Kornimate/medical-research-clean huggingface dataset:
effectiveness of delirium simulation education of nurses in intensive care unit

Conditions: Self Efficacy; Nursing Caries; Intensive Care Unit Delirium; Simulation of Physical Illness

Summary: delirium is a common symptom in the intensive care unit, which greatly affects the prognosis of critically ill patients and increases medical costs. although many studies have implemented preventive measures, they have not been able to significantly improve the prevalence of delirium, because many medical measures devises in the intensive care unit are still necessary for patients. therefore, early detection of patients with delirium symptoms, risk factors, and immediate delirium management is important. nurses are the first line of clinically important roles in assessing delirium symptoms. so, design a delirium simulation education for nurses is important.

through literature review, the investigators found that research on delirium in the intensive care unit simulated education interventions are insufficient, and longitudinal studies to explore how long the effect can be maintained or delirium assessment and delirium management are designed dependent on theory are lacking. therefore, the purpose of this study was to investigate the effect of delirium simulation education on delirium knowledge, delirium critical thinking, delirium care self-efficacy and satisfaction among nurses in intensive care units, and to explore the influencing factors.

Eligibility criteria:
inclusion criteria: 1. nurses who have worked in the intensive care unit for more than 3 months, 2. no physical or mental illness or recent major family events, 3. never received delirium simulation training. exclusion criteria: 1. those who are not working in the intensive care unit for less than 3 months, 2. those who have recently suffered from physical and mental illness or a major family event recently, 3. those who have received delirium simulation training, 4. those who are currently working as nursing supervisors.

Keywords: intensive care unit,nurses,delirium,simulation
hyperbaric oxygen as an adjuvant treatment for patients with covid-19 severe hypoxemia

Conditions: Covid19

Summary: the severity of covid-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. the inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (hbo). recently, it has been reported benefits in this matter in patients with sars-cov-2 hypoxemic pneumonia in china; where the administration of repeated hbo sessions decreased the need for mechanical ventilation (mv) in patients admitted to the intensive care unit due to covid-19. hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. in addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. hbo is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. in the current context of the pandemic by covid-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by covid-19. that is why, it is proposed to carry out this research to assess whether hbo treatment can improve the evolution of patients with covid-19 severe hypoxemia.


Eligibility criteria:
inclusion criteria: * 18 years, all sexes. * no previous hospitalizations in the last 6 months. * positive diagnostic test for covid-19 according to the guidelines of the argetine ministry of health at the time of enrollment. * patient in intensive care unit with oxygen need: need for continuous supply of oxygen to maintain saturation by oximetry pulse (spo2) greater than or equal to 93% or arterial gas with pao2 value greater than 60 mmhg exclusion criteria: * 18 years of age. * person unable to give consent. * person who refuses to participate. * pregnancy and lactation * participating in other study * requirement for mechanical ventilation. * inability to maintain prolonged sitting position (at least 2 hours) * subject with contraindications to hbot (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade iii or iv).

Keywords: hyperbaric oxygen covid-19 hypoxemia sars-cov2 hyperbaric chamber
an study of efficacy and safety of clevudine

Conditions: Chronic Hepatitis B

Summary: randomized, double blind parallel group, positive control, multi-center trial. patients will be randomized at 1:1 ratio in group a or group b


Eligibility criteria:
1. patients are between 18 and 65, inclusive. 2. all the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study. 3. hepatitis b virus early antigen (hbeag) positive patient with hbv dna \>1 x 105 copies/ml, hbeag negative patient with hbv dna \>1 x 104 copies/ml within 30 days of baseline. 4. absolute neutrophil count \> 1500 /mm3. 5. alpha fetoprotein within normal laboratory limit at screening. 6. normal electrocardiogram (ecg) or clinically non-significant changes at screening. 7. able to participate and willing to give written informed consent before starting therapy. 8. able and willing to comply with study assessments and restrictions. 9. normal renal function to take adefovir without any dose modifications; creatinine clearance must be \>50 ml/min (based on the cockcroft-gault equation. exclusion criteria 1. subjects coinfected with human immunodeficiency virus (hiv), hepatitis a virus (hav), hepatitis c virus (hcv), hepatitis d virus (hdv) or hepatitis e virus 2. patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration. 3. other chronic hepatic disease. e.g. chronic alcoholism. wilson's disease. 4. poorly controlled type i or type 2 diabetes mellitus 5. donation or loss more than 400 ml blood within 60 days of baseline. 6. known serious allergies to nucleoside/nucleotide analogs. 7. subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.

