Kornimate/medical-research-clean huggingface dataset:
hospital-based contingency management

Conditions: Amphetamine-Related Disorders

Summary: this study aims to adapt an outpatient mobile app-based contingency management intervention to the hospital setting to understand how we can use contingency management to improve health outcomes in hospitalized patients with stimulant use disorders.

contingency management (cm), an evidence-based strategy that utilizes a reward-based system as positive reinforcement, has been most robustly studied in the outpatient setting, but also has the potential to improve hospital care for patients with stimulant use disorder. the hospital is a challenging environment for people who use drugs. conflicts with staff often result from in-hospital substance use, prolonged time off the unit, and missing medications, leading to negative health outcomes and re-admissions. by relying on positive rewards to encourage positive health behaviors, cm has the potential to improve staff-patient relationships, healthcare engagement, and reduce substance use in the hospital. stimulant use disorder is especially difficult to address in the hospital due to a lack of medications that can support cravings and withdrawal symptoms. however, little is known about cm implementation in hospitals and the hospital setting may introduce unique challenges. the objective of this study is to adapt an outpatient mobile app-based cm intervention to the hospital setting to understand the feasibility and acceptability of a hospital-based cm intervention to improve health outcomes in hospitalized patients with substance use disorders. we'll achieve this objective through following specific aims: aim 1: identify adaptations needed to implement an evidence-based outpatient mobile-app based cm intervention to the hospital setting for hospitalized patients with substance use disorders. aim 2: determine the feasibility, including facilitators and barriers, of implementing a mobile app-based cm intervention in the hospital setting. aim 3: assess the acceptability of a mobile app-based hospital-based cm intervention to patients and staff.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older * have moderate to severe stimulant use disorder, as diagnosed using dsm-5 criteria for stimulant use disorder by an addiction medicine provider * have an anticipated hospital length of stay greater than 2 weeks * be able to use a smartphone and agree to download and use the affect app as part of study-related procedures * be english speaking and be able to understand explanations of study procedures and the informed consent to participate exclusion criteria: * unable to engage in the intervention due to cognitive impairment or altered mental status * unable to engage in the intervention due to acute medical/mental health issues, per judgement of the research assistant

Keywords: amphetamine-related disorders substance-related disorders behavior therapy psychology reinforcement hospital medicine
the effect of virtual reality application in cervical dilatation and effacement teaching

Conditions: Virtual Reality; Educational

Summary: the aim of this project is to determine the effect of virtual reality application in cervical dilatation and effacement teaching on students' satisfaction, confidence and anxiety levels.

midwifery education is extremely important in terms of training midwives specialized in mother-child health. cervical dilation and effacement is one of the subjects that should be learned well in order to manage the birth process well. dilatation and effacement of the cervix is the enlargement (dilatation) and thinning (effacement) of the cervical opening and cervical canal when labor begins. cervical dilation and effacement training is a tactile skill practice that requires constant repetition and practice. therefore, it cannot be learned by observing, effective learning can be achieved by experiencing it repeatedly in pregnant women. midwifery students gain experience in the teaching process by practicing with simulation training, laboratory studies and clinical applications. when the literature is examined, no study has been found about the virtual reality application related to cervical dilatation and effacement teaching. the study will be an original study as it focuses on the effect of virtual reality application in cervical dilatation and effacement education on students' satisfaction, self-confidence and anxiety levels. the findings of the study will shed light on the literature in terms of determining the effects of virtual reality application on students in cervical dilatation and effacement teaching. in addition, our project will be a pioneering study in terms of the use of virtual reality application in cervical dilatation and effacement teaching. within the scope of the study, students will be examined in the focus of their satisfaction, self-confidence and anxiety levels. in this respect, the study will increase awareness in terms of revealing the effects of virtual reality application, which is one of the different simulation teaching methods in cervical dilatation and effacement teaching. students will be examined as part of the study. in this way, students who have not received cervical dilatation and effacement training with virtual reality application before will have the opportunity to evaluate their exposure to this method.

