Kornimate/medical-research-clean huggingface dataset:
evaluation of training in de-escalation

Conditions: De-escalation Skills

Summary: the purpose of the study is to evaluate one of the chapters in the new national norwegian training manual (map). the chapter that is selected to be evaluated is the chapter on de-escalation. effective training in this topic should not only lead to changes in the level of knowledge and attitudes, but also changes in behavior and skills. experiencing better preparedness does not necessarily entail a change in behavior. this study wants to test whether training in de-escalation changes the participants' skills and experience of self-confidence, security and coping in threatening situations.

the theme is: • evaluation of the training program of de-escalation for third-year nursing students underlying research questions will be: * will the intervention provide increased de-escalation skills? * will training in de-escalation provide increased confidence in coping with patient aggression? the design used to answer the research questions is a cluster-randomized controlled study with an intervention group and a control group. the two study groups with nursing students will be exposed to two different scenarios (a and b) with simulated patient situations. students will conduct simulation a before the intervention and simulation b the same day after the intervention. a control group will also be included which will review scenarios a and b without intervention. the purpose of this is to see if the scenarios in isolation give any effect on the pre- and post-measurements. participants will also be asked to complete a questionnaire (thackreys, 1987) related to experienced coping security related to aggression management at four different times. the scenarios will be recorded on video. following all video data collection, 2 de-escalation experts will independently review the video data and quantify it using the emdabs instrument. they will be blinded and not aware of whether the video was recorded before or after the intervention. the data that this generates will then be statistically examined. the selection of participants will be made from three classes with third year nursing students. the classes consist of about 50 students. participation is voluntary. it is uncertain how many will participate, but on the basis of practical limits there is an upper limit of 15 participants per class for the intervention group (the selection is recruited from two classes), and 30 participants from the control group (the selection is recruited from a class). a total of n = 30 is desired in both the intervention group and the control group. the following two outcomes will be analyzed; de-escalating behavior (emdabs, mavandadi et al., 2016) and confidence in coping with patient aggression (thackrey, 1987).

Eligibility criteria:
inclusion criteria: * third year nursing student exclusion criteria: * has to talk and understand norwegian

Keywords: de-escalation aggression violence prevention
stand-alone totally thoracoscopic left atrial appendage occlusion using atriclip® device in non-valvular atrial fibrillation.

Conditions: Stroke Prevention; Atrial Fibrillation; Safety Issues

Summary: polish multicenter registry to assess safety and durability of totally thoracoscopic left atrial appendage occlusion for stroke prevention in atrial fibrillation.

the thoracs-laao registry is the polish multi-institutional registry of the consecutive patients with atrial fibrillation assigned for the totally thoracoscopic left atrial appendage occlusion (laao) for stroke prevention with designed epicardial clip atriclip®. the registry has no limit of the number of patient included. patients will be followed up with transoesophageal echocardiography at 6-12 months to assess the durability of left atrial appendage (laa) oclusion and collect the informations about possible adverse events.

Eligibility criteria:
inclusion criteria: * age \>18 years * lone atrial fibrillation * previous stroke or systemic thromboembolic complications * high risk of thromboembolic complications assessed with cha2ds2-vasc score \>2 * high bleeding risk assessed with hasbled score =\> 2. * contraindications to oral anticoagulation * complications of the oral anticoagulation * acceptable surgical candidate, including use of general anaesthesia exclusion criteria: * patient refusal * significant valve disease or coronary multi-vessel artery lesions requiring surgery * stroke/cerebrovascular accident (cva) within previous 30 days * critical preoperative state intra-operative exclusion criteria * presence of thrombus in the left atrium or laa as documented on intra-operative transesophageal echocardiography * laa tissue with significant adhesions (as evaluated by the surgeon) carries atriclip placement overly risky.

Keywords: stroke prevention atrial fibrillation totally thoracoscopic laao atriclip®
intranasal fentanyl for pain control during first-trimester uterine aspiration

Conditions: Pain Uterus

Summary: intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. the investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. the investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.


