Kornimate/medical-research-clean huggingface dataset:
nurses' knowledge, barriers and practices in the assessment of delirium in the intensive care unit

Conditions: Delirium; Health Knowledge, Attitudes, Practice; Critical Care Nursing

Summary: delirium in intensive care patients is a complication associated with many adverse consequences. it negatively affects patient outcomes, is an independent predictor of mortality, prolongs intensive care unit (icu) stay and causes cognitive impairment. it is estimated that delirium affects up to 80% of icu patients. unfortunately, delirium still remains undiagnosed in many cases. due to the high prevalence of this complication in critically ill patients, it is important to implement an effective management protocol to prevent delirium. nurses' knowledge of delirium, learning about nursing practices and identifying barriers to delirium assessment, may be an important basis for early recognition and the creation of procedures for delirium prevention in the intensive care unit.

the survey questionnaire is aimed at nurses working in the intensive care unit. first, respondents are asked to answer questions on socio-demographic data. then, two questionnaires were used to conduct the study: 1. the nurses' knowledge of delirium questionnaire. the questionnaire consists of two parts: * the first part deals with questions related to the definition of delirium and the tools used to detect specific conditions. * in the second part, participants are asked to answer questions about delirium and its associated risk factors by ticking respectively "agree", "disagree" or "not sure" to a series of 28 statements. fourteen of these statements relate to delirium, its symptoms and management, and 14 relate to risk factors for delirium. 2. nursing practices and perceptions towards delirium in the intensive care unit questionnaire. the questionnaire consists of two parts: * the first part consists of questions about sedation and delirium assessment. * the second part deals with practices/opinions about delirium and its assessment, including identification of potential barriers to delirium assessment consents were obtained from the authors for the use of both research tools. completion of the questionnaire is voluntary, anonymous and equivalent to giving informed consent to participate in the study.

Eligibility criteria:
inclusion criteria: * nurses, * icu staff. exclusion criteria: * other medical staff, * children's icu staff, * nurses working in other departments.

Keywords: knowledge barriers practices delirium icu nurse critical care
a study of tar-200 versus intravesical chemotherapy in participants with recurrent high-risk non-muscle-invasive bladder cancer (hr-nmibc) after bacillus calmette-guérin (bcg)

Conditions: Non-Muscle Invasive Bladder Neoplasms

Summary: the purpose of this study is to compare disease free survival (dfs) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (hr-nmibc) within 1 year of last dose of bacillus calmette-guérin (bcg) therapy and who refused or are unfit for radical cystectomy (rc), receiving tar-200 versus investigator's choice of single agent intravesical chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (hr-nmibc) \[defined as high-grade ta or any t1, no carcinoma in situ (cis)\] * participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. however, neuroendocrine, and small cell variants will be excluded * participants must be ineligible for or have elected not to undergo radical cystectomy (rc) * have an eastern cooperative oncology group (ecog) performance status grade of 0, 1, or 2 exclusion criteria: * presence of cis at any point from time of diagnosis of papillary-only hr-nmibc recurrence to randomization. additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, t2, t3, t4, n+, and/or m+) * presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of tar-200. participants with tumors involving the prostatic urethra in men will be excluded * a history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (\>4000 ml) * indwelling catheters are not permitted; however, intermittent catheterization is acceptable * previous treatment with tar-200
sustain - study of ranibizumab in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Conditions: Age Related Macular Degeneration; Choroidal Neovascularization

Summary: ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor a. this study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd).


Eligibility criteria:
patients who participated in this study included those who had completed participation in the study crfb002a2301 (anchor; nct00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression. inclusion criteria: * male or female patients \> 50 years of age * diagnosis of active primary or recurrent cnv secondary to amd, including those with predominantly classic, minimally classic or occult lesions with no classic component * the total area of cnv (including both classic and occult components) encompassed within the lesion must be \>= 50% of the total lesion area * the total lesion area must be \<= 12 disc areas * patients who have a bcva (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using etdrs-like (early treatment of diabetic retinopathy study) grading charts (approximately 20/40 to 20/320) exclusion criteria: * patients who have a bcva of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters) * laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding day 1 * previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase c inhibitors, etc.) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: amd, ranibizumab
open label, dose escalation phase i study of azd2281

Conditions: Advanced Solid Malignancies

Summary: the purpose of the study is to assess the safety and tolerability of azd2281 following single and multiple oral doses in patients in japan with advanced solid malignancies


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists. exclusion criteria: * patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin c or nitrosourea.

Keywords: cancer advanced solid malignancies
the association of g9a protein and outcome of patients with endometrial cancer

Conditions: Outcome of Endometrial Cancer

Summary: tumor invasion and metastasis are the major causes of cancer-related death. some studies have found that histone methyltransferases, such as ezh2, specifically affect metastasis in breast, gastric and prostate cancer. the functional roles of other members of the hmt family such as g9a in cancer remain obscure. therefore, the investigators will investigate whether g9a have a role in recurrence/metastasis of endometrial cancer.