Eligibility criteria:
inclusion criteria: * being a third year student of the midwifery department, * not having received training in cervical dilation and effacement application * volunteering to participate in the study exclusion criteria: * not voluntarily participating in the study, * having received training in cervical dilatation and effacement

Keywords: cervical dilation midwifery education simulation virtual reality
effect of ile-pro-pro (ipp) on endothelial function in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: this study will investigate whether the lacto-tripeptide ile-pro-pro (ipp) improves the function of the endothelium in patients with coronary artery disease. the study has a crossover design. participants will be treated with a protein hydrolysate rich in ipp for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. the investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. blood will be collected before and after each treatment. the investigators hypothesize that ipp will improve endothelial function.


Eligibility criteria:
inclusion criteria: * coronary artery disease exclusion criteria: * treatment with an ace inhibitor or arb * pregnancy * other major illness * treatment with an investigational drug within 4 weeks
survivor-sleep health information program

Conditions: Sleep Problem; Insomnia; Pediatric Cancer

Summary: the purpose of the study is to learn if an educational program delivered to parents/guardians can help improve the sleep of children experiencing sleep problems after completing cancer treatment. the name of the intervention is survivor-ship (sleep health information program).

this study will evaluate survivor-ship in a single-arm trial of 20 off-treatment childhood cancer survivors (ages 5-12). the intervention is an adapted version of the family-centered sleep health program designed at seattle children's hospital. the program offers parents information about how to utilize evidence-based strategies for their child's sleep, and has demonstrated success in a community-based sample of children with behavioral sleep problems. sessions will focus on providing parents with education about healthy sleep and setting targets for modifiable behaviors that can improve their child's sleep health. the study will include 3 education sessions taking place over videoconference. families will be asked to track their child's sleep using sleep diaries during the course of the program. prior to, and following the program, families will be asked to complete study questionnaires.

Eligibility criteria:
inclusion criteria: * child aged 5-12 years, with a history of a cancer diagnosis (except non-melanoma skin cancer). * no cancer therapy (excluding chemoprevention) in the past 6 months, and no further therapy planned. * child meets diagnostic criteria for insomnia disorder as determined by insomnia screening criteria (see appendix a) * parent/guardian is able to read and write in english. * regular access to a computer/smartphone with internet access at home. exclusion criteria: * reports child has been diagnosed with a seizure disorder or has experienced a seizure in the past 12 months. * reports child has been diagnosed with a developmental disorder such as autism spectrum disorder, cerebral palsy, fragile x syndrome, or moderate to profound intellectual disability. * reports child has been diagnosed with sleep apnea, and are not receiving recommended medical treatment for their sleep apnea. * intention to adjust (decrease or increase) child's use of any prescribed or over-the-counter sleep medications during the study period. * any impairment (e.g., hearing, visual, cognitive) that interferes with the parent/guardian's ability to complete all study procedures independently.

Keywords: sleep problem insomnia pediatric cancer behavioral intervention
a feasibility study evaluating the use of safebreak vascular in the geriatric trauma population

Conditions: IV Dislodgement

Summary: safebreak vascular is a medical device indicated for fluid flow control during the administration of iv fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of ivs. safebreak vascular may be used for any hospitalized patient with gravity tubing or iv pumps, for intermittent infusion or continuous infusion.the primary objective of this study is to determine if the delivery of iv medications and/or fluids with safebreak vascular functions with the same reliability as current standard iv tubing.

study participants will have a safebreak vascular installed in each of their existing or newly installed iv lines. the clinical literature shows in prospective observational studies that a mean of 9.2% of patients dislodge their peripheral ivs. safebreak vascular is a medical device designed to aid in the prevention of unintended disruption and dislodgement of ivs, such as peripheral ivs, peripherally inserted central lines, central lines, etc. safebreak iv will be installed in each iv line between the study participant's catheter and the iv tubing that goes to the iv bag or iv pump. when a harmful force is placed on the iv line, safebreak vascular is designed to separate so that the harmful force is removed from the line and iv dislodgement is prevented. safebreak vascular has a valve in each end of the device. upon separation, each valves closes, stopping the flow of fluid. the primary objective of the study is to determine if the delivery of iv medications and/or fluids with safebreak vascular functions with the same reliability as current standard iv tubing. the number of iv dislodgements and iv restarts will be recorded. the study will also collect data for analysis concerning the following: * device design characteristics * certain human factors (patient or operator) associated with the use of the device * the impact of this device usage on clinician workflow * any unknown safety concerns * obtain preliminary data for use in designing a subsequent pivotal study of the device.

