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NCT ID: NCT05276258 Enrolling by invitation - Pain Clinical Trials

Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.

NCT ID: NCT05274113 Enrolling by invitation - Post Operative Pain Clinical Trials

Low Dose Dexamethasone for Distal Radius Fractures

Start date: March 10, 2022
Phase: Phase 3
Study type: Interventional

The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.

NCT ID: NCT05273970 Enrolling by invitation - Cognition Clinical Trials

Electrochemical and Electrophysiological Study

Start date: September 7, 2022
Phase: N/A
Study type: Interventional

This study will utilize computerized algorithms in combination with real-time intracranial neurophysiological and neurochemical recordings and microstimulation to measure cognitive and affective behavior in humans. Questionnaires or simple behavioral tasks (game-like tasks on a computer or an iPad) may also be given to additionally characterize subjects on related cognitive or affective components. Importantly, for the purposes of understanding the function of the human brain, neural activity can be recorded and probed (i.e. microstimulation) while subjects are performing the same computerized cognitive and affective tasks. These surgeries allow for the in vivo examination of human neurophysiology and are a rare opportunity for such research. In addition to computerized testing, the investigators plan to characterize subjects' behavior on related cognitive or affective components. Some neuropsychological questionnaires, many of which are administered for clinical reasons (listed below under study population), may also be given to patients and healthy control subjects. All patients undergoing epilepsy surgery (the population from which subjects will be selected) undergo a standard clinical neuropsychological battery to assess aspects of cognitive function. This is a regular aspect of their clinical assessment carried out prior to consideration for study inclusion. All participants are selected uniformly because they are undergoing surgery for subdural electrode implantation. No particular ethnic group or population is targeted by or excluded from the study. Those to be considered for inclusion in the proposed study performing more than 2 standard deviations below the mean on any aspect of cognitive functioning as determined by standard preoperative neuropsychological testing will be excluded from the study. No additional neuropsychological testing will be necessary as part of the study itself.

NCT ID: NCT05273372 Enrolling by invitation - Fatigue Clinical Trials

RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

There is no approved treatment for fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a condition with as many as 2.5 million people in the US. Initial case studies have shown an improvement in fatigue in ME/CFS with anhydrous enol-oxaloacetate (AEO). This randomized, double blinded, placebo controlled trial will seek to further evaluate the efficacy of AEO to reduce fatigue in ME/CFS, based on change in the Chalder Fatigue Score (Likert Scoring) of the AEO group against the placebo group at 90 days. As secondary evaluations on other core ME/CFS symptoms, the investigators are measuring the health related quality of life as assessed by the SF-36, hours of upright activity, functional capacity (activity, steps, cognition, and heart rate variability), and general health status (global change, vitals) Finally, this test will gain preliminary insights on the safety, tolerability, and efficacy of AEO in ME/CFS patients.

NCT ID: NCT05270603 Enrolling by invitation - Surgery Clinical Trials

The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

ICARUS-C
Start date: March 15, 2022
Phase:
Study type: Observational

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications. The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.

NCT ID: NCT05270356 Enrolling by invitation - Clinical trials for Adult Congenital Heart Disease

MINDS Imaging Ancillary Study

MINDS
Start date: May 27, 2021
Phase:
Study type: Observational

This study is an ancillary study to the NHLBI-funded Pediatric Heart Network (PHN) "Multi-Institutional Neurocognitive Discovery Study" (MINDS) in Adult Congenital Heart Disease (ACHD). The MINDS-ACHD" study will recruit 500 complex CHD patients between18-30 years old. The investigators propose to quantitate multi-modal neuroimaging biomarkers (brain injury, structure and physiology) which are not only important components of brain and cognitive reserve but can be predictive of neurocognitive decline and early onset of dementia in the aging non-CHD population.

NCT ID: NCT05269277 Enrolling by invitation - Nurse Well-being Clinical Trials

Health System Methods to Improve Nursing Retention Amidst Ongoing COVID-19 Pandemic: a Mixed Method Study

Start date: February 23, 2022
Phase:
Study type: Observational

This study is a mixed-method exploratory study with the aim to determine an objective compensation or mechanism of support from a healthcare system standpoint to aid in retention of nursing staff amidst the ongoing COVID-19 pandemic. It will include semi-structured qualitative interviews of current and prior nursing staff from the Trauma/Surgical floor, Progressive Care Unit, and ICU, in addition to Trauma/Surgical unit and system administrators; the second portion of the study will include a quantitative survey distributed via email to current nurses on the Trauma/Surgical floor, Progressive Care Unit, and ICU to assess ranked priority of additional mechanisms of support to improve intention of retention.

NCT ID: NCT05266963 Enrolling by invitation - Type 1 Diabetes Clinical Trials

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

CREON
Start date: September 2, 2022
Phase: Early Phase 1
Study type: Interventional

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question. The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).

NCT ID: NCT05266196 Enrolling by invitation - Ewing Sarcoma Clinical Trials

A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577)

Start date: January 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This rollover protocol allows continued access to seclidemstat (SP-2577) for patients who are still receiving clinical benefit on completed or closed Salarius sponsored studies.

NCT ID: NCT05264298 Enrolling by invitation - Stroke Clinical Trials

Video-based Intervention to Address Disparities in Blood Pressure Control After Stroke

VIRTUAL
Start date: March 29, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the impact of a multidisciplinary telehealth-based model of outpatient stroke care on blood pressure control following stroke, and further, to evaluate its impact on racial disparities in post-stroke blood pressure control.