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NCT ID: NCT02242578 Terminated - Schizophrenia Clinical Trials

Treating Refractory Schizophrenia With rTMS

Start date: January 24, 2011
Phase: N/A
Study type: Interventional

Symptomatic treatment of the negative symptoms in schizophrenia (such as social withdrawal, affective flattening, poor motivation, and apathy) with medications and psychotherapy are almost non-existent, whereas treatment of the positive symptoms (hallucinations and delusions) has been more effective with psychotropic medications. The proposed research on human subjects using a non-invasive technology (such as repetitive transcranial magnetic stimulation [rTMS]) will provide efficacy data for treating negative symptoms. The hypotheses are that 1) Cerebellar stimulation will cause activation of thalamic and frontal cortical networks associated with attentional processes as a component of the "distracted" affect of schizophrenia; 2) Cerebellar stimulation will cause activation of the reticular activating system (RAS), and this will allow the "mutism", which is a negative symptom, to be partially improved.

NCT ID: NCT02242448 Terminated - Healthy Volunteers Clinical Trials

Imaging Techniques in CT: Technical Development

Start date: July 31, 2014
Phase:
Study type: Observational

Background: - Computed tomography (CT) scanning is a procedure that helps doctors with diagnoses. It uses X-ray radiation to produce an image in three dimensions. Researchers want to study how to get the best quality CT scans using the lowest possible radiation dose. Objective: - To determine how to improve CT scanning. Eligibility: - Adults 45 years of age and older who have not had a CT scan in the past year and do not have kidney disease. Design: - Participants will be screened with a medical history and blood and urine tests. - Nurses will put an intravenous (IV) line into an arm or hand vein. It will stay in for several hours during the magnetic resonance imaging (MRI) and CT scans. Through this IV, blood will be taken, dye will be injected, and medicine will be given. - Participants may have a CT scan of the heart, head, chest, abdomen, and/or pelvis. Participants will lie on their back on a table. The table will slide into a donut-shaped machine. An X-ray tube will move around the body, taking pictures. - Participants may be given a drug called a beta blocker by mouth or through the IV tube. - Participants heart rate and blood pressure will be monitored. - Participants may have an MRI scan. The MRI is a large hollow tube. The participant will lie on a table that will be moved into the tube, which contains a magnetic field. When the imaging starts, a thumping sound will be heard. Headphones or earplugs will be provided to muffle the sound. - Participants will give blood samples.

NCT ID: NCT02242409 Terminated - Pancreatic Cancer Clinical Trials

Study of Gemcitabine and Abraxane for Pancreas Cancer

Start date: September 2014
Phase: Phase 2
Study type: Interventional

A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

NCT ID: NCT02241798 Terminated - Epilepsy Clinical Trials

Pre-oxygenation and Measures of Gas Exchanges During Seizures in the Epilepsy Monitoring Unit