Eligibility criteria:
inclusion criteria: * geriatric trauma patients (\> or equal to age 55) * participants able to provide informed consent or have a legally authorized representative (lar) provide consent * the patients must have iv access (existing central venous catheter, peripherally inserted central catheter, or peripheral iv's) or need iv access * the patients must be at least 55 years of age. exclusion criteria: * unable to obtain informed consent or without an available lar to provide surrogate informed consent * age less than or equal to 54 * patient on comfort care only * predicted to have less than 24 hours survival * patient enrolled in an investigational drug or device study at the time of enrollment * investigator discretion that patient is not suitable for the study

Keywords: iv dislodgement
pilot study of an oral chemotherapy teaching tool to improve adherence in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma is an incurable cancer. therapies for it include oral chemotherapy pills. it is unknown whether patients regularly and correctly take these anti-myeloma pills. this study wants to measure the rate of adults with mm taking anti-myeloma pills correctly. the investigators also want to use a teaching tool to see if it will help patients feel more satisfied and more confident in taking their anti-myeloma pills correctly. the investigators hope to use this data from this small study to eventually do a larger study in this area.

the prevalence of patients with myeloma utilizing orally-administered myeloma therapy (omt) is expected to continuously rise within canada. the mascc oral agent teaching tool (moatt) interventional tool relies on the concept of improved patient education in turn leading to improved adherence. although the moatt intervention is currently endorsed by cancer care ontario, there is no data using the moatt intervention in patients with myeloma or within canada. prior to embarking on a larger, multi-center study, a pilot study is necessary to 1) understand the feasibility, acceptability of the moatt intervention and its preliminary efficacy 2) to determine the rates of adherence to omt and explore factors associated with non-adherence and 3) to determine the feasibility of a larger multi-centre trial.

Eligibility criteria:
inclusion criteria: * will include adults (age\>18) with multiple myeloma who will be initiating omt (lenalidomide or pomalidomide in the next 6 months) for either newly diagnosed, maintenance-phase or relapsed myeloma at the jcc exclusion criteria: * patients who reside in a facility in which their medications are administered to them (such as a nursing home)
cardiac output in children during anesthesia

Conditions: Perioperative Period; Cardiac Output; Pediatric Anesthesia; Arterial Hypotension

Summary: this study investigates cardiac output in young children under 18 months of age during the perioperative period by means of electrical cardiometry.

young children are particularly prone to hemodynamic instability during the perioperative period which, in turn, may lead to organ morbidity. currently, in routine surgical procedures in otherwise healthy children, hemodynamic status in the perioperative period is primarily assessed by non-invasive systemic blood pressure management. while this approach can detect systemic arterial hypotension, it does not provide us with guidance on whether the decrease in blood pressure is the result of changes in cardiac output and/or in systemic vascular resistance. this information would be important to know since treatment modalities may differ. recent technical development in electrical cardiometry allows us to non-invasively monitor cardiac output. the accuracy of the method has been validated in neonatal and pediatric cohorts, and electrical cardiometry is now regularly used to monitor cardiac output in the perioperative setting. nevertheless, the temporal patterns of cardiac output changes in otherwise healthy young children undergoing routine surgical procedures have not been systematically reported. this information is important since it will increase our understanding of hemodynamic changes in small children during anesthesia/surgery and would ultimately lead to a better anesthesia care in this patient population. the primary objective of this pilot exploratory observational study is to describe temporal patterns of cardiac output in young children ( under18 months of age) during the perioperative period. the secondary objectives are to describe how changes in cardiac output are associated with (i) non-invasively-measured systemic arterial blood pressure; (ii) near-infrared spectroscopy; (iii) other anesthesia factors (arterial oxygen saturation, concentration of anesthesia agents, co2 levels).

