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NCT ID: NCT01543672 Completed - Lung Cancer Clinical Trials

Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

VOLUMES
Start date: November 22, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

NCT ID: NCT01543542 Completed - Clinical trials for Metastasis to Brain of Primary Cancer

A Phase II Multi-institutional Study Assessing Simultaneous In-field Boost Helical Tomotherapy for 1-3 Brain Metastases

TOMOSIBII
Start date: April 2010
Phase: Phase 2
Study type: Interventional

Helical tomotherapy is a novel radiation treatment machine that combines two existing technologies: spiral radiotherapy treatments combined with simultaneous computed tomotherapy imaging of the body. This new machine can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with existing radiation machines. In this study, helical tomotherapy will be used to provide radiation treatments (whole brain radiotherapy, daily over 10 treatments) that are commonly used to treat cancer metastatic to the brain. In addition, the individual spots of cancer (metastases) in the brain will be treated to a higher dose (approximately 2 times higher) than the dose to the whole brain. The purpose of this study is to determine the effectiveness of whole brain radiation with lesion boosting with the helical tomotherapy machine.

NCT ID: NCT01543282 Completed - Solid Neoplasms Clinical Trials

Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles

Start date: December 10, 2011
Phase: N/A
Study type: Interventional

This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in consecutive patients. Summary Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies comparing them regarding efficacy and feasibility are lacking. Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of the conventional 22 G compared with the 25 G needle. Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant coagulopathy (APT < 50% or platelets < 50000/mm3), use of warfarin or other anticoagulants, use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent and pregnancy or suspected pregnancy will be excluded. Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. The diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value. An expected rate of 85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.

NCT ID: NCT01543256 Completed - Biliary Stricture Clinical Trials

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Start date: September 18, 2012
Phase: N/A
Study type: Interventional

The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months. Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

NCT ID: NCT01542788 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

POSITRON
Start date: March 2012
Phase: Phase 3
Study type: Interventional

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

NCT ID: NCT01542385 Completed - Clinical trials for ST-elevation Myocardial Infarction

Primary Reperfusion Secondary Stenting Trial

PRIMACY
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.

NCT ID: NCT01542177 Completed - Pancreatic Cancer Clinical Trials

A Study Using 18F-FAZA and PET Scans to Study Hypoxia in Pancreatic Cancer

Start date: February 2012
Phase:
Study type: Observational

This is a diagnostic study to look for low levels of oxygen (hypoxia) in pancreatic cancer using an imaging test called positron emission tomography (PET). Hypoxia can influence how pancreatic cancer grows and responds to treatments such as chemotherapy and radiotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans using a tracer called 18F-FAZA (18F-Fluoroazomycin Arabinoside) can provide useful information about hypoxia in pancreatic cancer. Also as part of the study, a blood sample will be taken to study biomarkers (substances in the body that may be important indicators of hypoxia and/or pancreatic cancer) that may be useful in studying pancreatic cancer and hypoxia.

NCT ID: NCT01542034 Completed - Clinical trials for Moderate or Severe Submental Fullness

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

REFINE-1
Start date: February 2012
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

NCT ID: NCT01541839 Completed - Nasal Obstruction Clinical Trials

Comparison of a Septal Stapler to Suture Closure in Nasal Septoplasty

Start date: February 2012
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine if there is a time savings in the operating room by using a septal stapler instead of suture in closure of primary septoplasty. The secondary objectives are to determine the subjective outcome of patients undergoing closure with the septal stapler instead of suture via questionnaire, and to determine if there is a difference in postoperative complications between groups.

NCT ID: NCT01541540 Completed - Hypertension Clinical Trials

e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension

REACH
Start date: February 2012
Phase: N/A
Study type: Interventional

This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and adherence to prescribed medications. Finally, we will quantify the amount of e-counseling support that is required during REACH to evoke a significant reduction in blood pressure. It is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide information that is critical to our understanding of how internet-based programs can help to improve blood pressure and to reduce the risk for cardiovascular disease.