Kornimate/medical-research-clean huggingface dataset:
evaluation of an e-learning program for assessing pressure ulcer risk and pressure ulcer classification - a pilot study

Conditions: Learning; Efficiency

Summary: the purpose of this study is to determine wether e-learning is a more effective than traditional classroom teaching at norwegian nurses ability to use the braden risk assessment scale and pressure ulcer classification.

most pressure ulcers (pu)can be prevented and assessment of the patient skin and risk factors for pressure ulcers is the first step. epidemiological studies are also an important element in the prevention of pu and requires consistent registration based on standardized definitions and tools. staff knowledge is critical in this work. however showed a norwegian pilot study on the prevalence of pu deficient knowledge among nursing staff in terms reliable classification of pu and pu-assessment of risk. the pilot study showed the need for training to reduce the incidence of pressure ulcers and to ensure data quality in future studies. e-learning is an alternative to traditional courses and will help to streamline and standardize training by allowing a larger number of personnel be reached with this method of training. it is not designed norwegian e-learning program that addresses the use of risk assessment instrument or classification of pu. we have developed one program to train personnel in the pu-classification and risk assessment and plan to evaluate this. the program will be an important contribution to the pu-prevention as well as the program will be used in the execution of a multicenter prevalence study of pu-prevalence. nurses will randomly assign to a lecture, e-learning or to a control group. the lecture and e-learning are based on the same content. the nurses will score five patient cases with braden scale before and after intervention and 20 pictures of pressure ulcers in different categories before and 40 after intervention. the control group will only do a pretest.

Eligibility criteria:
inclusion criteria: * registered nurse and postgraduate nurse working at somatic ward, emergency ward, surgical department, intensive care unit,recovery, nursinghome or homecare exclusion criteria: * working at maternity ward, pediatric ward, psychiatric ward

Keywords: e-learning education
neuropsychiatric symptoms in spontaneous intracerebral hemorrhage survivors

Conditions: Primary Disease or Condition Being Studied, or Focus of the Study

Summary: compared to the united kingdom and the united states, spontaneous non-traumatic intracerebral hemorrhage (ich) is more common among people in taiwan. the prevalence rate of ich was 14.0% for people aged 36 years or older in taiwan. primary ich originates from the spontaneous rupture of small vessels damaged by chronic hypertension or cerebral amyloid angiopathy (caa). emotional disturbances are frequent symptoms in stroke survivors and negatively impact on functional recovery, the patient's quality of life and are distressing for both the patients and their caregivers. furthermore, the emotional disturbances are associated with impaired cognitive. however, these issues are often unnoticed and most of the studies had been performed in ischemic stroke survivors rather than in patients with ich. in this study, we will be recruited participants from national taiwan university hospital bei-hu branch and national taiwan university hospital. we aim to enroll respectively maximum number of 60 patients who had previous spontaneous ich. each participant will receive neuropsychiatric assessment, cognitive screening tests, domain-specific cognitive tests, a questionnaire for their quality of life and blood drawing for apoe genotyping. the main aims of this study include (1) to investigate the prevalence of distinct neuropsychiatric symptoms in ich survivors (2) to investigate the impact of non-cognitive neuropsychiatric issues on the cognitive functions and quality of life in ich survivors. our results may remind clinicians to pay more attention to the early diagnosis and effective management of neuropsychiatric symptoms to improve clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. the patient is older than 20-year-old (older than 18-year-old from jan 1st, 2023) with a past medical history of spontaneous intracerebral hemorrhage. 2. the weight of patient is over 50 kilograms 3. patient agrees to participate in the study exclusion criteria: 1. patients who experience acute phase of stroke or neurological disorders, or vision loss and hearing impairment 2. patient cannot cooperate with the interview including those with aphasia, conscious disturbance or bedridden status
the role of arnica on muscle pain following eccentric exercise

Conditions: Muscles; Exercise; Arnica

Summary: arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs.

design: the design is a randomized, placebo-controlled, double-blind trial. each participant will receive 2 containers of gel. one container will be marked "left" and one "right." one container will contain a commercially available arnica gel formulation, and the other will contain a placebo gel, identical in appearance to the arnica. subjects will not know which container contains which product. each participant will also be given a form containing an analog pain scale for each leg. the participant will rate his or her pain in each leg separately on the day before exercise. each subject will then be asked to perform calf raises using the following protocol: * the participant removes shoes. * active range of motion of the ankle is measured bilaterally using a goniometer. * he or she places the metatarsal portion of his or her foot on a step that is 7 inches above the floor. handrails are provided for safety and comfort * he or she then performs heel lifts by rising up on the stair using the foot on the stair, holds this for 2 seconds, then maximally dorsiflexes the foot for a count of 2 seconds. a metronome set to generate a tone every 2 seconds guides the pace of this. * this is repeated 25 times, or until the subject is unable to complete a full cycle. * he or she then performs the same sequence using the other leg. * a second set of 20 repetitions is performed in each leg, followed by a final 15 repetitions. * the gel is applied immediately after exercise to both lower legs. subjects are instructed not to wash off the leg for at least one hour after application. * the pain score is completed for each leg 24 hours later, and the gel is applied to each leg. again, subjects are instructed to leave the gel undisturbed for at least one hour. * approximately 48 hours later the subject returns for measurement of ankle range of motion, again completes a pain score and applies the gel for a final time. subjects are instructed to leave the gel on the legs for at least one hour. * to measure muscle tenderness, a 1cm sphere is placed on the subject's mid-calf, and compressed by a standardized 5 pound weight. the subject provides a tenderness score for each leg using the same pain score. * a final pain score is completed by each subject at approximately 72 hours. neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation (placebo vs. arnica). controls are within-subjects.