Eligibility criteria:
inclusion criteria: * age 0 to 17 months included * undergo general anesthesia for surgery that is expected to last more than 30 minutes (combines anesthesia and surgical time) * parental/guardian permission (informed consent) obtained * asa 1-3 status exclusion criteria: * structural/anatomical anomaly or other circumstances (e.g. patient positioning) making it difficult to apply the sensors to the body * history of congenital heart diseases * known allergy to electrodes' glue * emergency surgery * prematurity (born before 37 week pma)
safety and efficacy of adaptive dbs vs conventional dbs in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this is an exploratory study to preliminary assess safety and efficacy of an adaptive deep brain stimulation (dbs) closed-loop method in patients with pd. the study has been designed as a double blind randomized crossover trial that uses conventional dbs as a concurrent control in pd patients in need of implantable pulse generator (ipg) replacement.

pd patients in need of ipg replacement will be screened to identify the ones eligible for enrollment. randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cdbs and adbs), in a well-controlled environment (i.e. during hospitalization). during each experimental session experienced neurologists will collect information on safety and efficacy endpoints.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd; * dbs implant since at least 3 years and in need of battery replacement, defined by battery level \<25%; * patients must be able to sign the informed consent document to participate in the clinical trial; * patients with a suboptimal response to dbs treatment. exclusion criteria: * patients with severe cognitive decline (mmse \<25); * patients with major psychiatric issues; * patients with any medical condition potentially interfering with dbs battery replacement surgery; * patients that cannot tolerate an interruption of dbs stimulation; * patients taking only one levodopa dose per day; * patients with no lfps recorded from any contacts pair, during intraoperatory ipg replacement procedure; * pregnant or breastfeeding women.
clinical trial for a robotic endomicroscopy to better define resection strategies applied to urology surgery

Conditions: Prostate Cancer

Summary: this multicenter study aimed at assessing the feasibility of probe-based confocal laser endomicroscopy (pcle) during robotic-assisted radical prostatectomy or laparoscopic radical prostatectomy for intra-operative characterisation of surgical margins.

prostate cancer is one of the most diagnosed cancer in men. several treatments are available depending on patient's clinical features. when the cancer is localised or locally advanced, one of the possible treatment is radical prostatectomy. a risk of that procedure is the incomplete removal of cancer tissues due to the presence of cancer cells within the resection margin. a histological analysis of the resected prostate allows to assess surgical margins. if cancer cells comes out to the edges of the removed tissue, it is called positive surgical margin (psm). several studies showed that psms are more frequent in case of extra-prostatic extensions of the cancer and are correlated with biochemical recurrence. a study conducted on 21 patients scheduled for robotic-assisted radical prostatectomy has already demonstrated the feasibility of the intra-operative observation of microscopic features of prostatic and periprostatic tissues in vivo and ex vivo with the cellvizio® 100 series system combined with the celioflex™ probe. the main objective of the study is to assess the feasibility and safety of pcle technology during radical prostatectomy (rp) and to assess the diagnostic performance of pcle technology for the definition of the resection margins. this method could be used to guide surgeons during nerve sparing surgery and provide real-time feedback for adequate dissection of nvb. as well, ex vivo characterisation of benign and cancerous glandular structures could provide an efficient and rapid method for intra-operative surgical margin assessment the study is divided in 2 parts: 1. ex vivo study an ex vivo study will be carried out on 15 firsts prostate specimens for pathologist training and generation of ex vivo pcle images atlas. 2. in vivo study prior to pcle analysis, a contrast agent (fluorescein) will be administered: * by intravenous injection in each prostatic pedicles before their ligation * topically, after nvb dissection, in a spray solution through a catheter inserted in an assistant trocar or with a soaked gauze. the cellvizio will be used during the nvb dissection to acquire in vivo images and sequences of prostatic tissues.

Eligibility criteria:
inclusion criteria: * over 18 years * localised or locally advanced prostate cancer * agreement given for radical prostatectomy * not eligible or refusing an active surveillance protocol * having given its signed informed consent exclusion criteria: * under 18 years * previously treated for pca (hormones, ebrt, focal treatments) * surgical history of bph treatment * known allergy to fluorescein