Eligibility criteria:
inclusion criteria: * seeking office based uterine aspiration * gestational age at 14 weeks or less * age 14 years or older with parental consent to participate in this research study if 14-17 years old * able to read, speak, and understand english * ability to understand materials and consent forms exclusion criteria: * seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management * gestational age greater than 14 weeks * age less than 14 years old * inability to read, speak, and understand english * current incarceration * weight less than 40kg * self-reported or documentation of significant cardiopulmonary disease * self-reported or documentation of alcohol or substance dependence or abuse * contraindications, relative contraindication to fentanyl use
ultra-brief online mindfulness-based intervention during covid-19 movement control order

Conditions: Mental Health Wellness; Psychological Security; Psychological Distress

Summary: the federal government of malaysia implemented a nationwide movement control order (mco) to control the covid-19 outbreak. the mco, however, has been found to have a negative impact on people's mental wellbeing. interventions that can improve mental health under restricted movement condition is urgently. the present study investigated the impact of a brief, online mindfulness-based intervention on mental health using two-arm randomized controlled trial design. a total of 161 participants self-reported their feeling, anxiety, psychological insecurity, and well-being at baseline (t1) and post-test (t2), while 61 of them answered the same set of measures and the fear of covid-19 scale in a follow-up study two weeks later (t3).


Eligibility criteria:
inclusion criteria: * people residing in malaysia during the movement control order. exclusion criteria: * people who are unable to read or write in either malay, english or mandarin languages.

Keywords: mindfulness online intervention covid-19 movement control order
comparison of pain relief post knee arthroscopy using ipack + adductor canal block vs. adductor canal block alone

Conditions: Postoperative Pain

Summary: in this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (ipack) and adductor canal block vs. adductor canal block alone after arthroscopic knee surgeries.

patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group a for adductor canal block alone and odd numbers will be enrolled in group b for adductor canal block and ipack block.

Eligibility criteria:
inclusion criteria: * physical status: asa 1 or 2 * age group: 21-40 years. * no sex predilection. * patients undergoing arthroscopic knee surgery under spinal anesthesia. exclusion criteria: * patient refusal * physical status: asa iii or above. * patients with contraindications for spinal anesthesia. * patients with history of drug allergies to study drugs. * evidence of local infection at site of injection. * neuromuscular pathology (example: - multiple sclerosis)
characteristics of patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: this was a retrospective descriptive analysis of health care claims data using the iqvia open source medical and pharmacy claims databases.

patients with a diagnosis of scd between november 1, 2018 and april 30, 2021 were identified. among these patients, those who initiated crizanlizumab between november 1, 2019 and january 31, 2021 (index period) were selected into the treatment cohort. the indexing timeframe allowed for a 1-year lookback period and a minimum of 3 months (3m cohort) of follow-up. a subset of the 3m cohort with 6-months of available (6m cohort) follow-up was performed. the index date was the date of the first crizanlizumab administration. study period: 01 november 2018 - 30 april 2021 index period: 01 november 2019 - 31 january 2021 index date: date of the first claim for administration of crizanlizumab in the index period

Eligibility criteria:
inclusion criteria: * at least 1 claim in iqvia patient centric medical claims database (dx) with scd diagnosis (icd-10 d57.xx, except d57.3) within the study period; * at least 1 claim for administration of crizanlizumab within the index period. index date was the date of first administration; * at least 1 claim with hcpcs for crizanlizumab (j0791) or with at least one claim for an unspecified biologic (j3590) on the same day as a claim for scd (icd-10 d57.xx, except d57.3) or with at least one claim with hcpcs c9053; * at least 16 years of age on the index date; * linkage to the iqvia longitudinal prescription database (lrx) within the study period; * stability and eligibility in dx during the 12 months prior to the index date; * stability and eligibility in lrx during the 12 months prior to the index date exclusion criteria: * none

Keywords: crizanlizumab, sickle cell disease
cardiotoxicity of cancer therapy (cct)

Conditions: Breast Cancer

Summary: the objective of this study is to define the clinical significance of mechanistic biomarkers (including neuregulin-1beta) and novel echocardiographic measures of cardiac function in predicting the incident risk of cancer therapy cardiotoxicity.