Keywords: clevudine efficacy safety chronic hepatitis b
transplantlines insulin resistance and inflammation biobank and cohort study

Conditions: Death; Graft Failure; Death, Cardiac; Diabetes

Summary: short-term (1-year) results of renal transplantation are now excellent (over 95%). long-term (10-year and longer) results are, however, still disappointing. where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. this study is a biobank and cohort study which investigates this hypothesis.

short-term (1-year) results of renal transplantation are now excellent (over 95%). long-term (10-year and longer) results are, however, still disappointing. where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. to investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. at the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (nodat).

Eligibility criteria:
inclusion criteria: * more than one year after renal transplantation * history of renal transplantation exclusion criteria: * signs of active infection * signs of active cardiac decompensation * active malignancy other than skin cancer * prognosis \< 1 year
the effect of losartan on emotional processing in healthy volunteers

Conditions: Healthy Volunteers

Summary: this experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fmri.

losartan has been shown to accelerate fear extinction in animals and to prevent the development of anxiety disorders in humans, emphasising its potential to possibly enhance exposure therapy in humans. this study explores the basic effects of losartan on emotional processing, to identify neural mechanisms by which the drug might have synergistic effects on psychological treatment in humans. in a double-blind between-groups design, 30 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo, and this study will measure the effects of probing renin-angiotensin function on emotional information processing, using functional magnet resonance imaging (fmri). such knowledge will ultimately be essential for the development of more effective pharmaco-psychological treatment approaches for anxiety disorders.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * male or female, aged 18-50 * body mass index (bmi) of 18-30 kg/m2 * fluent english skills * non- or light-smoker (\< 5 cigarettes a day) exclusion criteria: * female participant who is pregnant or breast-feeding * central nervous system (cns) active medication during the last 6 weeks * current blood pressure/other heart medication (esp. aliskiren or beta blockers) * intravascular fluid depletion * past or present dsm-iv (diagnostic and statistical manual of mental disorders) axis-i diagnosis * alcohol or substance abuse * first-degree family member with a history of a severe psychiatric disease * impaired liver or kidney function * lifetime history of epilepsy or other neurological disease, systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * insufficient english skills * participated in another study involving certain medication during last 6 weeks * contraindication to magnet resonance imaging (mri) scanning (e.g. pacemaker)

Keywords: losartan emotional processing anxiety magnet resonance imaging mri
therapeutic issues for autism

Conditions: Autism Spectrum Disorder

Summary: this study aimed to show the effects of hyperbaric oxygen therapy and/or risperidone in improving symptoms of autism

autism spectrum disorders (asds) are clinical disorders with multiple developmental disabilities in skills associated with overall behavior and communication. the term (asd) includes autistic disorder (ad), pervasive developmental disorder-not otherwise specified (pdd-nos), and asperger's disorder . hyperbaric oxygen therapy (hbot) is a treatment in which patients inside a hyperbaric chamber breathe a concentrated oxygen pressurized more than sea level (1 atmosphere absolute) . it was obvious that autistic children may have some benefits of hbot by increasing in cerebral perfusion during treatment. inhalation of more pressurized oxygen might elevate partial pressure of oxygen in the arterial blood, and increased oxygen that reaches the brain . another mechanism of action of hbot that it might have anti-inflammatory properties by reduction of pro-inflammatory cytokines, interleukins 1 and 6, interferon-γ, and tumor necrosis factor-α. furthermore, hbot might enhance mitochondrial dysfunction, and upregulate the antioxidant enzymes production. risperidone is a second generation antipsychotic, approved by the food and drug administration (fda) for treatment of autism-related irritability. its approved in 2006 only for children not less than 5 years old . this trial aimed to study the effects of hyperbaric oxygen therapy and/or risperidone in management symptoms of autism.

