Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety
Physician FatigueIn this proposal, we seek to address conclusively two knowledge gaps: 1) the lack of data on the relationship between PGY2+ (post graduate year 2) sleep deprivation and patient safety; and 2) the lack of data on the relationship between resident sleep deprivation and preventable patient injuries. Through the Clinical and Translational Science Award (CTSA)-funded Sleep Research Network, the largest and only federally-funded sleep science network in the U.S., we propose conducting a multi-center randomized crossover trial in six pediatric ICUs staffed by PGY2 and PGY3 residents. We will compare rates of all serious errors (i.e., rates of harmful and other serious medical errors due to any cause, including but not limited to fatigue-related errors, handoff errors, and provider knowledge deficits) of a sleep and circadian science-based (SCS) intervention schedule with a traditional schedule that includes frequent shifts of 24 hours or longer. Our specific aims will be: To test the hypothesis that PGY2&3 residents working on an SCS intervention schedule will make significantly fewer harmful medical errors (preventable adverse events) and other serious medical errors (near misses) while caring for ICU patients than residents working on a traditional schedule; (primary endpoints: resident-related preventable adverse events and near misses) To test the hypothesis that rates of harmful medical errors (preventable adverse events) and other serious medical errors (near misses) throughout the ICU (i.e., those involving and those not involving residents) will be lower in ICUs when PGY2&3 residents work on an SCS intervention schedule than when residents work on a traditional schedule; (major secondary endpoints: ICU-wide preventable adverse events and near misses) To test the hypothesis that resident physicians' risk of neurobehavioral performance failures and motor vehicle crashes - as assessed through simple visual reaction time tasks [Johns Drowsiness Score (JDS) and Psychomotor Vigilance Task (PVT) lapses] - will be lower on the SCS intervention schedule than on the traditional schedule. (major secondary endpoints: resident neurobehavioral performance and predicted driving safety)
Treating Cancer-Related Fatigue Through Systematic Light Exposure
Hematopoietic Stem Cell TransplantationBreast Cancer5 moreCancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. There is currently no effective treatment for CRF. The purpose of this study is to investigate whether systematic exposure to light (from a commercially available Litebook) reduces CRF or other symptoms.
Coping With Chronic Fatigue Syndrome: Development of a Community-based Patient Education Program...
Chronic Fatigue SyndromeCoping1 moreThe aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare. In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual. The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.
Optimizing Sleep/Wake Related Cognitive Efficacy
LaboristSleep2 moreThis is a pilot study designed to elucidate sleep/wake patterns and associated cognitive efficacy of laborists involved in shift work at Mayo Clinic Rochester.
A Study to Evaluate Efficacy of IP on Alertness and Mental Fatigue
Mental FatigueThe current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental alertness as compared to placebo.
Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for...
Brain and Central Nervous System TumorsCognitive/Functional Effects3 moreRATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment. PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
DGB-01 Effects on Endurance Exercise
FatigueThe purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km time trial in trained male cyclists. The investigators believe that DGB-01 will improve performance on the time trial as measured by a reduction in the amount of time required to complete the distance, using a computerized cycle ergometer.
Phase II Early Behavioral Intervention in BMT w/ Sleep Disturbance-Assess QOL+Fatigue+Cognitive...
Cognition DisordersFatigue2 moreThis pilot clinical trial studies early brief behavioral intervention in treating sleep disturbance and improving quality of life in patients undergoing bone marrow transplant (BMT). A brief behavioral intervention may reduce symptoms of insomnia and fatigue and improve quality of life and cognitive function in patients undergoing BMT
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
PainFatigueEffective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects from pain relieving medication minimized with a potential for a more rapid postoperative recovery and less complications. IV application of lidocaine should de-crease the duration of bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay (primary outcome). We expect that the intraoperative inflammatory response can significantly be reduced.
S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer...
Breast CancerChemotherapeutic Agent Toxicity3 moreRATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.