the overall study objectives are: 1. to determine the longitudinal relationships between circulating markers, such as neuregulin (nrg)-1beta levels and incident risk of adverse cardiovascular outcomes in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. we hypothesize that a sustained increase in nrg-1beta, indicative of enhanced cardiac stress with exposure to chemotherapeutic agents, is predictive of an increased risk of cardiac dysfunction and heart failure. 2. to study the single nucleotide polymorphism (snp)/haplotype variation in pathways of interest, such as the neuregulin/epidermal growth factor (erbb) signaling pathway, on incident risk of adverse cardiovascular outcomes. we hypothesize that there will be snp/haplotypes variations that are associated with incident cardiovascular outcomes. 3. to determine the longitudinal relationships between novel echocardiographic measures, such as strain and strain rate and incident cardiac dysfunction in patients exposed to anthracycline, trastuzumab, or a combination of the two agents. we hypothesize that early declines in strain and strain rate are predictive of an increased risk of future cardiac dysfunction and heart failure. 4. to explore the changes in biomarkers such as nrg-1beta levels and the relationships with novel echocardiographic measures of cardiac function. 5. to create a biobank as a future resource for additional questions in novel biomarkers and genetics. 6. to determine the long-term effects of cancer therapy cardiotoxicity by following patients yearly for 5 years after their exposure to cancer therapy, with the option to extend up to an additional 5 years.

Eligibility criteria:
inclusion criteria: * age 18 years or older * her-2 positive breast cancer designated to receive trastuzumab chemotherapy with or without prior exposure to anthracycline-based chemotherapy * non-her-2 positive breast cancer designated to receive treatment with an anthracycline-containing regimen exclusion criteria: * other contraindications to trastuzumab or anthracycline chemotherapy. * vulnerable populations

Keywords: chemotherapy-induced cardiotoxicity anthracycline trastuzumab
gore® excluder® thoracoabdominal branch endoprosthesis post-approval study

Conditions: Abdominal Aortic Aneurysm; Pararenal Aortic Aneurysm; Thoracoabdominal Aortic Aneurysm

Summary: this study aims to confirm that the benefit-risk assessment of the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device) remains positive in real-world use and to ensure the adequacy of the tambe device training program.

a maximum of 300 adult subjects will be enrolled at up to 60 u.s. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the tambe device. subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Eligibility criteria:
inclusion criteria: the subject is / has: 1. treated with the aortic component of the gore® excluder® thoracoabdominal branch endoprosthesis (tambe aortic component) to allow endovascular repair of an aortic disease involving the visceral vessels. 2. age ≥18 years at the time of informed consent signature. 3. an informed consent form signed by subject or legal representative. exclusion criteria: the subject is / has: 1. any contraindications for the tambe device according to the ifu. 2. planned parallel grafting with the tambe aortic component. 3. intent to modify tambe aortic component (e.g., in situ fenestration).
effects on health status in patients early discharged after primary percutaneous coronary intervention (pci)

Conditions: Acute Myocardial Infarction

Summary: in patients with st elevation myocardial infarction (stemi)treated with primary percutaneous coronary intervention (ppci) a subset with low risk for late complications can be identified. early discharge (\<72h) of these patients can compromise initiation of prophylaxis, information and other investigations. the researchers want to investigate prospectively whether early discharge compared to regular care have comparable patient centered outcomes at 30 days follow-up.

the safety and feasibility of early discharge of low-risk stemi treated with thrombolysis or ppci patients have previously been investigated. it is possible to identify a subset of patients with very low risk for subsequent cardiac events in the short-term, where prolonged hospital stay beyond three days does not alter the outcome. early discharge have however, not been included in stemi management guidelines formally. the effects of this discharge regimen on stemi patients' health status (symptoms, functional capacity and quality of life) is not previously investigated. shorter hospital stays saves health care resources. on the other hand, short in-hospital stay can affect the perceived satisfaction of care. initiation of medical treatment, patient education, life style counselling and follow-up routines may suffer. additionally, early discharge can increase anxiety and symptom level reducing the health related quality of life (hrqol) and also lead to readmission. patient satisfaction has become a recognised measure of the quality of health care.currently there is little information on how early discharge influence the patients' satisfaction with the health care or the subjective perceived of hrqol after discharge. we therefore wish to perform a prospective trial comparing outcomes with regard to satisfaction of care and hrqol in patients admitted for stemi randomised to either early discharge or standard care.

Eligibility criteria:
inclusion criteria: * st elevation acute myocardial infarction * undergoing primary pci exclusion criteria: * zwolle low risk criteria score \>4 * re-infarction, post ami ischemia. * need for urgent repeat invasive procedures. * non-cardiac complication (bleeding, stroke oa.) or concomitant diseases likely to increase length of hospital stay. * patient or caring physician refuse to early discharge or study inclusion. * early discharge impossible due to social, nursing or family reasons.

