Treatment Trials

2,177 Clinical Trials for Various Conditions

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RECRUITING
Assessment of Medrol Dosepak to Reduce Opioid Consumption in Foot and Ankle Surgical Patients
Description

This clinical trial aims to determine the effects of a 6-day low-dose methylprednisolone course on pain, nausea, and total opioid consumption in patients undergoing foot and ankle surgeries. The secondary objective of the study is to determine and monitor the effects of the course on complications following surgery and patient-reported outcomes

NOT_YET_RECRUITING
Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative
Description

The purpose of this project is to introduce and implement music therapy as an evidence-based pain management protocol focused on reducing postoperative pain levels among Video-Assisted Thoracoscopic Surgery (VATS) patients in the Post-Anesthesia Care Unit (PACU) of the project site. The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.

RECRUITING
Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC
Description

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

Conditions
NOT_YET_RECRUITING
Pip Care to Improve Surgical Patient Outcomes - Phase II
Description

Pip Care is developing a personalized, interactive surgical journey platform with a live health coach that works directly with health systems to optimize the perioperative care process. Our Health Insurance Portability and Accountability Act (HIPAA)-compliant platform, Pip, can be integrated into any electronic medical record (EMR), thus alleviating the administrative burden by making operational workflows more efficient. The PIP empowers patients and their families to be more involved in their care by breaking down a patient's healthcare plan into definable, easy-to-understand, and easy-to-complete tasks. Additionally, a health coach completes a health intake to create a personalized perioperative care plan, meets regularly with the patient to encourage goal accomplishment, and facilitates care coordination. This project has 2 phases; Phase I is to assess usability of the Pip Care platform in surgical patients, Phase II is a RCT (Randomized Controlled Trial) to assess surgical clinical outcomes while using Pip compared to standard of care.

RECRUITING
Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients
Description

Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.

NOT_YET_RECRUITING
Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
Description

The goal of this phase II single arm clinical study is to evaluate the effect of antibiotics (metronidazole) and oral chlorhexidine (CHX) in reducing the bacteria load within tumors of patients undergoing surgery for oral cancer.

RECRUITING
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
Description

The purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-Factor Perceived Shared Mental Model Scale (5-PSMMS) in a healthcare setting and whether the perception of Shared Mental Model (SMM) mediates the effect of the intraoperative handoff tool on postoperative outcomes

RECRUITING
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients
Description

The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function. This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.

RECRUITING
Early Detection of Infection Using the Fitbit in Pediatric Surgical Patients
Description

The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.

RECRUITING
Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer
Description

This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

RECRUITING
Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Description

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

RECRUITING
Symbiotic Use in Post-Bariatric Surgery Patients
Description

The purpose of this double blind, randomized control trial would be to test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients by testing stool samples prior to administration and then three months post administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal related symptoms.

RECRUITING
Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Description

Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance \[FGP\]) in older patients presenting for major surgery. Participants in this feasibility trial will serve as a pilot population to estimate postoperative delirium incidence in patients willing and able to complete the brief, self-directed, brain exercise experience on a portable electronic device in various preoperative encounters, and will provide insight into which preoperative encounter (outpatient clinic or morning of surgery preoperative holding) may be more conducive to brief preoperative cognitive evaluations and interventions in future studies. First gameplay performance obtained during study procedures will be compared based upon postoperative delirium status (positive verse negative) to evaluate predictive value of the custom 6-game battery. This will guide future studies of FGP as a quick, quantitative measure of cognitive reserve in older surgical patients, with potentially more utility in preoperative patients than other assessments of cognitive function.

ENROLLING_BY_INVITATION
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
Description

This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

RECRUITING
Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
Description

The purpose of this study is to investigate orthopedic patients undergoing either a total hip replacement (THR) or total knee arthroplasty (TKR) using two dietary supplements, PREPARE and RECOVER, and their recovery times post-surgery.

RECRUITING
Decreasing Post-Operative Nausea and Vomiting in the Bariatric Surgical Patient
Description

From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.

RECRUITING
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Description

This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.

COMPLETED
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
Description

The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.

