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NCT ID: NCT02724761 Not yet recruiting - Postoperative Pain Clinical Trials

Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

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

Our double-blinded, randomized control trial will assess the effect of nebulized racemic epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures. The investigators have had success in managing post-operative dysphagia in patients undergoing ACDF with the administration of this drug. Half of the participants will review nebulized epinephrine. The other half will receive placebo.

NCT ID: NCT02720874 Not yet recruiting - Clinical trials for Arthritis, Rheumatoid

Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis

MAPPIT-RA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.

NCT ID: NCT02712151 Not yet recruiting - Pain, Postoperative Clinical Trials

Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

Laparoscopic cholecystectomy is associated with considerable postoperative pain and surgeon-administered local anesthetic infiltration is the standard practice for achieving post-operative analgesia. However, recent studies have shown that pediatric patients continue to experience significant pain during the first 24 hours. The investigators plan to conduct a prospective, double-blinded, randomized study where patients will be designated into either a test group receiving an ultrasound-guided transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and surgical team will both be blinded as well as the research personal in the postoperative period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing laparoscopic cholecystectomy will be included. The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single shot transversus abdominis plane and rectus sheath blocks, are superior to local wound infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain related behavior and facilitating functional recovery.

NCT ID: NCT02708082 Not yet recruiting - Glaucoma Clinical Trials

Glaucoma HFA / OCT Specificity Study

Start date: March 2016
Phase: N/A
Study type: Observational

Study consists of five visits over a one to three month time period.

NCT ID: NCT02703831 Not yet recruiting - Clinical trials for Scoliosis, Unspecified

Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery:

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

Two recent studies showed that having two attending spine surgeons performing complex adult spine deformity surgery instead of one, decreased complications, unplanned surgeries within 30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein thrombosis and post-operative neurologic complications [Sethi]. However, both studies were retrospective and did not evaluate any cost-savings associated with having two spine surgeons instead of one performing complex spine deformity surgery. Most cost-effectiveness studies have used traditional accounting (TA) methods to determine costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC) [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery. Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce downstream costs compared to a single spine attending for complex spine surgeries using traditional accounting methods; and (2) to demonstrate an application of the TDABC method to evaluate the operating room phase during complex adult spinal deformity surgery and compare it to traditional accounting methods (TA).

NCT ID: NCT02701790 Not yet recruiting - Spinal Cord Injury Clinical Trials

Improving Motor Function After Spinal Cord Injury

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

The goals of this study are to examine the physiology of Central Nervous System pathways contributing to the control of upper and lower extremity movements after SCI, and to promote the recovery of extremity movements by using non-invasive brain stimulation and motor training.

NCT ID: NCT02691728 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

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

This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease

NCT ID: NCT02677519 Not yet recruiting - Clinical trials for Attention Deficit Disorder With Hyperactivity

A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD

EF004
Start date: September 2016
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed with ADHD. Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ). Secondary objectives include assessment of long-term efficacy of Aptensio XR®. Secondary measures include: - Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version) - Clinical Global Impressions-Severity Scale (CGI-S ) - Connors Early Childhood Behavior-Parent Short form [Conners EC BEH-P(S)]

NCT ID: NCT02665442 Not yet recruiting - Atrial Fibrillation Clinical Trials

Retracting the Esophagus During AF Ablation

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

This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.

NCT ID: NCT02661919 Not yet recruiting - Epilepsy Clinical Trials

Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved. Several ways of preventing SUDEP have been identified. These include seizure control, stress reduction, physical activity, family's ability to perform CPR, and night supervision. A mattress alarm system that monitors nocturnal seizures can alert family members of night time seizure activity. Thus, a family member could provide aid and therefore potentially avoid SUDEP. The Emfit monitor is intended to perform these tasks. Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device has a high predictive value for detection of generalized convulsions and that it can notify caregivers in the early stages of convulsive activity. This study will further investigate the upgraded (connected to a cloud server via an integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification system.