Kornimate/medical-research-clean huggingface dataset:
effect of continuous glucose monitoring system alerts on diabetes management in the hospital

Conditions: Diabetes Mellitus

Summary: current continuous glucose monitoring (cgm) devices provide features that alert for current and impending adverse glycemic events.this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

glycemic management for patients with diabetes during hospitalization is highly challenging, especially for those requiring intensive insulin therapy. for those patients, hypoglycemia is a common adverse event, which is associated with adverse clinical outcomes. bedside capillary point-of-care (poc) glucose monitoring is the standard of care to assess glycemic control in the hospital. however, poc glucose testing only provides glucose measurements at specific time points, leading to missed information important for glycemic control. continuous glucose monitoring (cgm) measures interstitial glucose every 5 min, thus providing a more complete glycemic profile during a 24 h period compared with standard poc glucose testing. the cloud-based real-time continuous glucose monitoring (rt-cgm) and management system was previously observed to be safe and effective in guiding intensive insulin therapy. therefore, this cgm intergraded system holds promise for improving glucose control in patients with diabetes during hospitalization. however, it is currently unclear if alerts are the main reason for the better outcome in the rt-cgm groups, or rather the fact that sensor values are available in real-time. moreover, the current system provided the feature of predictive threshold alerts that could alert before the onset of clinical hypoglycemia or hyperglycemia. thus, this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years. 2. type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization, as determined by endocrinologists following clinical guidelines. 3. willingness and ability to comply with the clinical investigation plan. exclusion criteria: 1. significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion. 2. female subjects who are pregnant or have a plan of pregnancy at time of enrollment into the study. 3. current users of real-time glucose monitoring sensors or flash-glucose monitoring. 4. participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area. 5. patients expected to require operation, admission to the icu and mri procedures during hospitalization. 6. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
open-label brexpiprazole fmri trial in adults with major depressive disorder and anxiety

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this study is to use fmri to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with mdd and symptoms of anxiety, aged 18 to 65.


Eligibility criteria:
inclusion criteria: * 18 to 65 year of age * major depressive disorder (mdd) with symptoms of anxiety * stable treatment with less than 50% improvement exclusion criteria: * contraindicated to perform fmri scan * previous exposure to brexpiprazole

Keywords: major depressive disorder (mdd) symptoms of anxiety fmri brain networks modularity community structure brexpiprazole default mode network salience network central executive network functional brain connectivity
the benefit of hippotherapy in stroke patients

Conditions: Stroke

Summary: this study aims to explore the interest of hippotherapy in the management of patients with stroke in the sequelae phase by evaluating the psychological and physical well-being. it is a controlled and randomized prospective longitudinal study. hippotherapy is a rehabilitation method entrusted to a paramedical or medical profession that uses the horse in its treatment program in addition to conventional medical care. hippotherapy has benefits at the psychomotor and motor level. the method is based on the use of the horse's characteristic movements when walking to provide sensory information and to induce motor adjustment responses mainly at the level of the pelvis and the trunk of the rider in order to work on balance, postural control, muscle tone and joint mobility of the patient sitting on his back. in particular for people with paresis or plegia sequelae, it contributes to rehabilitation programs. in addition, by inducing a helical movement of the pelvis, the horse's walk reproduces in the the disabled rider a pattern of trunk reactions very similar to that of the normal human walking pattern. this pattern can be integrated as a normal sensorimotor reaction and help the patient to improve his sitting balance and his coordination. hippotherapy is also interesting because getting out of the traditional rehabilitation framework and being in contact with an imposing animal has positive repercussions on the psyche and therefore on functional recovery. all patients will undergo an assessment that will focus on their physical and psychological well-being at the beginning and end of the study as well as during a follow-up at 2 weeks, one month and 3 months. patients assigned to the experimental group (eg) will receive, in addition to their physical therapy, a weekly hippotherapy session of 30 minutes. the follow-up will take place during 3 months for a total of 12 sessions. the eg will also be monitored in the short term (before and after each session) for well-being and fatigue. quality of life will be explored using the sf-36 questionnaire and the ss-qol scale. self-esteem will be measured using the rosenberg scale. patients' physical abilities will be assessed with functional tests, standing balance measurements on a strength platform and the abc-s self-evaluation scale.


Eligibility criteria:
inclusion criteria: * patients who have suffered a stroke and who are in a sequelae phase (after hospitalization or discharge from the rehabilitation center) * patients who have sufficient trunk balance to hold on to the horse * patients who have the consent of their doctor * patients who indicated their agreement to participate in the study by signing the consent form exclusion criteria: * pressure sore at the seat level * other lesion or neurological history * severe cognitive deficits affecting the understanding * do not understand french language * allergy to horses * weigh more than 100 kg * acute pain syndrome * epilepsy * patient has benefited from hippotherapy sessions during the last 6 months
effects of fast-tracking geriatric hip fracture patients

Conditions: Hip Fracture

Summary: the purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.

each year about 18000 persons in sweden suffer from a hip fracture. these people are often among the oldest and have many complicating diseases. the one-year mortality after hip fracture is 20%. due to the complexity including many comorbidities in these patients, it is of great value that the care of these patients is optimal. today, most of the patients with suspected hip fracture in the catchment area of sahlgrenska university hospital, gothenburg, are transported directly to the radiology unit. thereafter, the patient waits in the emergency room (er) for an othopedic examination before being admitted to primarily a geriatric medicine ward where they wait for the operation. the average waiting time in the er is today around four hours. the current scientific evidence for fast-tracking hipfracture patients is limited. the aim of our randomized controlled trial is to determine the effect of fast-tracking hip fracture patients at geraitric medicine wards compared to standard care regarding complication rate (primary endpoint), lenght of hospital stay and time to operation (secondary outcomes).