Start date: August 2013
Phase: N/A
Study type: Interventional

The primary goal of the study is to assess the effect of pre-oxygenation on oxygen and carbon dioxide levels during seizures in patients admitted at the Epilepsy Monitoring Unit (EMU). The investigators hypothesize that providing oxygen prior to seizures will help eliminate the drops in changes seen during seizures, such as the drop in oxygen saturation and increase in carbon dioxide levels. Research will be done on patients that are admitted to the EMU specifically to have seizures occur and to be recorded on video electroencephalography (vEEG), and the only research intervention will be the use of oxygen prior to some of the seizures. The importance of this research relates to the phenomenon of sudden unexplained death in epilepsy patients (SUDEP). SUDEP cases are typically patients with epilepsy who are found dead by their families in the morning, without a clear cause for death. The risk of SUDEP is as high as 9.3 per 1000 person-years (Shorvon and Tomson 2011). There may be multiple mechanisms for SUDEP to occur, however a leading hypothesis is a decrease in ventilation during the seizure leading to hypoxia. Blood oxygen saturation levels have been found to decrease significantly in 25-50% of patients during or shortly after a seizure while being monitored in hospitals. In rare situations, a significantly lowered oxygen level may trigger a cascade of events from which the body may not be able to recover, leading to SUDEP. In animal models, providing oxygen prior to seizures occurring has been shown to eliminate oxygen desaturation, but more importantly eliminate mortality in animals prone to death due to seizures. Pre-oxygenation is a standard procedure during rapid-sequence induction anesthesia as it reduces the risk of oxygen desaturation during the apneic period of the procedure. On room air, the estimated duration of safe apnea is 1 minute, but this can increase to 8 minutes following pre-treatment with high FiO2 (Weingart and Levitan 2012). This is primarily due to oxygen replacing nitrogen within alveoli, creating a reservoir of oxygen within the lungs from which transfer to the bloodstream can continue despite the lack of ventilation. The apneic episode during seizures should benefit from the same principle. The main purpose of the Epilepsy Monitoring Unit (EMU) is to evaluate patients to better characterize seizures, to identify the main seizure focus. In addition to standard EEG with electrodes on the scalp, some patients require invasive localization of the epileptic focus by surgically placing electrodes within the skull (often referred to as GRID patients) on or within the brain, with the goal of being able to resect the area that is causing seizures. To identify where seizure originate electrically, it requires that seizures occur during the vEEG procedure. To provoke seizures, medications are typically lowered, and both partial seizures and those with secondary generalization to full tonic-clonic (GTC) seizures will occur. Prior research has shows that oxygen desaturation below 90% occurs with some complex partial seizures, but hypoxia is more common and more profound with GTCs. Some centers use oxygen saturation and CO2 monitors as their standard of care, and at NYULMC the investigators also have the capability for both for clinical usage. Oxygen is not currently a mandated standard-of-care, but is often provided by nasal prongs following seizures as part of the post-ictal nursing care, though there is no outcome data to support its use. It is unknown whether pre-treatment with oxygen will reduce the rate of oxygen desaturations clinically, as seen in animal models, and this is the goal of this research project.

NCT ID: NCT02241785 Terminated - Clinical trials for Relapsing Multiple Sclerosis

Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis (MS) After Failure on Other Therapies

ESCALATE
Start date: September 2014
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have failed Gilenya or BRACET (Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera) as measured by the proportion of participants with no evidence of disease activity (NEDA) at Year 1. The secondary objectives in this study population are: Change in total T1 hypointense and total T2 hyperintense lesion volume; Proportion of participants with NEDA at Year 2; Evaluation of the impact of natalizumab on annualized relapse rate (ARR); and Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical impact score.

NCT ID: NCT02241720 Terminated - Upper GI Cancer Clinical Trials

Regorafenib Second Line Treatment of Metastatic or Advanced Upper GI Cancers

Start date: May 2014
Phase: Phase 2
Study type: Interventional

Regorafenib as a Second Line Single Agent in the Treatment of Metastatic or Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction or Stomach

NCT ID: NCT02241551 Terminated - Clinical trials for Borderline Resectable Pancreatic Cancer

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

Start date: December 2014
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized phase II trial. Patients diagnosed with borderline resectable pancreatic adenocarcinoma will be randomly assigned to one of two treatment arms, either mFOLFIRINOX or gemcitabine and nab-paclitaxel. After three cycles of treatment in the gemcitabine/nab-paclitaxel arm and 6 cycles in the mFOLFIRINOX arm, patients will be restaged with CT scans and if they remain borderline resectable or have improvement of their disease They will then proceed to SBRT followed by surgical resection.

NCT ID: NCT02241525 Terminated - Pulmonary Embolism Clinical Trials

CT for Pulmonary Thromboembolic Disease

CT for PE
Start date: February 2016
Phase:
Study type: Observational

Examine the feasibility and efficacy of individually optimized uniform contrast enhancement in CT pulmonary angiography (CTPA) for the diagnosis of pulmonary thromboembolic disease.

NCT ID: NCT02241512 Terminated - Clinical trials for Post-ERCP Acute Pancreatitis

IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Start date: September 2014
Phase: Phase 2
Study type: Interventional

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.

NCT ID: NCT02241486 Terminated - Burn Pain Clinical Trials

Sublingual Fentanyl and Procedural Burn Pain

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.