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NCT ID: NCT02324530 Recruiting - Breast Cancer Clinical Trials

Evaluation of Continuous Positive Airway Pressure for Tumor Motion Management in Radiotherapy

Start date: December 2013
Phase: Phase 2
Study type: Interventional

This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.

NCT ID: NCT02324517 Recruiting - Severe Hemophilia Clinical Trials

Ex Vivo Laboratory Assays Application for Therapy Tailoring in Patients With Severe Bleeding Disorders

Start date: March 2010
Phase: N/A
Study type: Observational

Therapy of patients with severe hemophilia (including hemophilia with inhibitors) and other severe bleeding disorders could be monitored and guided based upon special clotting assays , eg thrombin generation and thromboelastography. In this study blood sampled from patients with bleeding disorders will be evaluated applying ex- vivo spiking assays with various coagulation concentrates to potentially address the feasibility of replacement /bypass agents/ combined therapy for future bleeding episodes. Patients that will be further treated by any regimen potentially suggested (as standard care- not within trial) will be thereafter followed , including repeated lab studies to assess the impact of therapy upon hemostasis.

NCT ID: NCT02324400 Not yet recruiting - Renal Insufficiency Clinical Trials

Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.

NCT ID: NCT02323932 Recruiting - Hearing Loss Clinical Trials

Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users

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

The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

NCT ID: NCT02323503 Completed - Device Replacement Clinical Trials

Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

BioCONTINUE
Start date: June 9, 2015
Phase:
Study type: Observational [Patient Registry]

Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

NCT ID: NCT02322814 Terminated - Breast Cancer Clinical Trials

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Start date: March 12, 2015
Phase: Phase 2
Study type: Interventional

This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.

NCT ID: NCT02322463 Recruiting - Limb Fracture Clinical Trials

Ethnicity and Analgesic Practice in a Pediatric Emergency Department

Start date: December 2014
Phase: N/A
Study type: Observational

Early and appropriate pain management in the emergency department (ED) is an important aspect of child care. Studies in the adult population revealed that ethnicity might be associated with disparities in analgesia and opioid treatment in ED patients suffering from limb fractures. The investigators aim to explore if ethnicity has an influence on analgesic practice in the pediatric ED. The objective of this study is to determine whether minority population Arab children with orthopedic injuries are less likely than Jewish children to receive oxycodone for limb fracture.

NCT ID: NCT02321761 Recruiting - Clinical trials for Traumatic Brain Injury

Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Start date: June 2014
Phase: Phase 4
Study type: Interventional

Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning. A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Patients demonstrated significantly worse performance with leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of neglect patients. This difference was significantly reduced during and following treatment. Our objective is to investigate whether Amantadine Hydrochloride is effective in improving allocation of spatial attention and improving function in people with Traumatic Brain Injury.

NCT ID: NCT02321722 Completed - Clinical trials for Intraocular Pressure

The Effect of Colonoscopy on Intralocular Pressure

Start date: January 2015
Phase:
Study type: Observational

Glaucoma is an eye disease that damages the optic nerve, it cause blindness if not diagnosed and treated properly. The major risk factor for the development and progression of glaucoma is increased intraocular pressure. Colonoscopy is one of the most preformed world wide screening exam. It is used to detect colon cancer at its early stages. As part of this examination, the examiner inflates the inspected colon with air in order to increase the colon lumen for better visualization of the colon. As a consequence of the insufflation the intrabdominal pressure increases as well. the increase in intrabdominal pressure could increase intraocular pressure. The aim of this study is to evaluate the intraocular pressure increase while preforming colonoscopy.

NCT ID: NCT02319629 Recruiting - Morbid Obesity Clinical Trials

Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

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

Risk factor of cholelithiasis is rapid weight loss after bariatric surgery and change in the gallbladder function which is secondary to surgery. Many observational studies support this fact, and a high incidence of 28% -71% after gastric bypass surgery (RYGB) was reported in them. According to another publication, the incidence of gallbladder diseases is 5-36% after jejunoileal bypass surgery and 2.8-36% after gastric bypass surgery.