27 Clinical Trials for Various Conditions
Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. We hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology. Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.
Engaging patients and families to take an active role in their healthcare leads to improved outcomes. Providing physicians and families with near real-time data on outcomes in children with similar medical conditions can allow families to form realistic expectations and take an active role in their child's health. It also provides physicians with near real-time feedback on patient-reported outcome measures to guide both conversations and recommendations for therapy at the point-of-care. A rapid learning healthcare system (RLHS) is a system that merges clinical research and clinical care. It is designed to collect data during routine patient care and then utilize the data to rapidly generate evidence to improve patient care, provide information to patients and families, and track quality measures. The investigators created a RLHS that integrates pre-specified data elements and validated surveys within the clinical workflow in order to operationalize automated research data collection and integrate predictive analytics into the electronic health record (EHR). Patients, caregivers, and physicians can access data in order to make informed, shared decisions about care and align expectations about outcomes.
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.
The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful. There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.
The goal of this observational study is to learn if surgical weight loss can improve chronic widespread pain in people living with higher BMI who self-identify as Hispanic/Latino ethnicity or non-Hispanic Black based on the United States census racial categories. The main questions the study aims to answer are: 1. Do pain at rest (primary outcome) and movement-evoked pain (secondary outcome) improve after bariatric surgery? 2. Do pain processing and joint function change after bariatric surgery? 3. Are pain processing and joint function associated with clinically significant pain change after surgical weight loss? Researchers will compare pain and function before and 6 months after bariatric surgery in a single cohort.
The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are: * Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure? * Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure? * What is the relationship between nutrition and clinical outcomes? Researchers will compare not fasting and fasting to see if it has an effect on recovery. Participants will: * Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure. * Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting. * Receive a phone call from the study team about 3 months after they enter the study to see how they are doing and complete a questionnaire. '
The purpose of this study is to determine whether eating solid food prior to undergoing a wide awake local-only no tourniquet (WALANT) procedure reduces anxiety in patients or has any effect on outcomes. Patients will be split randomly into two groups and told whether to eat or fast before their procedure. We will then compare levels of anxiety and nausea on the day of the procedure as well as satisfaction with the procedure and other outcome measures at follow-up visits. Our hypothesis is that patients who are instructed to eat before their WALANT procedure will have less anxiety, nausea, and overall higher satisfaction compared to those who are instructed to fast prior to their procedure.
The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are: * What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery? * What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard? The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects \>7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects \<7yrs of age and not expected to get an IV induction will be assigned to Cohort #2. * Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line. * Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
The purpose of this research is to estimate the frequency of postoperative lasting muscle weakness in patients receiving Sugammadex after undergoing liver transplant surgery by using electromyographic device (EMG), such as TetraGraph.
The purpose of this study is to investigate whether selected, short laryngologic surgical procedures can be safely and potentially more effectively performed without the use of endotracheal tube or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannulae: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).
The purpose of this study is to investigate whether laser laryngeal surgery can be safely and potentially more effectively performed without the use of tracheal intubation or jet ventilation, under completely tubeless conditions. The patient's gas exchange will be supported by rapid insufflation of high-flow oxygen through specialized nasal cannula: the so called Transnasal Humidified Rapid- Insufflation Ventilatory Exchange (THRIVE).
The purpose of this study is to compare the effect of the 25° head-up position versus the 55° head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for laparoscopic adjustable gastric band surgery following maximum preoxygenation and rapid-sequence induction (RSI) of anesthesia.
The purpose of this study is to retrospectively review our preliminary experience during a surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following CPB and cardiac surgery for repair of CHD in infants and children.
Measurement of the cardiac output is one of the important hemodynamic monitoring tools in cardiac surgery. It helps determine the type of medications needed to maintain optimal hemodynamic status in the entire perioperative period. Thermodilution method using pulmonary artery catheter is considered has the gold standard for the measurement of cardiac output. Investigators would like to compare the most popular minimally-invasive devices used to measure cardiac output using arterial waveform: LiDCO Rapid and TEE with the thermodilution method at various phases of the cardiac surgery.
The purpose of this study is to determine if the addition of Battlefield Auricular Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to ambulation without assistance, hours missed from work and increases quality of life after lower extremity surgery at two Air Force Medical Centers.
