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

Hepatitis C is the most common reason for liver transplantation in the United States and affects nearly 4 million Americans. Treatments for hepatitis C are available but are poorly tolerated and are not always effective. Morbidity and mortality from hepatitis C are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. Efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions. Scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. This cell carries a receptor for angiotensin, a hormone, when activated. If this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. Thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis C.

NCT ID: NCT00938990 Withdrawn - Trauma Clinical Trials

The Effect of Etomidate on Outcomes of Trauma Patients

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

Rationale: The drug etomidate causes increased mortality if used for continuous sedation in mechanically ventilated patients; however, etomidate continues to be widely used as a single-bolus induction agent for endotracheal intubation because of its favorable hemodynamic properties. Recent data have raised questions regarding the safety of using etomidate for even a single bolus in patients at risk of adrenal insufficiency, emphasizing the fact that single bolus doses of etomidate cause measurable adrenal suppression, and consequently may cause increases in vasopressor requirements and in hospital length of stay. Alternative FDA-approved induction agents, such as midazolam, may be safer than etomidate; however, no studies have formally compared these agents. Research Hypothesis: The investigators hypothesize that in critically ill trauma patients presenting to the emergency department requiring rapid sequence intubation, the hospital length of stay for patients given etomidate will be greater than for patients given midazolam for induction. Specific Aims: The specific aim is to determine the difference in hospital length of stay between trauma patients given etomidate and those given midazolam for induction during rapid sequence intubation in the emergency department. The investigators plan to compare the two groups in terms of hospital length of hospital stay, length of stay in the intensive care unit, and duration of intubation by performing a prospective, randomized, trial of critically ill trauma patients presenting to the emergency department requiring intubation. The investigators will also compare the mortality rates in these two groups while controlling for severity of illness and the use of steroids while hospitalized. Significance: If the use of etomidate to induce anesthesia prior to intubation adversely affects the hospital length of stay of trauma patients, this length of stay might be reduced in such patients by using alternative agents for induction. Since etomidate is currently in widespread use as an induction agent, the results of this study could have significant implications for patient management.

NCT ID: NCT00944593 Withdrawn - Clinical trials for Diabetic Gastroparesis

Gastric vs Jejunal Feeding in Diabetic Gastroparesis

Start date: n/a
Phase: Phase 4
Study type: Interventional

Diabetic 'Gastroparesis' or 'Gastroenteropathy' is a condition in which patients suffer episodes of nausea, vomiting, abdominal bloating and pain after eating. These symptoms occur in the absence of any structural abnormality of the stomach, rather abnormal gastric function underlies the condition. Up to one in five patients with type I diabetes experience symptoms consistent with this diagnosis. The effects on diabetic control, physical health and emotional quality of life are severe. Patients do not respond reliably to general supportive management or conventional medications. Surgical options have disappointing results. The need for more effective treatment is acknowledged universally. Feeding into the small bowel beyond the stomach (jejunal feeding) is established management in diabetic patients with gastroenteropathy that are malnourished due to poor oral intake. The benefits have been assumed secondary to improved nutrition and diabetic control; however this assertion has never been studied. Recently we observed that patients with severe gastroenteropathy recovered promptly and could eat normally during and for a few hours after jejunal feeding. These observations suggest that jejunal feeding has 'quasi-pharmacological' effects in patients with gastroenteropathy. One attractive explanation for these observations is that gastroenteropathy represents a failure of oral intake to 'switch' the stomach from the fasted to the fed state. According to this hypothesis, jejunal feeding 'restores' the normal fed state by bypassing the dysfunctional stomach. This project will assess the effects of feeding on gastrointestinal (GI) sensory and motor function in diabetic gastroenteropathy. Healthy volunteers and diabetic controls without symptoms will also be investigated. Studies will assess: 1. Effects on GI symptoms and function to gastric distension in fasted and fed states 2. Effects on GI symptoms and function to oral vs. nasogastric delivery of a test meal 3. A trial of gastric feeding with and without prior jejunal feeding on GI symptoms and function Non-invasive magnetic resonance imaging (MRI) techniques will be applied to assess complex gastric response to feeding. In addition the effects of feeding on symptoms and gastric function will be related to alterations in GI hormones and autonomic nervous activity (eg cardiovagal tone) to assess how the integrated response of the GI tract to feeding fails in patients with diabetic gastroenteropathy. The primary aim of this project is to assess the effectiveness of jejunal feeding in the management of diabetic gastroenteropathy. However, by defining the processes that 'switch' gastric function between the fasted and the fed states and control gastric emptying, we hope also to identify candidate targets for more effective pharmacologic treatment of this severe disease. - Trial with medical device