Keywords: st elevation acute myocardial infarction primary percutaneous coronary intervention discharge health status quality of care
young patients with early breast cancer

Conditions: Breast Cancer Female

Summary: the prognosis of young patients with breast cancer is relatively poor. chemotherapy damages ovarian function. endocrine treatment for up to 10 years delays the childbearing time of patients. treatment regimens in young breast cancer patients are still controversial in the following: 1. exemption from chemotherapy based on gene prediction results; 2. removing drugs that damage ovarian function from chemotherapy regimens; 3. giving ovarian protection drugs during chemotherapy for patients with hormone receptor (hr)+; 4. the right time to get pregnant. in view of the above problems, the treatment scheme recommended in the guidelines cannot meet the personalized needs of young breast cancer patients. the project plans to establish a prognosis model for young patients with breast cancer, and provide the patients hierarchical and refined management, which is significant for prolonging survival time, improving quality of life, and protecting fertility. this project plans to observe the relationship between the characteristics of immune genes, pathological staging, molecular typing, treatment plans and prognosis in the cohort of young breast cancer patients, and establish a young breast cancer prognosis model and verify it. the project is expected to establish a prognosis model and provide a hierarchical and personalized precision treatment plan for young breast cancer patients, so as to prolong the survival time, improve the fertility rate, and improve the quality of life.


Eligibility criteria:
inclusion criteria: * patients with breast cancer received operation in peking union medical college hospital * age ≤40 year old and ≥20 years old * treatment regimen was made in peking union medical college hospital exclusion criteria: * patients without pathological information * patients with metastasis * patients with history of other malignant tumor (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma) * patients with palliative resection of breast

Keywords: young patients
effect of intake of citron(citrus junos siebold ex tanaka) peel extract on blood cholesterol.

Conditions: Hyperlipidemia

Summary: this study was conducted to investigate the effects of daily supplementation of citron(citrus junos siebold ex tanaka) peel extract on improvement of blood cholesterol.

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. twenty subjects were randomly divided into citron(citrus junos siebold ex tanaka) peel extract or a placebo group. blood cholesterol profiles before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 19-75 years with total cholesterol 200-239 mg/dl exclusion criteria: * lipid lowering agent within past 6 months * severe cardiovascular disease(mvodardial infarction, stroke, etc) * renal disease(heredity hyperlipidemia, acute/chronic renal failure, nephrotic syndrome, ect) * cancer, respiratory organ disease(asthma, chronic obstructive pulmonary disease) * diabetes mellitus * allergic or hypersensitive to any of the ingredients in the test products * history of disease that could interfere with the test products or impede their absorption * under antipsychotic drugs therapy within past 2 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * pregnancy or breast feeding * not contraception(except: surgery for female infertility)
implementing behavioral sleep intervention in urban primary care

Conditions: Sleep Disturbance; Sleep Deprivation; Sleep

Summary: investigators will enroll up to 20 participants from 3 children's hospital of philadelphia (chop) primary care locations. the primary objective is to determine the whether the sleep well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. the direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.

behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (ses) children. despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-ses children or in primary care, an accessible service delivery setting. the primary objective of this study is to determine the whether the sleep well! behavioral sleep intervention is feasible and acceptable to families. we will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. this is a preliminary open trial of the sleep well! program with pre-intervention and post-intervention assessments.caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from chop urban primary care sites. sleep well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported sleep problem or who are not getting enough sleep. the intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. the primary outcomes for this open trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. secondary outcomes are the direction and magnitude in any pre- to post-intervention change in child sleep.

Eligibility criteria:
inclusion criteria: * caregiver participant is the parent or legal guardian of the child subject. * caregiver/legal guardian 18 years of age. * child between the ages of 1 and 5 years. * presence of caregiver-reported child sleep problem determined by a brief child sleep questionnaire item, included in an eligibility screening questionnaire or child meets american academy of sleep medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire. * english-speaking. exclusion criteria: * caregiver is not parent or legal guardian of child participant. * presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder; trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep. * caregivers/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: difficulty falling asleep difficulty staying asleep not getting enough sleep