The purpose of the study is to look at which nonpermanent superficial closure method, cyanoacrylate tissue glue or fast absorbing gut suture, leads to a better cosmetic and functional outcome in repairs of facial wounds after Mohs surgery.
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function. Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs (surgical wound complication defined as surgically treated sternal wound infection and sternal instability/non-union) as outlined in the protocol. For a given study endpoint, the null hypothesis will be no difference between the Rapid Sternal Closure System group and the control group. The alternative hypothesis will be a difference between 2 groups. The statistical objective of this study is to reject the null hypothesis in favor of the alternative hypothesis.
The military is subject to traumatic wounds of various types and severity. Such wounds are predisposed to infection because they 1) tend to be extensive and deep, 2) may affect areas of normal carriage of potentially pathogenic bacteria in the gastrointestinal tract, upper respiratory tract, and the female genital tract, 3) typically produce tissue damage, 4) may introduce foreign bodies, 5) may interfere with local blood supply, 6) tend to produce ischemia, edema and hemorrhage, 7) may be complicated by fractures or burns and 8) may lead to shock and overwhelming of the body's systemic defenses. It will not always be possible in the military setting to cleanse and debride the wound promptly and effectively or to promptly provide surgery in the event of damage to vital structures. In the active military setting, the probability of wound infection following trauma is relatively high. In the absence of rapid identification of infecting flora and provision of information on antimicrobial susceptibility, clinicians must resort to empiric therapy rather than a tailored therapy. There is a tendency to use one of the top available agents that would likely be active against the vast majority of bacteria. This leads to increases in antimicrobial resistance, an important problem. The investigators hypothesize that the use of molecular biology techniques will provide identification of the microorganisms responsible for wound infection more rapidly and accurately. The investigators will evaluate real-time PCR (polymerase chain reaction) technique under this proposal. This procedure can be applied directly to material from the wound without need for first growing the organisms. It can be used to define the total flora of the wound within five hours. The investigators will first develop primers and probes that will detect the various bacteria anticipated in a given wound in a certain location. These primers and probes will be used in real-time PCR for rapid and accurate identification of the wound flora. The information obtained with real-time PCR is quantitative so that one may judge the relative importance of different isolates. The investigators will also use another molecular approach, 16S rRNA gene cloning, and conventional cultures; these will provide further information about the flora of various wounds. Definitive identification of anaerobes can be provided quickly and that, along with information on usual antimicrobial susceptibility patterns, can be life-saving or shorten the course of the infection considerably.
This study will determine if laparoscopy can be used successfully to find and remove insulinomas (insulin-secreting tumors of the pancreas). These tumors are very small and often difficult to locate with magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound. Invasive procedures, such as arteriograms (X-ray imaging using a contrast agent injected into the bloodstream through a catheter) and venous sampling are more successful but involve more patient discomfort and greater risk. This study will test whether laparoscopy can be used to replace some or all of these tests, as well as more extensive surgery. Patients 11 years of age and older with low blood sugar (hypoglycemia) probably caused by an insulinoma may be eligible for this study. Candidates will have their hypoglycemia confirmed (with tests done under NIH protocol 91-DK-0066: Diagnosis and Treatment of Hypoglycemia) and will have CT imaging of the abdomen and MRI and ultrasound tests of the liver and pancreas. Patients whose tumors are not found by these studies will undergo arteriography of the pancreas and hepatic (liver) venous sampling. Patients will then have laparoscopy. This surgical procedure uses a laparoscope-a tube-like device with special cameras and an ultrasound probe attached through which the surgeon can see and operate inside the abdomen. Laparoscopy is commonly done to remove the gallbladder and is also used to remove portions of the pancreas. For the current procedure, the surgeon makes small incisions in the abdomen, inserts tubes, fills the abdomen with gas, and proceeds to explore and operate on the pancreas. The surgeon will try to locate the tumor with the laparoscope. If the tumor is found, the location will be verified by the imaging study results. If it cannot be located by laparoscopy, the results of the imaging studies will be disclosed to enable removal. If the tumor cannot be successfully removed using the laparoscope, standard surgery will then be performed. If the tumor cannot be found though laparoscopy, imaging studies, or traditional surgery, the operation will be concluded without removing any of the pancreas. Medical treatment will be initiated and re-evaluation will be recommended after 6 months.