Eligibility criteria:
inclusion criteria: * age 18 or older * two fully functional legs exclusion criteria: * allergy or sensitivity to the ester family * open wound or inflammatory condition on legs * chronic or acute leg pain * neuropathy involving one or both legs

Keywords: arnica muscle soreness exercise eccentric
development and validation of a questionnaire for assessing activity limitation in patients with lumbar spinal stenosis : the cochin l3s questionnaire

Conditions: Lumbar Spinal Stenosis

Summary: to develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (lss).

construction of the provisional questionnaire : in a first step, semi-structured in-depth individual interviews were conducted from september 20, 2016 to january 4, 2017, in 20 patients fulfilling inclusion criteria to collect concepts related to lss-specific activity limitation, participation restriction and patients' views about their condition. thematic content was analysed using investigator triangulation. overall, 57 items were generated by patients. 48 items were related to lss-specific activity limitation and were used to construct the provisional 48-item cochin l3s questionnaire (cl3s-48). acceptability and understandability of the provisional cl3s-48 questionnaire was tested and consolidated in 10 patients with lss. item reduction and validation of the questionnaire : in a second step, 200 eligible patients according to our medical records will be informed by email of the purpose of the study, their non-opposition to the collection of data will be collected and patients will be invited to complete the following online self-administered questionnaires at baseline, 7 days and 3 months: * demographical and clinical characteristics at baseline * consolidated version of the cl3s-48 questionnaire * lumbar pain numeric rating scale (nrs) * radicular pain nrs * zurich claudication questionnaire (zcq) physical function subscale * oswestry disability index (odi) * fukushima lss scale 25 (fls-25) * 12-item short form health survey (sf-12) * 1 anchoring question about patient acceptable symptom state * 1 anchoring question about patient minimal clinically important difference at 3 months. in a third step, the number of items will be reduced according to their metrological qualities. the psychometric properties of the new scale will be assessed and the scale will be consolidated to provide the final questionnaire

Eligibility criteria:
inclusion criteria: * patients ≥ 50 year old * with lumbar spinal stenosis (lss) according to medical records. exclusion criteria: * lumbar spinal surgery, * cognitive impairment and inability to speak and/or understand french.

Keywords: lumbar spinal stenosis lss specific activity limitation development and validation of new questionaire
a pan asian trial comparing efficacy and safety of nn5401 and biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this clinical trial is to compare nn5401 (insulin degludec/insulin aspart (idegasp)) with biphasic insulin aspart (biasp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age (at least 20 years for japan) * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * subject on basal human or analogue insulin, once daily (od) or twice daily (bid) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, od or bid, with or without metformin, for at least 3 months * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * body mass index (bmi) maximum 35.0 kg/m\^2 exclusion criteria: * treatment with oral antidiabetic drugs (oads) (except metformin) within the last 8 weeks prior to visit 1 * treatment with thiazolidinediones (tzds) or glucagon like peptide 1 (glp-1) receptor agonists within 3 months prior to visit 1 * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
initial experience with spatial resynchronization therapy in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: demonstrate initial safety and performance of spatial resynchronization therapy (srt) in patients with persistent atrial fibrillation.

this is an acute study to test the ability of a custom external device (max-srs) to sense atrial rhythms, determine when af is present and deliver spatial resynchronization therapy (srt) to terminate af. patients will have commercially available diagnostic electrophysiologic catheters placed in the coronary sinus and on the heart. the catheters will be connected to the max-srs. if af is not present, standard pacing measures will be used to induce af. once \> 1 minute of af is recorded, the max-srs will be activated to sense the rhythm and deliver srt pacing to terminate the af. up to five srt deliveries using the same or different srt algorithms will be attempted. after the first successful termination of af or after five srt attempts the study is complete for each patient. diagnostic catheters will be removed after the conclusion of the srt pacing study.