Eligibility criteria:
inclusion criteria: * age of 5-7 years * weight of at least 15 kg exclusion criteria: * absence of significant medical problems and any other neuropsychiatric disorder requiring drug therapy (e.g., bipolar disorder, psychosis). * no concomitant treatment with psychotropic medication was allowed during the study. * weight less than 15 kg. * other cardiac, liver, gastrointestinal, renal, endocrine, blood and metabolic diseases

Keywords: autism childhood autism rating scale hyperbaric oxygen risperidone
performance and safety assessment of t4020 in managing corneal epithelial defect following epi-off accelerated crosslinking

Conditions: Keratoconus

Summary: the purpose of this study is to assess the performance and safety of t4020 versus saline solution.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with progressive keratoconus * patients who signed and dated informed consent exclusion criteria: * patient under 18 years * history within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess * corneal thickness\< 400µm
epidural clonidine for lumbosacral radiculopathy

Conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy

Summary: this was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. the hypothesis was that clonidine will be as effective as steroid for this condition.

patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). patients received one to three injections administered at about 2 weeks apart. patients, investigators, and study coordinators were blinded to the treatment. the primary outcome was an 11-point pain intensity numerical rating scale at 1 month. the hypothesis was that clonidine will be as effective as steroid for this condition.

Eligibility criteria:
inclusion criteria: * residents 18 years or older of olmsted or contiguous counties and identified as having an acute unilateral radicular syndrome of less than 3 months duration (leg pain\>back, discogenic cause, one or more of the following: * positive straight leg raise (slr) test * myotomal weakness * dermatomal sensory loss) and with concordant * confirmatory findings on recent mri or ct myelogram exclusion criteria: * history of recent spinal trauma * cauda equina syndrome (this is a serious neurologic condition in which there is acute loss of function of the lumbar plexus, neurologic elements of the spinal canal below the termination of the spinal cord.) * progressive neurological deficit * motor deficit * pathological or infectious etiology * involvement in workers' compensation claim * history of adverse reaction to corticosteroids, local anesthetic or clonidine * history of one or more corticosteroid injection(s) (equivalent to 40 mg of triamcinolone acetate) in the preceding 4 months * pregnant * severe medical disease

Keywords: herniated disk radiculopathy clonidine epidural steroid corticosteroid nucleus pulposus transforaminal
a study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of exenatide in adolescent subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.


Eligibility criteria:
inclusion criteria: * treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months. * has hba1c 6.0% to 11.0%, inclusive, at screening. * has a body weight of \>= 50 kg at screening. exclusion criteria: * received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening. * currently participates in any other interventional study. * is currently treated with any of the following excluded medications: * sulfonylurea chlorpropamide * thiazolidinedione within 3 months of screening. * αlpha glucosidase inhibitor within 3 months of screening. * meglitinide within 3 months of screening. * insulin within 3 months of screening. * pramlintide within 3 months of screening.