Eligibility criteria:
inclusion criteria: * all cases with endometrial cancer underwent staging operation exclusion criteria: * nil
non-invasive pain monitoring in post-operative patients

Conditions: Pain, Postoperative

Summary: during the current pain monitoring system the patient is awake and he/she is asked to give a numerical scale rating from 0 (no pain) to 10 (extreme pain). the purpose is to correlate the non-invasive measurements of the prototype device anspec-pro with these numbers to develop later a method/algorithm for automatic evaluation of pain (objective measurement of pain). the measurement is done using standard ecg electrodes placed in the hand palm of the patient. the patient feels nothing during the observations, perhaps irritation of skin may occur as result of long time measurement. as a comparison to the investigators prototype, a commercial device is also used in (randomly selected) patients, i.e. the medstorm device. the study will try to answer the following questions: * are the measurements with the anspec-pro correlated with the nrs values? * what is the (mathematical) relationship between the measured values and the nrs? * is there difference between the two devices in measuring pain levels? and what is this difference if pain alleviation medication is given to the patient? * a number of 26 patients is envisaged for this study, equally distributed to be evaluated with the two devices.


Eligibility criteria:
inclusion criteria: * patients postoperative of a painfull operation * between 18 and70 years old exclusion criteria: * day surgery patients * chronic pain patients * taken medication : anticonvulsants

Keywords: skin impedance pain monitoring observational study pacu/icu
effect of the use of a 3d scanner application on a smartphone to mold garchois orthotic device in neuromuscular diseases patients with scoliosis

Conditions: Neuromuscular Diseases; Scoliosis

Summary: neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. thoracic braces are necessary to slow down the deformation. in france, garchois brace is largely used in this context because of a better pulmonary tolerance. historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. he/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). the position during molding could be very uncomfortable and anxious. with the development of new technologies, a 3d scan application on smartphone to obtain the volume and deformations of the patient was developed. this tool enables digital acquisition of trunk and head volume while bypassing the seated patient. no plaster strips are used. the resulting negative is digitally filled to obtain a positive. the positive is then corrected before the corset is made, either digitally or after 3d scanning, in plaster or foam. this application was first used in our department in 2017. the aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding.


Eligibility criteria:
inclusion criteria: * clinical suspicion or genetically confirmed neuromuscular disease * neuromuscular scoliosis, with garchois brace indication * under 18 at the time of the first garchois brace molding exclusion criteria: * other neuro-orthopaedic disease such as cerebral palsy * other thoracic brace than garchois * any spine surgery

Keywords: scoliosis neuromuscular diseases orthotic device brace cast 3d scan application
dog-assisted therapy for children and adolescents with fasd

Conditions: FASD

Summary: the rationale of the present study was to evaluate the efficacy of dat in children and adolescents with fasd in relation to its effects on social skills, internalized and externalized symptomatology and on severity of fasd symptoms. this objective was accomplished through a randomized controlled pilot study of dat for children and adolescents with fasd.

the rationale of this study was to evaluate the efficacy of dog assisted therapy in children and adolescents with fasd. the investigators conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with fasd. participants were randomly assigned either to dat group (n=17) or treatment as usual (tau control group) (n=16). the investigators evaluated changes on social skills, internalized and externalized symptomatology and on severity of fasd symptoms at pre-treatment and post-treatment.

Eligibility criteria:
inclusion criteria: * patients diagnosed with fasd between 6 and 18 years (fas, pfas or arnd) * with or without comorbidities * stabilized doses of medication for at least 2 months before the study * patients with borderline iq or mental retardation. exclusion criteria: * patients who were not behaviorally stable * patients that required hospitalization, day hospital or more intensive treatments.

Keywords: fasd animal-assisted therapy dog-assisted therapy
descriptive analysis of real-world data collected with me&mgopen

Conditions: Myasthenia Gravis

Summary: the me\&mgopen smartphone application is an investigational software for research purposes only, developed by ad scientiam. it features digital tests to assess the respiratory capacity ("my breathing" test), dysarthria ("my voice" test), ptosis ("my eyelids" test), as well as upper and lower limb muscle function ("my arms" test and "my legs" test). the mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression. the objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use.

the me\&mgopen smartphone application is an investigational software for research purposes only, developed by ad scientiam. it features digital tests to assess the respiratory capacity ("my breathing" test), dysarthria ("my voice" test), ptosis ("my eyelids" test), as well as upper and lower limb muscle function ("my arms" test and "my legs" test). the mobile app also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression. the objectives of the study are to collect data on patients' symptoms with the application in a real life setting, to assess adherence to the use of the tool, user experience and satisfaction with the application, and safety of use. analyses will also be performed to identify factors that may influence these parameters and provide levers for understanding and improvement. the existence of a possible learning effect on active testing will also be explored as a data point of interest. the results will allow researchers to extend their knowledge of gmg from real-life data and of the use of digital tools in a gmg patient population