Eligibility criteria:
inclusion criteria: * patients with low energy trauma with pain at the hip and/or groin and * respiratory frequency: 8-25/minute and * saturation: 90% or higher on air and * pulse: 50-119 beats per minute and * systolic blood pressure: \>90 mmhg and * level of consciousness: reaction level scale (rls) 1 or glasgow coma scale (gcs) 14-15 and * plasma-glucose: 3,0-25 mmol/l exclusion criteria: we will exclude patients based on the following criteria: * distal status affected * suspicion of other simultaneous fracture * suspicion of head trauma or affected consciousness * suspicion of acute cardiac disease * signs of acute cardiac ischemia in electrocardiogram * generalized symtoms, except for pain in the hip

Keywords: hip fracture fast-tracking complications
computerized cognitive exercise training treatment for adults with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: cognitive impairment remains a major disability for individuals with multiple sclerosis (ms). the primary objective of this study is to evaluate the efficacy for treating ms-associated cognitive deficits using a unique computer-based plasticity-based and adaptive cognitive remediation treatment (pacr) compared to a computer-based control. this novel cognitive remediation approach has led to striking improvements in cognitive functioning in other disorders (schizophrenia, traumatic brain injury, aging, and dementia) but has never been applied to individuals with ms. the investigators will enroll 136 ms participants who will be randomized in a 2:1 pattern to complete either the treatment or control condition for 60 hours across a 12-week treatment period. both the treatment and control conditions will be accessed remotely by the subjects from a study-provided laptop computer. study outcomes will include program compliance, performance on study tasks and neuropsychological measures, quality of life and functional status. given the success of this program with other disorders and strong preliminary data from our feasibility study, the investigators believe pacr is an exciting untapped opportunity to improve cognition in individuals with ms.


Eligibility criteria:
inclusion criteria: * ages 18-70 * definite ms diagnosis, any subtype \[83\] * probable cognitive impairment as defined by a score ≤ 1 sd below the mean of normative data on the sdmt * concurrent medications to be kept constant over three months (as possible) * no relapse or steroids in previous month * reading score on wrat-3 of 37 or greater * visual, auditory and motor capacity to operate computer software, as judged by treating neurologist or study staff * willing to sign agreement to borrow laptop exclusion criteria: * history of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment * primary psychiatric disorder that would influence ability to participate * other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction) * alcohol or other substance use disorder * history of computer-based training manufactured by posit science * learned english language after 12 years of age

Keywords: multiple sclerosis cognitive remediation plasticity-based, adaptive, computerized cognitive remediation cognitive impairment
determining how the nervous system processes pain in adults with fibromyalgia

Conditions: Fibromyalgia; Rheumatoid Arthritis

Summary: fibromyalgia (fm) is a disabling chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points, specific places on the body that become painful with only slight pressure. pain associated with fm cannot be explained medically, often leading to a delayed diagnosis and delayed treatment. the purpose of this study is to evaluate how the nervous system, specifically the brain, processes pain in women with fm.

the cause of fm remains unknown, and more than half of all fm patients do not experience adequate pain relief from current treatment. identifying the mechanisms of unexplained pain in people with fm is necessary to develop more beneficial treatments. one possible cause of fm may be associated with problems in how the body processes pain. people with fm appear to be hypersensitive to stimuli that normally are not painful. specifically, the brain and spinal cord may not signal sensations correctly, resulting in abnormal pain sensations. this study will use functional magnetic resonance imaging (fmri) to examine how pain is processed in the brain of adults with fm compared with adults with rheumatoid arthritis (ra), another chronic disease characterized by long-term pain with a known cause. this study will also determine the effect that anticipation and attention have on the processing of nonpainful stimuli in women with fm and ra. both groups of people will also be compared to a control group of healthy people. participants in this study will include only women. this study will include two study visits that will occur on separate days. each study visit will last from 2 to 3 hours. during the first study visit, participants will complete questionnaires. they will then rate heat stimuli applied to their hand and perform mental tasks while in a mock mri machine. the mental tasks will consist of naming the color of words. some participants will receive nonpainful heat stimuli; others will receive both painful and nonpainful heat stimuli. during the second study visit, participants will undergo the exact same procedures while in an actual mri machine. there will be no follow-up visits for this study.