Keywords: diabetes adolescents exenatide amylin lilly
a study of sodium carboxymethylcellulose for post cataract surgery dry eye symptoms

Conditions: Dry Eye Syndromes; Cataract

Summary: this study will evaluate the effect of sodium carboxymethylcellulose eye drops in the treatment of dry eye after cataract surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of age-related cataract in the study eye * scheduled for cataract surgery and lens implant exclusion criteria: * diagnosis of ocular surface disease or glaucoma * ocular surgery in the past 3 months * wearing a corneal contact lens in the study eye
balance and mild traumatic brain injury (tbi)

Conditions: Brain Concussion; Traumatic Brain Injury

Summary: the purpose of this pilot project is to determine whether using one inertial sensor on the waist during routine clinical balance testing (i.e. balance error scoring system (bess)), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild traumatic brain injury (mtbi).

the purpose of this pilot project is to gather preliminary data to determine whether using one inertial sensor at the waist during the bess could provide the examiner with a more immediate, objective, reliable and sensitive way to quantify deficits in postural control in the post-concussive population. the investigators hypothesize that the metrics obtained from the isway will be better able to distinguish mtbi subjects from control subjects than the standard clinical assessment. the specific aims are: 1. to determine test-retest and inter-rater reliability of the clinical bess compared to the instrumented bess test. 2. to determine if an instrumented bess can distinguish mtbi from age-matched control subjects better than the commonly used bess and to determine the best metrics of sway to separate groups.

Eligibility criteria:
inclusion criteria: * have a mild traumatic brain injury or concussion * between the ages 12-40 years exclusion criteria: * out of age range

Keywords: mtbi concussion mild traumatic brain injury balance sensors
wearable devices in the recovery phase of acute exacerbations of copd (aecopds)

Conditions: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Exacerbation

Summary: the purpose the study is to successfully characterize the recovery phase of acute exacerbations of copd in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with aecopd recovery, and to further document the feasibility, data quantity, data quality, and copd outpatient usability experience with wearable devices.


Eligibility criteria:
inclusion criteria: 1. males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history 2. currently experiencing/receiving treatment for a physician-diagnosed aecopd 3. forced expired volume in the first second (fev1) / forced vital capacity (fvc) \< 0.7 (gold 1-4) 4. ability to provide informed consent exclusion criteria: 1. no existing copd diagnosis 2. history of cardiac arrhythmia 3. presence of pacemaker/defibrillator 4. any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire 5. have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their aecopd
catheter resistance monitoring to predict catheter-associated adverse events in children and adolescents

Conditions: Cancer; Hematologic Disorders

Summary: catheter occlusion and dysfunction are common complications of central venous access device (cvad) use in children with cancer and hematologic disorders. these events can lead to interruption of therapy and may require device removal and replacement. attempts to clear occlusion can cause device fracture. there is a clear link between catheter occlusion and other serious complications including bloodstream infection and intravascular thrombosis. there is evidence that catheter occlusion or dysfunction may be preceded by subclinical catheter narrowing, which could be detected by accurate measurement of catheter resistance. this study aims to observe and describe the feasibility and results of catheter resistance monitoring (crm) over time with the aim of prospectively identifying patients at high risk of catheter occlusion. if crm is feasible and proves to be sensitive and specific, it could provide an opportunity for preemptive therapy to prevent occlusion, which might also prevent bloodstream infection or thrombosis.

weekly measurement of catheter resistance will be determined using the alaris® syringe module (carefusion inc., san diego, usa), a commercially available, fda-approved intravenous (iv) pump which is able to deliver accurate flow-rates and obtain accurate pressure measurements. the inline pressure will be measured at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve. primary objective * to describe the feasibility of weekly crm in children and adolescents treated at st. jude. secondary objectives * to describe patient and caregiver adherence with weekly crm in children and adolescents treated at st. jude. * to explore the correlation between results of crm and catheter occlusion or dysfunction.

Eligibility criteria:
inclusion criteria: * receiving treatment for any disease at st. jude children's research hospital (sjcrh). * age ≥5 years to \<25 years. * participant is using either a single or double lumen tunneled cvad (ports will not be eligible) as part of standard clinical care. * participant anticipates being present weekly at sjcrh for at least 12 weeks exclusion criteria: * plan to remove cvad within 12 weeks. * expected survival less than 12 weeks * past enrollment in the carma study or past catheter resistance monitoring

Keywords: central venous access device catheter resistance monitoring