Eligibility criteria:
inclusion criteria: * aged 18 + years old * diagnosis of gmg with positive serologic test for anti-achr autoantibody at screening * who has read the information sheet and signed the informed consent form * owns a personal smartphone which version is above 14 for ios and 8 for android included * able to use a smartphone * able to perform the me\&mg tests (based on investigator's judgment) * able to read language in which the mobile application is available (english, spanish, german) and able to understand pictograms exclusion criteria: * participating in another me\&mg trial * aged 17 years or younger * a medical, psychological, or behavioral condition which interferes with compliance
imaging cardiac electrical remodeling with electrocardiogram imaging (ecgi)

Conditions: Sick Sinus Syndrome

Summary: a consequence of chronic rv pacing is a process of electrical remodeling that alters myocardial repolarization to reflect the altered depolarization induced by the rv lead. when rv pacing is discontinued, the altered repolarization persists for several weeks. this phenomena is traditionally described as "t-wave memory" based upon the 12-lead ecg appearance of inverted t-waves. the investigators are using the ecgi technique to produce three dimensional electroanatomical images of this phenomena in patients with dual chamber pacemakers. echocardiography will also be used to image the mechanical effects of rv pacing and t-wave memory. the images will show the spatial distribution of altered repolarization and allow us to correlate any mechanical consequences of this phenomena that may exist.


Eligibility criteria:
inclusion criteria: * implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block. exclusion criteria: * persistent atrial fibrillation that is not suppressed by medications.

Keywords: t-wave memory sick sinus syndrome
palliative pancreatic duct stenting in patients with inoperable pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatic Duct Stricture

Summary: patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. the patients also often need pancreatic enzyme supplements. in this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. the study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.

in this prospective study all patients have inoperable pancreatic cancer. in these patients the pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. patients also suffer from chronic abdominal pain caused by pancreatic cancer. the strength of the pain the patients are experiencing is evaluated with visual analogue scale (vas). patients in this study report experiencing chronic abdominal pain at least the strength of vas 4 at the time of recruitment. in this pilot study a total of 40 patients are recruited. patients are divided into to two 20 patient groups. first group will receive a pancreatic duct stent followed by pain medication if needed and the control group will go with conventional pain relief methods only. all patients are asked to evaluate the strength of experienced pain with visual analogue scale at the time of recruitment, and then every 4 weeks up to 24 weeks. the patients will also be asked to evaluate their quality of life with a standardized eortc-qlq c30 version 3 quality of life questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks. the patients are also asked to report their body weight, and the amount of pancreatic enzyme supplements needed at every point of survey.

Eligibility criteria:
inclusion criteria: * patients have inoperable pancreatic cancer. * pancreatic tumor causes radiologically visible dilatation of the pancreatic duct proximally to the tumor with a minimum diameter of 6mm. * patients in this study report experiencing chronic abdominal pain at least the strength of vas 6 (visual analogue scale) at the time of recruitment. exclusion criteria: * patients are not fit enough to undergo ercp

Keywords: pancreatic cancer pancreatic duct stricture endoscopic treatment
aurinia renal assessments 2: aurinia renal response in lupus with voclosporin

Conditions: Lupus Nephritis

Summary: the purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the aurora 1 study in subjects with lupus nephritis (ln).

the aim of the phase 3 continuation study (aurora 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in ln, for an additional 24 months, following a treatment period of 52 weeks in the aurora 1 study (aur-vcs-2016-01). all subjects will continue to receive background therapy of mycophenolate mofetil (mmf) and/or oral corticosteroids starting at the same dose as at the end of the aurora 1 study. subjects with ln, who have completed 52 weeks of treatment with study drug in the aurora 1 study, will be eligible to enter the study. the long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.

Eligibility criteria:
inclusion criteria: 1. subjects who have completed 52 weeks of treatment with study drug in the aurora 1 study. subjects who had a temporary interruption and successfully restarted study drug during the aurora 1 study will be allowed with medical monitor approval. 2. written informed consent before any study-specific procedures were performed. 3. in the opinion of the investigator, subject required continued immunosuppressive therapy. 4. women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at month 12. 5. subject is willing to continue taking oral mycophenolate mofetil (mmf) for the duration of the study. exclusion criteria: 1. currently taking or known need for any of the medications or food items listed in section 7.8, prohibited therapy and concomitant treatment during the study. 2. subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 3. a planned kidney transplant within study treatment period. 4. subjects with any medical condition which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes. 5. subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 6. vaccines using live organisms, virus or bacterial, while taking the study treatment.

Keywords: lupus nephritis calcineurin inhibitors voclosporin