Eligibility criteria:
inclusion criteria: * diagnosis of fm or ra or healthy * right-handed exclusion criteria: * diagnosis of depression * using illegal drugs * claustrophobic * metal objects in body * require cardiovascular, high-dose antidepressant, or certain analgesic medications

Keywords: pain nociception
nordic-baltic coronary revascularization study in patients with proximal left descending coronary artery (lad) lesion.

Conditions: Coronary Artery Disease

Summary: the nordic-baltic heart team initiative for improved long-term coronary artery revascularization outcome compares quality of life and survival after coronary bypass grafting (cabg) vs. percutaneous coronary intervention (pci) in patients with 1-vessel disease and proximal stenosis of the anterior descending artery (lad/in patients with isolated proximal left descending coronary artery (lad) lesion

it is not clear how operable 1-vd patients with stable or stabilized coronary artery disease involving a plad lesion should be treated to optimize long-term survival and quality of life. according to recent european guidelines, significant plad disease may be treated by pci or by cabg. this recommendation is based on two meta-analyses including 1.210 and 1.952 randomized and non-randomized patients. generally, the patients were followed for 4-5 years. the analyses reported similar rates of mortality, mi and stroke, but more repeat revascularizations after pci. only one study including129 patients provided more than 5-year follow-up. thus, the there is limited documentation for long-term effect of pci vs. surgical re-vascularization in plad disease. the american 2014 guidelines on coronary revascularization recommends cabg for improved survival in patients with solitary proximal lad stenosis. cabg the angiographic 90% lima patency rate after 1, 2 and 3 decades is well described and suggestive of a survival benefit of surgical revascularization. therefore, there is scientific background for an cabg lima-to-lad vs. pci comparison in 1-vd patients with a plad lesion. substantiated expectations: * pci is superior to bypass operation concerning short-term quality of life. * off-pump lima-to-lad is superior to pci concerning long-term all-cause mortality. * long-term (≥10-year) follow-up is essential to evaluate coronary revascularization strategies. * outcome may be dependent on lesion complexity, diabetes and gender.

Eligibility criteria:
inclusion criteria: heart team decision on treatment 1-vd patients with stable coronary artery disease or stabilized unstable angina pectoris/nstemi or silent ischemia proximal lad (plad) stenosis (\>90% by visual assessment or ffr \<80% the lesion may be treated by both pci and surgery exclusion criteria: st-elevation myocardial infarction within 24 hours. expected survival \<1 year, because of high age or severe cardiac or non-cardiac disease. significant lm disease. earlier cabg. pci within 3 months. significant valvular heart disease. renal failure on dialysis earlier disabling stroke relative or absolute contraindication to dual antiplatelet therapy. allergy relevant to the study treatments. age \< 18 years. study required information and consent suboptimal or impossible.

Keywords: coronary revascularization
evaluation of volatile induction and maintenance anesthesia (vima) with sevorane in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on the cardiovascular system in common clinical practice

Conditions: Anesthesia, General

Summary: the main objective of this post-marketing observational study (pmos) is to collect data of using general anesthesia in patients undergoing any surgery to create local recommendations. these data will be based on the evaluation of volatile induction and maintenance anesthesia (vima) with sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on the cardiovascular system in common clinical practice in ukraine.

this pmos will be conducted in a prospective, multi-centre format. it is a non-interventional, observational study in which sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. no additional procedures (other than standard of care) shall be applied to the patients. each patient will be observed from the starting of anesthesia till the anesthesia end. markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with sevoflurane as a single anesthetic will be assessed.

Eligibility criteria:
inclusion criteria: * patients needing general anesthesia for planned or urgent surgery for whom sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist exclusion criteria: * known sensitivity to sevoflurane or other anesthetic containing halogen * known or suspected genetic susceptibility to malignant hyperthermia * receiving regional anesthetic techniques * receiving intravenous anesthesia * a history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics

Keywords: sevorane sevoflurane general anesthesia inhalation anesthesia general surgery
ribfix blu thoracic fixation system versus non-surgical treatment in non-flail chest rib fractures

Conditions: Rib; Fracture

Summary: this is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of ribfix blu thoracic fixation system.

the objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (ssrf) in patients with non-flail chest rib fractures using ribfix blu thoracic fixation system when compared to non-surgical (analgesia and symptomatic management) treatment. the study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.

Eligibility criteria:
inclusion criteria: * age 18 and above (inclusive) * simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements * indicated for surgical repair of rib fractures using ribfix blu thoracic fixation system or non-surgical treatment (analgesia and symptomatic management treatment) * willing and able to complete scheduled follow-up evaluations as described in the study protocol * has participated in the informed consent process and is willing and able to sign an institutional review board or ethics committee (irb/ec) approved patient information/ informed consent form (picf) exclusion criteria: * flail chest rib fractures based on radiological or clinical findings * previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma * presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery * chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest * has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome * any contraindications listed in the manufacturer's instruction to use for ribfix blu thoracic fixation system as per below: * spanning a midline sternotomy * active infection * foreign body sensitivity * is known to be pregnant * is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails. * participation in another surgical intervention that may influence any of the outcome parameters.

Keywords: non-flail chest