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NCT ID: NCT02636816 Completed - Pregnancy Clinical Trials

Cardiovascular Effects of Carbetocin Given During Elective Cesarean

Start date: March 2016
Phase: Phase 4
Study type: Interventional

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

NCT ID: NCT02636699 Completed - Peanut Allergy Clinical Trials

Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy

PEPITES
Start date: December 2015
Phase: Phase 3
Study type: Interventional

The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).

NCT ID: NCT02636023 Completed - Clinical trials for Cardiovascular Risk Factor

Correlation Between the SPhENo-Cardiographâ„¢, a Seismocardiograph Device, and GE Vivid Q, an Echocardiograph, for Known Systemic Timing Intervals (STI)

Start date: August 2015
Phase: N/A
Study type: Interventional

The study Sponsor, Heart Force Medical Inc. (HFM), has developed a patented medical device called the SPhENo-CardiographTM. The SPhENo-Cardiographâ„¢ provides a non-invasive assessment of the electro-mechanical function of the heart. The electrocardiograph (ECG) represents the waveform of the electrical stimulus to the cardiac muscle. The mechanical actions of the electrical potentials delivered in the ECG are revealed as the seismocardiograph (SCG). The SCG represents the changes in acceleration of the heart during the cardiac cycle. The SCG waveform reflects the ultra-low frequency vibrations of cardiac contraction. These low frequency vibrations are transmitted through the sternum. Using the point of initiation of ventricular contraction on the ECG, the Q wave, with fiduciary points on the synchronous seismocardiograph, it is possible to determine timing events of the cardiac cycle. The timing events of the cardiac cycle during systole are referred to as Systolic Timing Intervals (STI) and comprise the Pre-Ejection Period (PEP) and the Left Ventricular Ejection Time (LVET). The PEP is the time from the Q wave to the Aortic valve opening. The Left Ventricular Eject Time (LVET) is the time between the Aortic Valve opening and closing. The ratio of PEP/LVET in individuals with established heart disease is > 0.42. It is based on the formula described by Dr Arnold Weissler and first published in Circulation in 1968 (Weissler et al,1968). Weissler et al showed that the PEP/LVET ratio >0.42 are indicative of a lengthening of the PEP with some marginal shortening of the LVET. This is indicative of pathology associated with the coronary circulation (Ahmed et al, 1972;). This ratio can then be used as part of a non-invasive quantitative assessment of cardiac performance (Lewis et al 1977). Using the SPhENo-CardiographTM, HFM has developed an algorithm to assess heart health that otherwise requires a number of technologies; stethoscope, ECG and Carotid pulse tracing to identify the dicrotic notch or Aortic Valve closure.

NCT ID: NCT02635776 Completed - Peanut Allergy Clinical Trials

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

PALISADE
Start date: December 22, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

NCT ID: NCT02635555 Completed - Hypotension Clinical Trials

The Effects of Height and Weight Adjusted Dose of Local Anesthetic.

Start date: April 2016
Phase: N/A
Study type: Interventional

At our centre a conventional dose of 12 mg of hyperbaric bupivacaine in combination with a short acting opioid fentanyl (to increase block density) and a long acting opioid morphine (to provide post-operative pain relief ) is used for spinal anesthesia for cesarean section.However, larger doses of local anesthetic drug when used in caesarean section commonly cause low blood pressure and requires drugs (vasopressors) to treat it. In our study the investigators will standardize the doses of both opioids (fentanyl/morphine) and adjust the dose of local anesthetic (bupivacaine) based on the patients height and weight .One of the obvious challenges anesthesiologists face is providing adequate anesthesia to the patient whilst minimizing harmful side effects. Our primary concern is the low blood pressure as an effect of the spinal anesthetic as it is harmful to both mother and the baby. The investigators propose that the extent of surgical anesthetic block, which is dependent on height and weight in our adjusted dose group, will provide adequate anesthesia for surgery and minimise maternal low blood pressure.

NCT ID: NCT02635217 Completed - Anemia Clinical Trials

Same Day Bidirectional Endoscopies - Does the Sequence of Procedures or Choice of Insufflator Matter?

Start date: January 2016
Phase: N/A
Study type: Interventional

Upper endoscopies (Esophagogastroduodenoscopies-EGDs) as well as a lower endoscopies (Colonoscopies) are routinely performed by gastroenterologists to assess the lining of patients' upper and lower gastrointestinal tracts using a video endoscope (a long tube with a video camera on the end). An EGD is performed to examine the upper digestive tract to look for areas of inflammation, ulcerations, or other abnormalities in the swallowing tube, stomach, or duodenal lining. Similarly, a colonoscopy is performed to directly visualize the large bowel for polyps, inflammation, or other abnormalities in the lower bowel lining. During these procedures, room air is routinely used to insufflate (expand/inflate the stomach and the colon) to allow for better viewing of the lining of the upper and lower gastrointestinal tracts; however, recently the use of carbon dioxide (CO2) (instead of air) has been shown to possibly have less post-procedure patient discomfort. Additionally, when both procedures are performed in the same day, it is currently unknown as to which sequence of procedures is better overall -whether to perform the EGD before colonoscopy or vice versa. The overall aim of our research is to compare patients' comfort, total amount of sedation used, and overall satisfaction with the procedures between four randomly allocated groups, to see which method of insufflation and which procedural sequence is better when both procedures need to be performed in the same day. We hypothesize that in patients requiring same day endoscopies, performing an EGD prior to Colonoscopy with carbon dioxide (CO2) used as an insufflator is the best tolerated sequence associated with decreased sedation use and increased patient satisfaction/comfort.

NCT ID: NCT02634762 Completed - Heart Failure Clinical Trials

Acute Congestive Heart Failure Urgent Care Evaluation

ACUTE
Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST) have been previously derived.

NCT ID: NCT02634567 Completed - Multiple Sclerosis Clinical Trials

Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training

Start date: April 2016
Phase: N/A
Study type: Interventional

Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of attention problems will be randomized to standard medical care (treatment as usual) or attention training, which will be completed at their home using a commercially available attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will undergo cognitive testing before and after intervention and at 6 months follow up.

NCT ID: NCT02634333 Completed - Clinical trials for Diabetic Retinopathy

Anti-VEGF Treatment for Prevention of PDR/DME

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Multiple studies have implicated vascular endothelial growth factor VEGF as a major causative factor in human eye diseases characterized by neovascularization including proliferative diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema (DME). While there is strong evidence that PDR outcomes are markedly reduced in eyes that are treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent dosing during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol I), it is unknown whether or not an earlier but less frequent dosing regimen would result in similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently would result in favorable visual acuity outcomes. If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe non-proliferative diabetic retinopathy) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented. The primary objectives of this protocol are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially, and treated only if high-risk PDR or CI-DME with vision loss develops. Secondary objectives include: - Comparing other visual acuity outcomes between treatment groups, such as proportion of eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of at least 5 letters at the consecutive study visit just before and at the 2- or 4-year visit - Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT central subfield thickness and volume from baseline - Comparing proportion of eyes with at least 2 and 3-step worsening or improvement of diabetic retinopathy severity level (scale for individual eyes) by central reading center from baseline - Comparing associated treatment and follow-up exam costs between treatment groups - Comparing safety outcomes between treatment groups

NCT ID: NCT02634307 Completed - Multiple Sclerosis Clinical Trials

A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

Start date: December 10, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.