Eligibility criteria:
inclusion criteria: * have af that persists (persistent af) for more than 7 days but less than 1 year; or has required cardioversion for termination of af in the past 6 months; and is not due to a reversible cause. * be scheduled to undergo open-heart surgery * be able to adhere to follow-up requirements exclusion criteria: * have active pericarditis or any systemic infection * have left atrial thrombus (including left atrial appendage) * have had a previous attempt to ablate atrial fibrillation * scheduled for left atrial exclusion or excision * have had previous surgical intervention in the left atrium, including left atrial appendage implant or exclusion * have nyha class iv heart failure * have long-standing persistent or permanent af * long-standing persistent af is defined as af that persists for greater than 1 year * permanent af is defined as af where termination (sinus rhythm) is no longer pursued * have any condition that prevents placement of a catheter on the posterior wall of the left atrium * history of left atrium (la) infarction

Keywords: atrial fibrillation spatial resynchronization
comparison of the efficacy of oral oxycodone and oral codeine in the treatment of postcraniotomy pain

Conditions: Postcraniotomy Pain

Summary: the efficacy of codeine is dependent on its demethylation to morphine. this extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors. codeine has been the mainstay of analgesia for patients after craniotomy for many years. traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine). however, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. many studies have compared codeine to other drugs such as pca morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction. no study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine. hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.


Eligibility criteria:
inclusion criteria: * ages 21-70 years of age * planned elective craniotomy * asa 1-3 * gcs 15 pre and post-op * able to understand and use the visual analogue scale exclusion criteria: * patients with gcs \< 15 pre and/or post-op. * patients who are unable to quantify pain according to vas scale. * patients who will be left intubated post-op. * contraindications and/or allergies to any of the trial drugs. * patients with renal and/or hepatic impairment. * patients with decreased respiratory reserves. * patients with post-op cognitive dysfunction.

Keywords: analgesic efficacy oral codeine oral oxycodone postcraniotomy
drug study in pediatric subjects with migraines (mk0462-083 am1)

Conditions: Migraine Disorders

Summary: a study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines. after completion of a portion of the study (panels a and b), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. therefore, the study was amended to add an additional panel of subjects (panel c) to ensure gender balance specifically in this age group.


Eligibility criteria:
inclusion criteria: * panel a and b: male and female subjects (non-smokers) ages 6 to 17 with a history of migraines * panel c: male subjects (non-smokers) ages 12 to 17 with a history of migraines * subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration exclusion criteria: * subject has no history of migraine headaches * taking medications that are monoamine oxidase inhibitors (maoi) and selective serotonin reuptake inhibitors (ssri) * subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
strain index ratio as a biomarker for mechanical complication of hemorrhagic myocardial infarction

Conditions: Acute Myocardial Infarction; Hemorrhagic Myocardial Infarction; Myocardial Stunning; Myocardial Hemorrhage; Myocardial Reperfusion Injury; Myocardial Rupture (Post Infarct)

Summary: hemorrhagic myocardial infarctions are at high risk for mechanical complications including cardiac rupture. prediction of vulnerable myocardial segments is an important step for the stratification of hemorrhagic mi patients. wall motion index ratio is an important parameter to determine regions of high vulnerability within the 17-segment lv model of hemorrhagic mi.


Eligibility criteria:
inclusion criteria: * index stemi * primary pci * able to complete cardiac mr - strain protocol exclusion criteria: * contraindication to cmr (contrast hypersensitivity, metallic implants, abnormal rhythms, breathing difficulties)
evaluation of the efficacy of the two-point method in percutaneous transhepatic choledoscopy and the influence of the long-term recurrence of hepatolithiasis

Conditions: Hepatolithiasis; Endoscopy, Digestive System

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。the main questions it aims to answer are: ① by comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged. ② to analyze the probability of short-term complications of the two-point method during the operation and to judge its safety. ③ patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications. the researchers will compare the two-point method with conventional ptcs to evaluate its effectiveness.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * ptcs were only used for the treatment of hepatolithiasis * patients receiving ptcs for the first time. exclusion criteria: * ptcd failure and withdrawal from treatment due to patients' subjective wishes were excluded.
adapted physical activity effect on aerobic function and fatigue at home in patients with breast cancer treated in adjuvant or neoadjuvant phase

Conditions: Breast Cancer

Summary: physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. it contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. the physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. the aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * females between 18 and 75 years of age; * signed written informed consent; * willing to take part in the trial and to follow the instructions; * breast tumour, histologically documented; * patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3fec100 +3 taxanes or 6 fec) +/- radiotherapy+/- herceptin has been scheduled; exclusion criteria: * metastatic cancer; * disability preventing a proper understanding of the instructions for the trial; * patients who are subject to a court protection, wardship or guardianship order; * uncontrolled hypertension; * family history of sudden death in a first-degree relative; * unstabilised heart disease; * current treatment with beta-blockers; * chronic or acute pulmonary disease associated with dyspnoea upon moderate effort; * uncontrolled thyroid dysfunction; * uncontrolled diabetes; * any other serious conditions that are unstabilised, * disabling or in which physical exercise is contra-indicated; * unable to attend for follow-up throughout the duration of the study; * ventricular ejection fraction (vef) \< 50%, pregnancy or suckling.