RECRUITING
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
Description

This is a prospective randomized blinded controlled trial that will enroll 175 subjects undergoing cardiopulmonary bypass at NorthShore University HealthSystem. The purpose of this study is to compare clinical outcomes in elective and urgent cardiac surgical patients at NorthShore University HealthSystem when receiving sugammadex, a common neuromuscular blockade reversal drug given after surgery and before the breathing tube is removed vs. those patients who do not receive sugammadex (placebo) group. The Investigators will compare the following outcomes in both the sugammadex and placebo groups during patients hospital stay: # of patients who have the breathing tube removed within 6 hour of the end of surgery, time it takes to remove the breathing tube after surgery, ICU and hospital length of stay, cost of the ICU stay, time to achieve a train of four ratio of \> or equal to 0.9, whether patients develop pneumonia or not, whether they require the breathing tube to be replaced during their hospital stay and to compare the nursing perception of patients recovery within first 24 hours of their ICU stay.

Conditions
COMPLETED
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Description

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

COMPLETED
Surgical Patient Education in Pediatric Urology
Description

Randomized study to assess the impact of supplemental educational YouTube videos on postoperative healthcare utilization following ambulatory pediatric urologic surgery

RECRUITING
Remote Cognitive Assessment for Surgical Patients
Description

This is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone.

COMPLETED
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Description

To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.

COMPLETED
Remote Monitoring of Surgical Patients Through VALIDIC
Description

We propose to assess the feasibility and outcomes of use of a wearable activity tracker for monitoring daily step counts in the peri-operative and 30 day post-operative period in elderly patients receiving elective abdominal surgery at Duke. We will use the information as guidance for improving activity in surgical patients at Duke. The activity tracker will be worn for the peri-operative period which starts at the time of the surgery/clinic visit and continues during the inpatient hospital stay and for 30 days following discharge. The vivosmart®HR is a commercially available device that is made of plastic and designed to be worn around the wrist. Aggregate data will be analyzed to assess feasibility and effectiveness of this device in improving patient recovery. No discomfort or burden is expected from wearing the monitor, and patients will have continuous feedback on their daily activity.

COMPLETED
De-adopting Routine Preoperative Benzodiazepines for Older Surgical Patients
Description

Over 21 million surgical procedures take place among adults aged 65 and older in the US each year, and most older surgical patients in the US now receive benzodiazepines (e.g., midazolam, lorazepam) during anesthesia care. This occurs despite recommendations to avoid these medications in older patients due to associated medical risks and lack of demonstrated benefit. In other words, routine benzodiazepine administration to older surgical patients is likely to represent low-value care that is a suitable target for de-adoption. In this study, we will evaluate a United States Anesthesia Partners (USAP, Dallas, TX) quality improvement initiative using peer comparison feedback to clinicians and/or mailed informational letters to patients as strategies to encourage physician de-adoption of routine preoperative benzodiazepine administration to older surgical patients. In partnership with USAP, this study will be conducted using randomization to evaluate its effect.

Conditions
RECRUITING
App Delivered Brief Mindfulness Intervention for Surgical Patients
Description

This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.

RECRUITING
Implementation of a Prehabilitation Program for Surgical Patients
Description

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

ACTIVE_NOT_RECRUITING
Clinical Markers of Dysphagia in Cardiac Surgical Patients
Description

Although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. This longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. Statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.

RECRUITING
Development of an Application-Based Digital Navigator for Perioperative Breast Surgery Patients
Description

The goal of this research study is to learn how accessible JEEVA is for patients during the perioperative period (the time after the pre-operative surgical appointment, and up to 30 days after surgery

Conditions
COMPLETED
Sugammadex Titration in Cardiac Surgery Patients
Description

Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade. Clinical studies and experience have suggested that smaller doses may be effective. The purpose of this observational study is to determine the minimal effective dose of sugammadex by administering 50 mg every 5 minutes until the train-of-four ratio is 0.9 in a cohort of cardiac surgery patients, and to determine the duration of action by measuring the train-of-four every hour for up to 6 hours following reversal.